university of tennessee knoxville institutional review...
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University of Tennessee Knoxville
Institutional Review Board
Guide for Faculty, Staff, and Students
Revised October 7, 2012
IRB Administration
Office of Research
1534 White Avenue
University of Tennessee, Knoxville
(865) 974-3466
http://research.utk.edu/humansubjects/
University of Tennessee Institutional Review Board Guide for 1
Faculty, Staff and Students - Revised December 20102
Introduction3
This guide was prepared to help researchers comply with the University of Tennessee, Knoxville4
(UT Knoxville) policies and procedures, as well as federal regulations concerning the involvement of5
humans in research.6
This guide sets out the basic policies and procedures of the UT Knoxville system of project review.7
If you need more information or would like to discuss specific aspects of your research with someone8
from the UT Knoxville Institutional Review Board (IRB), please contact the IRB Administration Office9
at 974-3466 or visit the office at 1534 White Avenue. 10
Fundamental UT Knoxville Policy on Human Research11
Participant Protection12
All UT Knoxville research involving human participants must be reviewed following UT Knoxville13
IRB policies and procedures. It must be approved prior to the initiation of research activity such as14
contact with potential human participants. The place to start this process is with your Departmental15
Review Committee (DRC). Although certain research is exempt from review, these projects must be16
certified as exempt by (a) your DRC, (b) your Department Head, and, finally, (c) the UT Knoxville IRB17
or its representative. Federal regulations allow no exceptions to this policy.18
Guide Revisions and Additional Information Sources 19
The information in this guide is considered to be in full compliance with all applicable federal and20
state laws and regulations and UT Knoxville policies concerning the use of human participants in21
research. As changes in laws and policies occur, the guide will be revised. In addition, suggestions for22
improving information contained in the guide and its presentation are always welcomed. Major23
revisions of this guide will be posted on the IRB Administration Web site24
http://research.utk.edu/humansubjects/.25
Tips for Using This Guide26
This guide contains a tremendous amount of information about many different aspects of the27
protection of human participants in research. You may not need to read the whole guide, but you should28
read all sections that pertain to your research project. Use the following steps as you initiate your29
application process:30
31
• Read Sections 1 and 2 to obtain a basic understanding about the protection of human participants in32
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research at UT Knoxville. 33
• Use the information in Section 3 to determine which application procedure (Form A or Form B1) is34
appropriate for your research project. 35
• Read Section 4 to learn more about informed consent procedures and documents. 36
• Read Section 5, 6, or 7 to obtain information about completing your application form.37
• Section 8 presents step-by-step instructions for preparing a Form B application. 38
• If you intend to involve children, pregnant women, decisionally impaired individuals, or prisoners in39
your research, read Section 9. 40
• If you intend to use participatory action research (PAR) techniques, read Section 10.41
• Section 11 describes the continuing oversight function of the UT Knoxville IRB.42
• Section 12 describes operational policies and procedures of the IRB. It is of interest primarily to43
members and staff of the IRB. We include it here in the interest of transparency.44
• Section 13 is a glossary of key terms used throughout the document.45
If you have any questions about the preparation of your application, after reading this guide, please46
contact the IRB Administration Office at 974-3466. 47
1To find IRB forms online, go to: http://research.utk.edu/forms/index.shtml#c4
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Institutional Review Boards: The Basics48
What Do Institutional Review Boards Do?49
The responsibilities of IRBs fall into three main categories: (A) initial review, (B) oversight, and50
(C) continuing review of research involving human participants.51
A. Initial Review: IRBs review and approve a research plan before the research can be carried out. This52
review encompasses the research protocol, the informed consent document to be signed by participants,53
any advertisements, e-mails, web postings, or other materials to be used in recruiting participants, and54
other relevant documents. In carrying out this review, IRBs seek to ensure that: 55
(a) risks to participants are minimized, 56
(b) any risks participants may incur are warranted in relation to the anticipated benefits; 57
(c) informed consent documents clearly convey the risks and the true nature of the research; 58
(d) recruiting materials are fully informative and not misleading; and 59
(e) the selection of participants is equitable and justified. 60
IRBs focus much attention on the informed consent document because it is the vehicle for providing61
information to potential research participants. 62
B. Oversight: The IRB is charged by federal regulations with ensuring that the research is carried out63
following the guidelines that were approved. To this end, representatives of the IRB may conduct64
periodic audits - interviewing study personnel, examining study documents, perhaps observing the65
consent process.66
C. Continuing Review: The continuing review process is multifaceted and includes required reviews67
"at an interval appropriate to the degree of risk but not less than once per year." In addition to this68
continuing review, study amendments and reports of unexpected adverse experiences by participants are69
received and reviewed to ensure that the risk-benefit ratio of the research remains acceptable.70
Why Were IRBs Established?71
As public awareness and concern about the treatment of human participants in research increased,72
the need for additional review mechanism was evident. These concerns grew from accounts of the abuse73
of prisoners revealed during the World War II trials at Nuremburg, the introduction of thalidomide in74
Europe resulting in numerous children born with birth defects, the so-called "Tuskegee Syphilis Study"75
in which African-American men with syphilis were denied possible treatment in order to study the76
natural history of the disease, the administration of cancer cells to chronically ill and senile patients at a77
hospital in New York, and other controversial research. The formal requirements for the establishment78
of IRBs were outlined in regulations stemming from the National Research Act of 1974 and in FDA79
regulations first issued in 1981.80
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How Are IRBs Organized?81
Federal regulations require that boards have at least five members with varying backgrounds. At82
least one member must have primarily scientific interests, one must have primarily nonscientific83
interests, and one must be otherwise unaffiliated with the institution in which the IRB resides. Most84
IRBs are associated with hospitals and/or academic institutions, although a few "central" or commercial85
IRBs have been established in recent years.86
How Does the Department of Health and Human Services (DHHS) Oversee87
IRBs?88
Two agencies within DHHS share responsibility for IRB oversight: the Office for Human Research89
Protections (OHRP)2 and the Food and Drug Administration (FDA)3. Basic federal regulations are set90
out in 45 Code of Federal Regulations (CFR) 46, the first part of which - referred to as "the Common91
Rule"- has been adopted by 17 federal agencies4. 92
Additional regulations for research involving drugs and devices regulated by the FDA are set out in93
21 CFR 50 and 21 CFR 56. Since there is a great deal of overlap between OHRP and FDA documents,94
these procedures will reference primarily the regulations in 45 CFR 46.95
The OHRP's main tool for oversight is the process of registration and the assurance document. Any96
institution that intends to conduct DHHS-funded research must have a registered IRB of its own or else97
an association with a registered IRB. The federal-wide assurance (FWA) is a commitment by the98
institution that it will comply with federal regulations. The OHRP also conducts a small number of site99
visits. 100
The FDA's main mechanism for IRB oversight is the inspection process. The FDA also inspects101
research sponsors and research investigators.102
Other federal agencies that adopt the Common Rule may add special requirements to those basic103
regulations. If you are proposing to apply for funding to those agencies, you should check with them and104
with the IRB Administration to get information about any such requirements.105
Do You Have Additional Questions About the UT Knoxville IRB?106
Please review the information contained in this guide, or contact the IRB Administration Office at107
974-3466.108
2See http://www.hhs.gov/ohrp/index.html
3See http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm
4The following agencies adopted the Common Rule: Department of Agriculture; Department of Energy; NationalAeronautics and Space Administration; Department of Commerce; Consumer Product Safety Commission; InternationalDevelopment Cooperation Agency-Agency for International Development, Department of Housing and Urban Development;Department of Justice, Department of Defense; Department of Health and Human Services; Department of Education;Department of Veterans Affairs; Environmental Protection Agency; National Science Foundation; Department ofTransportation; Central Intelligence Agency; and the Social Security Administration.
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Table of Contents109
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -2-110
Fundamental UT Knoxville Policy on Human Research Participant Protection. . . . . . . . . . . . . . . -2-111
Guide Revisions and Additional Information Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -2-112
Tips for Using This Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -2-113
Institutional Review Boards: The Basics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -4-114
Why Were IRBs Established?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -4-115
How Are IRBs Organized?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -5-116
How Does the Department of Health and Human Services (DHHS) Oversee IRBs?.. . . . . . . -5-117
Do You Have Additional Questions About the UT Knoxville IRB?. . . . . . . . . . . . . . . . . . . . -5-118
Table of Contents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -6-119
Section 1. Basic Overview of the UT Knoxville IRB. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -13-120
1.1 Activities of the UT Knoxville IRB and Federal Regulations. . . . . . . . . . . . . . . . . . . . . -13-121
1.2 Fundamental Principles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -13-122
1.3 Jurisdiction of the UT Knoxville IRB. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -13-123
1.4 Human Participants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -14-124
1.5 Definition of Research.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -14-125
1.6 Participant Data and Identity Confidentiality Considerations.. . . . . . . . . . . . . . . . . . . . . -15-126
1.7 Research Methods Instruction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -16-127
Section 2. Review System and Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -17-128
2.1 Description of the Review Process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -17-129
2.2 Investigators’ Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -17-130
2.3 Departmental Review of Research Projects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -18-131
2.3.1 Research Center Reviews. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -18-132
2.4 Department Head's Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -18-133
2.5 Departmental Review Committee Appointments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -19-134
2.6 Important Departmental Files. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -19-135
2.7 Departmental Review Committee Recommendations.. . . . . . . . . . . . . . . . . . . . . . . . . . . -19-136
2.7.1 Scientific merit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -19-137
2.7.2 Form A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -19-138
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2.7.3 Form B1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -20-139
2.7.4 Possible DRC Recommendations for Form B Projects.. . . . . . . . . . . . . . . . . . . . . -20-140
2.8 University Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -20-141
2.9 IRB Administration Responsibilities.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -20-142
2.10 Institutional Review Board Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -21-143
2.10.1 Composition of the Institutional Review Board. . . . . . . . . . . . . . . . . . . . . . . . . . -21-144
2.10.2 IRB Rulings.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -21-145
2.11 Appeals Procedures for UT Knoxville IRB Actions. . . . . . . . . . . . . . . . . . . . . . . . . . . . -22-146
2.11.1 Composition of the Appeals Board. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -23-147
Section 3. Guidelines for Selecting the Appropriate Review Procedures. . . . . . . . . . . . . . . . . . . -24-148
3.1 Definition of Minimal Risk. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -25-149
3.2 Exempt Research Categories (Form A).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -25-150
3.3 Expedited Research Categories (expedited Form B). . . . . . . . . . . . . . . . . . . . . . . . . . . . -26-151
3.4 Categories of Full IRB Reviewed Research (Form B). . . . . . . . . . . . . . . . . . . . . . . . . . . -28-152
3.5 Audio- and Videorecording Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -28-153
3.5.1 Form B Application Information.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -28-154
3.5.2 Informed Consent Form Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -29-155
3.5.3 Storage and Future Use Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -29-156
3.6 Internet Research. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -30-157
3.6.1 Presentation of Research Findings on the Internet. . . . . . . . . . . . . . . . . . . . . . . . . -30-158
3.6.2 Electronic Transmission and Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -31-159
3.6.3 The Internet and "Public Behavior". . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -31-160
3.6.4 Recruitment in Internet Research. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -31-161
3.6.5 Privacy and Confidentiality in Internet Research. . . . . . . . . . . . . . . . . . . . . . . . . . -32-162
3.6.6 Skype. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -32-163
3.6.7 Informed Consent Online. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -33-164
3.6.8 Risk in Internet Research. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -33-165
3.7 Procedures for Projects that Require Approval from Other UT Knoxville Compliance166
Committees.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -33-167
3.8 Application Procedures for Off-Campus Research. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -33-168
3.8.1 Relationship with the Graduate School of Medicine IRB.. . . . . . . . . . . . . . . . . . . -34-169
3.8.2 Research Conducted on the Knoxville Campus by Outside Researchers. . . . . . . . -34-170
3.8.3 International Research.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -34-171
3.9 Advertising to Recruit Participants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -34-172
3.10 General Policy on the use of Children in Research. . . . . . . . . . . . . . . . . . . . . . . . . . . . . -35-173
3.11 General Policy on the use of Vulnerable Individuals in Research. . . . . . . . . . . . . . . . . -35-174
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Section 4. Informed Consent Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -37-175
4.1 General Policy on Informed Consent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -37-176
4.2 Basic Elements of Informed Consent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -37-177
4.2.1 Additional Elements of Informed Consent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -38-178
4.3 Sample Informed Consent Document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -39-179
4.3.1 Additional Notes to Investigators:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -41-180
4.4 Sample Short Form Consent Document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -42-181
4.4.1 Sample Information Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -43-182
4.5 Pregnancy and Consent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -45-183
4.6 Waiving or Altering Elements of Informed Consent. . . . . . . . . . . . . . . . . . . . . . . . . . . . -45-184
4.7 Waiving the Requirement of Written Documentation of Informed Consent. . . . . . . . . . -45-185
4.8 Health Insurance Portability and Accountability Act (HIPAA). . . . . . . . . . . . . . . . . . . . -46-186
4.8.1 Subject Authorization to Use and Disclose Individually Identifiable Health187
Information in Research. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -46-188
4.9 Foreign-Language Consent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -48-189
Section 5. Research Exempt from Review: Form A Applications. . . . . . . . . . . . . . . . . . . . . . . . . -49-190
5.1 Exempt Research Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -49-191
5.2 Minimal Risk Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -49-192
5.3 Exempt Research Categories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -50-193
5.4 Preparing an Exempt Research Protocol (Form A).. . . . . . . . . . . . . . . . . . . . . . . . . . . . . -51-194
5.5 Review Procedures for Form A Applications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -52-195
5.6 Final Approval Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -52-196
5.7 IRB Certification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -53-197
5.8 Informed Consent Considerations for Exempt Research. . . . . . . . . . . . . . . . . . . . . . . . . -53-198
5.9 Investigator Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -54-199
5.10 Graduate Students and Advisors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -54-200
5.11 Renewal and Termination Procedures for Exempt Projects. . . . . . . . . . . . . . . . . . . . . . -55-201
5.11.1 Renewal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -55-202
5.11.2 Termination. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -55-203
Section 6. Research Eligible for Expedited Review: Expedited Form B Applications. . . . . . . . . -56-204
6.1 General Information about Expedited Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -56-205
6.2 Expedited Review Categories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -56-206
6.3 Applicability of Expedited Review Categories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -58-207
6.4 Expedited Review Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -58-208
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6.4.1 Form B.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -59-209
6.4.2 Departmental Review:.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -59-210
6.4.3 Institutional Review Board Review:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -59-211
6.5 Informed Consent Considerations for Expedited Review. . . . . . . . . . . . . . . . . . . . . . . . . -60-212
6.6 Investigators' Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -60-213
6.7 Renewal and Termination Procedures for Expedited Projects. . . . . . . . . . . . . . . . . . . . . -61-214
6.7.1 Renewal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -61-215
6.7.2 Termination. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -62-216
Section 7. Research Requiring Full IRB Review: Form B Applications. . . . . . . . . . . . . . . . . . . . -63-217
7.1 Categories of Full IRB Reviewed Research. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -63-218
7.2 Full IRB Review Process.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -63-219
7.2.1 Departmental Review:.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -64-220
7.2.2 Institutional Review Board Review:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -64-221
7.3 Informed Consent Considerations for Full Board Protocols. . . . . . . . . . . . . . . . . . . . . . . -65-222
7.6 Investigators' Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -65-223
7.7 Renewal and Termination Procedures.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -66-224
7.7.1 Renewal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -66-225
7.7.2 Termination. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -66-226
Section 8. Instructions for Completing Form B. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -67-227
Section 9. Research Involving Special or Vulnerable Populations. . . . . . . . . . . . . . . . . . . . . . . . -75-228
9.1 General Issues About Vulnerability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -76-229
9.2 CHILDREN.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -77-230
9.2.1 General Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -77-231
9.2.2 Identifying and Recruiting Potential Child-Participants. . . . . . . . . . . . . . . . . . . . . -77-232
9.2.3 Informed Consent Procedures for Children. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -78-233
9.2.3.1 Permission of Parent or Guardian. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -78-234
9.2.3.2 Assent of the child.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -79-235
9.2.4 Risk and Benefit Assessment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -79-236
9.2.4.1 Risk Assessment:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -79-237
9.2.4.2 Benefit Assessment:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -80-238
9.2.4.3 Use of Educational Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -80-239
9.2.5 Protection of Pupil Rights Amendment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -81-240
9.2.6 Projects Eligible for Expedited Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -81-241
9.2.7 Quick Checklist for Protocols Involving Children as Participants. . . . . . . . . -82-242
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9.3 DECISIONALLY IMPAIRED INDIVIDUALS.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -82-243
9.3.1 General Information about Decisionally Impaired Individuals. . . . . . . . . . . . . . . -82-244
9.3.2 Additional Considerations.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -83-245
9.3.3 Minimal Risk Projects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -83-246
9.3.4 Greater Than Minimal Risk Projects with Expected Direct Participant Benefits247
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -83-248
9.3.5 Greater Than Minimal Risk Projects without Expected Direct Participant Benefits249
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -83-250
9.3.6 Informed Consent Procedures for Decisionally Impaired Individuals. . . . . . . . . . -84-251
9.3.6.1 Assent of Participants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -84-252
9.3.6.2 Permission from the Participant's Guardian. . . . . . . . . . . . . . . . . . . . . . . . . -84-253
9.4 PREGNANT WOMEN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -84-254
9.4.1 Special Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -84-255
9.4.2 Added Protections for Pregnant Women . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -85-256
9.4.3 Informed Consent Procedures for Possibly Pregnant Women. . . . . . . . . . . . . . . . -85-257
9.5 PRISONERS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -85-258
9.5.1 General Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -85-259
9.5.2 Definition of “Prisoner”. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -85-260
9.5.3 Definition of Minimal Risk:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -86-261
9.5.4 Informed Consent Procedures for Prisoners. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -86-262
9.5.5 IRB Review Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -86-263
9.5.6 Permitted Categories of Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -86-264
9.5.7 Special IRB Composition Requirements.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -86-265
9.5.8 Seven Required Findings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -87-266
Section 10. Participatory Action Research. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -88-267
10.1 General Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -88-268
10.2 Project Classifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -88-269
10.3 Additional Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -90-270
10.3.1 "Plain English" Principles of Research Ethics. . . . . . . . . . . . . . . . . . . . . . . . . . . -90-271
10.3.2 Basic Ethical Principles.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -91-272
Section 11: IRB Oversight Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -92-273
11.1 Purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -92-274
11.2 Authority. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -92-275
11.3 Audit Selection Criteria. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -92-276
11.4 Audit Procedure.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -92-277
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11.5 Follow-up Actions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -94-278
11.6 Research Team Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -94-279
Section 12: IRB Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -95-280
12.1 The Membership of UT Knoxville IRB - Appointment of Members . . . . . . . . . . . . . . -95-281
12.1.1 Regular Members. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -96-282
12.1.2 Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -96-283
12.1.3 Compensation of UT IRB Members . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -96-284
12.1.4 Member Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -96-285
12.1.5 Alternate IRB Members . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -96-286
12.1.6 Non-Voting Members. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -97-287
12.1.7 Consultants/Ad hoc Reviewers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -97-288
12.1.8 Confidentiality.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -97-289
12.1.9 Conflict of Interest. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -97-290
12.2 Management of UT Knoxville IRB Process .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -98-291
12.2.1 UT Knoxville IRB Chair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -98-292
12.2.1.1. Responsibilities of the Chair include: . . . . . . . . . . . . . . . . . . . . . . . . . . . . -98-293
12.2.2 Administrative Support - The IRB Administration Office. . . . . . . . . . . . . . . . . . -98-294
12.2.2.1 The IRB Administration Office: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -98-295
12.2.2.2. Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -99-296
12.3 Functions of UT Knoxville IRB and Scope of Review . . . . . . . . . . . . . . . . . . . . . . . . . -99-297
12.4 Operations of UT Knoxville IRB - Scheduling of Meetings . . . . . . . . . . . . . . . . . . . . -100-298
12.4.1 Submission of Applications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -100-299
12.4.2 Determination of Type of Review.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -101-300
12.4.3 Full Board Review Process - Primary Reviewer Assignment . . . . . . . . . . . . . . -101-301
12.4.4. Use of Consultants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -101-302
12.4.5 Notification of Meetings and Distribution of Materials .. . . . . . . . . . . . . . . . . . -102-303
12.4.6 Urgent Review of Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -102-304
12.4.7 Meeting Procedures.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -102-305
12.4.8 Studies Designated "Revise and Resubmit to Full Board". . . . . . . . . . . . . . . . . -103-306
12.4.9 Meeting Minutes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -104-307
12.4.10 Expedited Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -104-308
12.4.11 Exempt Research.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -105-309
12.4.12 Research approved conditional upon modifications required to secure approval310
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -105-311
12.4.12.1 for minor modifications the adequacy of the modifications to be verified by312
the IRB administration.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -105-313
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12.4.12.2 for more significant modifications, the adequacy of the modifications to be314
reviewed by a subcommittee of the IRB .. . . . . . . . . . . . . . . . . . . . . . . . . . . . -106-315
12.5 Special Consideration for Projects Involving Vulnerable Populations . . . . . . . . . . . . -106-316
12.6 Suspension or Termination of IRB Approval .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -107-317
12.7 Noncompliance Investigations and Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -107-318
12.8 Review of Unanticipated Problems involving Risks to Subjects or Others . . . . . . . . . -109-319
12.9 Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -110-320
12.9.1. Maintaining FWA and UT IRB Registration. . . . . . . . . . . . . . . . . . . . . . . . . . . -110-321
12.9.2. IRB Determinations Requiring Reporting .. . . . . . . . . . . . . . . . . . . . . . . . . . . . -110-322
12.10 Undue Influence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -111-323
12.11 Tennessee Laws Governing Research Activities. . . . . . . . . . . . . . . . . . . . . . . . . . . . -111-324
Section 13. Glossary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -113-325
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Section 1. Basic Overview of the UT Knoxville IRB326
Section 1 Contents327
1.1 Activities of the UT Knoxville IRB and Federal Regulations. . . . . . . . . 13328
1.2 Fundamental Principles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13329
1.3 Jurisdiction of the UT Knoxville IRB. . . . . . . . . . . . . . . . . . . . . . . . . . . 13330
1.4 Human Participants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14331
1.5 Definition of Research. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14332
1.6 Participant Data and Identity Confidentiality Considerations. . . . . . . . . 15333
1.7 Research Methods Instruction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16334
1.1 Activities of the UT Knoxville IRB and Federal Regulations335
The University of Tennessee, Knoxville Institutional Review Board (UT Knoxville IRB)336
implements the regulatory requirements mandated by the U.S. Department of Health and Human337
Services (DHHS) as presented in the "Federal Policy for the Protection of Human Subjects." This338
document incorporates the "Protection of Human Research Subjects," (45 Code of Federal Regulations339
(CFR) Part 46) of the DHHS, "Protection of Human Subjects" (21CFR 50), and "Institutional Review340
Boards" (21 CFR56) of the U.S. Food and Drug Administration (FDA). The UT Knoxville IRB operates341
under the University of Tennessee "Federal-Wide Assurance (FWA)." The UT-Federal-Wide342
Assurance is an agreement between UT Knoxville, represented by the Vice Chancellor for Research343
(who serves as our officially designated "institutional official"), and the DHHS, represented by the344
Office for Human Research Protections (OHRP).345
1.2 Fundamental Principles346
The specifics of federal regulations are grounded in fundamental values and principles of ethics.347
One important statement of these is in a document that has come to be known as "the Belmont Report."348
Officially entitled "Ethical Principles and Guidelines for the Protection of Human Subjects of349
Research," this report was written by the National Commission for the Protection of Human Subjects of350
Biomedical and Behavioral Research (the same entity that developed the initial version of the Common351
Rule). The report identifies three basic principles that underlie measures to protect human participants:352
respect for persons, beneficence, and justice. A link to the Belmont Report can be found on the IRB353
Administration website.354
Many scholarly disciplines have developed codes of ethics or statements of principles regarding355
research practices to deal with issues that arise in their areas of research. The IRB Administration356
website has links to many of these. If the documents in your discipline are not referenced there, please357
notify the IRB Administration Office of the web link, and we will add them.358
1.3 Jurisdiction of the UT Knoxville IRB359
The UT Knoxville IRB was established to protect the rights and welfare of human participants in360
research conducted under the auspices of any unit of UT Knoxville, the Institute of Agriculture, and UT361
Space Institute.362
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The UT Knoxville IRB has the authority to approve, disapprove, or require modifications in363
research activities that fall within its jurisdiction. The UT Knoxville IRB may work in conjunction with364
other university committees, but it reviews research protocols independently, determining whether365
human participants are adequately protected. 366
Prior to preparing a research application, investigators should determine (1)367
whether the project involves research, as defined in federal regulations, and (2)368
whether the project will involve human participants. 369
1.4 Human Participants370
"Human subjects"1 are defined in the regulations [45 CFR 46.102(f)] as "living individuals about371
whom an investigator conducting research obtains (a) data through intervention or interaction, or (b)372
identifiable private information." 373
What counts a “private” information is not well-defined. In general, we understand it as374
information that others could not readily find out about a person. Thus, name, address, occupation are375
not private information; but personal attitudes and behaviors are. With regard to what is “identifiable,”376
look at our discussions of privacy and confidentiality below.377
What counts as an “intervention or interaction”? An “intervention” is something that changes one’s378
behavior - for example, asking you to perform a certain activity or eat a certain food or the like. An379
“interaction” would include asking you to fill out a questionnaire or observing your behavior in a certain380
setting.381
1.5 Definition of Research382
Research is defined in the federal regulations as: "a systematic investigation, including research383
development, testing and evaluation, designed to develop or contribute to generalizable knowledge." [45384
CFR 46.102(d)]385
In other words, research is systematic observation and data collection which:386
! is intended for release to the scientific community as a contribution to knowledge (e.g., Investigators387
undertake work that they anticipate might be shared in published form or otherwise made public),388
and/or 389
! is portrayed (explicitly or implicitly) by university students, faculty, or staff as "research" or390
"experimental" investigation, and/or 391
! is intended to fulfill requirements for a masters thesis, doctoral dissertation, or other research392
requirements at the University. 393
If a proposed activity can be defined as "research" by one or more of these criteria, the protocol394
must receive the appropriate review by the Departmental Review Committee (DRC) and by the UT395
Knoxville IRB. 396
If a proposed activity cannot be defined as "research" by one or more of these criteria, then the397
1The term used in the regulations is "human subject." We prefer the term "participant," and that is what we will usethroughout this document. When you see the term "human subject" in this guide, it will be a direct quotation from the federalregulations or similar document.
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protocol does not have to be reviewed by the DRC or UT Knoxville IRB. 398
Examples of observation or data collection activities involving human participants that do not399
require DRC or IRB review include: 400
! Data collection for internal departmental or other university administrative purposes (e.g., teaching401
evaluations, student evaluations, and staff evaluations). 402
! Program evaluation carried out under independent contract for an external organization that is for their403
internal purposes only. Examples of program evaluation include: personnel studies, staff effectiveness404
studies, human cost benefit analysis, treatment effectiveness studies, or human engineering studies. 405
It sometimes happens that data gathered in these ways prove to be of wider scholarly interest. To406
enable publication of these findings in such cases, it is wise to fulfill the fundamental requirements for407
research involving human participants even when the activity is not strictly "research" under this408
definition. In particular, it is wise to obtain informed consent from participants that includes an409
agreement that the data could be made available in scholarly publications or presentations. If the data is410
obtained on the basis of an explicit promise that it will not be used for purposes other than internal411
evaluation, then it is not appropriate to use it in scholarly reports later.412
1.6 Participant Data and Identity Confidentiality Considerations413
Federal regulations say: "When appropriate, there are adequate provisions to protect the privacy of414
subjects and to maintain the confidentiality of data." [45 CFR 46.111(a)(7) - our emphasis] There are415
times when confidentiality is not an issue. For example, in collecting oral histories of a neighborhood,416
the participants might want their names to be identified with their contribution. Defining the domain of417
privacy and confidentiality is a matter of judgment, and thus the IRB must make its own judgment about418
each protocol we review, both about the need for limits and protective measures and about the adequacy419
of those that have been proposed. Confidentiality is a matter of degree. If all ten members of a research420
team know the identities of participants, there is less confidentiality than if that information is restricted421
to the PI and the Co-PI.422
Whenever researchers promise participants that their responses and data will be maintained in423
confidence, all research project members (investigators, directors, transcribers, students, and staff) are424
required to prevent accidental and intentional breaches of confidentiality. In most cases, confidentiality425
can be assured by following fairly simple practices (e.g., substituting codes for identifiers, removing426
survey cover sheets that contain names and addresses, limiting access to identified data, and/or storing427
research records in locked cabinets). All measures used to assure confidentiality of data need to be428
understood by all research staff before research is initiated, and followed once research is underway.429
Confidentiality procedures must be described in detail in research applications that come before the UT430
Knoxville IRB.431
Researchers proposing projects that will address sensitive, stigmatizing, or illegal topics must432
explicitly outline the steps they will take to assure that any information linking participants to the study433
is maintained in confidence. 434
The requirement of signed consent forms is often waived in sensitive studies, if the consent435
document is the only written record linking participants to the project and a breach of confidentiality436
presents the principal risk of harm anticipated in that research. This makes participation anonymous,437
which is the strongest protection possible of privacy. Our understanding is that participation and data438
are anonymous only if no one could possibly identify the individual participant. If anyone knows, or439
could ascertain their identity, then confidentiality is the name of the measures taken to protect others440
from learning their identity.441
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The Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) imposes442
some additional safeguards on confidentiality for research in health care institutions (including the UT443
Knoxville Student Health Service, the Psychological Clinic, and the Speech and Hearing Center on444
campus). See Section 4 of this guide for further details.445
The Family Educational Rights and Privacy Act (FERPA) imposes some additional safeguards on446
confidentiality for research in educational settings. For further information, consult the U.S. Department447
of Education FERPA web site: http://www2.ed.gov/policy/gen/guid/fpco/ferpa/index.html (See also448
Section 9.2.4.3 below for guidelines on the use of educational records.)449
If there is any chance that data or participants' identities might be sought by law enforcement450
agencies or subpoenaed by a court, a certificate of confidentiality should be obtained. Under federal law451
(Public Health Act 301(d)), researchers, prior to the initiation of the research project, may request452
certificates of confidentiality to protect against forced data and participant identity disclosures. These453
provide protection for specific research projects where such protection is judged necessary to achieve454
the research objectives. If you believe your research project may require a certificate of confidentiality,455
please contact your Departmental Review Committee (DRC) Chair or the IRB Administration at 974-456
3466 or go to the NIH Certificates of Confidentiality kiosk at http://grants.nih.gov/grants/policy/coc/. 457
1.7 Research Methods Instruction458
Course activities that involve the use of human participants, but have no connection with research459
beyond the instructional function do not require certification or IRB review. However, efforts that lead460
to presentation outside of the classroom, and/or the publicizing of the student-prepared documents in461
any manner are considered research. If the investigator intends to use the data from such activities as the462
basis for a scientific contribution, or portrays the activity as "research" or "experiment," then the activity463
will be considered research involving human participants and will be subject to DRC and UT Knoxville464
IRB review. If the investigator intends to use the data for purposes of a masters thesis or doctoral465
dissertation, then the activity will be considered research involving human participants and will be466
subject to DRC and IRB review.467
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Section 2. Review System and Responsibilities468
Section 2 Contents469
2.1 Description of the Review Process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17470
2.2 Investigator's Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17471
2.3 Departmental Review of Research Projects. . . . . . . . . . . . . . . . . . . . . . . 18472
2.3.1 Research Center Reviews. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18473
2.4 Department Heads Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18474
2.5 Departmental/Unit Review Committee Appointments. . . . . . . . . . . . . . . 19475
2.6 Important Departmental Files. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19476
2.7 Departmental Review Committee Recommendations. . . . . . . . . . . . . . . 19477
2.7.1 Scientific Merit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19478
2.7.2 Form A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19479
2.7.3 Form B. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20480
2.8 University Responsibilities.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20481
2.9 IRB Administration Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . 20482
2.10 Institutional Review Board.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21483
2.10.1 Composition of the Institutional Review Board. . . . . . . . . . . . . 21484
2.10.2 IRB Rulings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21485
2.11 Appeals Procedures for UT Knoxville IRB Actions. . . . . . . . . . . . . . . 22486
2.11.1 Composition of the Appeals Board. . . . . . . . . . . . . . . . . . . . . . . 23487
488
489
2.1 Description of the Review Process490
All research involving human participants, including projects considered to be "exempt" from full491
IRB review must be reviewed and approved prior to commencement of the research. The following units492
are responsible for submitting research proposals to the UT Knoxville IRB:493
! All departments and units of the University of Tennessee Knoxville (UT Knoxville); 494
! All units of the University of Tennessee Space Institute; 495
! All units of the Institute of Agriculture; and 496
! All other off-campus units of UT Knoxville or units formally associated with UT Knoxville or units497
located in Knoxville, except498
" the University of Tennessee Medical Center, Knoxville499
" the University of Tennessee Graduate School of Medicine500
" the Department of Audiology and Speech Pathology. 501
The UT Knoxville IRB does not review research proposals from individuals, organizations, or units502
not affiliated with the University of Tennessee, unless they are enlisting UT Knoxville students, faculty,503
and/or staff as participants. (See Section 3.8.2 for further information about research conducted on the504
Knoxville campus by outside researchers.) 505
2.2 Investigators’ Responsibilities506
It is the responsibility of investigators (including students, faculty advisors, co/principal507
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investigators, etc.) to provide the appropriate review documents (Form A or B1) to their Departmental508
Review Committee chairs as soon as they know the extent to which humans will serve as participants in509
their research. It is the responsibility of the investigators to design and implement research so as to510
exclude or minimize risks to human participants, and to adhere to the highest standards of research511
design and procedure within the discipline of the proposed research. It is the responsibility of the512
investigators to adhere to the principles of the Belmont Report and to applicable codes of professional513
ethics for the discipline of the proposed research, and to ensure the use of appropriate professional514
competence and adequate support facilities for all research involving human participants. Investigators515
must adhere to the principles and procedures for the review of research described in this Guide.516
Once the protocol has been approved, it is the responsibility of the investigators to carry out the517
protocol as approved, to notify the IRB of any significant changes that are planned and to await518
approval before implementing them, to notify the IRB of any adverse events and work with the IRB to519
develop a plan to prevent a recurrence, and to instruct all students and staff working on the project in the520
proper procedures and the importance of showing respect for the human participants. 521
2.3 Departmental Review of Research Projects522
The Departmental Review Committee (DRC) will review all research projects involving human523
participants initiated by faculty, staff, and students in its department for scientific merit and also for524
compliance with legal, regulatory, and ethical provisions for the protection of research participants'525
rights. Applicable ethical standards include principles of the Belmont Report and codes of professional526
ethics governing the discipline(s) involved. The DRC will apply the same standards applied by the IRB.527
(See Section 12.3 below.)528
If the research includes recruiting student participants and offering course credit or extra-credit as529
an incentive, the DRC must determine (a) whether the procedure follows departmental guidelines for530
recruitment and (b) whether alternative means of earning equivalent course credit is available to the531
student, as required by regulations.532
2.3.1 Research Center Reviews533
Principal investigators or project directors in Research Centers that are not contained in or do not534
report to an academic department at the university should submit their research protocols to the DRC in535
the department where their academic appointments are maintained. If project investigators and directors536
are not affiliated with UT Knoxville academic departments or units, then their research protocols should537
be submitted to the DRCs in departments or units in which their Center Directors are affiliated.538
2.4 Department Head's Responsibilities539
The responsibilities of Department Heads include assisting faculty, staff, and students in meeting540
the requirements of law, regulations, policy, and procedures (as well as applicable standards of541
professional ethics) for research involving human participants. Departmental Review Committees542
review research protocols involving human participants on behalf of the Department Head. However,543
Department Heads cannot assign their legal, regulatory, policy or ethical responsibilities to the DRC. By544
signing off on a protocol, the Department Head attests to both the scientific merit of the proposal as well545
1To find IRB forms online, go to: http://research.utk.edu/forms/index.shtml#c4
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as its compliance with legal, regulatory, and ethical provisions for the protection of research546
participants' rights. 547
The Department Head is also responsible for monitoring and managing possible conflicts of interest548
on the part of the researchers.549
2.5 Departmental Review Committee Appointments550
If research involving human participants is a normal activity of the discipline, however regular or551
irregular its occurrence within the Department, the Department Head will appoint a DRC. The Head will552
report the names of the members of the DRC to the IRB Administrator on Form E annually. The size of553
the DRC may vary, but minimum recommended membership is three, with alternates available so that554
members may avoid reviewing their own research or projects in which they may have either an active555
role or a conflict of interest.556
2.6 Important Departmental Files557
Each department should maintain a file consisting of the following documents:558
! This Guide, copies of current University IRB Forms (e.g., A, B, and D), the Belmont Report, and copies559
of the DHHS regulations presented in 45 CFR 46, and FDA regulations presented in 21 CFR 50 and 56; 560
! Copies of other federal regulations relevant to research conducted in the department; and 561
! Copies of standards of professional ethics applicable to departmental research. 562
2.7 Departmental Review Committee Recommendations563
Prior to submission to the IRB, a research proposal must have DRC approval. 564
2.7.1 Scientific merit565
One of the criteria for approval of a research project specified in federal regulations is: "Risks to566
subjects are minimized: (I) by using procedures which are consistent with sound research design and567
which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures568
already being performed on the subjects for diagnostic or treatment purposes." [46 CFR 46.111(a)]569
Sound research design is to some extent discipline-specific. Therefore colleagues in the discipline570
are uniquely qualified to evaluate the research design and to consider whether there are alternatives that571
might minimize risk to subjects even further than what is proposed.572
By recommending IRB approval of the protocol, the DRC attests that they have evaluated the573
research design and that (a) it meets the standards of sound research design in their discipline and (b) no574
alternative method exists that would minimize risk to the subjects further.575
2.7.2 Form A1576
The DRC will evaluate the Form A protocol in accordance with the guidelines set out in Section 5577
1To find IRB forms online, go to: http://research.utk.edu/forms/index.shtml#c4
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of this Guide.578
! If they judge that it does not qualify for exemption, the Form A will be returned to the researcher to be579
reworked into a Form B submission.580
! If they judge that it does qualify for exemption, it will be forwarded to the Department Head and then581
on to the IRB with a recommendation for certification of exemption, including specification of the582
category under which it qualifies in the signature bloc of the Form A.583
2.7.3 Form B1 584
Departmental Review Committees conduct the initial reviews of Form B applications and indicate585
their approval by making one of the following recommendations to the IRB.586
2.7.4 Possible DRC Recommendations for Form B Projects587
! Recommendation for Expedited Review: This recommendation signifies that the project has been588
reviewed in accordance with the provisions of Section 6 of this Guide and is judged to be eligible for589
expedited review and approval by the designated representative(s) of the UT Knoxville IRB. The DRC590
Chair must identify the specific category(ies) under which the project qualifies for expedited review in591
the signature bloc of the Form B. Please note that the Department Head, the IRB Administration, or an592
expedited-process reviewer may override this recommendation and refer the project to the full IRB for593
review. 594
! Recommendation for Full IRB Review: This recommendation indicates that the DRC has reviewed595
the project in accordance with the provisions of Section 7 of this Guide and found the project eligible596
for review and approval by the UT Knoxville IRB.597
! If the DRC judges that the project is not suitable for approval, it should be returned to the researcher(s)598
with suggestions as to how (if at all) it might be reworked to make it suitable.599
The DRC does not have authority to disapprove a protocol categorically. Only the IRB can do that.600
If the DRC is uncomfortable with the protocol even after modifications, they should forward it to the601
Department Head and then on to the IRB with their re servations indicated in writing. The protocol will602
then be automatically scheduled for full board review, where it is possible for a categorical disapproval603
to be voted.604
2.8 University Responsibilities605
The University of Tennessee Federal-wide Assurance outlines the university's responsibilities with606
respect to research involving human participants that is conducted by university faculty, staff, and607
students. In addition, the university, through the Office of Research, provides administrative services608
necessary for the IRB Administration and UT Knoxville IRB to carry out their duties.609
2.9 IRB Administration Responsibilities610
The IRB Administration serves as the focal point for the review and approval of all UT Knoxville611
research involving human participants. The IRB Administration is part of the UT Knoxville Office of612
Research and administratively answers to the Associate Vice Chancellor for Research. The IRB613
Administration serves as a clearinghouse for compliance and regulatory information. The staff of this614
office may consult and aid investigators in the preparation of Form A and B applications. 615
As requested by Department Heads or DRC Chairs, IRB Administration staff conduct training616
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seminars concerning applicable human participant research policies and procedures for UT Knoxville617
faculty and students. The office also maintains two course management (Blackboard) sites dealing with618
aspects of responsible conduct of research that can be employed for training of students and research619
personnel.620
The IRB Administration maintains this Guide and in consultation with the UT Knoxville IRB and621
the Associate Vice Chancellor for Research institutes policy and procedural changes for the review of622
research involving human participants. All policy and procedural changes are required to conform to623
current applicable regulations, institutional requirements, and UT Knoxville IRB experience.624
The IRB Administration maintains records of all UT Knoxville research involving human625
participants for a period of ten years following the termination of the research project. The IRB626
Administration also maintains records of all UT Knoxville IRB proceedings and decisions. 627
The IRB Administration, through the Office of Research, is responsible for reports to the Office for628
Human Research Protection (OHRP) of DHHS concerning unanticipated risks or injuries to research629
participants.630
2.10 Institutional Review Board Responsibilities631
The UT Knoxville IRB is the review board for all units of the university in the Knoxville area,632
except for the University of Tennessee Medical Center, the Graduate School of Medicine, and the633
Department of Audiology and Speech Pathology. The UT Knoxville IRB is required to report the634
profession, relationship to the University and the qualifications of its membership to DHHS annually.635
2.10.1 Composition of the Institutional Review Board636
The composition of the board meets the requirements set forth by the DHHS (45 CFR 46.107). 637
! Members, including the Chair and Vice-Chair, are appointed by the Associate Vice Chancellor for638
Research. 639
! The length of appointment is five years. 640
! The UT Knoxville IRB consists of at least sixteen members chosen to ensure compliance with the641
following standards: 642
" Members come from diverse backgrounds to promote complete and adequate review of research643
activities and to provide the professional competence necessary to review specific research644
activities; 645
" Members are selected with consideration to their experience and expertise, their racial and cultural646
backgrounds, their sensitivity to such issues as community attitudes; 647
" The IRB includes male and female members who represent a variety of professions and includes at648
least one member whose primary expertise is in a nonscientific area and at least one member who649
is not otherwise affiliated with the University; and 650
" When research involving vulnerable participants (e.g., prisoners, children, or individuals who may651
be decisionally impaired) is reviewed, the IRB will include one or more members (or a consultant)652
who have primary concern for and knowledge about the welfare of these participants. 653
2.10.2 IRB Rulings654
The IRB issues the following rulings:655
! approve656
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! approve conditional upon modifications required to secure approval (the specifics to be communicated657
to the PI in writing)658
" for minor modifications the adequacy of the modifications to be verified by the IRB administration659
" for more significant modifications, the adequacy of the modifications to be reviewed by a660
subcommittee of the IRB (typically the primary reviewers plus others who had particular concerns661
about the protocol)662
! revise and resubmit to the full board for re-review (here again, specific concerns and/or suggestions for663
modifications will be communicated to the PI in writing)664
! disapprove (If the IRB decides to disapprove a research activity, it shall include in its written665
notification a statement of the reasons for its decision and give the investigator an opportunity to666
respond in person or in writing and/or to appeal the decision (see section 2.11 just below)) [45 CFR667
46.109(d)]668
669
2.11 Appeals Procedures for UT Knoxville IRB Actions670
Principal and co-principal investigators must try to resolve concerns about UT Knoxville IRB671
decisions regarding their research protocols by discussing their concerns with the Chair of the UT672
Knoxville IRB, the IRB Administrator, and the Associate Vice Chancellor for Research. If their673
concerns cannot be resolved through those discussions, they can petition the Associate Vice Chancellor674
for Research to establish and convene a UT Knoxville IRB Appeals Board. 675
Any action of the UT Knoxville IRB, including actions on exempt, expedited, and full board676
protocols, can be appealed by principal and co-principal investigators. However, these appeal677
procedures do not apply to actions taken by Departmental Review Committees. Actions of the DRC678
would be appealed to the IRB.679
Investigators wishing to appeal UT Knoxville IRB decisions should address a formal letter680
requesting an appeal to the IRB Administrator. The formal letter requesting an appeal should:681
! Identify the project, 682
! Identify the UT Knoxville IRB action in question, 683
! Describe any steps that have already been taken to attempt to resolve the concern, and 684
! List the reasons for appealing the UT Knoxville IRB decision. 685
Upon receipt of the letter formally requesting an appeal, the IRB Administrator will notify the UT686
Knoxville IRB Chair and the Associate Vice Chancellor for Research. If investigators have exhausted687
all other avenues of resolution, the Associate Vice Chancellor for Research will establish and convene688
an Appeals Board and serve as the Board's Chair. 689
The UT Knoxville IRB Appeals Board will meet at a time and location designated by the Board's690
Chair. Quorum and procedural rules for the Appeals Board will be the same as those governing the UT691
Knoxville IRB. The Appeals Board will review the investigators' appeal, review the UT Knoxville IRB692
decision in question, and receive additional appropriate information from other relevant sources.693
The Appeals Board cannot override a decision of the UT Knoxville IRB. It can only make694
recommendations to the UT Knoxville IRB for reconsideration of their ruling. The Board serves as an695
appellate body and can take the following actions:696
! Confirm the decision of the UT Knoxville IRB,697
! Request modification of the proposed research activities and recommend review of the modified698
protocol by the UT Knoxville IRB,699
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! Request modification of the UT Knoxville IRB decision in question and recommend further review by700
the UT Knoxville IRB to consider these recommendations, or 701
! Request disapproval of research activities previously approved by the UT Knoxville IRB and702
recommend further review by the UT Knoxville IRB to consider this recommendation.703
If the Appeals Board recommends any changes in the UT Knoxville IRB decision, it must submit its704
recommendation with reasons in writing to the UT Knoxville IRB. Any Appeals Board recommendation705
to the UT Knoxville IRB will initiate a new full-board review of the research activities in question706
which shall address all Appeals Board recommendations. The results of this full-board review will be707
sustained without further appeal.708
2.11.1 Composition of the Appeals Board709
The UT Knoxville IRB Appeals Board is appointed when the need arises by the Associate Vice710
Chancellor for Research. The composition of the UT Knoxville IRB Appeals Board is designed to meet711
the federal membership criteria for IRBs set forth in 45 CFR 46.107. Appeals Board membership712
includes the following individuals:713
! Associate Vice Chancellor for Research, 714
! IRB Administrator715
! UT Knoxville IRB Chair, and 716
! Five assigned current or former Board Members. 717
The five assigned Appeals Board members will be selected by the Associate Vice Chancellor from718
a set of senior and former UT Knoxville IRB members. The UT Knoxville IRB will be notified about 719
Appeals Board assignments by the Associate Vice Chancellor for Research, but the UT Knoxville IRB720
has no control over the selection of members. Appeals Board members are assigned to the Board for the721
period designated by the Associate Vice Chancellor for Research.722
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Section 3. Guidelines for Selecting the Appropriate Review723
Procedures724
725
Section 3 Contents726
3.1 Definition of Minimal Risk. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25727
3.2 Exempt Research Categories (Form A). . . . . . . . . . . . . . . . . . . . . . . . . . 25728
3.3 Expedited Research Categories (expedited Form B). . . . . . . . . . . . . . . . 26729
3.4 Categories of Full IRB Reviewed Research (Form B). . . . . . . . . . . . . . . 28730
3.5 Audio- and Videorecording Considerations. . . . . . . . . . . . . . . . . . . . . . . 28731
3.5.1 Form B Application Information. . . . . . . . . . . . . . . . . . . . . . . . . 28732
3.5.2 Informed Consent Form Information. . . . . . . . . . . . . . . . . . . . . . 29733
3.5.3 Storage and Future Use Considerations. . . . . . . . . . . . . . . . . . . . 29734
3.6 Internet Research. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30735
3.6.1 Presentation of Research Findings on the Internet. . . . . . . . . . . . 30736
3.6.2 Electronic Transmission and Storage. . . . . . . . . . . . . . . . . . . . . . 31737
3.6.3 The Internet and “Public Behavior”. . . . . . . . . . . . . . . . . . . . . . . 31738
3.6.4 Recruitment in Internet Research. . . . . . . . . . . . . . . . . . . . . . . . . 31739
3.6.5 Privacy and Confidentiality in Internet Research. . . . . . . . . . . . . 32740
3.6.6 Skype. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32741
3.6.7 Informed Consent Online. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33742
3.6.8 Risk in Internet Research. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33743
3.7 Procedures for Projects that Require Approval from Other UT Knoxville744
Compliance Committees. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33745
3.8 Application Procedures for Off-Campus Research. . . . . . . . . . . . . . . . . 33746
3.8.1 Relationship to Graduate School of Medicine IRB.. . . . . . . . . . . 34747
3.8.2 Research Conducted on the Knoxville Campus by Outside748
Researchers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34749
3.8.3 International Research.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34750
3.9 Advertising to Recruit Participants.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34751
3.10 General Policy on the use of Children in Research. . . . . . . . . . . . . . . . 35752
3.11 General Policy on the use of Vulnerable Individuals in Research. . . . . 35753
There are three categories of review by the UT Knoxville IRB:754
! Exemption: Research that does not require formal review by the UT Knoxville IRB process, nor does it755
require continuing review. However, a description of this research must be examined by the DRC,756
Department Head, and the IRB or its representative in order to certify that it meets the criteria for757
exemption. Furthermore, no interaction with participants is exempt from the basic moral principles of758
the Belmont Report as applied in the process of informed consent and other elements of research design.759
! Expedited: Research in this category may be reviewed by one or more representatives of the IRB760
instead of being reviewed by the full board at a convened meeting. One important advantage is that the761
review can be completed much faster since it does not have to wait for the monthly convened meeting of762
the full board. 763
! Full Board Review: Research in this category must be reviewed by the full board at a convened764
meeting. Three primary reviewers study the application especially carefully and present it to the other765
members of the board along with a recommendation about approval, but all members of the IRB are766
expected to review the protocol before the meeting and to participate in discussion of and vote on the767
application.768
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3.1 Definition of Minimal Risk769
Estimation of risk is an initial screening tool in classifying research.770
! Research projects must present no more than minimal risk to human participants in order to be771
considered for exemption from either full board or expedited review.772
! Similarly, research projects to be reviewed through an expedited procedure must present no more than773
minimal risk to human participants.774
! Research projects that receive full board review may include those that pose no more than minimal risk,775
as well as those that pose greater than minimal risk.776
Minimal risk in a research activity is defined in federal regulations [45 CFR 46.102(I)] as an777
anticipated risk of harm or discomfort in a proposed research that is no greater, considering probability778
and magnitude, than risks ordinarily encountered in daily life or during the performance of routine779
physical or psychological examinations or tests.780
This is obviously a judgment call. Researchers should present enough information about research781
procedures that the members of the IRB can make an informed judgment about the level of risk.782
3.2 Exempt Research Categories (Form A1)783
Research projects that meet one of the following exemption categories may be "exempted" from784
full or expedited IRB review, if (a) they place participants at no more than minimal risk, and (b) they do785
not involve minors2 (i.e., participants who are under 18 years of age), prisoners, fetuses or neonates, or786
pregnant women. Refer to Section 5 of this guide for more information about this category of review787
(See especially section 5.3 for some further explanation of these categories, including some examples.).788
Category 1: [45 CFR 46.101(b)1]789
Research conducted in established or commonly accepted educational settings, involving normal790
educational practices such as, research on regular and special education instructional strategies, or791
research on the effectiveness of or the comparison among instructional techniques, curricula or792
classroom management methods. 793
Category 2: [45 CFR 46.101(b)2] 794
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) including795
survey procedures, interviews, or observation of public behavior. 796
Category 3: [45 CFR 46.101(b)3]797
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey798
procedures, interview procedures, or observation of public behavior that would not be exempt under799
Category 2 may be exempt if participants are elected officials, appointed public officials, or candidates800
for public office; or federal statute(s) require(s) without exception that the confidentiality of the801
personally identifiable information will be maintained throughout the research and thereafter. 802
1To find IRB forms online, go to: http://research.utk.edu/forms/index.shtml#c4
2The exclusion of research involving minors from exemption is not dictated by federal regulations. It is a policydecision made by the UT Knoxville IRB that research involving minors should be given no less than the "expedited" level ofreview in which one of the reviewers has expertise in child development.
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Category 4: [45 CFR 46.101(b)4]803
Research involving the collection or study of existing data, documents, records, pathological specimens,804
or diagnostic specimens may be exempt if these sources are publicly available or if the information is805
recorded by the investigator in such a manner that participants cannot be identified, directly or through806
identifiers linked to the participants. 807
Category 5: [45 CFR 46.101(b)5]808
Research and demonstration projects which are conducted by or subject to the approval of federal809
department or agency heads, and which are designed to study, evaluate, or otherwise examine: 810
! public benefit or service programs; 811
! procedures for obtaining benefits or services under those programs; 812
! possible changes in or alternatives to those programs or procedures; or813
! possible changes in methods or levels of payment for benefits or services under those programs. 814
Category 6: (45 CFR 46.101(b)6)815
Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without816
additives are consumed, or (ii) foods are consumed that contain a food ingredient at or below the level817
and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the818
level found to be safe by the Food and Drug Administration or approved by the Environmental819
Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. 820
3.3 Expedited Research Categories (expedited Form B1)821
Minimal risk research that may be reviewed using expedited review procedures by the UT822
Knoxville IRB must fall under one of the following categories specified in federal guidelines :823
1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.824
a. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not825
required. (Note: Research on marketed drugs that significantly increases the risks or decreases the826
acceptability of the risks associated with the use of the product is not eligible for expedited review.)827
b. Research on medical devices for which (i) an investigational device exemption application (21828
CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the829
medical device is being used in accordance with its cleared/approved labeling.830
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:831
a. From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts832
drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently833
than 2 times per week; or 834
b. From other adults and children2 considering the age, weight, and health of the subjects, the835
1To find IRB forms online, go to: http://research.utk.edu/forms/index.shtml#c4
2Children are defined in the HHS regulations as ``persons who have not attained the legal age for consent totreatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will beconducted.'' [45 CFR 46.402(a)]
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collection procedure, the amount of blood to be collected, and the frequency with which it will be836
collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg837
in an 8 week period and collection may not occur more frequently than 2 times per week.838
3. Prospective collection of biological specimens for research purposes by noninvasive means. 839
4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation)840
routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where841
medical devices are employed, they must be cleared/approved for marketing. (Studies intended to842
evaluate the safety and effectiveness of the medical device are not generally eligible for expedited843
review, including studies of cleared medical devices for new indications.)844
Examples:845
a. Physical sensors that are applied either to the surface of the body or at a distance and do not846
involve input of significant amounts of energy into the subject or an invasion of the subject's847
privacy; 848
b. weighing or testing sensory acuity;849
c. magnetic resonance imaging;850
d. electrocardiography, electroencephalography, thermography, detection of naturally occurring851
radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and852
echocardiography; or853
e. moderate exercise, muscular strength testing, body composition assessment, and flexibility testing854
where appropriate given the age, weight, and health of the individual.855
5. Research involving materials (data, documents, records, or specimens) that have been collected or will856
be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some857
research in this category may be exempt from the HHS regulations for the protection of human subjects.858
[45 CFR 46.101(b)(4)]. This listing refers only to research that is not exempt.) 859
6. Collection of data from voice, video, digital, or image recordings made for research purposes.860
7. Research on individual or group characteristics or behavior (including, but not limited to, research on861
perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and862
social behavior) or research employing survey, interview, oral history, focus group, program evaluation,863
human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category864
may be exempt from the HHS regulations for the protection of human subjects [45 CFR 46.101 (b)(2)865
and (b)(3)]. This listing refers only to research that is not exempt.)866
8. Continuing review of research previously approved by the convened IRB as follows: 867
a. Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects868
have completed all research-related interventions; and (iii) the research remains active only for869
long-term follow-up of subjects; or 870
b. Where no subjects have been enrolled and no additional risks have been identified; or 871
c. Where the remaining research activities are limited to data analysis. 872
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9. Continuing review of research, not conducted under an investigational new drug application or873
investigational device exemption where the following conditions apply:874
a. Categories two (2) through eight (8) do not apply; and875
b. The IRB has determined and documented at a convened meeting that the research involves no876
greater than minimal risk and no additional risks have been identified.877
Refer to Section 6 of this guide for further information about the expedited review procedure.878
3.4 Categories of Full IRB Reviewed Research (Form B1)879
Categories of research that always require full IRB Committee review include: 880
! Most projects requiring the use of deception. 881
! Involvement of prisoners, pregnant women, fetuses or neonates, the seriously ill, decisionally impaired882
individuals, or others for whom a determination of vulnerability must be made. 883
! Collection of information or recording of behavior which, if known outside the research, could884
reasonably place the subject at risk of civil, or criminal liability or damage the participant's social885
standing, financial standing, or employability.886
! Collection of information regarding sensitive aspects of the participant's behavior such as: drug and887
alcohol use, illegal conduct, or sexual behavior.888
! Clinical trials889
! Projects which include procedures that present more than minimal risk to participants. 890
Please refer to Section 7 of this guide for more information about projects requiring full-IRB891
review. 892
3.5 Audio- and Videorecording Considerations893
Videorecording and audiorecording research participants are valid and useful data collection894
methods. However, the use of audio- or videorecordings makes all the more important an investigator's895
need to clearly specify the steps taken to maintain the confidentiality of this identifiable information.896
Investigators meet this need by describing - both in their Form B applications, and in their informed897
consent forms - the steps they will take to protect the confidentiality of research audio- or898
videorecordings. All research in which participants will be audio- or videorecorded requires the use of a899
Form B application. Expedited reviews of Form B applications are possible when the research does not900
involve vulnerable participants and the information collected is not of a sensitive nature (e.g., sexual901
behavior, illegal activities, etc.).902
3.5.1 Form B Application Information903
Section IV (the Methods and Procedures section) of an investigator's Form B should clearly specify904
the purposes and uses of the audio- or videorecordings. Investigators should directly relate the purposes905
and uses of the audio- or videorecordings to achieving the objectives of the project stated in Section II906
of the Form B. The investigator's audio- or videorecording procedures should be described in detail907
along with a discussion of the measures used to avoid the inclusion of nonparticipants on the audio- or908
videorecordings. Investigators should describe audio- or videorecordings storage procedures, the storage909
1To find IRB forms online, go to: http://research.utk.edu/forms/index.shtml#c4
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location, and the duration of storage. If the session is to be transcribed, the qualifications of the910
transcriber should be explained, along with a copy of the pledge of confidentiality the transcriber(s) will911
sign.1 Section IV should also contain a description of the investigator's procedures for controlling access912
to and use of the audio- or videorecordings, and the disposal of the audio- or videorecordings once the913
research use is completed. 914
Section VII (the "Methods for Obtaining Informed Consent From Participants” section) of a Form915
B should clearly specify the investigator's consent procedures. Usually the IRB requires full informed916
consent when audio- or videorecording procedures are used. However, the IRB may authorize the use of917
deception or incomplete disclosure about the real purpose of the research in the informed consent, if the918
proposed consent procedures are essential to the investigator's ability to carry out the research, and919
participants are exposed to no more than minimal risk. 920
If incomplete or deceptive consent procedures are used, then the investigator should address her/his921
plan for giving participants full information about their participation following the completion of their922
involvement in the study (i.e., what is called "debriefing"). If no debriefing is planned, a justification for923
its omission is necessary.924
925
3.5.2 Informed Consent Form Information926
In addition to all other basic elements of informed consent, a full informed consent should identify927
the purposes and uses of the audio- or videorecordings. The informed consent should provide928
information about who will have access to the audio- or videorecordings and how access will be929
controlled. Audio- or videorecordings storage information should state how long the investigator will930
store the audio- or videorecordings and what will be done with the audio- or videorecordings at the end931
of the storage period. The information provided in the informed consent should match the information932
provided in the Form B application. We recommend a separate signature bloc on the consent form to933
grant permission to be audio- or videorecorded in the course of the research. If audio- or videorecording934
is so integral to the study that participation is impossible without it, that can be explained in the consent935
bloc.936
Because the contents of audio- or videorecordings are identifiable, participants must give their937
explicit consent for any public use of audio- or videorecordings, such as use in the classroom or use in a938
public presentation of research results. The informed consent form or a separate release form must be939
used to obtain a participant's explicit consent for the public use of her or his voice and/or image on940
audio- or videorecording. Audio- or videorecordings of participants in studies using limited or deceptive941
informed consent procedures may not be publicly used without the explicit written consent of the942
participant, after full disclosure. Audio- or videorecordings or images of children may not be released943
for use on a website, nor may they be reproduced.944
3.5.3 Storage and Future Use Considerations945
If the researcher expects to store audio- or videorecordings in ways that will enable others to use946
them, or if the researcher expects to use the audio- or videorecordings in additional research projects947
that are not directly related to the objectives of the study under which they were initially created, these948
expectations must be clearly stated in the protocol and in the informed consent form. Given that the949
1A sample confidentiality pledge can be found on the IRB forms page:http://research.utk.edu/forms/index.shtml#c4
-29-
identities of participants do remain on the audio- or videorecordings until the recordings are erased or950
destroyed, participants must be informed about the possibility that others may use the audio- or951
videorecordings or that the audio- or videorecordings may be used in additional research projects. There952
are many legitimate reasons why one might want to use the audio- or videorecordings in future research953
projects, or to allow others to use the audio- or videorecordings, but the participants in the initial study954
need to know about these uses when they consent to participate. We recommend a separate signature955
bloc for consent for archiving audio- or videorecordings. A participant should be able to refuse the956
archiving of these materials while still approving their use in the present study. This is an implication of957
their right to withdraw from the study at any time.958
If it is anticipated that other researchers may use the audio- or videorecordings outside the present959
research project, then the procedures that will be used to grant other researchers access to these audio-960
or videorecordings must be specified in the Form B. The participant's informed consent form should961
state that other researchers may use the audio- or videorecordings in the future, indicating in clear terms962
the scope of possible future uses. We recommend yet another separate signature bloc for consent for963
uses that are outside the scope of the present study to make it clear that the participant may decline this964
use while still participating in the present study.965
If there is a plan to archive the audio- or videorecordings in a manner in which access to the966
recordings will be controlled by other individuals, libraries, or collections, the qualifications of the967
guardians of the audio- or videorecordings must be explicitly stated, as must procedures they will follow968
to protect the confidentiality of the participants when other researchers request access to the audio- or969
videorecordings. The participants in the study need to know when they consent to participate about any970
plans to allow others to control future access to the audio- or videorecordings, and these plans should be971
clearly stated in the protocol and informed consent form. 972
The passage of time does not diminish the responsibility to protect the confidentiality of the973
participants in research. The rights of a participant do not expire at the end of a research project, or after974
any other period of time. Audio- or videorecordings cannot be considered usable secondary data as long975
as they contain identifiable information. Please note that new research projects using the archived audio-976
or videorecordings will require a new Form B application if the new project was not described in the977
originally approved Form B and consent form. If the new research use was noted, but only partially978
described in the originally approved Form B application and informed consent form, then a Form D1979
that fully describes the new research use may be submitted. In either case, the audio- or videorecordings980
may not be used until final IRB approval is received.981
If you have any questions about the development of Form B application for a project involving982
audio- or videorecordings, please contact the IRB Administration at 974-3466.983
3.6 Internet Research984
The internet can be a powerful research tool, but it also poses some special challenges. 985
3.6.1 Presentation of Research Findings on the Internet986
The web can be a good place to disseminate research findings, but, once material is placed on the987
1To find IRB forms online, go to: http://research.utk.edu/forms/index.shtml#c4
-30-
internet, we lose control of it. Someone else can download it and reuse it or even alter it and then reuse988
it. This can especially be a problem with images. As attractive as it can be to enhance one's presentation989
with images of participants, it is essential that there be willing consent for using them based on a full990
understanding of the consequences. Given the endurance of images and the possibility of altering them,991
the UT Knoxville IRB is not comfortable approving plans for parental permission for posting images of992
small children on the web. Children are likely to be more aware of the possibilities of web images than993
their parents are. Only when the child himself or herself is old enough to give an educated approval is994
the posting of their image acceptable.995
3.6.2 Electronic Transmission and Storage996
Researchers who plan to transmit data electronically and/or to store it on computers have a997
responsibility to investigate security issues such as encryption and the use of passwords. The UT998
Knoxville IRB expects the protocol to contain enough detail about security measures to enable a999
judgment about the risks to privacy and confidentiality. This can be explained in either the section of the1000
Form B on "Risks and Protection Measures" or the section on "Facilities and Equipment." It is not1001
enough, for example, to say that the computer on which the data is stored is "password protected." How1002
secure is this password? Explain just how many people will have access to this password. If the1003
computer is a laptop, explain what steps will be taken to ensure that it is not lost or stolen, especially1004
when it is transported. The U.S. (as well as the European Union and a growing number of other1005
countries) have rules and laws (privacy laws) governing the online storage and transmission of1006
information which may be considered private or individually identifiable.1007
3.6.3 The Internet and "Public Behavior"1008
The internet has greatly complicated drawing the distinction between "public" and "private"1009
behavior. There may be some chat rooms in which participants have no expectation of privacy and are1010
aware of the presence of "lurkers," and thus observing behavior there may not be troublesome as long as1011
nothing is recorded that would identify the participant.1012
However, there are internet environments which participants consider to be at least somewhat1013
private - for example, a chat room dedicated to those with a certain medical condition; and they would1014
consider it an invasion of their privacy to have their conversations reported beyond that environment. 1015
In some cases, the content of the information being collected may warrant its designation as private,1016
even if it is being collected from public sources. Any discussion of illegal behavior, for example, should1017
be considered as inherently private; and special measures should be taken to disguise any identifying1018
details.1019
The burden of proof falls on the investigator to provide evidence that participants in a given web1020
environment have no reasonable expectation of privacy. Relevant language from the site's own1021
description of itself and/or communications with those who manage the site should be quoted in the1022
Form B.1023
3.6.4 Recruitment in Internet Research1024
The use of web resources for recruitment must also be handled carefully. To go into a chat room or1025
to send messages to contributors to a listserv or bulletin board which the participants consider private1026
and then to solicit participation in one's research is no less an intrusion than it would be for a researcher1027
to walk into an Oncologist's waiting room or the Oncology wing of a hospital and begin soliciting1028
-31-
participation. In the medical setting, it is customary to ask the physician to make first contact with1029
patients and give them information that would allow them to contact the researcher if they are interested1030
in participating in the research. A similar strategy should be used online. A message to the manager of1031
the chat room, listserv, or bulletin board asking them to pass along information about the research1032
(complete with contact information for the researcher) is more appropriate than direct contact.1033
As with other research, recruitment material and strategies must be reviewed and approved by the1034
IRB before being implemented. This should include a list of internet sites to be approached, with1035
enough information about each one to enable a judgment as to the appropriateness of the strategy. 1036
3.6.5 Privacy and Confidentiality in Internet Research1037
Use of the screenname chosen by a participant cannot be considered to confer anonymity. People1038
sometimes incorporate into their screnname a part of their name or something descriptive about them1039
that might allow them to be identified. And, even if it could never be correlated with their "offline"1040
(real-world) identity, there can be questions of violating the privacy of their online persona - revealing1041
something about them to others to whom they have chosen not to disclose this. A new pseudonym,1042
unrelated to the self-chosen one, should be substituted in publications and presentations.1043
It is not strictly true to say: "participants cannot be identified because it is a web-based survey."1044
There are often ways to trace back to the particular computer from which the survey was taken, and this1045
might identify the participant if she or he is the sole user of that computer or if a computer-lab log might1046
reveal who was using a certain computer at a given time. A more complete protection is for the1047
researchers to promise solemnly that they will make no attempt to trace the identity of the respondent.1048
(This might especially be a problem if the survey led the respondent to describe behavior that the1049
researcher might be legally required to report, such as child abuse.)1050
If contact information is to be gathered in order to direct an incentive such as a gift card, care must1051
be taken to separate this information from the responses to the questionnaire. Gathering this information1052
in a separate file may not be enough to preserve anonymity - if, for example, a print-out of the contact1053
list could be matched one-on-one to a list of the responses. It may be necessary to scramble the order of1054
one of these files to prevent linking the respondent to the response.1055
If identifying information is retained (to allow a follow-up survey at a later date, for example) care1056
must be taken to separate any files that would link respondent to response - the lists should be kept on1057
different strong-password-protected computers or, at the very least, in different directories of a1058
computer with each directory having a different strong password.1059
True anonymity is possible only if no identifying information is gathered (or traced). However, be1060
advised that the request to waive documentation of consent in this way requires some specific findings1061
on the part of the IRB. See Section 4.7 of this Guide for details.1062
Federal legislation offers special protections for children: Children's Online Privacy Protection Act1063
of 1998 (COPPA) http://www.ftc.gov/ogc/coppa1.htm 1064
3.6.6 Skype1065
Interviews conducted via Skype (or other internet audio- and/or video-device) are not anonymous1066
since the individual can be identified by image and/or voice. Confidentiality can be maintained if no1067
identifying details are given in research notes on the exchange. If voice or image is recorded, then all the1068
issues raised above about audio- and video-recording come into play.1069
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3.6.7 Informed Consent Online1070
An informed consent document does not serve its purpose unless it is read. There may be a1071
temptation on the part of potential participants to skip reading a lengthy consent document (like we all1072
do with the user agreements we are often confronted with in connection with new software). Some1073
researchers avoid this by mechanisms like placing checkboxes beside each paragraph to be checked1074
after that paragraph is read.1075
3.6.8 Risk in Internet Research1076
In a face-to-face interview, it will be pretty obvious if the respondent becomes upset at a question.1077
Even if the respondent is filling out a questionnaire in a classroom, an observant researcher can notice1078
signs of agitation - and there is someone ready at hand for the participant to turn to. However, these1079
clues are not available when a participant is filling out an online survey. When sensitive subjects are1080
being dealt with, provision must be made to offer online support to participants who become1081
emotionally distraught. We propose that a list of resources - including local resources if possible - be no1082
more than one click away at every point in the survey.1083
3.7 Procedures for Projects that Require Approval from Other UT Knoxville1084
Compliance Committees1085
Projects that involve the use of animals, radioactive substances, or biological dangers in addition to1086
human participants require approval from separate UT Knoxville institutional committees. These1087
committees share in the responsibility for protecting participants and researchers, but the final authority1088
with respect to the protection of human participants rests with the UT Knoxville IRB. 1089
If your project requires approval from another institutional committee, the appropriate applications1090
may be submitted to all the UT Knoxville institutional committees at the same time. However, final UT1091
Knoxville IRB approval to move forward with participant contact, recruitment, and enrollment will be1092
contingent on project approval from the other UT Knoxville institutional committees, as well as1093
approval from the UT Knoxville IRB. If you have questions about the need to submit project1094
applications to more than one UT Knoxville institutional compliance committee, please contact the IRB1095
Administration at 974-3466.1096
3.8 Application Procedures for Off-Campus Research1097
If your project involves the use of non-UT Knoxville facilities as research sites or recruitment sites,1098
then you must obtain letters of compliance from authorized individuals or committees, and/or IRB1099
approvals at those sites. Letters of compliance are obtained when the facility does not have its own1100
approved Federal-Wide Assurance (FWA) and IRB. These letters must be on the facility's letterhead,1101
and contain the statement that the organization will review and comply with procedures approved by the1102
UT Knoxville IRB. If the facility has an approved FWA and IRB, then that IRB must also review and1103
approve your project application before it receives final approval from the UT Knoxville IRB.1104
If your project requires letters of compliance or approval from an IRB at another facility, you may1105
submit your Form A or B to the UT Knoxville IRB before you receive approval from the non-UT1106
Knoxville facilities. However, final UT Knoxville IRB approval to move forward with participant1107
contact, recruitment, and enrollment will be contingent on project approval from the other IRB, or the1108
IRB Administration's receipt of an acceptable letter of compliance, as well as approval from the UT1109
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Knoxville IRB. If you have questions about the need to obtain letters of compliance or IRB approvals1110
from non-UT Knoxville facilities, please contact the IRB Administration at 974-3466.1111
3.8.1 Relationship with the Graduate School of Medicine IRB1112
If the research is to be conducted at the UT Medical Center at Knoxville, the Graduate School of1113
Medicine IRB should be listed as first review. A second IRB application should be submitted to the UT1114
Knoxville IRB for review as well. In most (but not all) cases, this IRB will accept the review of the1115
Graduate School of Medicine to expedite our review and approval. We reserve the right to refer the1116
proposal to full board review if it raises concerns in the mind of the expedited-process reviewer.1117
If the only involvement of the UT Knoxville campus in the study is to recruit participants from1118
among students or staff for a study being conducted in the clinical facilities at UT Medical Center at1119
Knoxville, then a copy of the IRB form and consent form submitted to the Graduate School of Medicine1120
IRB should be submitted to the IRB Administrator for review and recommendations.1121
3.8.2 Research Conducted on the Knoxville Campus by Outside Researchers1122
The UT Knoxville IRB must approve any research conducted on the Knoxville campus, whether by1123
researchers from our own institution or by those from other institutions. A copy of the protocol that was1124
approved by the researcher's home institution, along with the letter of approval, should be submitted to1125
the IRB Administrator. We do not generally require that a separate Form B be prepared. The IRB1126
Administrator will contact the unit on this campus where participation is being requested to make1127
certain that they are agreeable to having the research conducted within their unit. If they are, the1128
protocol can generally be approved through expedited review. However, if the proposed research raises1129
any concerns, the protocol will be referred to full board review (and, at this point, a Form B may be1130
required).1131
3.8.3 International Research1132
Federal regulations specify that research conducted in foreign countries must follow U.S.1133
guidelines, even when they are more stringent than the requirements of the host country. In addition,1134
review mechanisms and requirements of the host country must also be honored. Accordingly, the UT1135
Knoxville IRB will require documentation that host country guidelines are being followed in the same1136
way we require documentation from another institution in the U.S. where research is being conducted.1137
OHRP maintains a a listing of over 1,000 laws, regulations, and guidelines on human subjects1138
protections in over 100 countries and from several international organizations at1139
http://www.hhs.gov/ohrp/international/index.html.1140
3.9 Advertising to Recruit Participants1141
All advertisements, posters, flyers, and correspondence aimed at attracting potential research1142
participants must be provided as a part of Form A or Form B applications. If these materials are not1143
available when the research application is submitted, they must be submitted and reviewed before final1144
approval can be granted. Only reviewed and approved recruiting materials may be used. 1145
In general, recruiting materials should contain contact information, an accurate and brief description1146
of the research objectives, and basic eligibility criteria. The documents should also indicate whether1147
participants will be paid or receive free treatments as an incentive to participate.1148
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3.10 General Policy on the use of Children in Research1149
Federal regulations [Title 45 CFR Part 46, Subpart D] require that the researchers explicitly address1150
the measures taken to protect the welfare and rights of children participating in research projects. At the1151
University of Tennessee, the adequacy of these measures is assessed by the UT Knoxville IRB during1152
the review process. Because of the potential vulnerability of children, a higher standard of protection1153
must be demonstrated for approval. As a result, all research involving children requires expedited or1154
full-IRB review of Form B applications. Minimal risk projects that would normally be considered1155
exempt from IRB review (Form A applications) are not exempt when children are involved.1156
Please note that you may not initiate contact with potential child-participants, or begin data1157
collection, before you have received final approval from the IRB. Although Form B applications take1158
longer to prepare and review than Form A applications, most Form B applications are reviewed and1159
approved within three weeks of submission (expedited review). However, the approval process1160
sometimes takes longer than this, especially if significant revisions are required. Therefore, please give1161
yourself adequate time to prepare and submit your application. Please understand that the complexity of1162
your project and the initial quality of your application affect the time required for approval.1163
Section 9.2 of this guide addresses several significant areas of concern that commonly arise during1164
IRB reviews of research involving children. When preparing your Form B application, follow the Form1165
B Application Guidelines in. Section 8 of this guide.1166
If you have additional questions about your specific research project or need further clarification,1167
please contact the IRB Administration at 974-3466.1168
3.11 General Policy on the use of Vulnerable Individuals in Research1169
The UT Knoxville IRB is required to determine that the selection of research participants is1170
equitable. 1171
In addition to children, the U.S. Department of Health and Human Services (DHHS) recognizes1172
three other groups as vulnerable populations: pregnant women, prisoners, and individuals who may be1173
decisionally impaired. The DHHS also considers other individuals vulnerable if they are identified as1174
potential participants because of their availability, compromised positions, or potential susceptibility to1175
manipulation (e.g., students, subordinate employees, economically or educationally disadvantaged1176
individuals) rather than for reasons directly related to the objectives of the study. As a result, the UT1177
Knoxville IRB must also determine that the identification and selection of potential research participants1178
from vulnerable populations is reasonable and not opportunistic. 1179
This added scrutiny should not be interpreted as a signal to avoid the use of individuals from1180
vulnerable populations in your research. Adequate representation of individuals from all vulnerable1181
populations is important, especially in research that relates directly to issues, disorders, or conditions1182
that disproportionately affect members of vulnerable populations. The other side of the IRBs mandate to1183
ensure that selection of participants is equitable is to question whether people are excluded from1184
participation for reasons that amount to discrimination against them.1185
Please note that Form B applications must be used for research involving persons from vulnerable1186
populations. As researchers prepare their Form B applications, they should state why their research1187
requires or justifies using individuals from vulnerable populations, and identify any special risks posed1188
by the research methods. When appropriate, researchers should specify mechanisms that will be used to1189
reduce pressures on susceptible or compromised populations. For additional information about the UT1190
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Knoxville IRB policies concerning projects that will use vulnerable individuals as research participants,1191
please refer to Section 9 of this guide. If you have additional questions, please contact the IRB1192
Administration at 974- 3466. 1193
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Section 4. Informed Consent Procedures1194
1195
Section 4 Contents1196
4.1 General Policy on Informed Consent. . . . . . . . . . . . . . . . . . . . . . . . . . . . 371197
4,2 Basic Elements of Informed Consent. . . . . . . . . . . . . . . . . . . . . . . . . . . . 371198
4.2.1 Additional Elements of Informed Consent. . . . . . . . . . . . . . . . . . 381199
4.3 Sample Informed Consent Document.. . . . . . . . . . . . . . . . . . . . . . . . . . . 391200
4.3.1 Additional Notes to Investigators. . . . . . . . . . . . . . . . . . . . . . . . . 411201
4.4 Sample Short Form Consent Document. . . . . . . . . . . . . . . . . . . . . . . . . . 421202
4.4.1 Sample Information Sheet.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 431203
4.5 Pregnancy and Consent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 451204
4.6 Waiving or Altering Elements of Informed Consent. . . . . . . . . . . . . . . . 451205
4.7 Waiving the Requirement of Written Documentation of Informed 1206
Consent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 451207
4.8 Health Insurance Portability and Accountability Act (HIPAA). . . . . . . . 461208
4.8.1 Subject Authorization to Use and Disclose Individually 1209
Identifiable Health Information in Research. . . . . . . . . . . . . . . . . 461210
4.9 Foreign-Language Consent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 481211
4.1 General Policy on Informed Consent1212
Informed consent is a core element in the protection of research participants' rights and welfare.1213
Investigators must also recognize that informed consent is an ongoing process that assures participants 1214
are provided information about the research needed to knowledgeably and voluntarily decide whether to1215
participate and to continue to participate. Investigators should seek consent only under circumstances1216
which provide the prospective participants sufficient opportunity to consider whether to participate, and1217
which minimize the possibility of coercion or undue influence. Consent and information forms must be1218
written in language that is understandable and clear to potential participants. The consent process may1219
not include exculpatory statements through which participants waive or appear to waive any legal rights,1220
or release or appear to release the investigator, sponsor, institution, or agents from liability for1221
negligence.1222
For research involving children, see parental permission and assent procedures described in Section1223
9.2.3 of this guide.1224
4.2 Basic Elements of Informed Consent1225
As you develop your consent form or procedure, federal regulations [45 CFR 46.116(a)] require1226
that you include the following information. 1227
! State that the study involves research. 1228
! Explain the purposes of the research and the expected duration of the participants' participation. 1229
! Describe the procedures that directly involve human participants, and identify any procedures that are1230
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experimental.1 1231
! Describe any foreseeable risks or discomforts to participants. 1232
! Describe any benefits to participants or to others that may reasonably be expected from the research.2 1233
! Disclose alternative procedures or courses of treatment, if any, that might be advantageous to1234
participants. 1235
! Describe the extent to which confidentiality of records identifying participants will be maintained, that1236
the records will be stored securely on the UT Knoxville campus3, and who will have access to the1237
records.1238
! For research involving more than minimal risk, explain whether any compensation or medical1239
treatments are available if injury occurs. If compensation or treatments are available, they should be1240
described. The procedures for obtaining additional compensation/treatment information should be1241
stated. 1242
! Identify the persons participants can contact for answers to pertinent questions about the research1243
(usually the PI or a representative), and participants' rights (usually the IRB Administrator). 1244
! State that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to1245
which participants are otherwise entitled, and that participants may discontinue participation at any time1246
without penalty or loss of benefits to which they are otherwise entitled.41247
4.2.1 Additional Elements of Informed Consent1248
The following are among the additional elements of informed consent that may be required in1249
certain situations, as determined by the IRB [45 CFR 46.116(b)]:1250
! A statement that the particular treatment or procedure may involve risks to the participant that are1251
unforeseeable.1252
! Anticipated circumstances under which a participant's participation may be terminated by the1253
investigator without regard to the participant's consent. 1254
! Any additional costs to the participant or to their health insurance that may result from participation in1255
the research.1256
! The consequences of a participant's decision to withdraw from the research, and procedures for orderly1257
1It is also helpful to identify what elements are NOT experimental. For example, in a study to test certaininnovative approaches to math instruction, the student who declines to participate in the research may be spared taking certaintests whose sole purpose is to evaluate the effectiveness of this approach and, perhaps the student will by-pass certainsupplemental instruction - but the student needs to know that she or he will NOT be able to by-pass math class or regularmath tests by declining to participate in the research.
2It is important to distinguish benefits from incentives. Incentives are things (e.g., cash payments, gifts, parkingpasses, course extra credit) which participants receive to entice them to agree to participate. Benefits stem from the researchactivity itself - e.g., better math skills. To say something like “participants will gain an understanding of the process ofresearch” is also somewhat extraneous to the specific research. Any benefits that might stem from these particular researchactivities are the key things to indicate here.
3It is safest not to tell participants exactly WHERE on the Knoxville campus material will be stored - although theIRB expects that specific information in the Form B.
4The phrase “or loss of benefits to which you are otherwise entitled" should be used only in situations in whichthere are benefits to which participants are otherwise entitled - e.g., service settings.
If part or all of promised incentives will be withheld from those who withdraw before the research activities arecompleted, this must be clearly stated.
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termination of participation. 1258
! A statement that significant new findings developed during the course of the research that may relate to1259
the participant's willingness to continue participation will be provided to the participant. 1260
! The approximate number of participants involved in the study.1261
If you have any questions about preparing an informed consent form or procedure, please check1262
with your Departmental Review Committee or the IRB Administration at (974-3466).1263
4.3 Sample Informed Consent Document1264
(Include or exclude information as applicable)1265
======================= Beginning of Sample Consent =========================1266
INFORMED CONSENT STATEMENT1267
[List project title here]1268
INTRODUCTION1269
State that participants are invited to participate in a research study. State the purpose/1270
objectives of the study. 1271
INFORMATION ABOUT PARTICIPANTS' INVOLVEMENT IN THE STUDY1272
List all procedures, preferably in chronological order, that will be employed in the study.1273
Point out any procedures that are considered experimental. Clearly explain technical and1274
medical terminology using nontechnical language. Explain all procedures using language that1275
is appropriate for the expected reading level of your participants.1276
State the amount of time required of participants per session and for the total duration of1277
the study. 1278
If audiorecording or videorecording procedures are going to be used, provide information1279
about the use of these procedures. (If applicable, please review section 3.5 of this Guide.) 1280
If you are planning to include children in your study, please review Section 9.2 of this1281
Guide. 1282
For other vulnerable participants, consult the appropriate sub-section of Section 9.1283
RISKS AND PROTECTIONS1284
List all reasonably foreseeable risks, if any, of each of the procedures to be used in the1285
study, and any measures that will be used to minimize the risks.11286
1Virtually no activity is entirely free from risk In filling out a benign questionnaire, the participant mightexperience a paper cut. Thus, “This research carries minimal risk.” is more appropriate than “This research poses no risk.”
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BENEFITS1287
List the benefits you anticipate will be achieved from this research, either for the1288
participants, for others, and/or for the body of knowledge.1289
COMPENSATION (If applicable to your study, add compensation information here)1290
Indicate what compensation (including course credit) participants will receive for their1291
participation in this study. Indicate other ways participants can earn the same amount of1292
course credit. State whether participants will be eligible for compensation if they withdraw from1293
the study prior to its completion. If compensation is pro-rated over the period of the1294
participant's involvement, indicate the points/stages at which compensation changes during the1295
study.1296
CONFIDENTIALITY 1297
If appropriate, state that the information in the study records will be kept confidential. Data1298
will be stored securely and will be made available only to persons conducting the study. State1299
that no reference will be made in oral or written reports which could link participants to the1300
study.11301
Specify who will have access to potentially identifiable data (e.g., transcriptionist,1302
qualitative research group) and make it clear that they will pledge confidentiality.1303
EMERGENCY MEDICAL TREATMENT (appropriate only if there is some risk of harm or injury1304
as a result of the study) The University's General Counsel recommends the following language1305
here: 1306
The University of Tennessee does not "automatically" reimburse participants for medical1307
claims. If harm or injury is suffered in the course of research, please notify the investigator in1308
charge. (List investigator's name and telephone number).1309
CONTACT INFORMATION 1310
If you have questions at any time about the study or the procedures, (or you experience1311
adverse effects as a result of participating in this study,) you may contact the researcher,1312
[Name], at [Office Address], [Office Phone Number] or [e-mail address]. If you have questions1313
about your rights as a participant, contact the IRB Administrator in the Office of Research at1314
(865) 974-3466 or [email protected]
{Note: Although we encourage the use of an office phone number and discourage the use1316
of a home phone number, we recognize that many people nowadays use a cell phone as their1317
primary contact number and thus we will approve substitution of a cell phone number if given a1318
satisfactory rationale for its use.}1319
1If you would like to identify participants in publications (as might be the plan, for example, in an oral history inwhich participants would want to be identified with their stories), you should add to this sentence the phrase: "unlessparticipants specifically give permission in writing to do otherwise" and then add a section below the general consent toparticipate in the study requesting consent to use the persons' name (and perhaps offering to use a pseudonym of the person'schoosing as an alternative).
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PARTICIPATION 1320
Your participation in this study is voluntary; you may decline to participate without penalty.1321
If you decide to participate, you may withdraw from the study at anytime without penalty and1322
without loss of benefits to which you are otherwise entitled.1323
Explain what will be done with the data already collected if the participant withdraws from1324
the research.1325
Say something like EITHER 1326
"If you withdraw from the study before data collection is completed, your data will be1327
returned to you or destroyed"1328
OR 1329
"If you withdraw from the study, data gathered to that point will be retained for analysis to1330
the extent necessary for completing the research."1331
Explain to the IRB (in the Methods section of the Form B) the basis of the need to retain it.1332
{Note: Please delineate the "Consent" section of the Informed Consent Form by drawing a1333
line across the page. This delineation is especially important when your consent form grammar1334
shifts from second person to first person, as shown in this example.)1335
CONSENT 1336
I have read the above information and had all my questions answered. I have received a1337
copy of this form. I agree to participate in this study.1338
_____________________________________________ ________________________1339
Participant's signature Date 1340
======================== End of Sample Consent ============================1341
4.3.1 Additional Notes to Investigators:1342
! Researchers are urged by the Committee to use the wording in the checklist and follow the format in the1343
sample, unless researcher-supported reasons are provided for alternative wording. Use of alternative1344
wording or different format may slow down the review process. All sections of the consent form, except1345
the "Consent Section" should be written in second person ("You are invited..."). Use of first person ("I")1346
can be interpreted as suggestive and coercive. 1347
! Be sure to follow the directions for preparing the signature lines. Separate forms should be prepared1348
when minors are used; one for the minor’s assent and one for the parent’s permission. See Section 9.2.31349
of this guide for further instructions about preparing these forms.1350
! If your form is more than one page, there should be a line at the bottom of each page for the subject's1351
initials, except for the last page where the signature is obtained. 1352
! Be sure to include all elements of informed consent that are appropriate to your study. If they apply to1353
your study, they must be included. On the other hand, sections like the “Emergency Medical1354
Treatment” section do not need to be included unless the nature of the research poses some risk of1355
physical injury. For example, filling out a questionnaire is unlikely to involve such a risk.1356
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! Statements like “This project has been approved by the University of Tennessee Knoxville Institutional1357
Review Board” are not appropriate in the consent form. This might suggest a stronger endorsement by1358
the IRB than is warranted. All we actually do is to rule that your proposal meets minimal standards of1359
acceptability. 1360
4.4 Sample Short Form Consent Document1361
There are times when it is most appropriate to conduct the consent procedure orally rather than in a1362
written document. To allow for this, regulations permit the IRB to authorize the use of a "short form" in1363
place of the standard consent form. [45 CFR 46.117(b)(2)] The short form states that the details of the1364
project have been explained orally and the person consents to participate.1365
========================= BEGIN Sample Short Form =========================1366
Consent to Participate in Research1367
You are being asked to participate in a research study.1368
Before you agree, the investigator must tell you about (i) the purposes, procedures, and1369
duration of the research; (ii) any procedures which are experimental; (iii) any reasonably1370
foreseeable risks, discomforts, and benefits of the research; (iv) any potentially beneficial1371
alternative procedures or treatments; and (v) how confidentiality will be maintained.1372
Where applicable, the investigator must also tell you about (i) any available compensation1373
or medical treatment if injury occurs; (ii) the possibility of unforeseeable risks; (iii)1374
circumstances when the investigator may halt your participation; (iv) any added costs to you or1375
your insurance; (v) what happens if you decide to stop participating; (vi) when you will be told1376
about new findings which may affect your willingness to participate; and (vii) how many people1377
will be in the study.1378
If you agree to participate, you must be given a signed copy of this document and a written1379
summary of the research.1380
You may contact the researcher, [Name], at [Office Address], [Office Phone Number] or1381
[e-mail address] any time you have questions about the research or what to do if you are1382
injured.1383
You may contact the UT Knoxville IRB Administrator at (865) 974-3466 or1384
[email protected] if you have questions about your rights as a research participant.1385
Your participation in this research is voluntary, and you will not be penalized or lose1386
benefits if you refuse to participate or decide to stop.1387
Signing this document means that the research study, including the above information, has1388
been described to you orally, and that you voluntarily agree to participate.1389
___________________________________________ ____________1390
Signature of participant date1391
___________________________________________ ____________1392
Signature of witness date1393
========================= END Sample Short Form ==========================1394
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NOTE the line provided for a witness. This is required by federal regulations. The witness attests to1395
both the fact that a detailed oral explanation of the research was provided and that the participant1396
willingly consented.1397
4.4.1 Sample Information Sheet 1398
The regulations require that a written summary of the oral presentation be provided. A copy must1399
be included in the Form B so the IRB can evaluate its adequacy, and a copy must also be made available1400
to the participant following the oral presentation. We recommend the following format for this1401
summary.1402
====================== BEGIN Sample Information Sheet =======================1403
Sample Information Sheet1404
Include or exclude information as applicable.1405
If you have any questions, please contact the IRB Administration at 974-3466.1406
[List title of study here]1407
INTRODUCTION1408
State that participants are invited to participate in a research study. State the1409
purpose/objectives of the study. 1410
INFORMATION ABOUT PARTICIPANTS' INVOLVEMENT IN THE STUDY1411
List all procedures, preferably in chronological order, that will be employed in the study.1412
Point out any procedures that are considered experimental. Clearly explain technical and1413
medical terminology using nontechnical language. Explain all procedures using language that1414
is appropriate for the expected reading level of your participants.1415
State the amount of time required of the participant per session and for the total duration of1416
the study.1417
RISKS1418
List all reasonably foreseeable risks, if any, of each of the procedures to be used in the1419
study, and any measures that will be used to minimize the risks.1420
BENEFITS1421
List the benefits you anticipate will be achieved from this research, either to the1422
participants, others, or the body of knowledge.1423
COMPENSATION (If applicable to your study, add compensation information here)1424
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Indicate what compensation (including course credit) participants will receive for their1425
participation in this study. Indicate other ways participants can earn the same amount of1426
course credit. State whether participants will be eligible for compensation if they withdraw from1427
the study prior to its completion. If compensation is pro-rated over the period of the1428
participant's involvement, indicate the points/stages at which compensation changes during the1429
study. 1430
CONFIDENTIALITY (This section can be omitted for anonymous surveys.)1431
State that the information in the study records will be kept confidential. Data will be stored1432
securely and will be made available only to persons conducting the study unless participants1433
specifically give permission in writing to do otherwise. No reference will be made in oral or1434
written reports which could link participants to the study.1435
Specify who will have access to potentially identifiable data (e.g., transcriptionist,1436
qualitative research group) and make it clear that they will pledge confidentiality.1437
CONTACT (Use the following contact information format in your information sheet)1438
If you have questions at any time about the study or the procedures, you may contact the1439
researcher, [Name] , at [Office Address] , or [Office Phone Number] or [e-mail address]. If you1440
have questions about your rights as a participant, contact the IRB Administration at (865) 974-1441
3466 of [email protected]. 1442
PARTICIPATION (Use the following voluntary participation information in your information1443
sheet.)1444
Your participation in this study is voluntary, you may decline to participate without penalty.1445
If you decide to participate, you may withdraw from the study at anytime without penalty and1446
without loss of benefits to which you are otherwise entitled.1447
Explain what will be done with the data already collected if the participant withdraws from1448
the research.1449
Say something like EITHER 1450
"If you withdraw from the study before data collection is completed, your data will be1451
returned to you or destroyed"1452
OR 1453
"If you withdraw from the study, data gathered to that point will be retained for analysis to1454
the extent necessary for completing the research."1455
Explain to the IRB (in the Methods section of the Form B) the basis of the need to retain it.1456
===================== END of Sample Information Sheet ========================1457
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4.5 Pregnancy and Consent1458
For any research which includes procedures or elements that might pose a risk to the fetus, the1459
consent form should include a sentence along the lines of the following: "You are not pregnant, nor are1460
you likely to become pregnant during the course of this research."1461
4.6 Waiving or Altering Elements of Informed Consent1462
The IRB can authorize a consent procedure which does not include or which alters some or all the1463
elements of consent or even waive the requirement to obtain consent, but only if the following four1464
conditions are met: [45 CFR 46.116(d)]1465
1. The research involves no more than minimal risk to the subjects;1466
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;1467
3. The research could not practicably be carried out without the waiver or alteration; and1468
4. Whenever appropriate, the subjects will be provided with additional pertinent information after1469
participation.1470
The Form B should contain an explicit request for the waiver or alteration, an explanation of the1471
rationale for it, and documentation that the four conditions above are met.1472
If de-briefing is planned following the research activities to provide additional pertinent information1473
after participation, a script for the de-briefing should be included with the Form B. If de-briefing is not1474
planned, a rationale should be included for its omission.1475
There can be several reasons for altering consent procedures. In some cases, the research design1476
requires that participants not be given full information about the focus of the investigation or even that1477
they be deceived as to its real purpose.1478
4.7 Waiving the Requirement of Written Documentation of Informed Consent1479
The IRB can waive the requirement for a signed consent form when either of the following1480
conditions is met: [45 CFR 46.117(c)]1481
1. (a) the only record linking the participant and the research would be the consent document and (b) the1482
principal risk would be potential harm resulting from a breach of confidentiality. In general, each1483
participant will be asked whether she or he wants documentation linking them with the research, and the1484
participant's wishes will govern; or1485
2. the research presents no more than minimal risk of harm to participants and involves no procedures for1486
which written consent is normally required outside of the research context.1487
In cases in which the documentation requirement is waived, the IRB may require the investigator to1488
provide participants with a written statement regarding the research (see the Information Sheet discussed1489
above in Section 4.4.1).1490
Cases in which this sort of waiver is especially appropriate include 1491
• surveys dealing with sensitive issues in which no individually identifiable information is gathered, so1492
participation would be anonymous without a signed consent form. A statement should be included on1493
the survey form that says something like "Completion of this survey constitutes consent for participation1494
in this study."1495
• interviews that will be audiorecorded and then transcribed and the recording destroyed so that, although1496
the recorded voice precludes anonymity, identification of the participant will no longer be possible after1497
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the destruction of the recording. In these cases, the participant can voice consent at the beginning of the1498
recording. The researcher's explanation of the research may also be recorded.1499
1500
4.8 Health Insurance Portability and Accountability Act (HIPAA)1501
The Privacy Rule which was developed under this legislation puts significant limitations and1502
regulations on the disclosure of Protected Health Information (PHI). The Rule applies only to health1503
care entities which engage in electronic transactions (e.g., filing claims to insurance companies1504
electronically). These are called “Covered Entities” in the regulation.1505
On the UT Knoxville campus, there is only one covered entity: the Student Health Service.1506
However, two additional entities have agreed to voluntarily comply with the Privacy Rule regulations in1507
order to train their students in the regulations and to extend this further protection to their clients. These1508
two units are: the Psychological Clinic and the Speech and Hearing Center. 1509
The HIPAA Privacy Rule stipulates that patients must give explicit consent for the release of any1510
PHI. Here is the wording we suggest to convey the information that is required:1511
4.8.1 Subject Authorization to Use and Disclose Individually Identifiable Health Information1512
in Research1513
1514
CONFIDENTIALITY1515
1. Provide a statement explaining how individual identifiers will be used in maintaining the1516
research records. (E.g., "Your research record will be labeled with your name." or "Your research record1517
will be labeled with a code number. A master key that links your name and the code number will be1518
maintained in a separate and secure location.") 1519
2. If the study involves the use of a federal Certificate of Confidentiality, provide the information1520
about the certificate and how it protects subject information from re-disclosure.1521
3. If information about the subject's participation in the study or the results of procedures performed1522
in the study will be placed in the subject's clinic record (as contrasted with the research record), then this1523
should be explained. Indicate that information placed in the medical record may be available to the1524
participant's insurer.1525
4. State that individual subjects will not be identified in any presentations or publications based on1526
the results of the research study.1527
5. Insert the HIPAA authorization portion of the confidentiality section. [template below]1528
================= BEGIN Template for Confidentiality Section =====================1529
TEMPLATE FOR HIPAA PORTION OF THE CONFIDENTIALITY SECTION OF THE1530
STUDY CONSENT FORM1531
The subject authorization language provided below should be inserted at the appropriate1532
location in the confidentiality section of the study consent form. The language in the template1533
should be precisely followed. The material in Roman type is the required authorization1534
language. The italicized material in parentheses provides directions for including material1535
that may or may not be relevant for particular studies. Material in bold italics indicates1536
-46-
specifications to be added.1537
Under federal privacy regulations, you have the right to determine who has access to1538
your personal health information (called "protected health information" or PHI). PHI collected in1539
this study may include [specify what information will be shared with researchers], as well1540
as basic demographic information. By signing this consent form, you are authorizing the1541
research team at the University of Tennessee to have access to your PHI collected in this1542
study (if the study will use PHI in the possession of another covered entity, add) and to receive1543
your PHI from (either) your physician (and/or) facilities where you have received health care. (If1544
the study is multi-institutional, add the following sentence.) In addition, your PHI may be1545
shared with other persons involved in the conduct or oversight of this research, including1546
researchers at [name of the institution(s)]. The Institutional Review Board (IRB) at the1547
University of Tennessee Knoxville may review your PHI as part of its responsibility to protect1548
the rights and welfare of research subjects. Your PHI will not be used or disclosed to any other1549
person or entity, except as required by law, or for authorized oversight of this research study1550
by other regulatory agencies, or for other research for which the use and disclosure of your1551
PHI has been approved by the IRB. Your PHI will be used only for the research purposes1552
described in this consent form. Your PHI will be used 1553
(either) until the study is completed 1554
(or) until [insert ending date] 1555
(or if the data is to be archived and made available for future studies within the scope1556
specified in the consent form) indefinitely.11557
You may cancel this authorization in writing at any time by contacting the principal1558
investigator listed on this consent form. If you cancel the authorization, continued use of your1559
PHI is permitted if it was obtained before the cancellation and its use is necessary in1560
completing the research. However, PHI collected after your cancellation may not be used in1561
the study. If you refuse to provide this authorization, you will not be able to participate in the1562
research study. If you cancel the authorization, then you will be withdrawn from the study.1563
Finally, the federal regulations allow you to obtain access to your PHI collected or used in this1564
study. (If the research study includes a component that would be kept secret from participants1565
while it is being conducted, add the following sentences.) However, in order to complete the1566
research, your access to this PHI may be temporarily suspended while the research is in1567
progress. When the study is completed, your right of access to this information will be1568
reinstated.1569
==================== END Template for Confidentiality Section ===================1570
UT Knoxville faculty, staff, and students may encounter HIPAA regulations when they conduct1571
research at off-campus covered entities. Researchers are advised to check with appropriate officials of1572
those institutions to see if they require specific HIPAA language which differs from that suggested here.1573
1A rationale must be presented in the Form B for retaining data indefinitely. We recommend a separate signaturebloc on the consent form to authorize retention, which includes a statement of the scope of the uses that will be made of thedata
-47-
The UT Knoxville IRB will need to review and approve any substitutions.1574
4.9 Foreign-Language Consent1575
Federal regulations require that information be provided "in language understandable to the subject"1576
[45 CFR 46.116]. Researchers must supply both the English-language version and the translated version1577
of the consent form or information sheet with the Form B. In addition, the IRB is required to arrange an1578
independent translation of the foreign-language document back into English. It may take some time to1579
find foreign-language-speakers to provide these back-translations, so researchers with foreign-language1580
documents should allow extra time for IRB review1581
1582
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Section 5. Research Exempt from Review: Form A1583
Applications1584
1585
Section 5 Contents1586
5.1 Exempt Research Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 491587
5.2 Minimal Risk Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 491588
5.3 Exempt Research Categories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 501589
5.4 Preparing an Exempt Research Protocol (Form A). . . . . . . . . . . . . . . . . 511590
5.5 Review Procedures for Form A Applications.. . . . . . . . . . . . . . . . . . . . . 521591
5.6 Final Approval Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 521592
5.7 IRB Certification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 531593
5.8 Informed Consent Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 531594
5.9 Investigator Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 541595
5.10 Graduate Students and Advisors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 541596
5.11 Renewal and Termination Procedures for Exempt Projects. . . . . . . . . . 551597
5.11.1 Renewal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 551598
5.11.2 Termination.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 551599
5.1 Exempt Research Overview1600
The human subjects regulations from the U.S. Department of Health and Human Services (DHHS)1601
exempt certain types of research from formal review by Institutional Review Boards (IRB). [45 CFR1602
46.101(b)]1603
However, the judgment as to whether a given research project falls under one of these exemption1604
categories, or whether instead it requires formal review remains a responsibility of the UT Knoxville1605
IRB. A fundamental principle of the federal regulations is that someone other than the researcher must1606
make these judgments. The policy of the UT Knoxville IRB is to assign the first determination as to1607
whether the research fits under exemption categories to the appropriate Departmental Review1608
Committee (DRC), with the decision to be certified by the IRB Administration.1609
Thus, the term "exempt" is somewhat misleading because it only means that a research activity is1610
exempt from formal (full or expedited) review by the UT Knoxville IRB.1611
This process of DRC review and certification by the IRB Administration must be completed prior to1612
commencement of the research. It is the responsibility of investigators to provide the appropriate review1613
documents to their DRC as soon as they know the extent to which humans will serve as participants in1614
their research and then to see that the documents are forwarded to the IRB Administration after DRC1615
review.1616
5.2 Minimal Risk Definition1617
The first criterion for exemption from formal review is that the research be estimated to involve no1618
greater than "minimal risk." Minimal risk in a research activity is defined in the regulations as an1619
anticipated risk of harm that is no greater, considering probability and magnitude, than risks ordinarily1620
encountered in daily life or during the performance of routine physical or psychological examinations or1621
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tests. [45 CFR 46.102(I)]1622
5.3 Exempt Research Categories1623
Research projects that place participants at no more than minimal risk may be "exempted" from full1624
or expedited IRB review if they meet one of the following exemption categories: 1625
The following exemptions do not apply to research involving minors1 (participants under 18 years1626
old), prisoners, fetuses or neonates, or pregnant women. 1627
Departmental Review Committees should use the following category descriptions to determine1628
whether a proposed research project meets the exemption criteria. The DRC report should specify the1629
category that is judged to apply on the approval line of the Form A. If you need clarification or would1630
like representative examples, please contact the IRB Administration at 974-3466: 1631
Category 1: [45 CFR 46.101(b)1]1632
Research conducted in established or commonly accepted educational settings, involving normal1633
educational practices such as, 1634
• research on regular and special education instructional strategies, or 1635
• research on the effectiveness of or the comparison among instructional techniques, curricula or1636
classroom management methods. 1637
Category 2: [45 CFR 46.101(b)2] 1638
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey1639
procedures, interviews, or observation of public behavior. 1640
Category 3: [45 CFR 46.101(b)3]1641
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey1642
procedures, interview procedures, or observation of public behavior that would not be exempt under1643
Category 2 may be exempt if 1644
• participants are elected officials, appointed public officials, or candidates for public office; or 1645
• federal statute(s) require(s) without exception that the confidentiality of the personally identifiable1646
information will be maintained throughout the research and thereafter. 1647
Category 4: [45 CFR 46.101(b)4]1648
Research involving the collection or study of existing data, documents, records, pathological specimens,1649
or diagnostic specimens may be exempt 1650
• if these sources are publicly available or 1651
• if the information is recorded by the investigator in such a manner that participants cannot be identified,1652
directly or through identifiers linked to the participants. 1653
1The exclusion of research involving minors from exemption is not dictated by federal regulations. It is a policydecision made by the UT Knoxville IRB that research involving minors should be given no less than the "expedited" level ofreview in which one of the reviewers has expertise in child development.
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Limitations to Category 4 - The requirement for consent of the participants is waived if the data, documents,1654
records, or specimens are publicly available. The authorization of the custodian of the data or documents, together1655
with the process of removing identifiers, can serve in lieu of specific participant consent for access to the data, in1656
cases in which the data, or records are not publicly available. However, the investigator and the UT Knoxville1657
IRB must be satisfied that the custodian is authorized to release the data for research purposes. Note that some1658
records are by nature confidential (e.g., school records) and others are the property of clients only held in trust by1659
an institution (e.g., patient records). Special care must be taken to ensure that the researcher has the right to access1660
these records - usually requiring the consent of the subject of the records or their legally authorized representative1661
as well as the custodian.1662
Category 5: [45 CFR 46.101(b)5]1663
Research and demonstration projects which are conducted by or subject to the approval of federal1664
department or agency heads, and which are designed to study, evaluate, or otherwise examine: 1665
• public benefit or service programs; 1666
• procedures for obtaining benefits or services under those programs; 1667
• possible changes in or alternatives to those programs or procedures; or1668
• possible changes in methods or levels of payment for benefits or services under those programs. 1669
Category 6: [45 CFR 46.101(b)6]1670
Taste and food quality evaluation and consumer acceptance studies, 1671
(i) if wholesome foods without additives are consumed, or 1672
(ii) foods are consumed that contain a food ingredient at or below the level and for a use found to be1673
safe, or agricultu ral chemical or environmental contaminant at or below the level found to be safe by1674
the Food and Drug Administration or approved by the Environmental Protection Agency or the Food1675
Safety and Inspection Service of the U.S. Department of Agriculture. 1676
5.4 Preparing an Exempt Research Protocol (Form A)1677
Use the Form A application to provide your DRC with the information it needs to determine if your1678
project qualifies as an exempt research activity. You may obtain a copy of the current Form A from your1679
DRC Chair, the IRB Administration at 1534 White Avenue, or by downloading it from the Web site:1680
http://research.utk.edu/forms/index.shtml#c4 1681
Objectives: Briefly state the purpose of the research, with special reference to and emphasis upon1682
the exact procedures in which human subjects will be involved. If the research occurs in a larger1683
context, such as a training program, clearly separate out the research component, describing the1684
remainder as the context of the research. 1685
Subjects: Briefly describe the participants, the criteria of selection or exclusion, the population1686
from which they will be selected, methods of recruitment, the duration of involvement, and any special1687
characteristics they have or must have relative to the research. Form A research is restricted to adults1688
and must not involve persons the IRB classifies as vulnerable (e.g., pregnant women, neonates, persons1689
of questionable decisional capacity). If you make use of a control group as well as an experimental1690
group, be sure to specify the selection methods and source populations for both. 1691
Methods or Procedures: Briefly enumerate, using nontechnical language, the research methods1692
that will involve the use of human subjects. List any potential risks to the subjects along with the1693
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protective measures you will apply to minimize those risks. Give enough information to enable1694
members of the DRC and the IRB Administration to make an informed judgment of the level of risk. If1695
the subjects will remain anonymous, describe how you will accomplish this. Describe how you will1696
secure the confidentiality of the data and the subject identities (if applicable), and note where materials1697
with names will be stored, along with the names of the persons who will have access to the names and1698
data. 1699
In this section, also mention what appropriate method of obtaining informed consent you will use.1700
If consent is to be waived, provide a short justification either in the space available or on an attached1701
sheet. There are certain determinations which must be made in order to waive or alter any aspect of1702
informed consent or its documentation. You must provide enough information in the Form A for the1703
DRC, Department Head, and IRB to certify these determinations. See Sections 4.6 and 4.7 above for1704
lists of the determinations which are required.1705
Category: Referring to the list in Section 5.3 of this document or to the list of exempt categories of1706
research on the reverse side of Form A, cite the paragraph number that you deem entitles your research1707
project to exemption from review by the IRB. If uncertain which paragraph applies to the proposed1708
research, consult with Chair of the Departmental Review Committee or the IRB Administration. 1709
5.5 Review Procedures for Form A Applications1710
Procedures used to review Form A applications vary between departments. However, all research1711
activities qualify for exemption, if they meet these four criteria:1712
• Participants will be subject to no more than minimal risk; 1713
• The project satisfies the fundamental requirements for the protection of and respect for human1714
participants, including minimizing risk, informed consent, and equitable selection of subjects1715
• The participants are not minors (under 18 years old), prisoners, fetuses or neonates, or pregnant; and 1716
• The research activities proposed meet the definitions of one or more the federally approved exempt1717
categories (Section 5.3). 1718
5.6 Final Approval Procedures1719
A DRC can take the following actions: 1720
• Request modifications to the proposed research project or Form A application. 1721
• Recommend final certification of exempt status for a Form A application.1722
This recommendation signifies that the project has been reviewed against the provisions of this section1723
and certification is recommended by the DRC. However, final certification must be granted by the UT1724
Knoxville IRB Administration. The DRC should forward the original signed Form A to the UT Knoxville1725
IRB Administration only after it reviews and recommends approval of a Form A. 1726
Form A applications will either be approved or returned to the DRC for clarification within five1727
working days of receipt by the UT Knoxville IRB Administration. Participant recruitment and data1728
collection may not begin until final certification of exempt status has been granted by the UT Knoxville1729
IRB Administration. 1730
• Reject the Form A application.1731
This recommendation should be used when the DRC does not believe the proposed research is1732
contained within the scope of the outlined exempt categories. The researcher is then free to resubmit a1733
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Form B for the project, requesting either expedited or full board review. The DRC should take this1734
occasion to communicate to the researcher whether they judge it to be eligible for expedited review.1735
5.7 IRB Certification1736
Once the DRC and the Department Head have signed the Form A recommending exemption from1737
full board review, the Form A must be forwarded to the University's Institutional Review Board (IRB) at1738
the IRB Administration Office at 1534 White Avenue. Please note that your department's policy may be1739
that you are responsible for delivering your own application to the IRB Administration, so check your1740
department's procedures to avoid an unnecessary delay. 1741
The paper copy of the Form A application submitted to the IRB Administration must contain1742
original signatures. Once the full application has been received in either paper or electronic format, the1743
IRB Administration staff reviews the application and determines whether it can be certified for1744
exemption.1745
Once the IRB certifies that your project qualifies as exempt, you may initiate your research. If you1746
make significant changes to your research protocol after the Form A has been approved, you should1747
contact the DRC. They may approve minor changes that preserve exempt status. If they determine that1748
the changes are such that they nullify exempt status, contact the IRB Administration staff. You may1749
need to submit additional information about the substance of your project changes and you may even1750
need to complete a Form B at this point. Also, if unforeseen risks to subjects arise as you conduct your1751
research, contact the IRB Administration immediately.1752
If the IRB Administration staff determines that the application must receive either an expedited or1753
full IRB committee review, you and your DRC will be notified of this change in review procedures and1754
you will be asked to complete a Form B for your project. Full IRB committee reviews may take over a1755
month to complete.1756
If revisions are requested in your original plan, you will be given a list of items that must be1757
addressed prior to submission of the Form B to the IRB. You will need to submit your Form B1758
application to your DRC for review. The IRB Administration staff can assist you during the revision1759
process. Consultation is encouraged to speed the process. 1760
5.8 Informed Consent Considerations for Exempt Research1761
Full compliance with regulations includes securing voluntary informed consent from all participants1762
of research prior to the conduct of the research activity involving them. A discussion of informed1763
consent appears in Section 4 of this guide. UT Knoxville investigators conducting exempt research are1764
not exempt from informed consent process or requirements (another way in which the term "exempt" is1765
misleading).1766
If the only document linking the identities of the participants to the research would be the informed1767
consent document, then the requirement for written consent may be waived upon request and1768
justification within Form A. Verbal consent is still required after providing the subject with a fair and1769
reasonable explanation of the research, the participant's role in it, anticipated risks and protection1770
measures, and a statement that the participant is free to withdraw at any time without penalty. (The1771
information to be given to the potential participant verbally must be conveyed to the IRB in written form1772
for review. The format we recommend is the Information Sheet discussed in Section 4.4.1 of this guide.)1773
The potential subject should understand that her or his participation is voluntary, and he/she should1774
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have an opportunity to ask questions about the research. These requirements apply to all direct contacts1775
with subjects and also to research methods such as telephone surveys that are less direct.1776
With mail questionnaires and drop-box surveys, where the respondent remains anonymous, the1777
researcher should provide a similar explanation about the purpose of the research and the procedures for1778
completing the questionnaire. This material may be contained in the cover letter accompanying the1779
questionnaire or at the head of the questionnaire itself. The explanation should close with a statement to1780
the effect that "return of the questionnaire will constitute your informed consent to participate." 1781
Online questionnaires may be treated in the same way, even though they are not, strictly speaking,1782
anonymous since it is possible in principle to trace the IP address of the computer from which they take1783
the survey and this may sometimes amount to identifying the individual. Researchers should include an1784
assurance in the information sheet that they will not make any attempt to trace the identity of the1785
respondent.1786
If the participant does not remain anonymous – that is, if the investigator can initially identify each1787
return with a participant – as is often the case where follow-up questionnaires may be planned – this fact1788
should be revealed to the subject and written consent procedures used. 1789
5.9 Investigator Responsibilities1790
By signing a Form A, you commit yourself to abiding by the regulations governing research1791
involving human participants, including those provisions specifying the means of obtaining informed1792
consent. In addition, you commit yourself to abiding by the applicable ethical standards of your1793
discipline and those found in the Belmont Report. 1794
Research design should meet applicable research ethics standards of the investigator's professional1795
association or society. In all cases, the standards of respect for persons, beneficence, and justice1796
enumerated by the Ethical Principles and Guidelines for the Protection of Human Subjects of Research1797
(the Belmont Report1) apply to all research involving human participants conducted at UT Knoxville. 1798
If your project will make use of the facilities of another institution or a business, obtain letters (on1799
their letterhead) of permission, cooperation, or support to use them and to interact with personnel there.1800
If the institution requires its own research review, you must comply with their review procedures. In1801
such cases, you should note the submission on your Form A and provide a copy of the other location's1802
IRB approval (along with any project modifications the external institution may require) for your UT1803
Knoxville IRB and DRC files. 1804
If any participants suffer adverse reactions occurring during your research, you must notify your1805
DRC and the UT Knoxville IRB. You should also take immediate steps to prevent further problems and1806
indicate those steps taken in your statements to your DRC and the UT Knoxville IRB. 1807
5.10 Graduate Students and Advisors1808
The Graduate School requires every student to verify that they have complied with the appropriate1809
UT Knoxville approval procedures prior to initiation of their thesis- or dissertation-related research.1810
Students should consult with their advisors as they develop research projects and begin to prepare Form1811
A applications. Advisors indicate their review of the student's research project by signing the Form A.1812
An advisor's signature also certifies that the student's research plan was approved by the appropriate1813
1http://ohsr.od.nih.gov/guidelines/belmont.html
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graduate committee.1814
5.11 Renewal and Termination Procedures for Exempt Projects1815
5.11.1 Renewal1816
Certification of exemption from review is not subject to routine continuing review. Unless your1817
research moves in a new direction (e.g., major changes in the objectives or involvement of human1818
participants which would make it no longer eligible for exemption), your department will have1819
responsibility for reviewing and approving changes in your research. Investigators and their DRC are1820
responsible for determining whether the changes will affect the current status of the project or will1821
require a Form B to be submitted for IRB review. If there is any uncertainty about this, consult the IRB1822
Administration at 974-3466.1823
5.11.2 Termination1824
Orderly termination of your project is important. When you complete your research, file a Form D11825
and check the termination box. This will allow your DRC and the UT Knoxville IRB Administration to1826
close your project files. 1827
We would appreciate receiving a copy of any publications that result from the project for the IRB1828
files. 1829
If you have further questions about exempt research, contact the Chair of your Departmental1830
Review Committee, call the UT Knoxville IRB Administration (974-3466), or visit the IRB1831
Administration Office at 1534 White Avenue. 1832
1To find IRB forms online, go to: http://research.utk.edu/forms/index.shtml#c4
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Section 6. Research Eligible for Expedited Review: Expedited1833
Form B Applications1834
Section 6 Contents1835
6.1 General Information about Expedited Review. . . . . . . . . . . . . . . . . . . . . 561836
6.2 Expedited Research Categories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 561837
6.3 Applicability of Expedited Review Categories. . . . . . . . . . . . . . . . . . . . 581838
6.4 Expedited Review Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 581839
6.4.1 Form B. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 591840
6.4.2 Departmental Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 591841
6.4.3 Institutional Review Board Review. . . . . . . . . . . . . . . . . . . . . . . 591842
6.5 Informed Consent Considerations for Expedited Review. . . . . . . . . . . . 601843
6.6 Investigators' Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 601844
6.7 Renewal and Termination Procedures for Expedited Projects. . . . . . . . . 611845
6.7.1 Renewal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 611846
6.7.2 Termination.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 621847
6.1 General Information about Expedited Review1848
An expedited review procedure consists of a review of research involving human subjects by the1849
IRB chairperson and/or by one or more experienced reviewers designated by the chairperson from1850
among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.1851
For OHRP Guidance about the use of this procedure, see:1852
http://www.hhs.gov/ohrp/humansubjects/guidance/exprev.htm 1853
6.2 Expedited Review Categories1854
(List effective November 9, 1998)1855
http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm 1856
For further explanation of the categories that apply especially to social and behavioral research1857
activities, check out the nifty brochure developed by a unit of the National Science Foundation. Go to:1858
http://www.nsf.gov/pubs/2008/nsf08203/index.jsp 1859
Research categories that may be reviewed using expedited review procedures by the UT Knoxville1860
Institutional Review Board (IRB):1861
1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.1862
a. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not1863
required. (Note: Research on marketed drugs that significantly increases the risks or decreases the1864
acceptability of the risks associated with the use of the product is not eligible for expedited review.)1865
b. Research on medical devices for which (I) an investigational device exemption application (211866
CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the1867
medical device is being used in accordance with its cleared/approved labeling.1868
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2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:1869
a. From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts1870
drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently1871
than 2 times per week; or 1872
b. From other adults and children1 considering the age, weight, and health of the subjects, the1873
collection procedure, the amount of blood to be collected, and the frequency with which it will be1874
collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg1875
in an 8 week period and collection may not occur more frequently than 2 times per week. 1876
3. Prospective collection of biological specimens for research purposes by noninvasive means. 1877
4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation)1878
routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where1879
medical devices are employed, they must be cleared/approved for marketing. (Studies intended to1880
evaluate the safety and effectiveness of the medical device are not generally eligible for expedited1881
review, including studies of cleared medical devices for new indications.)1882
Examples:1883
a. Physical sensors that are applied either to the surface of the body or at a distance and do not1884
involve input of significant amounts of energy into the subject or an invasion of the subject's1885
privacy; 1886
b. weighing or testing sensory acuity; 1887
c. magnetic resonance imaging; 1888
d. electrocardiography, electroencephalography, thermography, detection of naturally occurring1889
radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and1890
echocardiography; or1891
e. moderate exercise, muscular strength testing, body composition assessment, and flexibility testing1892
where appropriate given the age, weight, and health of the individual.1893
5. Research involving materials (data, documents, records, or specimens) that have been collected or will1894
be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (Note: Some1895
research in this category may be exempt from the HHS regulations for the protection of human subjects.1896
[45 CFR 46.101(b)(4)]. This listing refers only to research that is not exempt.)1897
6. Collection of data from voice, video, digital, or image recordings made for research purposes.1898
7. Research on individual or group characteristics or behavior (including, but not limited to, research on1899
perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and1900
social behavior) or research employing survey, interview, oral history, focus group, program evaluation,1901
human factors evaluation, or quality assurance methodologies. (Note: Some research in this category1902
may be exempt from the HHS regulations for the protection of human subjects [45 CFR 46.101 (b)(2)1903
and (b)(3)]. This listing refers only to research that is not exempt.)1904
1Children are defined in the HHS regulations as "persons who have not attained the legal age for consent totreatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will beconducted.'' [45 CFR 46.402(a)].
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8. Continuing review of research previously approved by the convened IRB as follows: 1905
a. Where 1906
i. the research is permanently closed to the enrollment of new subjects; 1907
ii. all subjects have completed all research-related interventions; and1908
iii. the research remains active only for long-term follow-up of subjects; or 1909
b. Where no subjects have been enrolled and no additional risks have been identified; or1910
c. Where the remaining research activities are limited to data analysis. 1911
9. Continuing review of research, not conducted under an investigational new drug application or1912
investigational device exemption where the following conditions apply: 1913
a. Categories two (2) through eight (8) do not apply; and 1914
b. The IRB has determined and documented at a convened meeting that the research involves no1915
greater than minimal risk and no additional risks have been identified.1916
6.3 Applicability of Expedited Review Categories1917
A. Research activities may be eligible for expedited review if they present no more than minimal1918
risk to human subjects, and involve only procedures listed in one or more of the nine listed categories.1919
The nine categories of activities listed should not be considered to be of minimal risk simply because1920
they are listed. Inclusion on this list means that the activity is eligible for review through the expedited1921
review procedure when the specific circumstances of the proposed research involve no more than1922
minimal risk to human participants. 1923
B. The categories in this list apply regardless of the age of subjects, except as noted (i.e., 2(b)). 1924
C. The expedited review procedure may not be used where identification of the subjects and/or their1925
responses would reasonably place them at risk of criminal or civil liability or be damaging to the1926
subjects' financial standing, employability, incurability, reputation, or be stigmatizing, unless reasonable1927
and appropriate protections will be implemented so that risks related to invasion of privacy and breach1928
of confidentiality are no greater than minimal. 1929
D. The expedited review procedure may not be used for classified research involving human1930
subjects. 1931
E. The standard requirements for informed consent (or its waiver, alteration, or exception) apply1932
regardless of the type of review – expedited or convened-meeting – utilized by the IRB. The expedited-1933
process reviewer would have to document that each of the conditions necessary for waiver are satisfied.1934
F. Categories one (1) through seven (7) pertain to both initial and continuing IRB review. 1935
6.4 Expedited Review Procedures1936
Once you have completed your Form B1 application, your application will move through the1937
following steps on its way toward approval. Please keep in mind that the review process takes time, and1938
1To find IRB forms online, go to: http://research.utk.edu/forms/index.shtml#c4
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you may not initiate your research until your Form B application is approved.1939
6.4.1 Form B1940
Your Form B application should include the following items:1941
• A copy of the Form B with original signatures from all relevant parties1942
• Copies of all instruments (e.g., questionnaires, tests, etc.) that will be used in the project. If you plan to1943
conduct qualitative research, include a list of expected questions or topic areas that may be addressed 1944
• Copies of all informed consent forms and/or procedures 1945
• Copies of all applicable letters of permission, cooperation, or support, and approvals from other IRB's1946
and/or cooperating institutions.1947
• Copies of applicable technical sections of grant applications or contracts 1948
• Copies of all recruiting materials (i.e., letters, e-mails, posters, advertisements)1949
1950
6.4.2 Departmental Review:1951
Departments or units that regularly conduct research involving human subjects utilize a1952
Departmental Review Committee (DRC) to review all Form A and B applications. Form B applications1953
must be approved for expedited review by the DRC before the department head will indicate her/his1954
approval by signing the Form B. For students, the faculty advisor's signature is also required. 1955
When the DRC approves an expeditable Form B, it must identify the expedited-process category (11956
- 9) under which it believes the research falls. The expedited-process category classification must be1957
listed on the signature page of the Form B application. 1958
If the DRC or department head does not approve the application for expedited review, the1959
researcher should receive an explanation. The review comments from the DRC and Department Head1960
can be used to revise the application. In many/some cases the chair or members of the DRC may be1961
willing to assist in revising the Form B application. If researchers need additional assistance, they1962
should contact the IRB Administration staff at 974-3466. 1963
6.4.3 Institutional Review Board Review:1964
Once the DRC approves an expeditable Form B application and the appropriate signatures are on1965
the original application, the application will be forwarded to the University's Institutional Review Board1966
(IRB) at the IRB Administration Office at 1534 White Avenue. Please note that your department's1967
policy may be that you are responsible for delivering your own application to the IRB Administration,1968
so check your department's procedures to avoid an unnecessary delay. 1969
The paper copy of the Form B application submitted to the Compliance Section must contain1970
original signatures. In addition, you must submit an electronic copy of all parts of the application in1971
either Microsoft Word or Adobe Acrobat format (or a mixture of the two). The electronic copy may be1972
e-mailed and thus it may arrive before the paper copy. Once the full application has been received in1973
either format, the IRB Administration staff reviews the application and determines whether it can be1974
given an expedited review. Expedited reviews take about a week to complete. If the IRB Administration1975
staff determines that the Form B application must receive a full IRB committee review, you and your1976
DRC will be notified of this change in review procedures. Full IRB committee reviews may take a1977
month or longer to complete.1978
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Once the UT Knoxville IRB review is completed, the IRB Administration staff will notify you1979
about the results of the review. If revisions are requested, you will be given a list of items that must be1980
addressed prior to resubmission to the IRB. (Unless you are requested to do so, you will not have to1981
resubmit your Form B application to your DRC, nor will new signatures need to be obtained.) The IRB1982
Administration staff can assist you during the revision process. Consultation is encouraged to speed the1983
process. 1984
Once the IRB gives final approval to your Form B application, you may initiate your research. If1985
you make significant changes to your research protocol after the Form B has been approved, contact the1986
IRB Administration staff. You may need to submit additional information about the substance of your1987
project changes on a Form D1. Also, if unforeseen risks to subjects arise as you conduct your research,1988
contact the IRB Administration immediately.1989
6.5 Informed Consent Considerations for Expedited Review1990
Informed consent is a core element in the protection of research participants' rights and welfare.1991
Investigators must also recognize that informed consent is an ongoing process that assures participants1992
have been provided information about the research needed to knowledgeably and voluntarily decide1993
whether to participate. Investigators should seek consent only under circumstances that provide the1994
prospective participants sufficient opportunity to consider whether to participate, and minimize the1995
possibility of coercion or undue influence. Consent and information forms must be written in language1996
that is clear and understandable to potential participants. The consent process may not include1997
statements through which participants waive or appear to waive any legal rights, or release or appear to1998
release the investigator, sponsor, institution, or agents from liability for negligence.1999
As you prepare your consent form or procedure, please refer to Section 4 of this guide. If your2000
research involves children, please review consent and assent procedures described in Section 9.2.3 of2001
this guide.2002
6.6 Investigators' Responsibilities2003
By signing a Form B, you commit yourself to abiding by the regulations governing research2004
involving human participants, including those provisions specifying the means of obtaining informed2005
consent. In addition, you commit yourself to abiding by the applicable ethical standards of your2006
discipline and those found in the Belmont Report2. 2007
Research design should meet applicable research ethics standards of the investigator's professional2008
association or society. In all cases, the standards of respect for persons, beneficence, and justice2009
enumerated by the Ethical Principles and Guidelines for the Protection of Human Subjects of Research2010
(the Belmont Report2) apply to all research involving human participants conducted at UT Knoxville. 2011
If your project will make use of the facilities of another institution or a business, obtain letters (on2012
their letterhead) of permission, cooperation, or support to use them and to interact with personnel there2013
(refer to section 3.8 of this guide for more information). If the institution requires its own research2014
review, you must comply with their review procedures. In such cases, you should note the submission2015
on your Form B and provide a copy of the other location's IRB approval (along with any project2016
1To find IRB forms online, go to: http://research.utk.edu/forms/index.shtml#c4
2http://ohsr.od.nih.gov/guidelines/belmont.html
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modifications the external institution may require) for your UT Knoxville IRB and DRC files. 2017
If any participants suffer adverse reactions during your research, you must notify your DRC and the2018
UT Knoxville IRB. You should also take immediate steps to prevent further problems and indicate those2019
steps taken in your statements to your DRC and the UT Knoxville IRB. In some cases, the IRB2020
Administration is required to report adverse events to granting agencies or other federal agencies. In the2021
case of serious adverse events, the IRB may be asked to review your plan to avoid a recurrence. 2022
Research investigators are responsible for providing a copy of the UT Knoxville IRB approved and2023
signed informed consent document to each participant at the time of enrolling them in the study, unless2024
the UT Knoxville IRB has specifically waived this requirement. All signed consent documents are to be2025
retained in a manner approved by the UT Knoxville IRB. 2026
Research investigators will submit proposed changes in previously approved human participant2027
research activities to their DRC and the UT Knoxville IRB using Form D1. The proposed changes will2028
not be initiated without DRC and UT Knoxville IRB review and approval, except where necessary to2029
eliminate apparent immediate dangers to the participants.2030
Research investigators are responsible for reporting progress of approved research to the UT2031
Knoxville IRB, as often as and in the manner prescribed by the UT Knoxville IRB on the basis of risks2032
to participants, but not less than once per year. (See "Renewal" just below.)2033
Upon termination of the study, researchers will report this fact to the DRC and the IRB so the study2034
files can be closed. (See "Termination" just below.)2035
6.7 Renewal and Termination Procedures for Expedited Projects2036
6.7.1 Renewal2037
Expedited approval is for a limited period of time, as specified in the approval letter. According to2038
federal regulations, a project cannot be approved for a period longer than one calendar year and the IRB2039
might judge that the level and/or type of risk dictates review in a shorter period of time. For example, if2040
the IRB judged that there was significant risk that participants in a certain project might experience2041
emotional distress, we might ask for review in three months to determine whether any participants have2042
had such a reaction by that time and whether the measures included to address this were adequate. If2043
not, the next approval might be for six months, or even for a full year. 2044
Approximately one month before the expiration date of the approval, the principal investigator of2045
every active research project will receive a Form R from the IRB Administration. Principal investigators2046
will use Form R to indicate if their projects remain active and UT Knoxville IRB approval needs to be2047
renewed for another period of time. Unless your research moves in a new direction (e.g., major changes2048
in the objectives or involvement of human participants), or participants have experienced adverse2049
reactions, then renewal is not a major hurdle. Renewal can almost always be expedited, so it need not be2050
delayed until the next convened meeting. Investigators and their DRC are the first level of review to2051
determine whether the changes will affect the current status of the project. If there is any doubt, contact2052
the IRB Administration (974-3466).2053
Projects that have not been reviewed and approved by the end of the approval period are2054
automatically terminated. All research activity must cease until a new Form B has been reviewed and2055
1To find IRB forms online, go to: http://research.utk.edu/forms/index.shtml#c4
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approved.2056
6.7.2 Termination2057
Orderly termination of your project is important. When you complete your research, file a Form D2058
and check the termination box. This will allow your DRC and the UT Knoxville IRB Compliances2059
Section to close your project files. 2060
If you have further questions, contact the Chair of your Departmental Review Committee, call the2061
UT Knoxville IRB Administration (974-3466), or visit in the IRB Administration Office in 1534 White2062
Avenue. 2063
We would appreciate receiving a copy of any publications that result from the project for the IRB2064
files.2065
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Section 7. Research Requiring Full IRB Review: Form B2066
Applications2067
Section 7 Contents2068
7.1 Categories of Full IRB Reviewed Research. . . . . . . . . . . . . . . . . . . . . . . 632069
7.2 Full IRB Review Process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 632070
7.2.1 Departmental Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 642071
7.2.3 IRB Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 642072
7.3 Informed Consent Considerations for Full Board Protocols.. . . . . . . . . . 652073
7.4 Investigators' Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 652074
7.5 Renewal and Termination Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . 662075
7.5.1 Renewal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 662076
7.5.2 Termination.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 662077
7.1 Categories of Full IRB Reviewed Research2078
Research projects are referred to the full board for review if it is considered that the collective2079
judgment of the group would be helpful in evaluating the proposal and developing suggestions for2080
improvement.2081
The following types of research projects are among those that typically require full UT Knoxville2082
IRB review: 2083
• Many projects requiring the significant use of deception2084
• Involvement of prisoners, pregnant women, fetuses or neonates, the seriously ill, or persons with2085
possible decisional incapacity, or other vulnerable individuals2086
• Collection of information or recording of behavior which, if known outside the research, could2087
reasonably place the participant at risk of civil, or criminal liability or damage their social standing,2088
financial standing, or employability2089
• Collection of information regarding sensitive aspects of the participant's behavior such as: drug and2090
alcohol use, illegal conduct, or sexual behavior2091
• Studies in which the anticipated risks exceed minimal risk 2092
• Studies which involve types of risks that have not been examined before2093
• Clinical trials 2094
• Projects that raise policy issues2095
7.2 Full IRB Review Process2096
Once you have completed your Form B application, your application will move through the2097
following steps on its way toward approval. Your Form B application should include the following2098
items:2099
• Copy of the Form B with original signatures from all relevant parties2100
• Copies of all instruments (e.g., questionnaires, tests, etc.) that will be used in the project If you plan to2101
conduct qualitative research, include a list of expected questions or topic areas that may be addressed2102
• Copies of all informed consent forms or procedures2103
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• Copies of all applicable letters of permission, cooperation, or support, and approvals from other IRB's2104
• Copies of applicable technical sections of grant applications or contracts2105
• Copies of all recruiting materials: letters, e-mails, flyers, posters, advertisements, etc.2106
2107
7.2.1 Departmental Review:2108
A completed Form B application must be approved by the DRC before the department head will2109
indicate her/his approval by signing the Form B. For students, the faculty advisor's signature is also2110
required. 2111
If the DRC or department head does not approve the application in its current form, the researcher2112
should receive an explanation and guidance as to how to revise the application. For additional2113
assistance, the IRB Administration staff can be contacted at 974-3466. 2114
Neither the DRC nor the department head has authority to disapprove an application categorically.2115
If either or both continues to have concerns after the Form B has been revised, it should be forwarded to2116
the IRB Administration with their reservations noted in writing. A categorical disapproval of a project2117
requires review and action by the full IRB.2118
7.2.2 Institutional Review Board Review:2119
Once your DRC approves your Form B application and the appropriate signatures are on the2120
original application, your application will be forwarded to the UT Knoxville Institutional Review Board2121
(IRB) at the IRB Administration Office in 1534 White Avenue. Please note that your department's2122
policy may be that you are responsible for delivering your own application to the IRB Administration,2123
so check your department's procedures to avoid an unnecessary delay.2124
Please keep in mind that the review process takes time, and that you may not initiate your research2125
until your Form B application is approved.2126
The copy of the Form B application that you submit to the IRB Administration must contain2127
original signatures from all the appropriate parties. In addition, you must submit an electronic copy of2128
all parts of the application in either Microsoft Word or Adobe Acrobat format (or a mixture of the two).2129
The electronic copy may be e-mailed and thus it may arrive before the paper copy. Form B applications2130
must be received by the IRB Administration at 1534 White Avenue two weeks prior to the regular2131
meeting of the UT Knoxville IRB. (The IRB typically meets on the third Thursday of each month; thus2132
the submission deadline is typically the first Thursday of the month.) The meeting and deadline2133
information for the current academic year is available on the following web page:2134
http://research.utk.edu/humansubjects/irb_dates.shtml 2135
Once the full application has been received in either format, the IRB Administration staff will2136
review the application and determine whether it can be given an Expedited Review, or whether it2137
requires a Full-IRB Committee Review. Expedited Reviews take about a week to complete. Full-IRB2138
Committee Reviews may take a month or longer to complete. 2139
Once the IRB review is completed, the researcher will be notified by the IRB Administration about2140
the results. If revisions are requested, you will be given a list of items that must be addressed prior to2141
resubmission to the IRB. (Unless specifically requested to do so, the Form B application will not have to2142
be resubmitted to the DRC, nor will new signatures need to be obtained.) The IRB Administration staff2143
can assist during the revision process and consultation is encouraged.2144
Once the IRB gives final approval to your Form B application, you may initiate your research. If2145
you make significant changes to your research protocol after the Form B has been approved, contact the2146
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IRB Administration staff. You may need to submit additional information about the substance of your2147
proposed changes on a Form D. Also, if unforeseen harms to participants arise as you conduct your2148
research, please contact the IRB Administration immediately.2149
7.3 Informed Consent Considerations for Full Board Protocols2150
Informed consent is a core element in the protection of research participants' rights and welfare.2151
Investigators must also recognize that informed consent is an ongoing process that assures participants2152
have been provided all the information about the research they need in order to knowledgeably and2153
voluntarily decide whether to participate. Investigators should seek consent only under circumstances2154
that provide the prospective participants sufficient opportunity to consider whether to participate, and2155
minimize the possibility of coercion or undue influence. Consent and information forms must be written2156
in language that is understandable and clear to potential participants. The consent process may not2157
include exculpatory statements through which participants waive or appear to waive any legal rights, or2158
release or appear to release the investigator, sponsor, institution, or agents from liability for negligence.2159
As you prepare your consent form or procedure, please refer to Section 4 of this guide.2160
If your research involves children or individuals who are unable to give informed consent, please2161
review consent and assent procedures discussed in Section 9.2.3 of this guide.2162
7.6 Investigators' Responsibilities2163
By signing a Form B, the researcher commits herself or himself to abiding by the regulations2164
governing research involving human participants, including those provisions specifying the means of2165
obtaining informed consent. In addition, they commit themselves to abiding by the applicable ethical2166
standards of their discipline and those found in the Belmont Report1. 2167
Research design should meet applicable research ethics standards of the investigator's professional2168
association or society. In all cases, the standards of respect for persons, beneficence, and justice2169
enumerated by the Ethical Principles and Guidelines for the Protection of Human Subjects of Research2170
(the Belmont Report)1 apply to all research involving human participants conducted at UT Knoxville. 2171
If the project will make use of the facilities of another institution or a business, letters must be2172
supplied (on their letterhead) of permission, cooperation, or support to use them and to interact with2173
personnel there (refer to Section 3.8 of this guide for more information). If the institution requires its2174
own research review, the researcher must comply with their review procedures. In such cases, the2175
submission should be noted on the Form B and a copy of the other location's IRB approval (along with2176
any project modifications the external institution may require) provided for the UT Knoxville IRB and2177
DRC files.2178
If any participants suffer adverse events during the research, the researchers must notify their DRC2179
and the UT Knoxville IRB. They should also take immediate steps to prevent further problems and2180
indicate those steps taken in statements to their DRC and the UT Knoxville IRB. 2181
Research investigators acknowledge and accept their responsibility for protecting the rights and2182
welfare of human research participants and for complying with all applicable UT Knoxville IRB2183
policies. 2184
Research investigators are responsible for providing a copy of the UT Knoxville IRB approved and2185
1http://ohsr.od.nih.gov/guidelines/belmont.html
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signed informed consent document to each participant at the time of consent, unless the UT Knoxville2186
IRB has specifically waived this requirement. All signed consent documents are to be retained in a2187
manner approved by the UT Knoxville IRB. 2188
Research investigators will promptly report proposed changes in previously approved human2189
participant research activities to their DRC and UT Knoxville IRB on Form D1. The proposed changes2190
will not be initiated without DRC and UT Knoxville IRB review and approval, except where necessary2191
to eliminate apparent immediate dangers to the participants.2192
Research investigators are responsible for reporting progress of approved research to the UT2193
Knoxville IRB, as often as and in the manner prescribed by the UT Knoxville IRB on the basis of risks2194
to participants, but not less than once per year. 2195
7.7 Renewal and Termination Procedures2196
7.7.1 Renewal2197
IRB approval is for a limited period of time, as specified in the approval letter. According to federal2198
regulations, a project cannot be approved for a period longer than one calendar year and the IRB might2199
judge that the level and/or type of risk dictates review in a shorter period of time. 2200
Approximately one month before the expiration date of the approval, the principal investigator of2201
every active Form B research project will receive a Form R from the IRB Administration. Principal2202
investigators will use Form R to indicate if their projects remain active and thus UT Knoxville IRB2203
approval needs to be renewed for another period of time. Unless your research moves in a new direction2204
(e.g., major changes in the objectives or involvement of human participants), or participants have2205
experienced adverse reactions, then renewal is not a major hurdle. If there is any doubt, contact the IRB2206
Administration (974-3466).2207
Projects that have not been reviewed and approved by the end of the approval period are2208
automatically terminated. All research activity must cease until a new Form B has been reviewed and2209
approved.2210
7.7.2 Termination2211
Orderly termination of your project is important. When you complete your research, file a Form D12212
and check the termination box. This will allow your DRC and the UT Knoxville IRB Compliances2213
Section to close your project files. 2214
We would appreciate receiving a copy of any publications that result from your project for IRB2215
files.2216
If you have further questions, contact the Chair of your Departmental Review Committee, call the2217
UT Knoxville IRB Administration (974-3466), or visit in the IRB Administration Office at 1534 White2218
Avenue. 2219
1To find IRB forms online, go to: http://research.utk.edu/forms/index.shtml#c4
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Section 8. Instructions for Completing Form B2220
Researchers: Please discuss your proposed research project with your Departmental2221
Review Committee and/or with the IRB Administration, (865) 974-3466, before you begin2222
preparing a Form B application. 2223
If your project only exposes your subjects to minimal risks and you do not intend to use2224
subjects from vulnerable populations, then it may be possible to use a Form A application.2225
(See section 5 of this guide.) 2226
Remember that all research using human subjects must be approved before the subjects2227
are contacted and research begins. After approval has been granted, you are assured that the2228
research is in compliance with sanctioned university research policies and procedures.2229
Form B Header The header on the first page of every Form B should be prepared2230
as follows:2231
[Note: Please Number the Pages of the Form B Application]2232
FORM B2233
IRB # _______ (Leave blank. This number is generated by the IRB Administration)2234
Date Received in Office of Research _______2235
THE UNIVERSITY OF TENNESSEE2236
Application for Review of Research Involving Human Subjects2237
Body of Form B -- The body of the Form B should include the following information:2238
(Please note that headings and subheadings printed in blue type must be included in your Form B2239
application even if your response under that heading or subheading is N/A.)2240
I. IDENTIFICATION OF PROJECT2241
• Principal Investigator (PI) or Co-Principal Investigators (Co-PI):2242
The person or persons responsible for the design and implementation of the research project are2243
considered the PI or CoPIs and should be listed in this section. At UT Knoxville (unlike some2244
institutions), students may be listed as PI and/or CoPI. or each PI or Co-PI, include the name of2245
the college and the name of the department, the mailing address (home or campus), telephone2246
number, and e-mail address. All communications and correspondence will be directed to the2247
first person listed as principal or co-principal investigator, unless otherwise requested and2248
noted on this form.2249
• Faculty Advisors: For student projects, students should be listed as investigators and their faculty2250
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advisors should be identified in this section. The names of the advisor's college and department, campus2251
address, campus telephone number, and e-mail address should be included. (Please note that faculty2252
advisors are not automatically considered project investigators unless they are listed as a PI or Co-PI.) 2253
• Department: State the name of the department located in the college.2254
• Project Classification: Provide an appropriate description (e.g., Research Project, Dissertation,2255
Thesis, Clinical Trial, etc.)2256
• Project Title: Provide the title of your project. If a title has not been determined, please provide a2257
tentative title for the project. If external support is sought or has been obtained, use the title of the2258
project listed on the application for external support in creating a title for this project. 2259
• Starting Date: Specify an intended starting date or state "Upon IRB Approval". 2260
• Estimated Completion Date:2261
• External Funding: (If this project is not externally funded, enter "N/A" and go on to Section II.): If2262
external funding is sought or was obtained for this project, please provide the following information:2263
• Grant/Contract Submission Deadline:2264
• Funding Agency:2265
• Sponsor ID Number (if known):2266
• UT Proposal Number (if known):2267
II. PROJECT OBJECTIVES:2268
Provide a brief rationale of the project in non-technical language so that reviewers from other2269
disciplines can understand and identify the objectives and goals of the research project. The statement of2270
objectives must be clear and accurate, revealing to reviewers the anticipated significance of the2271
proposed research. If you are seeking external support for this project, the objectives listed in this2272
section must coincide with the objectives and goals in any application for support. In addition, the2273
objectives listed in this section should coincide fully with the objectives described to participants in the2274
consent form. (If investigators have reason to withhold information about the objectives from2275
participants, they must justify this action in Section VII.)2276
III. DESCRIPTION AND SOURCE OF RESEARCH PARTICIPANTS2277
1. Describe your participants.2278
2. How you will gain access to those participants?2279
3. Include the criteria for selection and exclusion.2280
4. Include the number of participants you anticipate enlisting.2281
Explain the rationale for using any special groups, such as children, pregnant women, prisoners,2282
students, cognitively impaired, institutionalized individuals, or any participants whose ability to give2283
voluntary and informed consent may be questioned. (See Sections 3.10, 3.11, and 9 of this Guide for2284
special concerns regarding vulnerable participants.) Give a rationale for projects that restrict participants2285
based on gender, language spoken or any other category that might be regarded as constituting2286
inequitable selection of participants. 2287
Identify the source of your participants (e.g., school systems, hospitals, colleges and universities,2288
private companies, religious groups, governmental entities, community groups, internet groups, etc.) and2289
describe the methods for contacting and recruiting participants. Letters of permission, cooperation, or2290
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support are required from entities other than UT to conduct research at their site and/or to contact their2291
personnel. Letters of permission should authorize the investigators to contact potential participants2292
and/or to use of the facilities and/or records of that entity as appropriate. These letters must accompany2293
the Form B application at the time of submission for review.2294
Considerations of confidentiality can make recruiting complicated. We consider it a violation of2295
confidentiality, for example, for a medical office or hospital to allow a researcher direct access to patient2296
names and contact information. It is much preferred to have the institution make the first contact with2297
patients and give them information to contact the researcher if they are interested in learning more about2298
the research and/or willing to participate in the research. 2299
Disclose any relationship between researchers and participants - such as, teacher/student;2300
employer/employee; or superintendent/principal/teacher.2301
If an incentive such as a cash payment is to be provided, identify the incentive for participation,2302
payment procedures, and provide a rationale for using the incentive. Keep in mind that the value of2303
incentives to participants is relative, and reviewers may consider highly valued incentives as undue2304
influence. Make it clear in both the Form B and the consent form how the incentive is affected if the2305
participant withdraws from the study without completing all parts of it.2306
Investigators who plan to recruit UT students and offer course credit or extra credit for student2307
participation must follow the procedures maintained in the department whose classes are used.2308
Alternative means of earning equivalent credit must be offered. The DRC is responsible for evaluating2309
these measures in their review of the protocol. Departmental procedures must be filed with the IRB and2310
approved before they are instituted.2311
IV. METHODS AND PROCEDUR ES2312
Clearly and concisely describe in non-technical language the data collection and experimental2313
research methods used in this project that will directly involve human participants. This section should2314
be consistent in every detail with the description provided to participants in the consent form or2315
procedure. (Any omission or deviation in the methods and procedures information provided in the2316
consent process must be justified in Section VII.) Include non-technical descriptions of stresses to2317
participants, experimental manipulations, tests or measures, surveys, interviews, observations,2318
photography, and video- and audio recordings. Clearly distinguish between control and comparison, and2319
experimental and treatment participant groups.2320
If the project involves audiorecording, videorecording or photography of participants, explain the2321
need for these methods and describe how these data will be used. Describe how the photos or recordings2322
will be stored, and when and how they will be destroyed. Identify the individuals who will have access2323
to the recordings or photos, and on what basis they will have access. If the recordings or photos are to be2324
used in the future, explain the procedures for obtaining participants' informed consent for those uses,2325
and the conditions under which the recordings or photos would be used. See Section 3.5 for further2326
discussion of audio- and videorecording.2327
Describe how you will analyze and interpret the data. For qualitative research, if you plan to use a2328
research group to help analyze the data, describe the composition of the group.2329
2330
V. SPECIFIC RISKS AND PROTECTION MEASURES2331
Specify all potential risks to participants of the proposed research. Remember that "risk" refers, not2332
merely to the possibility of physical harm, but also encompasses psychological, social, economic, and2333
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legal harms. Estimate the nature and amount of potential risk, stress, or discomfort, and assess the2334
likelihood and its seriousness. Describe the precautions you will take to reduce risk and assess the2335
effectiveness of these protective measures. Identify specific controls, screening methods, and follow-up2336
to assure no residual physical, psychological, or social damage to the participants. If appropriate,2337
include a description of the means you will use to assist or treat participants who may incur injury from2338
one or more of the risks identified in this section. Provide sufficient detail to permit reviewers, who may2339
not be familiar with your area of study, to evaluate any specific risks to the participants of this research.2340
Describe how you will protect the privacy of participants. If they are filling out questionnaires in a2341
group setting, what measures are being taken to prevent others from seeing their answers? If they are2342
being interviewed, what measures are being taken to prevent others from overhearing their answers?2343
How is physical privacy being protected if bodily exercises or measuring or the like is involved. To2344
prevent coercion through peer pressure (real or perceived) on young persons recruited in a group setting,2345
measures ought to be taken to prevent peers knowing even whether they have agreed to participate in the2346
research. If the study involves students filling out questionnaires in the classroom, students who2347
declined to participate in the research ought to be given an alternative activity (e.g., a game worksheet)2348
that could not be distinguished by their peers from the research activity. If students are being removed2349
from the classroom for the research activity, an explanation for their leaving should be given that does2350
not stigmatize them as participating in the research.2351
Include the methods and provisions by which you will address the issue of anonymity or2352
confidentiality of data. Note that anonymity is only possible if not even the investigator can discover the2353
participant's identity from data collected or during the collection process. In either case, describe how2354
you will maintain the confidentiality of the participants' data. Identify security measures, such as2355
limiting access to data, purging identifying information from data, securing files, and other appropriate2356
measures. If files are to be transmitted or stored electronically, describe the security measures such as2357
encryption, strong-password-protection, etc. Identify all those to whom access is given and all who2358
might know the password to password-protected computers.2359
If the confidentiality of the participants' identities or data cannot or will not be protected, please2360
state how you will inform participants of this fact before their participation. It should be noted that2361
confidentiality is not a categorical requirement. There may be research projects in which there is no2362
expectation of privacy or confidentiality. For example, in some oral history projects, respondents want2363
to be identified as the source of the stories they contribute. (See Section 1.6 of this Guide for a2364
discussion of privacy and confidentiality.) It is essential that participants know what the status is of2365
information they provide.2366
If risks are minimal, state this and give enough information to allow the IRB to make our own2367
assessment. Federal regulations define "minimal risk" as follows: "Minimal risk means that the2368
probability and magnitude of harm or discomfort anticipated in the research are not greater in and of2369
themselves than those ordinarily encountered in daily life or during the performance of routine physical2370
or psychological examinations or tests." [45CFR46.102(I)]2371
VI. BENEFITS2372
Evaluate the reasonableness of the risks stated in Section V in relation to the anticipated benefits2373
(i.e., desired outcomes), if any, to the participants and/or to society. 2374
Note that in most research projects, the only relevant benefits are those that contribute to2375
generalizable knowledge in a field of research. In these cases, participant benefits are incidental. Do not2376
inflate the significance of incidental benefits to participants in your Form B application or your2377
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informed consent procedures. 2378
Note that payment for participation in research is an incentive for participation, and should not be2379
considered a "benefit" of the research.2380
VII. METHODS FOR OBTAINING "INFORMED CONSENT" FROM PARTICIPANTS2381
State the methods you will use to obtain legally effective informed consent, assent, and/or2382
permission (as applicable) from participants or participants' legally authorized representatives. Clearly2383
describe how you will seek consent from participants in a manner that allows them sufficient2384
opportunity to consider whether to participate, and that minimizes the possibility of coercion or undue2385
influence. Indicate that the language used in your informed consent procedure is understandable to your2386
participants or their legally authorized representatives. Describe the setting in which you will obtain2387
consent, the period of time your process allows for potential participants to think about their decision2388
and to ask questions, and the identity and qualifications of the person who will answer their questions2389
and negotiate the consent. As you describe your informed consent procedures, keep in mind that the2390
following procedures are typically used to obtain legally effective informed consent:2391
1. Use of a written consent document with all the basic elements of informed consent. This form is2392
signed by the participant or a legally authorized representative and an extra copy provided for2393
participant's use and information. A sample consent form is found in Section 4.3 of this guide. 2394
2.Use of a "short form" written consent document indicating that the basic elements of informed2395
consent have been presented orally to each participant or their legally authorized representatives.2396
Written summaries of what is to be said to the participant should be attached to the Form B for approval2397
by the IRB. The "short form" is to be signed by the participant or a legally authorized representative,2398
and by a witness to the oral presentation and participant's signature. An extra copy of the form that was2399
signed and a written copy of the information that was presented orally should be provided for the2400
participant's use and information. A sample Short Form is found in Section 4.4 of this Guide.2401
3. Information sheet - written consent document containing the basic elements of informed consent.2402
The information sheet is not signed. It can be used either in connection with the Short Form above (for2403
example, for non-English-speaking participants in a situation where a translator is available but there is2404
not time to prepare a written consent form in the prospective participant's language), in a situation in2405
which consent is to be recorded by a verbal statement at the beginning of an audio- or video-recording2406
or in connection with an anonymous survey. A sample study information sheet form is available in2407
Section 4.4.1 of this Guide.2408
The IRB may approve other procedures, if you explain your need for an alternative consent process.2409
Provision of informed consent by alternative means must be approved by the IRB and recorded in the2410
minutes signed by the IRB Chair. Federal regulations dictate that the following four conditions be2411
satisfied (as documented in the IRB minutes) for an alteration of the consent process to be approved [452412
CFR 46.116(d)]:2413
1. The research involves no more than minimal risk to the participants;2414
2. The waiver or alteration will not adversely affect the rights and welfare of the participants; 2415
3.The research could not practicably be carried out without the waiver or alteration; and 2416
4.Whenever appropriate, the participants will be provided with additional pertinent information2417
after participation.2418
Complete Section VII by stating the method and place of storage for signed consent documents.2419
During your research project storing signed informed consent forms at locations other than UT may be2420
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appropriate; however, the IRB must approve these sites and security measures. For legal purposes,2421
signed consent documents must be kept on the UT campus for three years following completion of the2422
research and be accessible to authorized personnel (including UT Knoxville IRB members and staff and2423
federal OHRP or FDA staff conducting audits).2424
As you prepare your consent form or procedure, please include the following basic elements of2425
informed consent: (See also Section 4.2)2426
1. Provide a statement indicating that the study involves human research.2427
2. Describe the purposes of the research and state the expected duration of the participant's2428
involvement in the research project. Describe the procedures to be followed that will directly2429
involve human participants, and specifically identify any procedures that are experimental.2430
3. Identify and describe any reasonably foreseeable risks to the participant or potential2431
discomforts the participant may experience during this research. If you judge the research to2432
be minimal risk, please explain the basis of your assurance that no more than minimal2433
participant risks or discomforts are anticipated. Give enough information that members of the2434
IRB can make an informed judgment of the level of risk.2435
For research involving children, there is an additional level of risk specified in certain regulations: 2436
"a minor increase over minimal risk." Here again, enough information about the specifics of the risks2437
should be included to allow members of the IRB to make an informed judgment.2438
4. Describe any benefits to the participant (or to others) that may reasonably be expected from2439
this research.2440
5. Provide a statement disclosing appropriate alternative procedures or courses of treatment, if2441
any, that might be advantageous to the participant.2442
6. Provide a statement describing the procedure for maintaining the participant's files/records.2443
Will the records identifying the participant remain confidential? Who will have access to them? 2444
Where will they be stored? Describe this in general terms – e.g. "In a locked cabinet inside a2445
locked office on the UT Knoxville campus" – DO NOT specify the room number or building2446
name in the consent form.2447
7. For research involving more than minimal risk to the participant, state whether any financial2448
compensation or any medical treatments are available should an injury occur. If so, describe2449
the nature and extent of the available compensation and medical treatments. Indicate where2450
further information on this subject may be obtained.2451
8. Identify the individual who may be contacted for responses to pertinent questions about the2452
research an the rights of the research participant.2453
9. Indicate that questions about one's rights as a research participant should be directed to Ms.2454
Brenda Lawson, IRB Administrator at 1534 White Avenue (865) 974-3466, or2455
10. Include a statement specifically noting the following: (a) participation in the research is2457
voluntary, (b) refusal to participate will involve no penalty or loss of benefits to which the2458
participant is otherwise entitled, and (c) the participant may withdraw from the research project2459
at any time without penalty of loss of benefits to which he or she is otherwise entitled.12460
1The phrase "or loss of benefits to which he or she is otherwise entitled" should be used only in settings in whichthere are such benefits (e.g., a service agency).
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Additional elements of informed consent may be required in some cases. (See Section 4.2.1 of this2461
Guide.) Please check with your Departmental Review Committee or the IRB Administration for further2462
information.2463
VIII. QUALIFICATIONS OF THE INVESTIGATOR(S)2464
Investigators must specify their relevant qualifications and those of other investigators involved in2465
this project to perform the proposed research. Include qualifications of personnel working on portions of2466
the research where special training, certification, or licensing is required for the performance of their2467
tasks. Be specific! Instead of saying "the students conducting the interviews will receive extensive2468
training"; say "they will receive x hours of training, conducted by y, and the interviewers will be2469
recruited from students who have completed course z (or, perhaps, 'have completed n hours of graduate2470
courses in field a')." Special experience and expertise is required on the part of researchers when2471
involving participants classified as vulnerable, such as children, pregnant women, prisoners, cognitively2472
impaired or institutionalized individuals. Address these special issues. 2473
Those working on the project should be identified by name (and title, if appropriate) and2474
qualifications. If, for example, the particular students who will be working on a project have not been2475
identified at the time the Form B is submitted, this information should be supplied on a Form D as soon2476
as they are selected. Personnel must not become involved in the research until the Form D has been2477
reviewed and approved by the IRB Administrator. This information is important for the audit function2478
of the IRB (see Section 11 of this Guide). We may need to contact selected study personnel in the2479
process of an audit.2480
IX. FACILITIES AND EQUIPMENT TO BE USED IN THE RESEARCH2481
Please provide a brief description of the facilities that will be used during the research, with an2482
evaluation of their adequacy for the intended project. Include a brief description of the equipment to be2483
used for storage and analysis of data. Note that computers - including web servers - are pieces of2484
equipment. You need to provide information about the equipment - and especially about its level of2485
security - for any computer or web site on which data will be gathered and/or stored.2486
If a project is to be conducted in a non-UT facility, an original letter of permission, cooperation, or2487
support to use the non-UT facility must accompany the Form B. These letters must be on the letterhead2488
of the organization and signed by authorized officials. If public school or school system facilities are to2489
be used, letters of permission from authorized officials in the superintendent of schools office, and2490
possibly from school principals must accompany the Form B.2491
X. RESPONSIBILITY OF THE PRINCIPAL/CO-PRINCIPAL INVESTIGATOR(S)2492
You must enter the following information verbatim in Section X:2493
By compliance with the policies established by the Institutional Review Board of The2494
University of Tennessee, the principal investigator(s) subscribe to the principles stated in "The2495
Belmont Report" and standards of professional ethics in all research, development, and related2496
activities involving human participants under the auspices of The University of Tennessee. The2497
principal investigator(s) further agree that: 2498
1. Approval will be obtained from the Institutional Review Board prior to instituting2499
any change in this research project.2500
2. Development of any unexpected risks will be immediately reported to the IRB2501
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Administration.2502
3. A continuing review and progress report (Form R) will be completed and submitted2503
when requested by the Institutional Review Board.2504
4. Signed informed consent documents and all other research data will be kept for the2505
duration of the project and for at least three years thereafter at a location approved by the2506
Institutional Review Board.2507
XI. SIGNATURES2508
When you submit your Form B applications for review note that all signatures must be original. As2509
your Form B application moves through the review process, you should maintain two identical Form B2510
applications both of which contain original signatures. As PI or Co-PI, you should keep one copy of the2511
Form B with original signatures and submit the other Form B with original signatures for review.2512
Use the following format to prepare your signature section (as needed, add signature lines2513
for all Co-Principal Investigators, collaborating and student investigators, faculty advisors, and2514
additional department heads and DRC chairs).2515
Principal Investigator _____________________________________________2516
Signature ______________________________ Date ____________________2517
Co-Principal Investigator __________________________________________2518
Signature _______________________________ Date ___________________2519
Student Advisor (if any) ___________________________________________2520
Signature _______________________________ Date ___________________2521
DEPARTMENT REVIEW AND APPRO VAL2522
The IRB departmental review committee has reviewed and approved the application2523
described above. The DRC recommends that this application be reviewed as: 2524
[ ] Expedited Review -- Category(s): ___________________2525
OR2526
[ ] Full IRB Review2527
Chair, DRC ______________________________________________________2528
Signature _______________________________ Date ___________________2529
Department Head _________________________________________________2530
Signature _____________________________ Date ____________________2531
Protocol sent to IRB Administration for final approval on (Date) _________2532
Approved:2533
IRB Administration Office of Research 1534 White Avenue2534
Signature _______________________________ Date ___________________ 2535
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Section 9. Research Involving Special or Vulnerable2536
Populations2537
Section 9 Contents2538
9.1 General Issues about Vulnerability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 762539
9.2 Children2540
9.2.1 General Information about Children. . . . . . . . . . . . . . . . . . . . . . . 772541
9.2.2 Identifying and Recruiting Potential Child-Participants. . . . . . . . 772542
9.2.3 Informed Consent Procedures for Children. . . . . . . . . . . . . . . . . 782543
9.2.3.1 Permission of Parent or Guardian. . . . . . . . . . . . . . . . . . . 782544
9.2.3.2 Assent of the Child. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 792545
9.2.4 Risk and Benefit Assessment. . . . . . . . . . . . . . . . . . . . . . . . . . . . 792546
9.2.4.1 Risk Assessment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 792547
9.2.4.2 Benefit Assessment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 802548
9.2.4.3 Use of Educational Records. . . . . . . . . . . . . . . . . . . . . . . 802549
9.2.5 Protection of Pupil Rights Amendment. . . . . . . . . . . . . . . . . . . . 812550
9.2.6 Projects Eligible for Expedited Review. . . . . . . . . . . . . . . . . . . . 812551
9.2.7 Quick Checklist for Research Protocols Involving Children. . . . 822552
9.3 Decisionally Impaired Individuals2553
9.3.1 General Information about Decisionally Impaired2554
Individuals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 822555
9.3.2 Additional Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 832556
9.3.3 Minimal Risk Projects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 832557
9.3.4 Greater Than Minimal Risk Projects with Expected2558
Direct Participant Benefits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .832559
9.3.5 Greater Than Minimal Risk Projects without Expected2560
Direct Participant Benefits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 832561
9.3.6 Informed Consent Procedures for Decisionally 2562
Impaired Individuals.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 842563
9.3.6.1 Assent of Participants. . . . . . . . . . . . . . . . . . . . . . . . . . . . 842564
9.3.6.1 Permission from the Participant's Guardian. . . . . . . . . . . 842565
9.4 Pregnant Women2566
9.4.1 Special Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 842567
9.4.2 Added Protections for Pregnant Women.. . . . . . . . . . . . . . . . . . . 852568
9.4.3 Informed Consent Procedures for Possibly Pregnant Women. . . 852569
9.5 Prisoners2570
9.5.1 General Information about Prisoners. . . . . . . . . . . . . . . . . . . . . . 852571
9.5.2 Definition of "Prisoner". . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 852572
9.5.3 Definition of Minimal Risk.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 862573
9.5.4 Informed consent Procedures for Prisoners. . . . . . . . . . . . . . . . . 862574
9.5.5 IRB Review Procedures for Prisoners. . . . . . . . . . . . . . . . . . . . . 862575
9.5.6 Permitted Categories of Research. . . . . . . . . . . . . . . . . . . . . . . . . 862576
9.5.7 Special IRB Composition Requirements. . . . . . . . . . . . . . . . . . . 862577
9.5.8 Seven Required Findings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 872578
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9.1 General Issues About Vulnerability2579
Because most research involves uncertainty and risk, all research participants are vulnerable in2580
some sense. However, it has been suggested that vulnerability, in the context of research, should be2581
understood to be a condition, either intrinsic or situational, of some individuals that puts them at greater2582
risk of being used in ethically inappropriate ways in research.2583
The National Bioethics Advisory Commission developed an analytical framework, identifying six2584
traits that might especially interfere with participants' ability to protect themselves in research:2585
1. Cognitive or communicative vulnerability. Participants may be insufficiently able to comprehend2586
information, deliberate, and make or express decisions. This could be due to cognitive incapacity or due2587
to circumstances, such as being presented with a consent form during a crisis or in a foreign language.2588
This form of vulnerability may diminish a participant's ability to receive, understand, appreciate, and2589
reason with information and to communicate a clear decision.2590
2. Institutional vulnerability. Individuals (e.g., prisoners or students) may be subjected to the formal2591
authority of others. This increases the risk that participation will not be truly voluntary and that2592
participants may be exploited or recruited solely for convenience.2593
3. Deferential vulnerability. Participants may be informally subordinate to another person. This could be2594
due to traditional roles within a culture or society. For example, in some cultures, women may defer to2595
their husband's wishes regarding participation, or some patients may routinely defer to the expressed or2596
merely perceived wishes of their physician. Again, this increases the risk that participation will not be2597
truly voluntary and that participants may be exploited.2598
4. Medical vulnerability. Individuals may have a serious health condition for which there is no satisfactory2599
standard treatment. This may lead to a perception that research offers the only hope and may contribute2600
to difficulties weighing risks and benefits. Individuals may also suffer from the so-called "therapeutic2601
misconception" in which research is mistaken for individually tailored therapy. This decreases2602
comprehension and appreciation of risk and benefits.2603
5. Economic vulnerability. Individuals may lack access to adequate income, housing, or health care. When2604
research appears to offer benefits that are badly needed and only available to the individual through2605
research participation, decisions may be unduly influenced and voluntariness compromised.2606
6. Social vulnerability. Some members of society may embrace stereotypes of participant groups or2607
disvalue their interests, welfare, and contribution to society. This increases the risk of unfair treatment2608
and stigmatiziation. For example, if a researcher stereotypes members of some groups as less intelligent,2609
they may be given inadequate information during the consent process. Alternatively, if researchers2610
insufficiently value members of a group, they may be willing to subject them to a risk/benefit ratio that2611
would not be acceptable to the general population.12612
The UT Knoxville IRB considers each of these dimensions of vulnerability in evaluating protocols.2613
The IRB may make recommendations for specific modifications in the project to address these2614
vulnerabilities.2615
Federal regulations single out several vulnerable groups for special protections. The UT Knoxville2616
IRB acknowledges the special protections contained in federal regulations:2617
1This characterization of the six categories is quoted from James M. DuBois, "Vulnerability in Research,"Institutional Review Board: Management and Function 2nd ed, ed. By Elizabeth A. Bankert and Robert J Amdur (Boston:Jones and Bartlett Publishers, 2006), p. 338. His discussion is a summary of "Vulnerability," pp. 85-92 in Ethical and PolicyIssues in Research Involving Human Participants: Volume I- Report and Recommendations of the National BioethicsAdvisory Commission (Bethesda, MD: 2001).
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9.2 CHILDREN2618
The information in this section is provided to clarify the Form B preparation and review process for2619
researchers who plan to include children as participants in their research projects. This information is2620
intended to facilitate the compliance approval process. If you have additional questions about your2621
research project, please contact the IRB Administration Office at 974-3466 for further information.2622
9.2.1 General Information2623
Federal regulations [45 CFR 46, Subpart D] require that the researchers explicitly address the2624
measures taken to protect the welfare and rights of children participating in research. At UT Knoxville,2625
the adequacy of the protection measures is assessed by the IRB during the approval process. Because of2626
the potential vulnerability of children, a higher standard of protection must be demonstrated for2627
approval. As a result, research involving children is not eligible to be considered exempt. All research2628
involving children requires expedited or full-IRB review of Form B applications; and the expedited-2629
review process always includes a reviewer especially designated to review research involving children2630
due to expertise for dealing with children. 2631
Note that researchers may not initiate contact with potential child-participants, or begin data2632
collection, before having received final approval from the IRB. Although Form B applications take2633
longer to prepare and review than Form A applications, most Form B applications are reviewed and2634
approved within three weeks of submission through the expedited-review process. However, the2635
approval process sometimes takes longer than this, especially if significant revisions are required.2636
Therefore, please allow adequate time to prepare and submit an application. The complexity of the2637
project and the initial quality of the application affect the time required for approval.2638
The following section addresses several significant areas of concern that commonly arise during2639
IRB reviews of research involving children. When preparing a Form B application, follow the Form B2640
Application Guidelines described in Section 8.2641
9.2.2 Identifying and Recruiting Potential Child-Participants2642
Clearly describe the methods used to identify and recruit potential child-participants. Describe the2643
measures taken to prevent potential concerns about coercion or breaches of confidentiality in the2644
identification and contact stages of your research project. Copies of notices or advertisements that will2645
be used should be included in your application.2646
Only after permission from the appropriate authorities has been granted in writing may potential2647
child-participants' identities be obtained from school classrooms, care-giving programs, or other2648
agencies. For example, researchers wishing to study students in public school systems must obtain2649
written permission from the school board or its authorized representative and also from the principal(s)2650
of the school(s) to be used before students can be contacted. This approval cannot be used to require2651
teachers or students to participate.2652
School board or institutional permission is often conditioned upon IRB approval of your project. If2653
your project must receive our approval prior to the granting of any institutional permission, please2654
contact the IRB Administration. This is a common complication that can be easily remedied without2655
delaying the approval process. 2656
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9.2.3 Informed Consent Procedures for Children2657
There are special difficulties with the notion of consent where minors are concerned. One has to2658
reach the age of majority to give legally valid consent; thus minors cannot give "consent" on their own2659
behalf. Furthermore, "consent" is a first-person concept; it does not make sense in legal terms for one2660
person to give "consent" on behalf of another. Thus the language of "consent" is dispensed with in2661
research involving children. Instead, we speak of the "permission" of parents or guardians for the child2662
to participate and the "assent" of the child to take part.2663
Federal law recommends the assent of the child and requires the permission of the parent(s), or2664
guardian(s), before a child may be involved in a research project. Research involving "mature" or2665
emancipated minors may not need parental permission, but full IRB committee approval must be2666
obtained to waive the parental permission requirement. Federal regulations leave it up to state law to2667
specify under what conditions a minor may give legally valid consent [45 CFR 46.402(a)]. If state law2668
permits a minor to give consent for something (e.g., in Tennessee, a minor may sign themselves in to a2669
drug rehabilitation program), then they may also give consent to participate in research within that2670
program. When the UT Knoxville IRB is in doubt about the appropriateness of consent by minors to a2671
study, we consult the representative of the Office of the General Counsel who serves as a consultant to2672
the IRB. If researchers are aware that their project falls under this exception, it would be helpful to the2673
IRB - and would speed the review process - to supply in the Form B citations to the statutes, regulations,2674
and/or court opinion on which this is based.2675
9.2.3.1 Permission of Parent or Guardian2676
Note: A guardian is an individual who is authorized under applicable state or local law to give2677
permission for a child to receive general medical care. The parents are presumed guardians, unless court2678
action has removed this authority from them. [45 CFR, 46.402(3)]. 2679
Permission is the explicit agreement of parent(s) or guardian to the participation of their child or2680
ward in research. Failure to object or other forms of passive acquiescence cannot be construed as2681
permission [45 CFR, 46.402(c)]. 2682
Both parents must give their permission in any research that places the child-participant at greater2683
than minimal risk [45 CFR, 46.406 and 46.607], unless one parent is deceased, unknown, incompetent,2684
not reasonably available, or when only one parent has legal responsibility for the care and custody of the2685
child [45 CFR 46.408 (b)].2686
The permission of one parent is sufficient for any research that places that child-participant at no2687
more than minimal risk [45 CFR 46.404]. Furthermore, the UT Knoxville IRB may consider that the2688
permission of one parent is sufficient for research involving greater than minimal risk, if there is a clear2689
prospect of direct benefit to the child-participant [45 CFR 46.408 (b)]. 2690
The requirement of parental permission may be waived in those cases where it is clear that the2691
parents' interests do not adequately reflect the child's interests (e.g., research on child abuse or neglect).2692
These cases require investigators to develop special procedures, which must be approved by the full-2693
IRB, that protect the rights and welfare of the children asked to participate.2694
When permission is required, the information contained in the permission procedure should include2695
all the elements normally required in an informed consent. (Review Section 4 of this guide for more2696
information about informed consent considerations and a listing of the basic elements of informed2697
consent - in Section 4.2.)2698
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9.2.3.2 Assent of the child2699
Assent is a child's affirmative agreement to participate in research. Assent is an ethical concept.2700
Failure to object cannot be construed as assent [45 CFR, 46.402(b)]. 2701
Researchers who include children in their research should be especially mindful of the rights of2702
children participating in their research. Even when assent is not required, researchers are asked to2703
demonstrate a good faith effort to enlist the willing cooperation of children who participate in their2704
research.2705
It is the responsibility of the IRB to decide whether researchers should seek a child's assent as part2706
of a project's consent procedure. The determination of a child's capacity to provide assent is based on the2707
nature of the research, and the child's age (typically the UT Knoxville IRB requires assent from children2708
age seven and older), maturity, and psychological state of the population of children from whom2709
participants will be drawn. The decision to require assent for a particular protocol depends on the2710
capacity of the children to appreciate the nature, extent, and probable consequences of their participation2711
in a given research project. This decision might be made for all children to be involved in research under2712
a particular protocol, or the IRB might require an assessment of each child individually by someone2713
with the expertise to evaluate the child's capacity [45 CFR 46.408(a)].2714
Assent is especially important in cases where there is no direct benefit to the child-participants.2715
The assent procedure should include an explanation of the proposed research in language that is2716
appropriate to the child's age and maturity. The investigator should indicate on their Form B what the2717
children will be told about the research and how the information will be conveyed. The investigator2718
should discuss how the information provided might vary with the age, maturity, and level of experience2719
of the children involved in the study. The assent process should be free from coercion and undue2720
inducements. All children who are capable of providing assent must be informed that they are free to2721
withdraw from participation at any time.2722
9.2.4 Risk and Benefit Assessment2723
9.2.4.1 Risk Assessment:2724
Federal regulations require IRBs to classify research involving children into one of four categories2725
and to document their discussions of the risks and benefits of the proposed research study. The four2726
categories of research involving children that may be approved by the UT Knoxville IRB, based on2727
degree of risk and benefit to individual participants are as follows:2728
1. Minimal Risk: A risk is minimal where the probability and magnitude of harm or discomfort anticipated2729
in the proposed research are not greater than those ordinarily encountered in daily life or during the2730
performance of routine physical or psychological examinations or tests [45 CFR 46.404].2731
Examples of research in this category might include: research on children's attitudes about2732
food preferences, surveys about play activities, etc. 2733
2. Research involving greater than minimal risk, but presenting the prospect of direct benefit to an2734
individual participant. Research in this category is approvable provided: (a) the risk is justified by the2735
anticipated benefit to the participant; and (b) the relationship of risk to benefit is at least favorable as2736
any available alternative approach [45 CFR 46.405].2737
Examples of research in this category might include: research on the coping strategies of2738
children living in foster care, or research on the effectiveness of drug-use intervention2739
programs for children testing positive for drug use.2740
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3. Research involving greater than minimal risk with no prospect of direct benefit to individual2741
participants, but likely to yield generalizable knowledge about the participant's disorder or condition.2742
Research in this category is approvable provided: (a) the risk represents a minor increase over minimal2743
risk; (b) the intervention or procedure presents experiences to participants that are reasonably2744
commensurate with those inherent in their actual or expected medical, dental, psychological, social, or2745
educational settings; and (c) the intervention or procedure is likely to yield generalizable knowledge2746
about the participant's disorder or condition that is of vital importance for the understanding or2747
amelioration of the participant's disorder or condition [45 CFR 46.406].2748
Examples of research in this category might include: research involving abused children that is2749
designed to identify early warning signs of potential abuse in the general population of school-2750
aged children; or research on the effectiveness of corporal punishment.2751
4. Research that is not otherwise approvable, but which presents an opportunity to understand, prevent,2752
or alleviate a serious problem affecting the health or welfare of children. Research that is not2753
approvable under 45 CFR 46.404, 46. 405, or 46.406 may be conducted or funded by DHHS provided2754
that the IRB, and the Secretary of Health and Human Services, after consultation with a panel of2755
experts, finds that the research presents a reasonable opportunity to further the understanding,2756
prevention, or alleviation of a significant problem affecting the health or welfare of children. The panel2757
of experts must also find that the research will be conducted in accordance with sound ethical principles2758
[45 CFR 46.407].2759
No examples of research in this category are provided because projects in this category are2760
unique and require federal approval.2761
Assessing probable risks is a central consideration of the IRB's approval process. The specific2762
condition of each child must be taken into account in assessing the probability and magnitude of harm.2763
The issue of what is considered as "ordinarily encountered in daily life or during the performance of2764
routine physical or psychological examinations" may vary depending on the circumstances or conditions2765
of the population from which the children are drawn. What hospitalized cancer patients encounter in2766
their daily life is quite different from what a healthy child encounters in attending public school. The UT2767
Knoxville IRB also considers the extent to which research procedures would be a burden to a child.2768
Behavioral interventions likely to cause psychological stress may be considered to exceed minimal risk.2769
9.2.4.2 Benefit Assessment:2770
In this section of the Form B, carefully identify and describe all reasonably anticipated benefits that2771
may be received by child-participants. As noted in the risk assessment subsection just above, anticipated2772
benefits to child-participants must exceed anticipated risks when research procedures expose child-2773
participants to greater than minimal risk. The Form B should contain enough specific information about2774
risks and possible benefits to provide the IRB a basis for making this determination.2775
9.2.4.3 Use of Educational Records2776
Federal law [34 CFR 99, especially 99.03 through 99.37] governs the privacy and access to2777
elementary and secondary school records. The primary rights of access to these records are given to2778
parents, guardians – and to students once they have reached 18 years of age. For other than routine2779
administrative purposes, schools must withhold access to personally identifiable information from2780
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educational records except with the written permission of the students' parents, or students themselves2781
once they have reached 18 years of age. To be valid, a written consent for disclosure of educational2782
records must include three items: 2783
• a specification of the records to be disclosed, 2784
• the purpose(s) of the disclosure, and 2785
• the party or class of parties to whom the disclosure will be made. 2786
The requirement for written permission applies to all research, except that conducted by or for2787
educational agencies or institutions developing, validating, or administering predictive tests,2788
administering student aid, or improving instruction (provided reports of these studies will not permit the2789
identification of individual students and that personally identifying data will be destroyed upon2790
completion of the study). For more information on the privacy of student records, go to the following2791
web site: http://www2.ed.gov/policy/gen/guid/fpco/ferpa/index.html 2792
9.2.5 Protection of Pupil Rights Amendment2793
Protections contained in the PPRA [20 U.S.C. § 1232h; 34 CFR Part 98] include:2794
• The right of parents to inspect, upon request, a survey created by a third party before the survey is2795
administered or distributed by a school to students.2796
• The right of parents to inspect, upon request, any instrument used in the collection of information about:2797
• political affiliations or beliefs of the student or the student's parent;2798
• mental and psychological problems of the student or the student's family;2799
• sex behavior or attitudes;2800
• illegal, anti-social, self-incriminating, or demeaning behavior;2801
• critical appraisals of other individuals with whom respondents have close family relationships;2802
• legally recognized privileged or analogous relationships, such as those of lawyers, physicians, and2803
ministers;2804
• religious practices, affiliations, or beliefs of the student or student's parent; or2805
• income (other than that required by law to determine eligibility for participation in a program or for2806
receiving financial assistance under such program).2807
• Arrangements to protect student privacy in the event of the administration of a survey to students,2808
including the right of parents to inspect, upon request, the survey, if the survey contains one or more of2809
the eight items specified just above.2810
• The right of parents to inspect, upon request, any instructional material used as part of the educational2811
curriculum for students.2812
• The administration of physical examinations or screenings that the school may administer to students.2813
• The collection, disclosure, or use of personal information collected from students for the purpose of2814
marketing or selling, or otherwise providing the information to others for that purpose.2815
For more information about this regulation, go to the following web site: 2816
http://www2.ed.gov/policy/gen/guid/fpco/ppra/index.html 2817
9.2.6 Projects Eligible for Expedited Review2818
Research projects that involve children may be eligible for expedited review if they present no more2819
than minimal risk to children, and involve only procedures listed in one or more of the nine listed2820
categories (See Section 6.2 of this Guide). The categories in this list apply regardless of the age of2821
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subjects, except as noted.2822
Please note that the activities listed should not be considered to be of minimal risk simply because2823
they are listed. Inclusion on this list means that the activity is eligible for review through the expedited2824
review procedure when the specific circumstances of the proposed research involve no more than2825
minimal risk to human subjects. An independent assessment of the level of risk is required as part of the2826
review.2827
9.2.7 Quick Checklist for Protocols Involving Children as Participants2828
If you have questions as you prepare your Form B, please contact the IRB Administration at 15342829
White Avenue or call 974-3466.2830
1. Are you preparing a Form B application? 2831
2. What is the level of risk?2832
a. If your project involves greater than minimal risk to children who participate in your project, then2833
your Form B application will require a full IRB committee review. Allow sufficient time for the2834
preparation and review of your Form B.2835
b. If your project involves minimal risk to children who participate in your project and only involves2836
procedures listed in one of the nine expedited review categories listed in Section 6.2 of this guide,2837
then your Form B application may receive an expedited review. 2838
3. Have you adequately described your methodology and procedures using nontechnical language? 2839
4. Have you clearly identified your methods for identifying and recruiting children? 2840
5. Do you intend to recruit children through schools, or conduct your research at schools? If so, your Form2841
B should include written permission to approach children and teachers from the school board and2842
principals in the schools you are targeting. For preadolescent children, at least, parental permission2843
should be obtained before approaching the children.2844
6. Have you described your parental permission procedures and included a copy of the parental/guardian's2845
permission form in your Form B? If a waiver of parental permission is requested, provide justification,2846
including explanation that each of the four findings listed in Section 4.6 are met. Waiver of parental2847
permission cannot be granted through expedited review, so allow time for full board review.2848
7. Have you described your child assent procedures? Assent should be sought from children seven years-2849
old and older. If a waiver of children's assent is requested, provide justification showing that the four2850
findings listed in Section 4.6 are met. 2851
8. Have you included an assessment of the probable risks and benefits anticipated in your research? 2852
9. Are you planning to use information from school records? If so, have you included a written consent for2853
disclosure of educational records that specifies the records to be disclosed, the purpose(s) of the2854
disclosure, and the party or class of parties to whom the disclosure will be made? 2855
10. Are you planning to take photographs, audiorecordings, or videorecordings? Check the guidelines in2856
Section 3.5.2857
9.3 DECISIONALLY IMPAIRED INDIVIDUALS2858
9.3.1 General Information about Decisionally Impaired Individuals2859
Research projects that plan to enroll decisionally impaired participants must be submitted as Form2860
B applications. The participation of decisionally impaired individuals in research that would otherwise2861
fall in exempt categories cannot be reviewed using exempt (Form A) procedures. Researchers should2862
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clearly describe their informed consent and assent procedures in their Form B applications.2863
Individuals are considered "decisionally impaired," if they have a diminished capacity for rationally2864
and autonomously providing informed consent due to a psychiatric, organic, developmental or other2865
disorder that affects cognitive or emotional functions. The diminution of capacity may be a temporary2866
impairment such as from physical trauma or emotional stress; or it may be chronic impairment such as2867
from neurologic, psychiatric or substance abuse problems. The IRB recognizes that some individuals2868
with these disabilities are capable to give informed consent. However, the IRB is not in a position to2869
determine whether an individual identified with a decisional impairment has the capacity to give2870
informed consent. If researchers believe that specific participants, although diagnosed with these or2871
similar conditions, are able to give informed consent, they should fully and explicitly describe in the2872
Form B their reasons for this judgment as well as the measures that will be taken to evaluate the mental2873
capability in each individual case. For any participants who are able to give informed consent, the2874
general IRB review requirements apply.2875
9.3.2 Additional Considerations2876
Researchers should clearly describe their participant identification and recruitment procedures. 2877
These procedures must take into account the role of guardians or other third-party decisionmakers and2878
the restrictions on access that may be imposed by institutions in which prospective participants may2879
reside or from which they may receive services. The situation of a person whose mental capacity is2880
compromised is in some ways like the situation of a minor; however no formal regulations to govern the2881
decisionally impaired have been issued by federal agencies.2882
9.3.3 Minimal Risk Projects2883
Research that poses no more than minimal risk to participants can be approved without special2884
limits as long as adequate provisions are made for obtaining the assent of the decisionally impaired2885
individual and permission from competent adults who are legally acting on their behalf. 2886
9.3.4 Greater Than Minimal Risk Projects with Expected Direct Participant Benefits2887
Projects that expose participants to more than minimal risk, but which promise to benefit individual2888
participants will be approved under the following conditions:2889
a. The risk is justified by the expected benefit to the participant;2890
b. The relationship between the risk and the benefit is at least as favorable to the participant as any2891
available from alternative approaches; and 2892
c. Adequate provisions are made for obtaining assent of decisionally impaired participants and2893
permission from competent adults who are acting on their behalf. 2894
9.3.5 Greater Than Minimal Risk Projects without Expected Direct Participant Benefits2895
Research that poses more than minimal risk to decisionally impaired participants and is not2896
expected to offer direct benefits to the participant will only be approved under the following conditions:2897
1. The risk is only a minor increase over minimal risk; 2898
2. The research will expose the participant to risks that are reasonably commensurate with those in2899
actual or expected medical, dental, psychological, educational, or social situations; 2900
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3. The research is likely to yield generalizable knowledge about the participants disorder or2901
condition which is important to the understanding or amelioration of that disorder or condition; and 2902
4. Adequate permission and assent procedures are in place. 2903
If participants are wards of the state, these measures still apply. 2904
9.3.6 Informed Consent Procedures for Decisionally Impaired Individuals2905
9.3.6.1 Assent of Participants2906
Researchers should develop reasonable procedures for obtaining assent from decisonally impaired2907
participants. The information that should be provided by the researcher to the participant in the assent2908
process is the same as the information provided when the participants are not decisionally impaired. The2909
methods used to convey the information should reflect sensitivity for the individual's disorder or2910
condition, and should be written in language that is appropriate for the individual's level of2911
understanding. The assent requirement may be waived if participants' abilities to give assent are so2912
limited that they cannot be reasonably consulted. 2913
9.3.6.2 Permission from the Participant's Guardian2914
Permission must be obtained from the decisionally impaired participant's guardian. If the2915
participants are under the age of 18, their parents are presumed to be their guardians. However, the2916
parents of decisionally impaired participants 18 years of age or older are not necessarily their legal2917
guardians. In all cases, researchers should determine if legal guardians have been appointed for their2918
decisionally impaired participants. If guardians have not been appointed, then the researcher should2919
propose a means for obtaining permission from a competent adult acting solely in the interests of the2920
decisionally impaired individual. The adequacy of these procedures must be consistent with Tennessee2921
and federal law.2922
The information provided the participant's guardian in the permission process must contain the2923
basic elements of informed consent discussed in Section 4.2 of this Guide. The permission should be2924
documented in written form. 2925
9.4 PREGNANT WOMEN2926
9.4.1 Special Considerations2927
A general exclusion of pregnant women from participating in research would be discriminatory and2928
unjustified. However, risks to the fetus as well as to the mother must be assessed and pregnant women2929
should be excluded if the risk to the fetus is greater than minimal. Pregnant women must be fully2930
informed about the research activity and its possible impact on the fetus. 2931
Researchers should obtain informed consent from both the pregnant woman and the father of the2932
fetus. Consent by the father is not necessary if:2933
1. The purpose of the study is to meet the health needs of the mother; 2934
2. The identity or whereabouts of the father cannot be reasonably ascertained;2935
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3. The father is not reasonably available; or 2936
4. The pregnancy is the result of rape.2937
9.4.2 Added Protections for Pregnant Women 2938
At least one of the primary reviewers for protocols involving pregnant women will be a health2939
professional with experience and expertise in dealing with pregnancy.2940
The added protections of 45 CFR 46, Subpart B will be incorporated into the IRB review.2941
9.4.3 Informed Consent Procedures for Possibly Pregnant Women2942
For any research which includes procedures or elements that might pose a risk to the fetus, the2943
consent form should include a sentence along the lines of the following: "You are not pregnant, nor are2944
you likely to become pregnant during the course of this research."2945
9.5 PRISONERS2946
9.5.1 General Information2947
Researchers should be aware that prisoners may be under constraints because of their incarceration,2948
and these constraints may affect their ability to make truly voluntary decisions about participation in2949
research projects. As a result, researchers should describe recruitment and identification procedures that2950
are fair to all prisoners and are immune from arbitrary intervention by prison authorities or fellow2951
prisoners. Any incentives used to recruit prisoners may not, when compared to standard prison2952
conditions, be so great that they impair a prisoner's ability to weigh the risks of participation. In general,2953
the IRB will incorporate into its review the added protections set out in 45 CFR 46, Subpart C.2954
9.5.2 Definition of “Prisoner”2955
"Prisoner" is defined by HHS regulations at 45 CFR part 46.303(c) as "any individual involuntarily2956
confined or detained in a penal institution. The term is intended to encompass individuals sentenced to2957
such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of2958
statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration2959
in a penal institution, and individuals detained pending arraignment, trial, or sentencing." 2960
The official interpretation from OHRP is that individuals fit under this definition even if they are2961
incarcerated AFTER being enrolled in the study. The assumption is that there might be constraints with2962
regard to their freedom to withdraw from the study if they are confined. This can complicate procedures2963
if, for example, someone enrolled in a study that has nothing to do with any issue of criminal justice is2964
arrested and detained. If the special composition requirements regarding prisoners were not satisfied at2965
the time the study was approved, the researcher will EITHER have to submit a Form D requesting that2966
the study be re-reviewed and these requirements applied OR ELSE the person will have to be dropped2967
from the study.2968
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9.5.3 Definition of Minimal Risk:2969
The definition of minimal risk in the section of the regulations that applies to prisoners is slightly2970
different from the one in the Common Rule: Here minimal risk is defined as "the probability and2971
magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the2972
routine medical, dental, or psychological examination of healthy persons" [45 CFR 46.303(d)].2973
9.5.4 Informed Consent Procedures for Prisoners2974
The information provided prisoners in the informed consent process must contain the basic2975
elements of informed consent discussed in Section 4.2 of this Guide. Prisoners should also be informed2976
that participation or non-participation will not be reported to parole boards (nor, to the extent possible,2977
to prison authorities).2978
9.5.5 IRB Review Procedures2979
The full IRB committee must review all research projects involving prisoners as participants, and2980
thus Form B protocol applications must be used by researchers. Research projects may present no more2981
than minimal risk to prisoner participants.2982
9.5.6 Permitted Categories of Research 2983
Federal regulations only permit the UT Knoxville IRB to approve research involving prisoners in2984
the following two categories: [45 CFR 46.306(a)(2)]2985
1. study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided2986
that the study presents no more than minimal risk and no more than inconvenience to the subjects; 2987
(Note that the definition of minimal risk for prisoner research at 45 CFR 46.303(d) differs from the definition of2988
minimal risk for other research, contained in 45 CFR 46.102(I))2989
2. study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the2990
study presents no more than minimal risk and no more than inconvenience to the subjects;2991
There are other categories of research that can be approved by action of the Secretary of Health and2992
Human Services [45 CFR 46.306(a) (2)(iii) and 45 CFR 46.306(a) (2)(iv)]. 2993
9.5.7 Special IRB Composition Requirements2994
At least one member of the IRB who is either a prisoner, or prisoners' representative, with2995
appropriate background and experience, must be at the meeting when the Form B application is2996
reviewed. If no current member of the IRB meets the prisoner or prisoners' representative criteria, then2997
the Chair will identify and recruit a qualified individual to fulfill this requirement and advise the IRB. In2998
addition, a majority of the IRB members at the meeting must not be associated with the prison [45 CFR2999
46.304].3000
• For research involving prisoners as subjects, the IRB must meet these special composition requirements3001
of for all types of review of the protocol, including initial review, continuing review, review of protocol3002
amendments, and review of reports of unanticipated problems involving risks to subjects. 3003
• If more than one IRB reviews a protocol, only one of them has to meet these special composition3004
requirements.3005
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9.5.8 Seven Required Findings3006
The IRB must certify the following seven findings for research involving prisoners: [45 CFR3007
46.305(a)] 3008
1. the research under review represents one of the categories of research permissible under 45 CFR3009
46.306(a)(2);3010
2. any possible advantages accruing to the prisoner through his or her participation in the research, when3011
compared to the general living conditions, medical care, quality of food, amenities and opportunity for3012
earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the3013
research against the value of such advantages in the limited choice environment of the prison is3014
impaired;3015
3. the risks involved in the research are commensurate with risks that would be accepted by nonprisoner3016
volunteers;3017
4. procedures for the selection of subjects within the prison are fair to all prisoners and immune from3018
arbitrary intervention by prison authorities or prisoners. Unless the principal investigator provides to the3019
IRB justification in writing for following some other procedures, control subjects must be selected3020
randomly from the group of available prisoners who meet the characteristics needed for that particular3021
research project;3022
5. the information is presented in language which is understandable to the subject population;3023
6. adequate assurance exists that parole boards will not take into account a prisoner's participation in the3024
research in making decisions regarding parole, and each prisoner is clearly informed in advance that3025
participation in the research will have no effect on his or her parole; and3026
7. where the IRB finds there may be a need for follow-up examination or care of participants after the end3027
of their participation, adequate provision has been made for such examination or care, taking into3028
account the varying lengths of individual prisoners' sentences, and for informing participants of this3029
fact. 3030
In preparing your Form B for research involving prisoners, be sure to provide sufficient information3031
on these issues to permit the IRB to make these determinations.3032
If you have any questions about the recruitment or use of participants from special or vulnerable3033
populations, please contact your DRC Chair, or the IRB Administration Office at 974-3466.3034
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Section 10. Participatory Action Research3035
Section 10 Contents3036
10.1 General Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 883037
10.2 Project Classifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 883038
10.3 Additional Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 903039
10.3.1 Background Principles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 903040
10.3.1 Basic Ethical Principles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 913041
10.1 General Considerations3042
Participatory Action Research (PAR) (also known as "Community-Based Research" or simply3043
"Action Research") is research that does not fit the usual model. Instead of a research plan generated by3044
the researcher who then must enlist participants, PAR begins with research interests or research3045
questions generated within a group. The group may then decide to contact university researchers to help3046
them design the best way to answer the question. Alternatively, the project might arise from a3047
preexisting service collaboration between university faculty and a community, which generates research3048
questions. In cases like this, such elements as informed consent take on a radically different meaning. If3049
the group has been involved in developing the research project, it seems redundant to try to describe the3050
project they already know as well as their faculty partners do in a formal informed consent form.3051
Furthermore, the procedural requirements for submitting a research protocol- although familiar to3052
university researchers- may be daunting to those outside the university community; and the hurdles they3053
pose may discourage the groups from seeking collaboration with university faculty- which would mean3054
a regrettable loss of scientific rigor in the attempt to answer the research questions.3055
In an attempt to facilitate research of this type- while at the same time preserving the protections3056
embodied in the federal regulations and the Belmont Report- we developed these less formal guidelines3057
for approval of PAR.13058
10.2 Project Classifications3059
3060
A. For a project for which there are no prospects of publication of the results of the research to3061
anyone other than the group involved in conducting it, EITHER because the project is a class exercise3062
OR because it is being conducted for a group whose interest in the findings is wholly internal, THEN3063
there is no need to seek IRB approval for the project at all. 3064
1. However, a listing of such projects (a) should be maintained by the UT Knoxville unit and (b) should be3065
made available for review by the IRB or its representatives upon request.3066
2. If confidentiality is not to be maintained (either with regard to the identities of subjects or with regard to3067
information that has been gathered about them), this should be made explicit. If it is to be maintained,3068
participants should be provided with (a) a list of those who will know subject identities and (b) a3069
1Special thanks to John Gaventa, both for prodding us to develop these guidelines and for working with us tostructure them.
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description of protection measures that will be employed to prevent confidential information from3070
becoming generally known.3071
3. All those involved in conducting the project should be informed at the outset that a more formal3072
approval by the IRB AND a more formal consent by the participants will be required if a decision is3073
made later to publish project results.3074
B. For a project classifiable as "contract research" -- i.e., for which the role of the UT Knoxville3075
unit is limited to carrying out a project on behalf of a local group, which was designed and will be3076
interpreted by the group itself, a short-form application will be submitted to the IRB which outlines the3077
limited role of the UT Knoxville unit and describes the nature of the cooperating group.3078
1. The project information sheet/informed consent form which is given to prospective subjects (a) should3079
NOT contain any statement indicating that the project has been approved by The University of3080
Tennessee, Knoxville IRB and (b) should indicate with some precision the limited role of the UT3081
Knoxville unit in designing, conducting, and/or interpreting this project.3082
2. Confidentiality provisions similar to those specified in A.2 should be distributed to all those asked to3083
serve as subjects of the research.3084
3. Future-consent provisions (cf. A.3) should be communicated to all involved.3085
C. For a project for which the UT Knoxville unit serves a co-equal role with the community group3086
in designing, conducting, and interpreting the research project, EITHER (a) both groups should be listed3087
on information sheets and/or consent forms -- as well as on a Form A or Form B (as appropriate)3088
submitted to the UT Knoxville IRB OR (b) the community partner should have completed an agreement3089
to abide by the fundamental principles of research ethics. (See "Additional Considerations" below for3090
this list.)3091
1. Confidentiality provisions outlined in A.2 apply.3092
2. Plans for publication (if any) should be included in the consent form. 3093
D. For a project for which the UT Knoxville unit is the PREDOMINANT party (e.g., in which the3094
community partner's role is limited to suggesting the research questions and receiving the interpreted3095
results), the UT Knoxville faculty who is carrying out the project will be listed as Project Director and3096
the standard approval process like that for traditional research will be undertaken, using Form A or3097
Form B, as appropriate.3098
IN ADDITION, we recommend that the community representation on the UT Knoxville IRB be3099
expanded to include at least one representative of the segment of the community that would be involved3100
in projects of this type.3101
NOTE: These proposals are framed in terms of the following typology of research elements:3102
community participants may have an active role in the research in one or more of the following ways:3103
• DEFINING the questions to be answered by the research3104
• DESIGNING the research method to explore the questions3105
• CONDUCTING the research project -- i.e., choosing subjects, administering questionnaires, etc.3106
• ANALYZING the data3107
• INTERPRETING the results -- i.e., evaluating the significance of the data and drawing conclusions3108
about the answers to the initial questions posed. 3109
• DISSEMINATING the results through publication, etc.3110
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(We are indebted to John Gaventa for this helpful listing of the constituent aspects of a research3111
project.)3112
10.3 Additional Considerations3113
10.3.1 "Plain English" Principles of Research Ethics3114
We here acknowledge our acceptance of the following research ethics standards as guiding3115
principles of our activity in partnership with a unit of The University of Tennessee, Knoxville: 3116
A. We will demonstrate our respect for all the people we encounter in the course of this research3117
project by:3118
1. Informing them fully of what we are doing;3119
2. Answering any questions they may have about the project;3120
3. Asking their consent before involving them in any way; and3121
4. Reminding them that they are free to refuse to participate.3122
5. If someone is not fully capable of understanding what we are asking them to do (young children, for3123
example), we will either not enlist them or we will seek consent from someone authorized to serve as3124
their guardian or surrogate.3125
B. We will demonstrate our concern for the welfare of all the people we encounter by:3126
1. Designing our project in a way that avoids harming them in any way -- including, not only physical3127
harm and emotional turmoil, but also embarrassment that might result from private information about3128
them being made public;3129
2. Monitoring how the project affects those involved throughout and inviting them to withdraw from3130
participation if harm results.3131
3. If significant harm does result, 3132
a. instructing the participants affected to withdraw,3133
b. helping them deal with the harm (e.g. by obtaining medical help or counseling services), and 3134
c. informing the UT Knoxville coordinators of the project immediately so they can report it to the3135
appropriate authorities.3136
4. At the end of the project, we will help participants deal with any confusion, misunderstanding, or harm3137
of any sort that might remain as a result of their participation.3138
C. We will demonstrate our concern for justice by:3139
1. Designing the project and choosing participants in such a way that no person or group of persons is3140
unduly burdened or placed at risk.3141
D. We will demonstrate our respect for the enterprise of scientific research by:3142
1. Recording all research information accurately;3143
2. Interpreting it fair-mindedly;3144
3. Reporting it honestly;3145
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4. Honoring the requests of the UT Knoxville coordinators for oversight of the process and allowing them3146
to discuss it with UT Knoxville research compliance authorities as required.3147
10.3.2 Basic Ethical Principles13148
Respect for Persons.--Respect for persons incorporates at least two ethical convictions:3149
1) That individuals should be treated as autonomous agents3150
2) That persons with diminished autonomy are entitled to protection.3151
An autonomous person is an individual capable of deliberation about personal goals and of acting3152
under the direction of such deliberation. To respect autonomy is to give weight to autonomous persons'3153
considered opinions and choices while refraining from obstructing their actions unless they are clearly3154
detrimental to others. Respect for the immature and the incapacitated may require protecting them as3155
they mature or while they are incapacitated.3156
Beneficence.--Persons are treated in an ethical manner not only by respecting their decisions and3157
protecting them from harm, but also by efforts to secure their well-being. Such treatment falls under the3158
principle of beneficence. The term "beneficence" is often understood to cover acts of kindness or charity3159
that go beyond strict obligation. In this document, beneficence is understood in a stronger sense, as an3160
obligation. Two general rules have been formulated as complementary expressions of beneficent actions3161
in this sense:3162
1) Do not harm3163
2) Maximize possible benefits and minimize possible harms3164
Justice.--An injustice occurs when some benefit to which a person is entitled is denied without3165
good reason or when some burden is imposed unduly.3166
There are several widely accepted formulations of just ways to distribute burdens and benefits.3167
Each formulation mentions some relevant property on the basis of which burdens and benefits should be3168
distributed. These formulations are:3169
1) to each person an equal share3170
2) to each person according to individual need3171
3) to each person according to individual effort3172
4) to each person according to societal contribution3173
5) to each person according to merit3174
1National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, BelmontReport - Ethical Principles and Guidelines for the Protection of Human Subjects of Research. 44 FEDERAL REGISTER 76(Wednesday, April 18, 1979), pp. 23192-23197.
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Section 11: IRB Oversight Function3175
Section 11 Contents3176
11.1 Purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 923177
11.2 Authority. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 923178
11.3 Audit Selection Criteria. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 923179
11.4 Audit Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 923180
11.5 Follow-up Action. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 943181
11.6 Research Team Training.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 943182
11.1 Purpose3183
It matters little that the Form B describes satisfactory procedures throughout if those procedures are not3184
carried out as planned. The purpose of auditing research projects is satisfy the IRB that research is being3185
conducted in accordance with approved procedures. Audits also serve an educational function by reviewing with3186
all study personnel the relevant aspects of their protocols.3187
11.2 Authority3188
Federal regulations give IRBs the responsibility and the authority, not only to conduct initial review of3189
proposed research and periodic continuing reviews, but also to audit the conduct of the research. [45 CFR3190
46.109(e)]3191
11.3 Audit Selection Criteria3192
Criteria for selecting research projects to audit include (but are not limited to) the following:3193
• at random3194
• at the direction of the IRB for any cause3195
• for projects that have been designated by the IRB as significant risk3196
• upon report of suspected noncompliance3197
• research that has been terminated by the IRB due to failure by the researcher to submit a Form D for3198
continuing review or failure to respond to a request for information from the IRB3199
• to verify continuing review reports (Form R)3200
• for studies reporting adverse events3201
• for studies that have requested modifications (Form D)3202
• for investigators or departments with a history of noncompliance3203
11.4 Audit Procedure3204
1. Projects to be audited will be selected by the IRB Administrator in consultation with the IRB Chair.3205
2. The selection for audit will be announced by the Associate Vice Chancellor for Research to 3206
a. The researcher3207
b. The Chair of the DRC that reviewed the protocol3208
c. The Head of the Department3209
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3. The IRB Administrator will contact the Researcher to schedule the date and time for the pre- audit3210
meeting. Required records will be requested at this time.3211
4. The audit will be conducted by the Chair or a member of the IRB, a member of the IRB administrative3212
staff, and/or a consultant engaged for the purpose. The IRB Auditor(s) will sign a pledge of3213
confidentiality with respect to information about participants they might encounter and information3214
about the research site and personnel that is extraneous to the audit itself.3215
5. Documents that may be selected for review include, but are not limited to:3216
a. Form A or Form B submissions and associated correspondence3217
b. Changes in the protocol and associated correspondence3218
c. Review of any lapses in IRB approvals3219
d. Review of inclusion and exclusion criteria3220
e. Review of recruitment materials and procedures3221
f. Review of informed consent forms and informed consent procedure3222
g. Review of data collection tools and procedures3223
h. Review of any adverse event reports3224
i. Review of continuing review reports3225
j. Review of training materials for research personnel3226
6. Prior to the audit, the researcher will be requested to provide a list of all study participants to date,3227
identifying them by code or study number only.3228
a. From the list, the IRB Auditor will select at random 20-30% of the study participants. A list of3229
selected subjects will be sent to the site in advance in order to facilitate gathering study instruments3230
to be reviewed.3231
b. In the case of a for-cause audit, the IRB may request a 100% audit of study participant's materials.3232
7. A pre-audit interview may be conducted with the researcher to document the delegation of authority for3233
the following activities:3234
a. Writing protocols for submission to the IRB3235
b. Ongoing communication with the IRB3236
c. Recruitment of study participants3237
d. Obtaining informed consent3238
e. Administering study instruments3239
f. Reporting adverse events, protocol violations and deviations3240
g. Reporting injury or other unforeseen event3241
h. Maintaining study documentation3242
i. Verification of continuing review reports3243
8. The IRB audit may consist of (but is not necessarily limited to) the following activities:3244
a. Examining the relevant documents, 3245
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b. Visiting the site to confirm security of storage of study materials and consent forms3246
c. Interviewing study personnel to verify that they understand their responsibilities and the procedures3247
that were approved by the IRB3248
d. Contacting randomly selected participants to review their experience and their understanding of the3249
study's purpose and procedures3250
e. Observing a consent process3251
9. The IRB Auditor(s) will write a report of the audit which will be reviewed by the IRB at he next3252
convened meeting.3253
11.5 Follow-up Actions3254
1. The audit report will be shared with the researcher along with any recommendations the IRB and/or the3255
auditor(s) may have - with copies to the DRC Chair and the Department Head.3256
2. Notification of observations of noncompliance will be accompanied with a detailed explanation of the3257
basis of these findings. This report will be reviewed with the researcher and an opportunity given for a3258
written response that will accompany the report when submitted to the Associate Vice Chancellor for3259
Research.3260
3. If serious noncompliance is observed, procedures for further investigation and possible suspension or3261
termination of IRB approval may be initiated. (See Section 12.6 below for these procedures.)3262
4. All correspondence about the audit and the audit report itself will be filed with the research protocol and3263
retained as other records for this protocol.3264
11.6 Research Team Training3265
Subject to personnel availability, IRB Administration personnel who coordinate audits will instruct research3266
team members at the initiation of a project in the details of the human participant protections measures that were3267
approved by the IRB - i.e., such things as the specifics of the approved consent procedure and/or the security3268
measures to protect confidentiality.3269
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Section 12: IRB Operations 3270
Section 12 Contents3271
12.1 Membership of the UT Knoxville IRB. . . . . . . . . . . . . . . . . . . . . . . . . . 953272
12.1.1 Regular Members. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 963273
12.1.2 Responsibilities.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 963274
12.1.3 Compensation of UT IRB Members. . . . . . . . . . . . . . . . . . . . . . 963275
12.1.4 Member Liability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 963276
12.1.5 Alternate IRB Members. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 963277
12.1.6 Non-Voting Members. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 973278
12.1.7 Consultants/Ad hoc Reviewers. . . . . . . . . . . . . . . . . . . . . . . . . . 973279
12.1.8 Confidentiality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 973280
12.1.9 Conflict of Interest. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 973281
12.1 Management of the UT Knoxville IRB Process. . . . . . . . . . . . . . . . . . . 983282
12.2.1 UT Knoxville IRB Chair.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 983283
12.2.1.1 Responsibilities of the Chair. . . . . . . . . . . . . . . . . . . . . . 983284
12.2.2 Administrative Support. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 983285
12.2.2.1 The IRB Administration Office.. . . . . . . . . . . . . . . . . . . 983286
12.2.2.2 Resources. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 993287
12.3 Functions of the IRB and Scope of Review. . . . . . . . . . . . . . . . . . . . . . 993288
12.4 Operations of UT Knoxville IRB. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1003289
12.4.1 Submission of Applications. . . . . . . . . . . . . . . . . . . . . . . . . . . 1003290
12.4.2 Determination of Type of Review. . . . . . . . . . . . . . . . . . . . . . 1013291
12.4.3 Full Board Review Process. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1013292
12.4.4 Use of Consultants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1013293
12.4.5 Notification of Meetings and Distribution of Materials. . . . . . 1023294
12.4.6 Urgent Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1023295
12.4.7 Meeting Procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1023296
12.4.8 Studies Designated "Revise and Resubmit to Full Board". . . . 1033297
12.4.9 Meeting Minutes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1043298
12.4.10 Expedited Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1043299
12.4.11 Exempt Research. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1053300
12.4.12 Research approved conditional upon modification3301
required to secure approval.. . . . . . . . . . . . . . . . . . . . . . . . 1053302
12.4.12.1 for minor modifications. . . . . . . . . . . . . . . . . . . . . . . . 1053303
12.4.12.2 for more significant modifications. . . . . . . . . . . . . . . 1063304
12.5 Special Consideration for Projects Involving Vulnerable3305
Participants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1063306
12.6 Suspension or Termination of IRB Approval. . . . . . . . . . . . . . . . . . . . 1073307
12.7 Noncompliance Investigations and Actions. . . . . . . . . . . . . . . . . . . . . 1073308
12.8 Review of Unanticipated Problems involving Risks. . . . . . . . . . . . . . 1093309
12.9 Reporting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1103310
12.9.1 Maintaining FWA and UT IRB Registration. . . . . . . . . . . . . . 1103311
12.9.2 IRB Determinations Requiring Reporting. . . . . . . . . . . . . . . . 1103312
12.10 Undue Influence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1113313
12.11 Tennessee Laws Governing Research Activities. . . . . . . . . . . . . . . . 1113314
12.1 The Membership of UT Knoxville IRB - Appointment of Members 3315
The Associate Vice Chancellor for Research appoints UT Knoxville IRB Chair, Vice Chair, members, and3316
alternates. The length of appointment is 5 years. 3317
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12.1.1 Regular Members3318
The UT Knoxville IRB has at least sixteen members including at least one member whose primary concerns3319
are in scientific areas and at least one member whose primary concerns are in nonscientific areas. UT Knoxville3320
IRB members are selected with varying backgrounds of expertise, experience, and diversity to promote complete3321
and adequate review of research activities commonly conducted by the institution. The UT Knoxville IRB3322
includes at least one member who is not otherwise affiliated with the institution and who is not part of the3323
immediate family of a person who is affiliated with the institution. Members drawn from the UT Knoxville3324
community may include faculty, students, or staff.3325
Membership rosters are maintained by the IRB Administrator and reviewed on an ongoing basis with the3326
IRB Chair to assure that expertise and experience is representative of the research under review including3327
expertise with vulnerable populations including, but not limited to those with mental disabilities or impaired3328
decision-making capacity. When a deficiency is identified, the IRB Administrator conducts directed recruitment3329
of individuals with the needed expertise or experience. Recommendations may come from UT Knoxville IRB3330
Chair, other IRB members, or academic unit Deans, Directors, or Department Heads. Recommendations are3331
reviewed with the Associate Vice Chancellor for Research who makes the final offer of membership. 3332
12.1.2 Responsibilities 3333
Responsibilities of members include reviewing human participant application materials in advance of3334
meetings and being prepared to discuss issues related to human participants protections, serving as primary3335
reviewer when requested, and having an understanding of the specific requirements of human participants3336
regulations. 3337
UT Knoxville IRB members serve at the discretion of the Associate Vice Chancellor for Research. Members3338
who do not adequately fulfill their responsibilities as judged by UT Knoxville IRB Chair may be asked to step3339
down from UT IRB membership by the Associate Vice Chancellor for Research. The reasons for this decision3340
will be documented in the IRB files. In other cases, members will be rotated off after a period of service in the3341
interests of bringing fresh perspectives to the deliberations of the IRB.3342
12.1.3 Compensation of UT IRB Members 3343
The Office of Research provides no compensation to members of UT Knoxville IRB with the exception of3344
parking vouchers provided to off-campus members to cover the cost of parking during meetings. Individual3345
colleges are expected to provide members in proportion to the amount and type of research submitted by their3346
faculty, staff, and students. UT Knoxville colleges may independently choose to provide support either to their3347
departments and/or to individuals to meet this expectation. The Chair receives a research fund annually as partial3348
compensation for his or her time commitment to UT Knoxville IRB. 3349
12.1.4 Member Liability 3350
UT Knoxville IRB members function as employees and agents of UT Knoxville. As such, when acting in3351
accordance with UT Knoxville IRB standard operating procedures, their actions are covered by UT Knoxville3352
general liability coverage. 3353
12.1.5 Alternate IRB Members 3354
Alternate IRB members, if appointed, are designated for a specific member or members. Alternate IRB3355
members are selected to assure comparable qualifications to the primary member based on discipline, expertise,3356
and/or education and professional experience as appropriate. If both the alternate IRB member and the primary3357
IRB member attend a meeting, only one of these two may vote. In these cases, the minutes reflect who is in3358
attendance as a voting IRB member. 3359
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12.1.6 Non-Voting Members3360
T he Associate Vice Chancellor for Research may, at her or his discretion, recruit non-voting, ex officio3361
members from among the academic or administrative staff of UT Knoxville whose presence at the meetings of UT3362
Knoxville IRB would aid the IRB in conducting their duties. These members may take part in all meetings of the3363
IRB, participate in the discussions, and make recommendations to influence decisions, but they may not vote on3364
the decisions. Non-voting members are not included in determining or establishing a quorum at the meetings. UT3365
Knoxville IRB meeting minutes reflect the presence of non-voting members. 3366
12.1.7 Consultants/Ad hoc Reviewers 3367
At its discretion, the UT Knoxville IRB may invite scientists or non-scientists from within or outside UT3368
Knoxville, who have special expertise, to function as consultants and ad hoc reviewers of a project application.3369
These individuals have access to all documents submitted to UT Knoxville IRB relevant to the specific project3370
under review, may participate in the deliberations and make recommendations on the project, but may not vote. 3371
12.1.8 Confidentiality3372
Protocols submitted to the IRB for review are considered confidential. IRB administrative staff and members3373
of the IRB will not share information they have learned through handling and reviewing protocols with anybody3374
outside the circle of the IRB. To underscore this commitment, IRB members (including non-voting members),3375
alternates, and administrative staff will sign a pledge of confidentiality annually. Consultants or ad hoc reviewers3376
will sign a pledge of confidentiality each time they are engaged to review a protocol. Members of appeals boards3377
(see Section 2.11), audit teams (see Section 11), or non-compliance subcommittees (see Section 12.7) will sign a3378
pledge of confidentiality at the beginning of their term of service.3379
12.1.9 Conflict of Interest3380
No UT Knoxville IRB member, consultant, or ad hoc reviewer may participate in the IRB review of any3381
project in which the member has a conflict of interest or any other relationship that may be inappropriate for3382
objective review, except to provide information requested by the board. The determination of a conflict is3383
ultimately a matter of judgment by the individual; however, in general it is clear that (a) serving as PI or Co-PI or3384
Faculty Advisor on a project does constitute a conflict of interest and (b) the mere fact that the PI, Co-PI, or3385
Faculty Advisor is a colleague in one's department or a student in one or two of one's classes does not constitute a3386
conflict. Having previously reviewed the project as a member of the DRC does not constitute a conflict. The3387
individual with a conflict can be a member of a UT Knoxville IRB; however, he or she cannot participate in the3388
review and approval process for any project in which she or he has a conflict of interest. This conflict of interest3389
policy includes all types of review (i.e., review by expedited-process , review by the convened IRB, review of3390
unanticipated problems involving risks to participants or others, or review of noncompliance with the regulations3391
or requirements of the IRB). If a member recognizes a conflict with regard to a protocol assigned for expedited-3392
process review, she or he notifies the IRB Administrator immediately so it can be assigned to a different expedited-3393
process reviewer or referred to a full board review. In cases where an assigned primary reviewer has a conflict of3394
interest, she or he notifies the IRB Administrator as soon as the conflict is recognized and that study application is3395
re-assigned to another primary reviewer. When the investigator-member has a conflicting interest, he or she may3396
be present at UT Knoxville IRB meetings, like any investigator, only to provide information requested by the3397
board. He or she must be absent from the meeting room during the subsequent discussion and voting phases of the3398
review and may not vote (e.g., agree, disagree, abstain) on the study. The absent member is not counted towards a3399
quorum when the vote on the study in question is taken. Minutes document that these requirements have been met. 3400
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12.2 Management of UT Knoxville IRB Process 3401
12.2.1 UT Knoxville IRB Chair3402
The UT Knoxville IRB has a Chair, and - at the discretion of the Vice Chancellor for Research - a Vice Chair.3403
These individuals are respected, active members of the University community who are well-informed about3404
regulations relevant to the use of human participants in research. The Associate Vice Chancellor for Research3405
appoints the Chair based on their experience in human research protections, professional discipline(s) and3406
achievements, educational background, and their availability to commit the appropriate amount of time and effort3407
to the UT Knoxville IRB program. The term of service is at the discretion of the Associate Vice Chancellor for3408
Research. The Chairs are evaluated formally on an annual basis in meetings with the Associate Vice Chancellor for3409
Research. The Chair's activities are also monitored on an ongoing basis through periodic reports of UT IRB3410
application activity.3411
Whenever the Chair is not available to conduct UT Knoxville IRB business, the Vice Chair assumes the duties3412
of the Chair. If the Vice Chair is also not available, the Chair is notified so that she or he may designate a board3413
member to assume her or his responsibilities during the period of absence. An IRB Chair designee will be a named3414
member of the IRB roster and will undergo a period of supervision and training for a minimum of three months3415
directly related to the designee's specific role by the IRB Chair prior to assuming designation responsibilities. 3416
12.2.1.1. Responsibilities of the Chair include: 3417
• determining the type of review for initial, continuing review, and modification applications (exempt,3418
expedited, full board) based on regulatory criteria, 3419
• conducting expedited reviews and approvals, 3420
• assigning primary reviewers for and running full board meetings, 3421
• reviewing minutes,3422
• reviewing specific revisions to protocols/consent documents that are required as conditions of3423
approval,3424
• signing the application form certifying project approval,3425
• reviewing reports of unanticipated problems involving risks to subjects or others,3426
• suspension of research procedures,3427
• referral to convened IRB for consideration of termination of research procedures.3428
• reports of unanticipated problems involving risks to subjects or others, of instances involving3429
serious or continuing noncompliance, or of suspension or termination of a research project are made3430
under signature of the Chair.3431
In addition, the Chair serves as resources for investigators and UT Knoxville IRB members regarding issues3432
related to University and federal policies. 3433
12.2.2 Administrative Support - The IRB Administration Office3434
UT Knoxville IRB Administration, a unit within the Office of the Research and reporting to the Associate3435
Vice Chancellor for Research, has been established to support the IRB process. 3436
12.2.2.1 The IRB Administration Office: 3437
• assists UT Knoxville IRB in preparing for and monitoring IRB meetings; 3438
• maintains files on all human participant research (including copies of all correspondence between3439
the IRB and investigators) that takes place at UT Knoxville; 3440
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• maintains databases for tracking studies; 3441
• assists with preparation of meeting minutes; 3442
• maintains files of minutes of convened full board meetings; 3443
• screens research applications for completeness prior to initiating the IRB review process; 3444
• acts as a resource for investigators on general regulatory information, guidance with forms, and3445
assistance in preparing an application for IRB review; 3446
• maintains the institution's Federal-wide Assurance, the IRB membership rosters, and a resume for3447
each IRB member; 3448
• provides staff support to the IRB for all written correspondence; 3449
• sends notices of approval, study closure (other than closure of the study by the investigator) for3450
externally sponsored projects to UT Knoxville Sponsored Programs Office; 3451
• generates and sends reminder notices to investigators of upcoming continuing reviews;3452
• maintains information on federal regulations relating to human participants research; 3453
• provides education regarding the IRB process and regulations to the University community;3454
• maintains a human participants research monitoring program;3455
• checks the short form consent process for compliance with regulatory requirements; 3456
• maintains all correspondence between the IRB and other compliance committees. 3457
12.2.2.2. Resources 3458
UT Knoxville provides adequate personnel, facilities and equipment to support the operation of UT Knoxville3459
IRB and IRB Administration Office in performing the functions described in this document. 3460
12.3 Functions of UT Knoxville IRB and Scope of Review 3461
After initial review of applications by the IRB Administration for completeness, UT Knoxville IRB convened3462
or expedited-process review of applications is conducted to: [cf. 45 CFR 46.111]3463
• consider the scientific or scholarly design to determine that the use of human participants is relevant and3464
appropriate to answer the questions being asked; 3465
• consider ethical issues with regard to the study's design and conduct; 3466
• determine that the proposed recruitment and enrollment plan, including the inclusion and exclusion3467
criteria used, afford selection of subjects from the population that is equitable given the potential benefits3468
and risks of the research; 3469
• identify the risks associated with the research, as distinguished from the risks of therapies, teaching3470
plans, or other interventions which the participants would receive even if not participating in research; 3471
• identify level of risk; 3472
• determine that the risks are minimized to the extent possible by using procedures consistent with sound3473
research design and which do not unnecessarily expose participants to risks, and when appropriate, by3474
using procedures which are already performed on participants for non-research diagnostic, treatment,3475
educational or other purposes; 3476
• identify the probable benefits to be derived from the research; 3477
• determine that the risks are reasonable in relation to the anticipated benefits to subjects, if any, and the3478
importance of the knowledge to be gained, considering only those risks and benefits that may result from3479
the research; 3480
• assure that potential subjects are provided with an accurate and fair description of the risks or3481
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discomforts and the anticipated benefits; 3482
• require informed consent be sought and documented from each prospective subject or their legally3483
authorized representative, or determine to waive these requirements according to appropriate regulatory3484
requirements; 3485
• assess any incentives offered for participation to ensure that they do not constitute undue inducement;3486
• determine intervals of periodic review; 3487
• where appropriate, determine that adequate plans are in place for data and safety monitoring;3488
• determine the adequacy of the provisions to protect the privacy of participants and to maintain the3489
confidentiality of the data; 3490
• where the subjects are likely to be members of a vulnerable population, determine that appropriate3491
additional safeguards are in place to protect the rights and welfare of these subjects.3492
12.4 Operations of UT Knoxville IRB - Scheduling of Meetings 3493
The UT Knoxville IRB is scheduled to meet once each month, ordinarily on the third Thursday of the month,3494
with a primary purpose of reviewing new protocols and modifications requiring full board review, as well as3495
conducting continuing reviews. If a scheduled meeting falls on a University holiday or break, the meeting will be3496
rescheduled, usually to the following Thursday.3497
The IRB Administrator, when assigning protocols to full board IRB meetings makes an initial assessment of3498
the member expertise in relation to the particular protocols requiring review. The IRB chair and/or the IRB3499
Administrator, or their designee, when assigning primary reviewers to protocols, assesses the expertise of the IRB3500
membership and, when relevant, their experience in dealing with vulnerable populations, and can make3501
arrangements for a consultant to be present to advise the IRB if it is judged that additional expertise is required. If a3502
Chair designee assigns primary reviewers to protocols, the IRB Chair will review and grant final approval of all3503
primary reviewer assignments. 3504
Monthly meetings of the IRB may be cancelled by the Chair due to a) insufficient applications requiring full3505
board review, or b) inability to secure a quorum for attendance, or c) other reasons as may arise that make a3506
scheduled meeting unnecessary or otherwise inappropriate.3507
12.4.1 Submission of Applications3508
All applications for review are submitted to the IRB Administration, 1534 White Avenue. One paper copy of3509
the application form must be submitted, containing signatures of researcher(s), DRC Chair, and Department Head.3510
An electronic version of the application must also be submitted via email for posting on the IRB Blackboard site3511
and distribution to the primary reviewers. 3512
The review process can begin as soon as the electronic copy is received, even if the paper copy with3513
signatures is still in transit.3514
As soon as an application is received, it is assigned a UT Knoxville IRB reference number. This unique3515
number remains with the study and is never reassigned to a different study. 3516
Applications are initially screened in the IRB Administration for completeness before determination of the3517
type of review or assignment to a monthly agenda. A complete submission for IRB review includes the following3518
items as applicable: 3519
1. Application form (Form A or Form B)3520
2. proposed Informed Consent Document(s) or other consenting materials, 3521
3. recruitment materials (including direct advertising materials, e-mails, letters, etc.), 3522
4. survey instruments, 3523
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5. pledge of confidentiality from study personnel who might have contact with study materials containing3524
identities of participants,3525
6. grant application, if applicable3526
7. other materials specific to the proposed study (e.g., sponsor correspondence, background information3527
relative to determinations of risk)3528
If the application is incomplete or otherwise not fully prepared for review, it is returned to the investigator or3529
a request is made for necessary changes or to provide additional information. 3530
12.4.2 Determination of Type of Review3531
The Chair and/or the IRB Administrator and/or an IRB-member designee reviews the entire application, as3532
well as the recommendation for type of review made by the DRC and the Department Head, and makes a3533
determination as to whether the project constitutes human participants research and, if so, the type of review (full3534
board review, expedited review, or exempt). All applications are assigned to full board review unless they pose no3535
more than minimal risk and (1) they meet the criteria for exemption listed in Section 5 of this Guide or (2) they3536
meet the criteria for expedited review listed in Section 6 of this Guide.3537
12.4.3 Full Board Review Process - Primary Reviewer Assignment 3538
The Chair, or designee, assigns three primary reviewers for each protocol well in advance of a full board3539
meeting (ideally 10 days before the meeting unless special circumstances make this impossible and then primary3540
reviewers must agree to the change of date of distribution). If a Chair designee assigns primary reviewers, the3541
Chair will provide final approval of the primary reviewer assignments to any given IRB agenda. The Chair may, at3542
her or his discretion, serve as primary reviewer. In selecting the three primary reviewers for each protocol,3543
consideration is given to the individual's knowledge of the subject area embodied in the proposal and/or special3544
expertise regarding the participant population (especially if it is deemed to be a vulnerable population).3545
If, in the opinion of the IRB Chair, the IRB membership or likely attendees for a scheduled meeting does not3546
include someone with the relevant scientific or scholarly expertise to conduct an in-depth review of a particular3547
protocol, the Chair may invite a consultant with the appropriate expertise to attend the meeting as one of the3548
primary reviewers. If the IRB chair chooses to invite a consultant to be a primary reviewer, the consultant would3549
act under the procedures for consultants as described in Sections 12.1.7 and 12.4.4 of this Guide.3550
For initial reviews, the primary reviewers each review the application, the proposed informed consent3551
document(s) (or parental permission and child assent documents), recruitment materials (including direct3552
advertising materials), study instruments, and, if applicable, the grant application, study protocol, and investigator's3553
brochure. 3554
For continuing review applications, the primary reviewer reviews the complete project application, which3555
includes all materials previously reviewed by UT Knoxville IRB under expedited or full board review, and reports3556
of unanticipated problems involving risks to subjects or others. 3557
The primary reviewers may contact the investigator in advance of or during the board meeting for additional3558
information or clarification. The primary reviewers each present their review and make a recommendation for3559
disposition of the application under review. The primary reviewer must not have a conflict of interest regarding the3560
project under review and is expected to notify the Chair of any conflict. Primary reviewers are provided a3561
worksheet to ensure that all criteria for approval of research have been fulfilled.3562
12.4.4. Use of Consultants 3563
At the time of preliminary review of a project application, the UT Knoxville IRB Chair and/or UTK3564
Administrator and/or one of the primary reviewers may determine that the study requires further review by a3565
consultant with expertise outside of the current UT Knoxville IRB membership. This determination may be made3566
based on the scientific design of the study, the ethical issues of the study, the potential risks or benefits of the3567
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study, specific privacy and confidentiality concerns, or considerations relative to a particular study population. 3568
Upon identifying the need for a consultant review, the IRB Administrator and/or primary reviewer in3569
consultation with the Chair will identify a consultant based on the particular issues to be addressed. The Chair will3570
determine that the consultant does not have a conflict of interest based on the definition provided in Section 12.1.93571
of this Guide. 3572
For issues requiring only simple clarification, a written set of questions will be developed for submission to3573
the consultant or the completion of a primary reviewer checklist may be required of the consultant. A signed3574
confidentiality agreement will be required from the consultant prior to completing the review process. The3575
consultant's written response to these questions will be provided to the full UT Knoxville IRB for review at the3576
time of the convened meeting. 3577
For issues requiring more than simple clarification, the consultant may also be asked to review the project3578
application in its entirety and complete a primary reviewer checklist and be invited to attend the full board meeting3579
during the review of that particular study and to serve as a primary reviewer. Documentation of the discussion with3580
the consultant will be included in the meeting minutes. 3581
12.4.5 Notification of Meetings and Distribution of Materials 3582
The agenda and application materials are posted on the IRB Blackboard site and thereby made available to all3583
UT Knoxville IRB members, the representative of the Office of General Counsel who serves as ex-officio3584
consultant to the IRB, and identified consultants, if applicable. This posting is done sufficiently in advance of the3585
meeting date to allow time for review, generally at least a week in advance. The agenda indicates the date, time,3586
and place of the meeting. Items posted include all the elements of an application, and other materials as determined3587
by the Chair. 3588
For continuing reviews or for modifications to be approved, all the elements submitted to the IRB3589
Administration office will be posted.3590
The primary reviewers receive materials in advance of the Blackboard posting.3591
All IRB members are expected to review all materials in sufficient depth to discuss them at the convened3592
meeting. 3593
In addition to the material posted, there is a link to a discussion board within the Blackboard course3594
management system for each protocol. This allows IRB members to post questions and observations about the3595
protocols as they review them. The IRB Administration will review the issues raised in these discussion boards3596
and, if necessary, contact the researchers to seek clarification or supplemental information or materials. The hope is3597
this might lead to clearing up some questions in advance of the convened meeting.3598
12.4.6 Urgent Review of Applications 3599
Urgent review procedures may be invoked only under unusual circumstances. This does not include urgency3600
that is a result of negligence or delay on the part of the investigator or her or his staff to submit human participants3601
applications in a timely fashion. 3602
On occasion, however, an investigator is faced with an immediate deadline beyond his or her control. If the3603
Chair permits urgent review of a protocol, the materials are distributed as soon as possible to UT IRB members to3604
allow sufficient time for review prior to the meeting. 3605
The investigator may be required to attend the meeting to answer any questions that arise. 3606
12.4.7 Meeting Procedures3607
UT Knoxville IRB meeting is called to order when a quorum of members is in attendance. A quorum consists3608
of more than half of the number of primary members and must include at least one non-scientist. The meeting ends3609
or is suspended whenever a quorum of members is no longer present. The quorum is monitored throughout the3610
meeting by an IRB Administration staff member or the IRB Chair. 3611
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At the discretion of the Chair and/or primary reviewers, the investigator(s) may be invited to attend the3612
meeting for the purpose of additional clarification or discussion. The investigator(s) is (are) required to leave the3613
meeting for subsequent discussion and voting. 3614
At the discretion of the Chair, voting may be by written ballot or a show of hands. The official meeting3615
minutes record a motion from the board and the number of votes which agree or disagree with the motion as well3616
as the number abstaining. 3617
In the event a member of UT Knoxville IRB elects to cast no vote, the minutes record such. 3618
A vote of approval by a member means that member has determined that 3619
• risks to subjects are minimized; 3620
• risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance3621
of the knowledge that may reasonably be expected to result; 3622
• selection of subjects is equitable, 3623
• informed consent will be sought from each subject or their legally authorized representative (or waived in3624
accordance with the criteria listed in Section 4.6 of this Guide); 3625
• informed consent will be appropriately documented (or documentation waived in accordance with the3626
criteria listed in Section 4.7 of this Guide); 3627
• when appropriate, there are adequate provisions to protect the privacy of subjects and maintain the3628
confidentiality of data; and 3629
• when some or all of the subjects are likely to be vulnerable to coercion or undue influence, additional3630
safeguards have been included in the study to protect their rights and welfare. 3631
A majority vote of the members present at the meeting is required for approval. Investigators are notified in3632
writing of the decision of UT Knoxville IRB and any changes required. 3633
The actions which the IRB may pass are: (cf. Section 2.10.2 of this Guide)3634
• approve3635
• approve conditional upon modifications required to secure approval (the specifics to be communicated to3636
the PI in writing)3637
• for minor modifications the adequacy of the modifications to be verified by the IRB administration3638
• for more significant modifications, the adequacy of the modifications to be reviewed by a3639
subcommittee of the IRB (typically the primary reviewers plus others who had particular concerns3640
about the protocol)3641
• revise and resubmit to the full board for re-review (here again, specific concerns and/or suggestions for3642
modifications will be communicated to the PI in writing)3643
• disapprove (If the IRB decides to disapprove a research activity, it shall include in its written notification3644
a statement of the reasons for its decision and give the investigator an opportunity to respond in person or3645
in writing and/or to appeal the decision (see Section 2.11 of this Guide for the appeal procedure and the3646
constitution of the Appeals Board) [45 CFR 46.109(d)].3647
12.4.8 Studies Designated "Revise and Resubmit to Full Board"3648
When a study is designated "revise and resubmit to full board" at a meeting (i.e. the majority vote3649
agrees with this motion), the study, after the investigators have addressed the IRB requirements, must be3650
returned to a convened full-board IRB meeting for review. The Full Board Meeting Procedures described3651
above are followed for these protocols. Additional materials distributed to members for tabled studies3652
include the primary reviewer reports, the minutes from the previous meeting, and any response to those3653
minutes from the investigators. 3654
When possible, the primary reviewers from the previous review will be assigned as the primary3655
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reviewer for the study at the re-review date.3656
12.4.9 Meeting Minutes3657
Minutes are generated that record the following information: 3658
• attendance at each meeting including those members or alternate members who participated through3659
videoconference or teleconference, and documentation that those members not physically present3660
received all pertinent materials prior to the meeting and were able to participate in all discussions. 3661
• indication by name when members absent themselves from the meeting due to a conflicting interest on3662
individual agenda items and the reason for absenting themselves, or indication by name that a member3663
was not present for discussion and voting on individual agenda items; 3664
• the vote on actions taken by the IRB including the number, for, against, abstaining, and not voting; 3665
• separate deliberations for each action, where applicable; 3666
• actions taken by the board including determinations as required by federal regulations and protocol-3667
specific findings justifying those determinations for waiver or alteration of the consent process, research3668
involving pregnant women, human fetuses, and neonates, research involving prisoners, and research3669
involving children; 3670
• justification of any deletion or substantive modification of information concerning risks or alternative3671
procedures contained in the DHHS-approved sample informed consent document;3672
• the basis for requiring changes in or disapproving research; 3673
• the length of time of an approval; 3674
• a written summary of the discussion of controverted issues and their resolution; 3675
• specific comments relevant to inclusion of certain populations; 3676
• whenever a significant risk/non-significant risk determination is made, the rationale for significant3677
risk/non-significant risk determinations;3678
• where appropriate, information regarding expedited approvals, modifications, terminations, unanticipated3679
problems involving risks to subjects or others, and any other business appropriate for board meetings. 3680
If the convened IRB approves research contingent on specific minor conditions and the IRB3681
Administrator, IRB Chair, or a subcommittee consisting of one or more other IRB members designated3682
by the Chair approves the modifications, the approval by the Chair or designee(s) is documented in the3683
minutes of the first IRB meeting that is convened after the date of approval. 3684
Minutes are available for review within three weeks of the meeting date. 3685
After approval by the IRB, the minutes cannot be altered by anyone including a higher authority. 3686
12.4.10 Expedited Review3687
The expedited review process may be used in accordance with federal regulations for applications3688
that qualify for expedited review [45 CFR 46.110 - also see Section 6 of this Guide]. The UT Knoxville3689
IRB Chair or her or his IRB-member designees (including the IRB Administrator) are responsible for3690
these reviews. The criteria for approval using the expedited procedure are the same as those for review3691
by a convened IRB (See Section 12.3 of this Guide). Approved studies are subject to at least annual3692
review and this information is communicated to the principal investigator in the approval letter. 3693
The IRB Chair or her or his IRB-member designee conducting an expedited review either concurs3694
with the investigator's protocol-specific findings justifying determinations required by the regulations or3695
document such findings themselves prior to approval. These include protocol-specific findings for: 3696
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• Waiver or alteration of the consent process (Sections 4.6 and/or 4.7)3697
• Research involving children (Section 9.2, especially 9.2.7)3698
The Chair and/or her or his IRB-member designee(s) may approve projects as submitted or require3699
modifications prior to approval. They are not empowered to disapprove projects reviewed through the3700
expedited process; in such cases, the application must be submitted for full board review along with the3701
comments and recommendations of the Chair and/or IRB-member designee(s). In cases where the full3702
board concurs with the recommendation, the investigator may appeal the decision as provided in Section3703
2.11 of this Guide). 3704
A listing of all protocols that have been reviewed and approved through the expedited process is3705
reviewed at the next convened meeting and posted on the UTK IRB Blackboard site on a monthly basis.3706
These reports include initial reviews, continuing reviews and reviews of modifications to previously3707
approved research.3708
The expedited review process may be used for the review of projects involving a) no more than3709
minimal risk, and b) only those procedures listed in one or more of the categories set out in Section 6.2 of3710
this Guide. 3711
12.4.11 Exempt Research3712
When a recommendation for exempt classification is received from the DRC and Department Head,3713
the Form A is reviewed by the IRB Chair and/or a designated member of the IRB Administration staff. 3714
If it is determined that the project is eligible for exemption, the PI, DRC Chair, and Department Head are3715
notified immediately by e-mail and/or telephone. The goal is to complete these reviews within 33716
working days, even at the busiest times. Participant recruitment and other project activities can begin as3717
soon as certification of exemption by the IRB representative is communicated. PIs will be advised that3718
exempt projects are not subject to routine continuing review, but they may be subject to audit.3719
If the determination is that this project is not eligible for exemption, the PI is notified immediately3720
by e-mail and/or telephone and advised to resubmit the project on a Form B. At that time, the IRB3721
representative advises the PI whether the protocol is eligible for expedited review or whether it will need3722
to be reviewed by the full board. 3723
A listing of all protocols that have been reviewed and certified to be exempt from expedited or full3724
board review is reviewed at the next convened meeting and posted on the UTK IRB Blackboard site on a3725
monthly basis.3726
Projects my be certified as exempt only if they involve a) no more than minimal risk, and b) only3727
those procedures listed in one or more of the categories set out in Section 5.3 of this Guide.3728
12.4.12 Research approved conditional upon modifications required to secure approval3729
( the specifics to be communicated to the PI in writing)3730
The PI will be notified of the modifications the IRB insist on, as well as those recommended but not3731
required and "friendly suggestions" for improvement of the study, within one week of the convened3732
meeting. PIs will be advised that a response is expected within 60 days. Delay beyond that may require3733
the protocol to be re-reviewed as a new submission.3734
12.4.12.1 for minor modifications the adequacy of the modifications to be verified by the3735
IRB administration3736
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When a response is received from the PI, a designated member of the IRB Administration staff will3737
review it promptly. 3738
If the modifications are determined to be satisfactory, the PI will be notified immediately by e-mail3739
and/or telephone, with a follow-up letter. This action will be communicated to the IRB at the next3740
convened meeting, and it will be posted on the UTK IRB Blackboard site.3741
If the designated IRB Administration staff have concerns about the response, it will be shared with3742
(a) the IRB Chair and/or (b) those who served as primary reviewers for the protocol. If warranted, the3743
response may be put on the agenda for the next convened IRB meeting for review by the full board.3744
12.4.12.2 for more significant modifications, the adequacy of the modifications to be3745
reviewed by a subcommittee of the IRB 3746
(typically the primary reviewers plus others who had particular concerns about the protocol)3747
When a response is received from the PI, the IRB Administration staff will forward it to those who3748
have been designated as the subcommittee to review it. A discussion board will be created on the UTK3749
IRB Blackboard site to facilitate interchange among the subcommittee as they review the response.3750
If the modifications are determined to be satisfactory by all members of the subcommittee, the PI3751
will be notified immediately by e-mail and/or telephone, with a follow-up letter. This action will be3752
communicated to the IRB at the next convened meeting, and it will be posted on the UTK IRB3753
Blackboard site.3754
If any members of the subcommittee have concerns about the response, the response will be put on3755
the agenda for the next convened IRB meeting for review by the full board.3756
12.5 Special Consideration for Projects Involving Vulnerable Populations 3757
The UT Knoxville IRB considers certain groups of human participants to be particularly vulnerable3758
in a research setting. The UT Knoxville IRB considers additional protections for research activities3759
involving pregnant women, human fetuses and neonates, prisoners, children, and persons with impaired3760
decisionmaking capacity. The UT Knoxville IRB may also consider additional protections for those who3761
are educationally or economically disadvantaged, students, or other groups that require special3762
consideration. In reviewing these research projects, the UT Knoxville IRB ascertains that the inclusion of3763
the vulnerable population is adequately justified and that safeguards are implemented to minimize risks3764
unique to each population. Special protections for these individuals are set out in detail in Section 9 of3765
this Guide.3766
Requests for approval of federally funded research that exposes children to risks that do not meet3767
one of the criteria in 46 CFR 45.404-406 are submitted to the United States Secretary of Health and3768
Human Services for review and approval. 3769
Determinations of approval by UT Knoxville IRB of federally funded research involving prisoners3770
are reported to the DHHS Office of Human Research Protections (OHRP). The UT Knoxville IRB must3771
have present at its meeting a designated prisoner advocate in order to review projects involving the use of3772
prisoners in research. The Chair or her or his IRB-member designee may approve new studies limited to3773
retrospective review of prisoners' records and minor modifications using expedited review procedures3774
after review and comment by the prisoner advocate. 3775
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The following restrictions also apply with respect to vulnerable populations: 3776
• Research involving fetuses cannot be approved. 3777
• Research involving in vitro fertilization cannot be approved. 3778
• Research involving children as subjects cannot be approved unless: 3779
• The study presents no greater than minimal risk. 3780
• The study meets all requirements of Subpart D of the DHHS or FDA regulations. 3781
12.6 Suspension or Termination of IRB Approval 3782
The UT Knoxville IRB has the authority to suspend or terminate approval of human participants3783
research that is not being conducted in accordance with the UT Knoxville IRB's requirements or that has3784
been associated with unexpected serious harm to subjects. Any suspension or termination of approval3785
includes a statement of the reasons for the IRB's action and is reported in writing within 5 working days3786
to the investigator, the Chair of the investigator's DRC and the Department Head, the Associate Vice3787
Chancellor for Research, and (when the study is externally funded) the Sponsored Programs Office.3788
Suspensions implemented by the IRB chair will be reported to and reviewed by the convened IRB.3789
The IRB may take actions, within its authority, as deemed appropriate. When suspending or terminating3790
IRB approval on an urgent basis, the IRB (or IRB Chair for suspensions): 3791
• considers actions to protect the rights and welfare of currently enrolled participants. 3792
• considers whether procedures for withdrawal of enrolled participants considered their rights and welfare.3793
• considers whether participants should be informed of the termination or suspension. 3794
• requires any adverse events or outcomes to be reported to the IRB. 3795
12.7 Noncompliance Investigations and Actions 3796
Human subjects research that deviates from the policies, procedures, stipulations, decisions, state, or3797
federal law is non-compliant and subject to further inquiry by the IRB and the IRB Administration. All3798
reports and complaints of non-compliance should be directed to the IRB Administrator (via email, phone,3799
mail, or in person). The IRB Administrator will immediately investigate all allegations of non-3800
compliance. If necessary, the IRB Administrator will send the investigator(s) in question a notice3801
requesting the immediate suspension of all specified research activities while the issue of non-3802
compliance is reviewed, consistent with Federal Mandate 45 CRF Part 46.113. This initial notice will3803
also include a statement detailing the rationale for the IRB’s action. There are three categories of non-3804
compliance: general, serious, and continuing.3805
1. Non-compliance: Any deviation from UT Knoxville IRB policies and procedures, federal regulations, or3806
state law is “non-compliance.” Failure to follow requirements and determinations of the IRB is also3807
considered “non-compliance.”3808
2. Serious Non-compliance: All non-compliance substantially affecting participants’ rights and / or3809
welfare, or impacting upon the risks or benefits is serious non-compliance.3810
3. Continuing Non-Compliance: Is a pattern of non-compliance that indicates an inability or unwillingness3811
to comply with the regulations or the requirements of the IRB.3812
4. Allegation of Non-Compliance: An assertion of non-compliance that is not yet proven or disproven.3813
5. Finding of Non-Compliance: Non-compliance that is established by a fair process. A finding of non-3814
compliance may exist because there is clear evidence, an admission, or an investigation into an allegation3815
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has determined the allegation to be true.3816
Allegations of non-compliance will first be investigated by the IRB Chair and the IRB3817
Administrator. If the general non-compliance is clearly neither serious nor continuing, and there is a3818
corrective action plan that can be readily implemented to prevent recurrence, then the matter may be filed3819
and no further action is needed (examples that might fall here include failure to sign the application or3820
consent forms stored at a place other than that specified in the protocol). Otherwise, the IRB Chair will3821
refer allegations and findings of non-compliance to undergo an evaluation by an ad-hoc IRB Non-3822
Compliance Subcommittee, selected by the IRB chair. This subcommittee, composed of two members of3823
the IRB and one staff member from the IRB Administration, will review the nature of the non-3824
compliance and make a recommendation based on each specific case. The subcommittee issues3825
recommendations to the IRB for a vote. For allegations of non-compliance, the subcommittee makes a3826
preliminary determination as to whether the allegation has a basis in fact. When allegations are found not3827
to have a basis in fact, the investigation is closed. For findings of non-compliance, when allegations are3828
substantiated, the subcommittee considers the following recommendations: 3829
• modifying the research protocol; 3830
• modifying the consent process; 3831
• contacting past or current participants with additional information (for current participants whenever that3832
information might affect their willingness to continue to take part in the research); 3833
• re-consenting participants; 3834
• modifying the approval period; 3835
• suspension; 3836
• termination; or 3837
• referring the case to other administrative authorities (e.g., the researcher’s department head or dean, or3838
the Vice Chancellor for Research) for further disciplinary action.3839
The IRB non-compliance subcommittee will also makes a preliminary determination as to whether3840
the non-compliance was serious or continuing.3841
The full IRB will review the preliminary findings and the recommendation(s) of the IRB non-3842
compliance subcommittee. All IRB members will be provided with a copy of the approved protocol,3843
current consent documents, and the report of the IRB non-compliance subcommittee with any supporting3844
documents. A member of the IRB non-compliance subcommittee will present the subcommittee’s report.3845
The IRB may accept, modify, or reject the subcommittee’s recommendation(s). The IRB will then assess3846
whether the incident of non-compliance was serious and/or continuing. If necessary, the IRB may request3847
additional information from researchers before issuing determinations. The IRB reserves the right to3848
request any appropriate additional consultation and expertise to resolve non-compliance. Deliberations3849
and determinations of the convened IRB will be fully documented in the IRB files for the project. Every3850
effort will be made to complete each stage of this process as quickly as possible, recognizing that3851
suspension of research may have deleterious effects on the research itself and, for funded research, on the3852
pay of study personnel. The expectation will be that each stage of this process (i.e., initial review,3853
subcommittee investigation, IRB review of subcommittee report,) will be completed within a week's3854
time. All cases of non-compliance which the IRB determines to be serious or continuing noncompliance3855
will be reported to the Associate Vice Chancellor for Research and to such other parties as the Associate3856
Vice Chancellor for Research deems appropriate.3857
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12.8 Review of Unanticipated Problems involving Risks to Subjects or Others 3858
Unanticipated problems involving risk to subjects or others are reported to the IRB by UT3859
investigators. Information reported indicates whether or not the investigator believes the reported event is3860
an unanticipated problem involving risks to subjects or others. The process for review of these reports is3861
as follows: 3862
• The IRB Administrator and/or the IRB Chair compares the content of the report with the previously3863
approved project materials such as applications, informed consent documents, protocols, investigator3864
brochures, or other supporting documents to determine whether this event meets the definition of an3865
unanticipated problem involving risk to subjects or others. 3866
• If the chair agrees the event meets the definition of an unanticipated problem involving risk to subjects or3867
others, the Administrator and/or Chair determines whether the event represents minimal risk of harm or3868
more than minimal risk of harm to subjects enrolled under the UT Knoxville study. 3869
• If the event represents minimal risk of harm, the Chair writes a notation to this effect for the IRB records3870
of this protocol. 3871
• If the event represents more than minimal risk of harm to subjects enrolled under UT Knoxville study,3872
the report is referred for full board review. 3873
• A primary reviewer is assigned to lead the discussion at the full board meeting. 3874
• All IRB members including the primary reviewer receive appropriate materials such as the initial3875
report, other communications with the Principal Investigator or other relevant individuals, approved3876
IRB application, consent documents and other documentation from the project files as appropriate,3877
prior to the full board meeting. 3878
• All IRB members are expected to review and be familiar with all materials. 3879
• The convened IRB makes a determination whether the event is an unanticipated problem involving3880
risk to subjects or others. 3881
• If the determination made by the convened IRB differs from that made by the IRB chair, the3882
determination of the convened IRB supersedes that made by the IRB chair. 3883
• When a quorum of IRB members is present, and after discussion, the IRB shall vote recommended3884
actions. 3885
• The IRB or IRB Chair may take any of the following actions or other actions as appropriate: 3886
• Modification of the protocol,3887
• Modification of the consent document,3888
• Providing additional information to current subjects - this is done whenever the information3889
may relate to the subject's willingness to continue participation,3890
• Providing additional information to past subjects,3891
• Requiring current subjects to re-consent to participation,3892
• More frequent continuing review or monitoring (this can include observation of the research3893
activities and/or the consent process),3894
• Requiring additional training of the investigator,3895
• Notification of investigators at other sites,3896
• Suspension or termination of the research 3897
• Obtaining additional information3898
• The IRB sends written notification of actions taken to the PI. Reports to other entities are made in3899
accordance with procedures described in Section 12.9.2 just below.3900
3901
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12.9 Reporting 3902
12.9.1. Maintaining FWA and UT IRB Registration3903
The IRB Administration maintains the FWA and IRB registrations notifies OHRP of any changes in3904
the FWA or IRB membership as they occur.3905
IRB staff maintains a list of the IRB members (IRB rosters) for the IRB that include the following3906
information: 3907
• The information required by 45 CFR 46.103(b)(3) and 21 CFR 56.115(a)(5). 3908
• Whether the member is a primary member or alternate member.3909
• The primary member(s) for whom each alternate member could substitute.3910
12.9.2. IRB Determinations Requiring Reporting 3911
The following policy outlines the procedure for reporting to the appropriate institutional departments3912
and offices, the institutional official, sponsors, and/or the appropriate regulatory agencies of events3913
determined by the IRB to be: 3914
• suspensions or termination of IRB-approval of research (see Section 12.6), 3915
• serious or continuing non-compliance (see Section 12.7), or 3916
• unanticipated problems involving risks to subjects or others (see Section 12.8) 3917
Following an IRB determination of any of the above, the full board IRB Administration staff in3918
collaboration with the IRB Chair prepares a letter for signature by the IRB Chair that contains the3919
following information: 3920
• The nature of the event (whether or not the event was an unanticipated problem involving risks to3921
subjects or others, serious or continuing non-compliance, or a suspension or termination of approval of3922
research or a combination of these events), 3923
• The title of the research project and/or grant proposal in which the problem occurred, 3924
• The name of the principal investigator on the protocol, 3925
• The IRB number assigned to the research project and the number of any applicable federal award(s) such3926
as grants, contracts, or cooperative agreements, 3927
• A short summary of the project, 3928
• A detailed description of the problem including the findings of the organization and the reasons for the3929
IRB's decision, 3930
• Actions the institution is taking or plans to take to address the problem (e.g. revise the protocol, suspend3931
subject enrollment, terminate the research, revise the informed consent document, inform enrolled3932
subjects, increase monitoring of subjects, increase IRB monitoring of the project, etc.), 3933
• Plans, if any, for any follow-up action. 3934
The IRB Administration staff sends a copy of this letter no more than one month following the3935
review and final determination by the convened IRB to: 3936
• Institutional Entities:3937
• The researcher3938
• The Chair of the researcher’s DRC and the Department Head3939
• The Associate Vice Chancellor for Research3940
• UT Knoxville Institutional Official (Office of the Vice Chancellor for Research),3941
• Sponsored Programs Office, if appropriate. The IRB Administrator, the Associate Vice Chancellor3942
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for Research, and the Sponsored Programs Office (if appropriate) then determine whether3943
notification of the sponsor or others is required by contract or agreement and notifies the sponsor or3944
appropriate others accordingly.3945
• Dean of the College of the principal investigator 3946
• Federal Agencies: 3947
• OHRP, if the study is subject to DHHS regulations or subject to a DHHS Federal wide assurance,3948
• FDA, if the study is subject to FDA regulations [21 CFR 50 and 56]3949
• If the study is conducted or funded by any Federal Agency other than DHHS that is subject to "The3950
Common Rule" (see Definitions in Section13), the report is sent to OHRP or the head of the agency3951
as required by the agency. 3952
• NOTE: Reporting to a regulatory agency does not occur if the event occurred at a site that was3953
not subject to the direct oversight of the organization, and the agency has been notified of the3954
event by the investigator, sponsor, another organization, or other mechanisms. 3955
• The IRB Administration can provide copies to others as deemed appropriate by the Institutional3956
Official. 3957
12.10 Undue Influence 3958
Investigations of attempts to unduly influence any member of UT Knoxville IRB or IRB3959
Administrative Support staff focus on the protection of the independence of the IRB members and3960
support staff so that they can function in the role of protecting research participants. Attempts to unduly3961
influence the IRB can be reported in the following manner. 3962
When an IRB Administrative Support staff member experiences undue influence, she or he should3963
report such an occurrence to the IRB Administrator. These reports of undue influence go to the Associate3964
Vice Chancellor for Research. If the staff member feels that undue influence is coming from the IRB3965
Administrator, she or he reports the occurrence to the Associate Vice Chancellor for Research directly. If3966
the staff member feels the undue influence is coming from any of the above individuals in the reporting3967
chain, the staff member can report the incident to the appropriate UT Knoxville Faculty or Staff3968
Ombudsperson.3969
When an IRB member experiences undue influence, she or he should first report the occurrence to3970
the IRB Chair. The IRB Chair can then notify the IRB Administrator. The report then goes to the3971
Associate Vice Chancellor for Research. If the IRB member feels that the undue influence is coming3972
from the IRB Chair or the IRB Administrator, the IRB member reports directly to the Associate Vice3973
Chancellor for Research. If the IRB member experiences undue influence from any of the above3974
reporting chain, the IRB member can report the incident to the UT Knoxville Faculty or Staff3975
Ombudsperson. Parties to whom the reports are made will evaluate the allegation and will determine a3976
course of action to be taken. Actions can include additional investigation, internal resolution, or referral3977
to the appropriate dean, the Vice Chancellor for Research, the Provost, the Chancellor, or the Office of3978
Human Resources. 3979
12.11 Tennessee Laws Governing Research Activities3980
The following are laws of the State of Tennessee that are taken into account in reviewing protocols3981
by the UT Knoxville IRB:3982
NOTE: Material for this section will be supplied at a later date by the Office of the General3983
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Counsel.3984
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Section 13. Glossary13985
Agent of the Organization Agents include all individuals performing institutionally designated activities3986
or exercising institutionally delegated authority or responsibility. 3987
Assent - Affirmative agreement by a child to participate in research, a supplement to the "permission"3988
given by parents or guardian. A partial substitute for consent (since a minor is not legally qualified3989
to give consent on their own behalf).3990
Chair - Chair or Vice-Chair, as designated on UT IRB roster submitted to OHRP, unless otherwise3991
indicated. 3992
Children (Child) 3993
DHHS definition: persons who have not attained the legal age for consent to treatments or procedures3994
involved in the research, under the applicable law of the jurisdiction in which the research will be3995
conducted.2 3996
FDA definition: persons who have not attained the legal age for consent to treatments or procedures3997
involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical3998
investigation will be conducted.3999
Clinical Investigation 4000
FDA definitions:4001
-any experiment that involves a test article and one or more human participants and that is one of4002
the following: 4003
subject to requirements for prior submission to the Food and Drug Administration under section 505(I) or4004
520(g) of the act, or 4005
is not subject to requirements for prior submission to the Food and Drug Administration under these4006
sections of the act but the results of which are intended to be submitted later to , or held for4007
inspection by, the Food and Drug Administration as part of an application for a research or4008
marketing permit. 4009
The term does not include experiments that are subject to the provision of 21CFR58, regarding4010
nonclinical laboratory studies. (From 21 CFR 50.3(c); 21 CFR 56.102(c)) -any experiment in which4011
a drug is administered or dispensed to, or used involving, one or more human participants. For the4012
purposes of this part, an experiment is any use of a drug except for the use of a marketed drug in the4013
course of medical practice. (From 21 CFR 312.3(b)) 4014
(Investigation): a clinical investigation or research involving one or more subjects to determine the safety4015
or effectiveness of a device. (From 21 CFR 812.3(h)) 4016
Confidentiality the ethical or legal right that information be considered private and be held secret unless4017
consent is provided permitting disclosure. Contrast anonymity, which applies only to cases in which4018
no one does or could know the identity of the participant (i.e., anonymous surveys in which no4019
1Adapted from University of Iowa Institutional Review Board Standard Operating Procedureshttp://research.uiowa.edu/hso/downloads/policies/UIIRBSOP.pdf
2In Tennessee, the age of consent is 18 except for certain special circumstances, including
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identifying information is reported and the ordinary requirement for signed consent is waived by the4020
IRB.)4021
Conflict of Interest Conflict of interest in research involves situations in which an investigator has a4022
significant financial interest that may compromise, or have the appearance of compromising,4023
professional judgment in the design, conduct, or reporting of research. The terms "investigator" and4024
"significant financial interest" are defined below. 4025
Investigators conducting research funded by the Public Health Service (including National Institutes4026
of Health) and National Science Foundation, as well as those conducting studies regulated by the4027
Food and Drug Administration, are subject to agency specific regulations. These regulations set forth4028
the obligations of investigators, sponsors and institutions for research involving significant financial4029
or other conflicts of interest, and affected parties are advised to review the relevant regulations prior4030
to submission of a research proposal or application. 4031
a. "Investigator" means the principal investigator and any other person, whether faculty, staff, or4032
student, who is responsible for the design, conduct, or reporting of research. "Investigator" also4033
includes the investigator's spouse and dependent children. 4034
b. "Significant financial interest" means anything of monetary value, including, but not limited to,4035
salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g.,4036
stocks, stock options, or other ownership interests); and intellectual property rights (patents,4037
copyrights, and royalties from such rights) held by an investigator or the investigator's immediate4038
family, individually or in aggregate, when such interest involves: 4039
i. Payments in excess of $10,000 (including salary, consulting fees, royalty or licensing payments4040
from intellectual property, and honoraria and/or gifts) received within the past 12 months or4041
anticipated for the next 12 months (excluding salary and other payments for services from the4042
University); 4043
ii. An equity interest in a publicly traded company worth more than $10,000 or more than 54044
percent of the business entity as determined by reference to its publicly listed price (excluding4045
mutual funds); 4046
iii. Any equity interest if the value cannot be determined by reference to publicly listed prices (i.e.,4047
an equity interest in a privately held company, such as a start-up company); 4048
iv. A position giving rise to a fiduciary duty, such as director, officer, partner, trustee, employee,4049
or any other position of management; or4050
v. Intellectual property rights (patents or copyrights) or royalties from such rights whose value4051
may be affected by the outcome of the research, including royalties distributable under4052
University policy or any royalty-sharing agreements involving the University. 4053
For UT Knoxville IRB members only, the following indicate a conflict of interest with a4054
protocol under review: she or he serves as a co-investigator, other member of the research team, or4055
faculty advisor or a member of his or her immediate family serves as a co-investigator, other4056
member of the research team, or faculty advisor.4057
Immediate family means spouse or domestic partner, and dependent children. 4058
Personal agreements between sponsors and investigators, IRB members, or their immediate4059
family members where the amount of compensation (consulting, board honoraria, or any other kind)4060
could change depending on the outcome of a study or any other activity the faculty/IRB member4061
performs as part of their University service are prohibited. In some cases, such arrangements are4062
illegal under state law.4063
Continuing Noncompliance Any noncompliance that occurs repeatedly to the point of suggesting a4064
pattern or an underlying problem. Continuing noncompliance may occur due to lack of knowledge4065
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(unintentional) or due to deliberate choice to ignore regulations or determinations of the IRB4066
(intentional). 4067
Existing (Data, Documents, Records, Pathological or Diagnostic Specimens) Existing with regards to4068
these materials means the items must be "on the shelf" or in existence at the time the project is4069
submitted to the IRB for review. 4070
Federal Agency Other than DHHS that is subject to "The Common Rule" Any one of the following:4071
Agency for International Development (22 CFR 225); Central Intelligence Agency (Executive4072
Order); Consumer Products Safety Commission (16 CFR 1028); Department of Agriculture (7 CFR4073
1c); Department of Commerce (15 CFR 27); Department of Defense (32 CFR 219); Department of4074
Education (34 CFR 97); Department of Energy (10 CFR 745); Department of Homeland Security4075
(Public law 108-458 Sec. 8306); Department of Justice (28 CFR 46); Department of Transportation4076
(49 CFR 11); Department of Veteran's Affairs (38 CFR 16); Environmental Protection Agency (404077
CFR 26); Housing and Urban Development (24 CFR 60); National Aeronautics and Space4078
Administration (14 CFR 1230); National Science Foundation (45 CFR 690); Office of Science and4079
Technology Policy (Adoption of policy); Social Security Administration (Public law 7.5.26) 4080
Guardian a person who is not the parent of a child, but who has been appointed by a court or juvenile4081
court having jurisdiction over the child, to have a permanent self-sustaining relationship with the4082
child and to make important decisions which have a permanent effect on the life and development of4083
that child and to promote the general welfare of that child. A guardian may be a court or a juvenile4084
court. 4085
Human participant 4086
DHHS definition: a living individual about whom an investigator (whether professional or student)4087
conducting research obtains a) data through intervention or interaction with the individual, or b)4088
identifiable private information. (From 45 CFR 46.102.(d)) 4089
FDA definitions (human participant): -an individual who is or becomes a participant in research, either as4090
a recipient of the test article o r as a control. A participant may be either a healthy human or a4091
patient. (From 21 CFR 50.3(g)) 4092
-(Subject): a human who participates in an investigation, either as an individual on whom or on4093
whose specimen an investigational device is used or as a control A subject may be in normal health4094
or may have a medical condition. (From 21 CFR 812.3(p)) 4095
Identifiable Private Information -private information about behavior that occurs in a context in which an4096
individual can reasonably expect that no observation or recording is taking place, and/or information4097
which has been provided for specific purposes by an individual and which the individual can4098
reasonably expect will not be made public (for example, a medical record). This information is4099
considered individually identifiable if the identity of the subject is or may readily be ascertained by4100
the investigator or associated with the information. [45 CFR 46.102(f)(2)]4101
If information includes Protected Health Information (as defined later under Protected Health4102
Information), identifiable information includes any of the following information for the individual,4103
relative, employer, or household member of the individual: 4104
(1) Names; 4105
(2) all geographic subdivisions smaller than a state, except for the initial three digits of the ZIP4106
code if the geographic unit formed by combining all ZIP codes with the same three initial4107
digits contains more than 20,000 people; 4108
(3) all elements of dates except year, and all ages over 89 or elements indicative of such age; 4109
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(4) telephone numbers; 4110
(5) fax numbers; 4111
(6) email addresses;4112
(7) social security numbers; 4113
(8) medical record numbers; 4114
(9) health plan beneficiary numbers; 4115
(10) account numbers; 4116
(11) certificate or license numbers; 4117
(12) vehicle identifiers and license plate numbers; 4118
(13) device identifiers and serial numbers; 4119
(14) URLs; 4120
(15) IP addresses; 4121
(16) biometric identifiers; 4122
(17) full-face photographs and any comparable images; 4123
(18) any other unique, identifying characteristic or code, except as permitted for re-4124
identification in the Privacy Rule. 4125
Interaction An interaction includes communication or interpersonal contact between investigator and4126
participant.4127
Intervention An intervention includes both physical procedures by which data are gathered (for example,4128
venipuncture) and manipulations of the participant or the participant's environment that are4129
performed for research purposes. 4130
Legally authorized representative (LAR)- an individual or judicial or other body authorized under4131
applicable law to consent on behalf of a prospective subject to the subject's participation in the4132
procedure(s) involved in the research. 4133
Minimal risk the probability and magnitude of harm or discomfort anticipated in the research are not4134
greater in and of themselves than those ordinarily encountered in daily life or during the4135
performance of routine physical or psychological examinations or tests. [45 CFR 46.102(I) and 214136
CFR 50.3(k)]4137
In research involving prisoners the probability and magnitude of physical or psychological harm4138
that is normally encountered in the daily lives, or in the routine medical, dental, or psychological4139
examination of healthy persons. [45 CFR 46.303(d)] 4140
Minor modifications modifications to a research project and/or consent documents that pose no4141
additional risk to subjects (e.g. changes in title, co-investigator(s), funding sources).If the4142
modification is an addition or modification of procedures they must fall into one of the categories4143
eligible for expedited review. To be considered a minor modification, it must also maintain similar4144
or increased safeguards to protect the subject. 4145
Noncompliance failure to follow the federal regulations with respect to protection of human participants4146
in research or failure to follow the determinations of the IRB with respect to conduct of the research4147
as approved by the IRB.4148
Nonscientist - an individual who has little or no formal scientific or medical training or experience. 4149
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Permission - Affirmative agreement by parents or guardians for a child to participate in a research, a4150
partial substitute for consent (since a minor is not legally qualified to give consent on their own4151
behalf). See also "assent."4152
Privacy freedom from unauthorized intrusion or the state of being let alone and able to keep certain4153
personal information to oneself. 4154
Protected Health Information (PHI) information that: 4155
1. is transmitted or maintained in any form (electronic, oral, paper) by a covered entity, and 4156
2. identifies the individual or could reasonably be used to identify the individual; and 4157
3. relates to the past, present or future physical or mental health or condition of an individual; the provision4158
of health care to an individual; or the past, present or future payment for the provision of healthcare to an4159
individual. [From 45 CFR 160.103]4160
Quorum a majority of voting members of an IRB, including at least one member whose primary4161
expertise is in a nonscientific area. 4162
Research - a systematic investigation, including research development, testing and evaluation, designed4163
to develop or contribute to generalizable knowledge. Activities that meet this definition constitute4164
research even if they are a component of a larger non-research activity (e.g., instruction,4165
demonstration.) [From 45 CFR 46.102(d)]4166
Research Misconduct fabrication, falsification, plagiarism, or other practices that seriously deviate from4167
those that are commonly accepted within the research community for proposing, conducting, or4168
reporting research. It does not include honest error or honest differences in interpretations or4169
judgments of data or creative innovations that are nonetheless ethical, legal and meet professional4170
standards. 4171
Risk the probability of harm or injury (physical, psychological, social, or economic) occurring as a result4172
of participation in a research study. Both the probability and magnitude may vary from minimal to4173
significant. 4174
Serious adverse drug experience Any adverse drug experience (associated with the use of the drug)4175
occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse4176
drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or4177
significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that4178
may not result in death, be life-threatening, or require hospitalization may be considered a serious4179
adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the4180
patient or subject and may require medical or surgical intervention to prevent one of the outcomes4181
listed above. ([rom 21 CFR 312.32(a)]4182
Serious Noncompliance Noncompliance that materially increases risks or that results in unexpected4183
substantial harm to subjects or others. In addition the following instance(s) of noncompliance, as4184
defined by OHRP, will always be determined as serious noncompliance: 4185
• Non-Exempt human participants research being carried out without IRB review and approval or4186
without appropriate informed consent. 04187
• Substantive modifications to IRB-approved research without IRB approval. 4188
Significant Risk (SR) device study - one that presents a potential for serious risk to the health, safety, or4189
welfare of a subject and (1) is intended as an implant; or (2) is used in supporting or sustaining4190
human life; or (3) is of substantial importance in diagnosing, curing, mitigating or treating disease,4191
or otherwise prevents impairment of human health; or (4) otherwise presents a potential for serious4192
risk to the health, safety, or welfare of a subject. [From 21 CFR 812.3(m)] 4193
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Suspension - By requirement of the convened IRB or the IRB Chair, a temporary halt to a selection of4194
research activities being conducted under an IRB-approved project or a temporary halt to the IRB4195
approved project as a whole. 4196
Termination - By requirement of the convened IRB, a permanent halt to some or all research activities in4197
a previously approved IRB project. 4198
Test Article any drug for human use, biological product for human use, medical device for human use,4199
human food additive, color additive, electronic product, or any other article subject to regulation4200
under the Federal Food Drug and Cosmetic Act, or under sections 351 or 354-360F of the Public4201
Health Service Act. (From 21 CFR 50.3(j) and 21 CFR 56.102(l)) 4202
Unanticipated adverse device effect Any serious adverse effect on health or safety or any life-threatening4203
problem or death caused by, or associated with, a device, if that effect, problem, or death the4204
frequency, specificity or severity of which has not previously been identified in the investigational4205
plan or application, or any other unanticipated serious problem associated with a device that relates4206
to the rights, safety, or welfare of subjects. [From 21 CFR 812.3(s)] 4207
Unanticipated problem involving risk to subjects or others Any problem or event that: 4208
a. was not expected given the nature of the research, the population under study and the approved4209
procedures or protocol for conduct of the study, impacts the rights, safety, or welfare of subjects or4210
others (e.g. those not directly involved in the research such as research staff or family members),4211
and 4212
b. is related to the research intervention, research procedures, and/or conduct of the research study. 4213
Unexpected adverse drug experience Any adverse drug experience (associated with the use of the drug),4214
the frequency, specificity or severity of which is not consistent with the current investigator4215
brochure; or, if an investigator brochure is not required or available, the specificity or severity of4216
which is not consistent with the risk information provided to subjects and the IRB. [from 21 CFR4217
312.32(a)] 4218
4219
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