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Tusculum Institutional Review

Board (IRB) Handbook

A guidebook to the function and protocol of the Tusculum Institutional Review Board.

Latest revision: September 26, 2018

Tusculum IRB Handbook 2

Committee Membership

The Institutional Review Board (IRB) is a non-faculty Tusculum committee that falls under the jurisdiction of the Vice President of Academics (VPA). Members and the chair are appointed and serve at the pleasure of the VPA. IRB members must complete and provide verification of IRB training prior to serving and must provide verification of ongoing training no less than every five years. Policy, as well as full IRB review, will require a quorum (a minimum of half of all members voting in the affirmative).

Members of Tusculum’s IRB

2018-2019 IRB Chair:

Robert Gall (Psychology) e-mail: [email protected] IRB Members by College: College of Health Sciences Robert Gall (Psychology) – [email protected] Kate Smith (Psychology) – [email protected] College of Civic & Liberal Arts Michael Bodary (English) - [email protected] Katherine Everhart (Social Sciences) - [email protected] College of Science, Technology, & Mathematics Susan Monteleone (Biology) - [email protected] Merve Kester Thomas (Mathematics) - [email protected] College of Business Jack McCann (Business) - [email protected] Harold Branstrator (Business) - [email protected] College of Education Jeff Burleson (Education) - [email protected]

Suzanne Byrd (Sports Study) - [email protected]

IRB Outside Member:


2017-2018

IRB Chair:

Robert Gall (Psychology) e-mail: [email protected]

IRB Members:

Michael Bodary (English),

Jeff Burleson (Education),

Suzanne Byrd (Sports Study),

Michael Dillon (Business),

Erica Hutton (Criminal Justice),

Merve Kester (Mathematics),

Jack McCann (Business),

Katherine Smith (Psychology),


IRB Outside Member:


2016-2017

IRB Chair:

Katherine Smith (Psychology) e-mail: [email protected]

IRB Members:

Michael Bodary (English),

Jeff Burleson (Education),

Suzanne Byrd (Sports Study),

Michael Dillon (Business)

Lois Ewen (Nursing),


Merve Kester (Mathematics),

Jack McCann (Business),

IRB Outside Member:

George Frye


Table of Contents

Committee Membership.................................................................................................................. 2

Members of Tusculum’s IRB.......................................................................................................... 2

2018-2019 ........................................................................................................................... 2

2017-2018 ........................................................................................................................... 3

2016-2017 ........................................................................................................................... 4

Mission Statement. .......................................................................................................................... 7

Purpose of the Institutional Review Board (IRB) ........................................................................... 8

Statement of Principles of Tusculum‘s IRB ................................................................................. 10

Student Research in Non-Research and Research Courses and in Research Internships ............. 11

Approval by an individual professor ................................................................................. 11

Approval by a divisional subcommittee ........................................................................... 11

How Tusculum’s IRB Reviews Research Proposals .................................................................... 14

Research with Human Subjects Definition? ..................................................................... 14

Levels of Review .............................................................................................................. 14

Assessment of risk ............................................................................................................ 15

Levels of Review in Detail ............................................................................................... 16

Exempt from review ............................................................................................. 16

Expedited review due to minimal risk .................................................................. 17

Full Review ........................................................................................................... 18

Decisions ........................................................................................................................... 18

Approved............................................................................................................... 18

Approved with conditions: .................................................................................... 19

Deferred due to serious concerns: ......................................................................... 19

Disapproved .......................................................................................................... 19

Submitting An Application ........................................................................................................... 20

IRB Application Form ...................................................................................................... 20

Consent, Permission, or Assent Forms ............................................................................. 20

The Purpose of Obtaining Informed consent ........................................................ 20

The Contents of the Consent/Permission Form .................................................... 22

What to do with the Consent Form ....................................................................... 24


Waiving the Requirement for a Consent Form ..................................................... 24

Requirements for Waiving the Documentation of Consent .................................. 24

Instructions for Preparing the Consent Form ........................................................ 25

Research with Vulnerable Populations ................................................................. 27

Instruments for Data Collection ........................................................................................ 29

Recruitment Materials ....................................................................................................... 29

IRB Training Verification ................................................................................................. 29

Important Additional Considerations ............................................................................................ 31

Safeguarding Information ................................................................................................. 31

Certificate of Confidentiality ............................................................................................ 32

Changes to the Protocol .................................................................................................... 34

Adverse Effects on Subjects ............................................................................................. 34

Renewed Approval............................................................................................................ 34

IRB Divisional Tracking for Research Course Assignments ....................................................... 35

Appendix: Definitions of Terms ................................................................................................... 36

Appendix: Template for Consent/Permission Form ..................................................................... 42

Appendix: IRB Divisional Tracking Form ................................................................................... 43

General Categories of IRB Submissions ....................................................................................... 44

Exempt .............................................................................................................................. 44

Expedited .......................................................................................................................... 45

Full Review ....................................................................................................................... 48

Appendix: Online Resources for IRBs ......................................................................................... 49


Mission Statement.

Tusculum’s IRB reviews research with human subjects and promotes ethical research. Research

is defined as a systematic investigation whose purpose is to contribute to generalizable

knowledge. At Tusculum, research is not expected to expose subjects to any risk of physical

danger or psychological distress other than what they would typically encounter as part of daily

living. As such, the committee seeks to protect the health and welfare of human subjects

involved in research conducted by or on faculty, staff, and student affiliated with Tusculum.


Purpose of the Institutional Review Board (IRB)

Tusculum is committed to the pursuit of high quality research and applied scholarship to

meet the needs and interests of the institution, the scientific community, and society. At the same

time, the Institution is committed to protecting the welfare of every person who may be involved

in research and training projects. Members of the Tusculum community, while upholding the

highest standards of freedom of inquiry and communication, accept the responsibility this

freedom offers: for competence, for objectivity, and for the welfare of every participant in a

project.

As such, Tusculum has established an Institutional Review Board (IRB) or Ethics Review

Board to review projects that involve human Subjects in order to ensure that each project

complies with the highest ethical standards. In addition to its mandated review functions, the IRB

is committed to serving as an educational resource for the Tusculum community.

The purpose of this document is to assist Tusculum investigators in the preparation and

submission of research proposals for review by the IRB. The policies and procedures of the IRB

are based on the rules and procedures mandated by DHHS Regulations for the Protection of

Human Research Subjects (45 CFR 46, as amended1) as well as the APA IRB Planning Guide.

It is the responsibility of the Tusculum IRB to protect human subjects and facilitate

research conducted by its faculty, staff, and students. When the IRB encounters questions about a

proposal, it will attempt to consult with someone knowledgeable in the investigator’s field of

study. If no one on the IRB meets this criterion, investigators may request that a particular person

who is an expert in the area and who is willing to act as a consultant to the IRB be involved in

1 http://www.hhs.gov/ohrp/humanparticipants/guidance/45cfr46.htm

http://www.hhs.gov/ohrp/humanparticipants/guidance/45cfr46.htm


the review. Although that person will not be able to vote on a proposal, their recommendations

will be weighed heavily in the IRB’s decisions.

In accordance with the Belmont Report2, Tusculum’s IRB research policies and

procedures are designed to ensure respect for Subjects, beneficence, and justice in the conduct of

all research. Respect ensures that the dignity of all Subjects is protected by ensuring their safety

and privacy. Likewise, Subjects are expected to be able to make informed judgments about their

desire to participate in a research project, and vulnerable Subjects are provided with extra

protections. Beneficence demands that any costs to individual Subjects must be outweighed by

clear benefits. Justice is carried out by ensuring that populations are included or excluded only

for reasons directly related to the research project itself.

It is the responsibility of all members of the Tusculum community to observe these policies

and procedures for themselves and on behalf of their research subjects. Tusculum assumes no

legal responsibility for individuals who do not conform to the IRB’s regulations and receive IRB

approval for all research projects. Furthermore, failure to comply with the IRB’s regulations

could impugn the investigator's own name and the reputation of Tusculum and could lead to

restrictions on the research activity of the individual and the Institution.

Finally, all research projects involving the use of human Subjects must be reviewed by

the IRB. Additionally, individual researchers are not allowed to determine if their research is

except, as this is a function of the IRB. Submission and review procedures are described in this

Guide.

2 http://ohsr.od.nih.gov/guidelines/belmont.html

http://ohsr.od.nih.gov/guidelines/belmont.html


Statement of Principles of Tusculum‘s IRB

Tusculum affirms the value and dignity of the individual person. The value of the person,

it is maintained, supersedes and anchors all other values. Persons are never to be treated as

merely a means but always, simultaneously, as ends in themselves.

The doctrine of the supreme worth of the person is reflected in American political society

in the theory of human rights that underlies the legal system. It is also articulated in such

statements as the United Nations' Universal Declaration of Human Rights (1948), the declaration

of the Helsinki Agreement (1964), and the Belmont Report (1979).

Moral principles not only serve as a basis of social unity but also can provide guidance

for individual decision-making. Cases of perplexity arise in various contexts, including that of

research involving human Subjects. Moral principles express ways of resolving perplexities that

are well established in scientific and medical practice. An examination of these principles may

provide insight into the possibility of making morally sound decisions.

A fundamental principle of morality is that of respect for persons, which embodies the

conviction that persons are to be treated as autonomous agents. In the context of research

involving human Subjects, respect for persons requires that Subjects be given the opportunity to

determine what shall or shall not happen to them. This opportunity is provided by the

requirement of informed consent. Consent is informed when the participant is fully appraised of

the procedures, risks, and benefits s/he may undergo in participating in a particular research

study. Consent is genuine when the participant has the right to refuse participation without

recrimination.


Student Research in Non-Research and Research Courses and in Research Internships

All human subjects research conducted at Tusculum must be evaluated for its ethical

implications and approved. This can be accomplished in a variety of ways. Approval can be

provided by the professor of a course, by a division review, by another institution’s IRB, or by

Tusculum’s IRB. The following descriptions outline the different means by which ethical

approval may be obtained at Tusculum.

Approval by an individual professor

If a professor obtains consent from all members of a course to collect data as part of the

course, then the professor may collect data only on the students in the course. For example, the

professor may demonstrate how to create and distribute questionnaires, give interviews, collect

observations, or run an experiment by having the students in the course serve as Subjects for one

another. The data collection must pose no risk to the students or Subjects; Subjects must have the

right to refuse to participate without penalty; confidentiality must be maintained to the greatest

extent possible; extra precautions must be taken with vulnerable populations (such as gender or

ethnic minorities); and the data may not be published. The professor of the course, however,

assumes responsibility. If a professor is uncertain whether a project is ethically sound, then the

project should be submitted to Tusculum’s IRB.

Approval by a divisional subcommittee

This option is best for situations where every student in a course will be collecting the

same data outside of the course for the same project and the project is associated with a course


grade. This option is only appropriate if the data collection poses no risk to either the students or

Subjects, and involves only a few Subjects. The data collected under this option may not be

published. Additionally, this option is not appropriate for theses, capstone projects, etc. For

example, observing a few individuals in public places, interviewing several individuals, holding

a focus group, conducting a completely physically and psychologically harmless experiment, or

providing a harmless intervention within a service learning course with a few individuals all are

acceptable. The divisional subcommittee, however, assumes responsibility. If a division is

uncertain whether a project is ethically sound, then the project should be submitted to

Tusculum’s IRB. The divisional subcommittee for each division will be comprised of members

of the full IRB. The form for submitting a proposal for divisional subcommittee review is

included in the Appendix of this guidebook, and can be submitted at any time.

Approval by the Tusculum IRB

(including research internships, senior research projects, individual student research

projects, as well as faculty and staff research) - This option is required for any student

conducting an individual research project. Additionally, this option is required, regardless of the

setting, where there is any risk to subjects, where there will be more than a few subjects, and/or

where the results of the project may be published. Note that for publication in many peer-

reviewed journals, IRB approval in advance of the project is a prerequisite for consideration, so

if there is any chance a student project may be published, it should be reviewed by the IRB. This

applies to student research conducted at Tusculum or at any other institution (for example,

another college, a university, or a hospital).


If the project has been approved already by another institution’s IRB, then the student

must submit documentation of approval from that institution to Tusculum’s IRB along with brief

descriptions of the project and the student’s specific role in the project. The documentation may

consist of the approval letter from the other institution’s IRB or of a signature by the principal

investigator of the project on which the student is working indicating that the principal

investigator has received IRB approval from the institution. The name of the institution, the

principal investigator, the student’s name, and the date the IRB approval was obtained must be

included. The IRB Chair then may either waive the requirement that the student submit to

Tusculum’s IRB or require that the student also submit the proposal to Tusculum’s IRB. As long

as the project complies with Tusculum’s policies, other institution’s IRB decisions will be

respected. This information may be submitted electronically to the IRB Chair. The IRB reserves

the right to disapprove of a student’s research. Student projects that require review by the

Tusculum IRB should be prepared following the guidelines presented in Sections VI-VIII,

including submission following the meeting schedule listed in Section VII.


How Tusculum’s IRB Reviews Research Proposals

Research with Human Subjects Definition?

Research is defined as (1) a systematic investigation (2) whose purpose is to contribute to

generalizable knowledge (Bankert & Amdur, 2006, p. 101). That is, a systematic attempt in

which “the primary goal of the activity must be to develop or contribute to generalizable

knowledge” (Bankert & Amdur, 2006, p. 101). Under this definition some demonstration,

service, and training projects may be considered to include research activities.

A human subject is defined “as a living individual about whom an investigator

conducting research obtains 1) data through intervention or interaction with the individual or 2)

identifiable, private information” (Bankert & Amdur, 2006, p. 101).

Levels of Review

An investigator submits a research proposal for one of three levels of review:

i. Exempt from review

ii. Expedited review

iii. Full review

Whether a research proposal is designated to be exempt from IRB review or will receive

an expedited or full review very much depends on the risk assessment. While researchers may

suggest the level of review they believe is most appropriate based on the criteria listed below, the

Chair of the IRB will make the final decision.


Assessment of risk

To determine whether the subject will be harmed in any way, the IRB will make a

decision based on common sense and sound professional judgment as to whether or not the

proposed research places the subject at risk. A subject is considered to be at risk if s/he may be

exposed to the possibility of harm, whether physical, psychological, sociological, or other. The

IRB will consider the fact that certain participant populations (e.g., minors, pregnant women,

prisoners, mentally handicapped, workers, culturally or socioeconomically disadvantaged

individuals) may be at greater risk than others.

Certain risks are inherent in life itself, but the IRB is not concerned with the ordinary

risks of public or private living. Risk as applicable to DHHS policy is most obvious in medical

and behavioral science research projects involving procedures that may induce a potentially

harmful altered physical state or psychological condition. There is a wide range of medical,

social and behavioral procedures and projects in which, although there may be no immediate

risk, procedures may be introduced that involve discomfort, anxiety, harassment, invasion of

privacy, or that constitute a threat to the participant's dignity.

If it is judged that the proposed research project will expose a participant to risk, then the

IRB must assure itself that (a) the rights and welfare of the subjects are adequately protected, (b)

the methods used to obtain informed consent are adequate and appropriate, (c) the risks to the

subjects are outweighed by the potential benefit to the subjects or by the importance of the

knowledge to be gained, and (d) risks to subjects are minimized by using procedures which are

consistent with sound research design and which do not unnecessarily expose Subjects to risk.


Levels of Review in Detail

Exempt from review

a. A research project is exempt from review if it consists of (1) Normal Educational

Practices in Typical Educational Settings, (2) Anonymous Educational Tests,

Surveys, Interviews, or Observations where Subjects cannot be identified and no

disclosure of Subjects’ responses could place them at risk civilly, criminally,

financially, or damage their financial standing or reputation, (3) Public officials or

candidates for public office are involved in #2, (4) Information has been collected

already and subjects cannot be identified (but see medical-HIPPA and

educational-FERPA regulations regarding privacy), (5) Public Department or

Agency Heads are examining Public Services, and (6) Taste and Quality Food

Studies with wholesome foods and contaminants below minimal acceptable levels

(Bankert & Amdur, 2006, pp. 94-95). Because it is difficult to know whether a

research project meets these criteria, an investigator must complete a proposal

submission form, and the IRB Chair will determine whether further review is

warranted.

b. If a submitted proposal is determined by the Chair of the IRB to be exempt from

review, the investigator will be notified rapidly. The investigator may begin the

study after the appropriate forms have been provided to the IRB chair and

approved. If a proposal does not qualify for exempt status, the investigator will be

notified and advised on the level of review required: expedited or full review.


Expedited review due to minimal risk

a. Research activities involving no more than minimal risk may be reviewed by the

IRB through the expedited review procedure. Continuing research activities that

were approved by the IRB within the past year also may be approved through the

expedited review procedure. Expedited review is appropriate for (1) collection of

biological specimens through non-invasive means excluding x-rays or

microwaves but including collection of bodily tissues or fluids, application of

physical sensors, physiological/neuroscience tests, moderate exercise and

flexibility, (2) research on materials already collected provided privacy is ensured,

(3) collection of data from voice, video, digital recordings, or image recordings

provided confidentiality is ensured and identification of the subjects and/or their

responses would not reasonably place them at risk of criminal or civil liability or

be damaging to the participant's financial standing, employability, insurability,

reputation, or be stigmatizing, (4) research on group characteristics or behavior as

long as the group will not face stigmatization, and (5) continuing review of

research previously approved by a full IRB review as long as no new types of data

are collected that would require a full IRB review (Bankert & Amdur, 2006, pp.

99-100).

b. The expedited review procedure may not be used unless reasonable and

appropriate protections will be implemented so that risks related to invasion of

privacy and breach of confidentiality are no greater than minimal.


c. The IRB may also use the expedited review procedure to review minor changes in

previously approved research during the period for which approval is authorized.

d. Under an expedited review procedure, the review may be carried out by the Chair

of the IRB, with or without consultation with other IRB members.

Full Review

a. All proposals that do not qualify for exemption or expedited review, including all

research that involves more than “minimal risk,” must be submitted for review by

the full IRB. Under a full review procedure, a majority of the members of the IRB

will be present, including at least one member whose primary concerns are in

non-scientific areas. The investigators may be invited to the meeting to clarify

parts of the proposal. In order for research to be approved, it must receive the

approval of a quorum of IRB members.

Decisions

If a research proposal is determined to exempt by the Chair of the IRB, then the

researcher can begin the study as soon as the paperwork has been submitted.

Decisions regarding expedited and full reviews will be assigned to one of four categories

(below). After all decisions, the investigator can contact either the Chair of the IRB or another

IRB member designated by the Chair to discuss the proposal.

Approved

The investigator may begin the study as soon as the paperwork for the proposal has been

submitted to the IRB and approved.


Approved with conditions:

The investigator will be notified in writing as to the nature of the required modifications.

The investigator must comply with all required modifications and resubmit a corrected proposal

to the Chair of the IRB incorporating the modifications. Once the Chair of the IRB approves the

research proposal, the investigator may begin the study as soon as the paperwork for the proposal

has been submitted to the chair of the IRB and approved.

Deferred due to serious concerns:

Members of the IRB or the full IRB are uncertain whether the researcher can address

adequately their concerns. The researcher will be notified in writing as to the nature of their

concerns. If the researcher believes s/he can address all the concerns, the researcher may

resubmit a corrected proposal to the Chair of the IRB incorporating the necessary modifications.

Once the Chair of the IRB or the full IRB approves the research proposal, the researcher may

begin the study as soon as the paperwork for the proposal has been submitted to the chair of the

IRB and approved.

Disapproved

The full IRB has decided that the investigator may not proceed with the project.


Submitting An Application

All IRB inquiries and proposals should be submitted via email to the current chair of the

IRB. The current chair for any given year can be found under the Members of Tusculum IRB

section.

IRB Application Form

All levels of submission require a completed IRB application as well as all relevant

documents to be submitted electronically to the chair of the IRB committee. The application can

be obtained either from the IRB website, the IRB section on Tusculum Governance Moodle site,

or by emailing the chair of the IRB.

Consent, Permission, or Assent Forms

A template of a consent/permission form is available in the appendixes.

The Purpose of Obtaining Informed consent

The informed consent of the individual is a vital element in the protection of human

Subjects. Before a person participates in an investigation involving risk or the likelihood of

substantial stress or discomfort, the nature of these hazards and the procedures to be followed are

to be carefully explained and participant consent obtained.

Three types of acquiescence to participate in a research project can occur.

i. First, those subjects who are over 18 years can consent to participate in research

themselves as long as they understand the research project and can voluntarily

choose whether to participate.


ii. Second, in cases in which a participant is under 18 or cannot be expected to

understand the research proposal or cannot voluntarily choose whether to

participate (typically a minor or cognitively impaired person), a legal guardian

can provide permission for that person to participate.

iii. Third, in the case when a legal guardian provides permission for a participant to

partake in the research project, the investigator generally should attempt to obtain

the actual subject’s assent, which may occur verbally. This generally requires a

simplified description of the research proposal. Because this is a critical

component of the respect for the dignity of subjects, the IRB will carefully review

the process and documents for consent, permission, and assent forms.

Investigators should seek consent under circumstances that provide the prospective

participant or the representative sufficient opportunity to consider whether or not to participate

and that minimize the possibility of coercion or undue influence. An individual does not give up

any rights by consenting to be a research participant. A participant has the right to withdraw

from a research project at any time or to refuse to participate without loss of benefits to which

the participant would otherwise be entitled. Further, a participant has the right to receive

appropriate professional care, to enjoy privacy and confidentiality in the use of personal

information and to be free from undue embarrassment, discomfort, anxiety, and harassment.

Unless the IRB issues a specific waiver of consent or of documentation of consent (see

below), documented written informed consent of subjects (through the use of a consent form) is

required for all research projects where there is any risk to the human subjects. If a participant is

not legally or physically capable of giving informed consent, a legally authorized representative

may give permission for the participant to partake in the research. Careful consideration will be


given to the representative's depth of interest in and concern for the participant's rights and

welfare.

The Contents of the Consent/Permission Form

Consent form should convey all of the following information, at a minimum. It should

also be simply written and easily understood. The appendix contains a sample

consent/permission template.

a. A statement that the study involves research, a readily understood explanation of

the purposes of the research and the expected duration of the participant’s

participation, a description of the procedures to be followed, including

identification of any procedures which are experimental

b. A description of how data will be handled (e.g. who will have access for what

purposes).

c. A description of how and to whom data and results will be disseminated (e.g.

intentions to present or publish, share with colleagues, and at what level of

aggregation, etc.)

d. A description of any reasonably foreseeable risks or discomforts to the

participant.

e. A description of any benefits to the participant or to others which may reasonably

be expected from the research and/or findings (e.g. if no direct benefit, this should

be stated).


f. A statement describing the extent, if any, to which confidentiality of records that

identify the participant will be maintained. (If signed Informed consent forms are

used, regulations require they must be kept for 3 years.)

g. An explanation of whom to contact for answers to pertinent questions about the

research and research subjects’ rights, and whom to contact in the event of a

research-related problem or injury to the participant.

h. For research involving more than minimal risk, an explanation as to whether any

medical or psychological treatments are available if injury occurs and, if so, what

they consist of, or where further information may be obtained.

i. A statement that participation is voluntary, that deciding not to participate will

involve no penalty or loss of benefits to which the participant is otherwise

entitled, and that the participant may discontinue participation at any time without

penalty or loss of benefits to which the participant is otherwise entitled.

j. A statement concerning costs or compensation to the participant, if any.

k. A statement similar to this in the consent document: If you have questions or

concerns about the research, you may contact [name and contact information of

investigator and/or the Chair of the Institutional Review Board at ____________.

Students should also include name of and contact information for their research

advisor or course instructor.

The IRB may require additional information to be included in the consent process and/or

included in the Consent Form.


What to do with the Consent Form

Researchers must insure that anyone signing a written Consent Form is given a copy of

that form before they participate in the project. Researchers are responsible for safeguarding the

consent documents signed by human research subjects for at least three years following the

termination of the project. Faculty supervisors must maintain the consent documents for student

investigators. In the event that a researcher leaves the institution prior to the three years, they are

required to turn in a copy of all consent forms to the IRB chair. Finally, the IRB committee can

request a copy of the signed consent forms at any time.

Waiving the Requirement for a Consent Form

The IRB may waive the requirement for the investigator to obtain a signed Consent Form

for some or all subjects if it finds that (Bankert & Amdur, 2006, p. 220):

a. The research involves no more than minimal risk to the subjects.

b. The waiver or alteration will not adversely affect the rights and welfare of the

subjects.

c. The research could not practicably be carried out without the waiver or alteration.

d. Whenever appropriate, the subjects will be provided with additional pertinent

information after participation (Bankert & Amdur, 2006, p. 217).

Requirements for Waiving the Documentation of Consent

The IRB may waive the requirement that the investigator document who signed Consent

Forms if it finds that (Bankert & Amdur, 2006, p. 221):


a. The only record linking the subject and the research would be the consent

document and the principal risk would be potential harm resulting from a breach

of confidentiality. Each participant must be asked whether s/he wants to be linked

with the research OR

b. The research presents no more than minimal risk of harm to subjects and involves

no procedures for which written consent is normally required outside of the

research context OR

c. The participant never signed a consent form, because the consent form

requirement was waived. In that case, the investigator should provide Subjects

with a written description of the project before initiating the project.

Reasons to waive use of a signed consent form should be given in the IRB Application

Form. When the documentation requirement is waived or altered, the IRB still requires an

informed consent process – providing subjects with a written or oral description of the research

and making sure they are freely choosing to participate.

Instructions for Preparing the Consent Form

a. Language - Style: The consent form should be written in the second person. When

combined with conditional language and the invitation to participate, use of the

second person communicates that the investigator believes there is a choice to be

made by the prospective participant. Use of the first person may be interpreted as

presumption of participant consent before consent has been legally obtained.

b. Language – Level: The information that is given to the participant or the

representative shall be in language understandable to the participant or the


representative. Keep in mind that terms commonly used by members of a

profession are a part of the professional's language, a language many people

outside that profession do not understand. If there is any doubt that a term may

not be understood, a definition should be added. If some of the anticipated

participant population does not understand English, appropriate translation should

be provided. Researchers are commonly advised to write consent materials for

about an 8th grade reading level.

c. Language - Exculpatory: The consent form must not contain any exculpatory

language through which the participant or the participant's representative is made

to waive or appear to waive any of the participant's legal rights, or through which

s/he releases or appears to release the research investigator, the sponsor, the

institution or its agents from liability for negligence.

d. Language – Foreign: If your research study will include individuals with

linguistic backgrounds other than English, the IRB will generally require that you

translate the Informed Consent Form into the appropriate other language. It must

be submitted with the other materials you are sending in your application. An

English “back translation” of the Form should be submitted, as well. In cases

where an individual may be unable to read—whether it is English or another

language—or has impaired vision, appropriate arrangements must be made to

orally convey the contents of the Informed Consent Form. Arrangements must

also be made for the individual to give or withhold their willingness to participate

in the research project. It should be noted that college and university students in


the United States are assumed to have passed the TOFEL exam, and as such, do

not require a consent form in their native language.

e. Length: The consent form should be long enough to explain consent factors

adequately but not so long or detailed as to lose the attention of the participant or

to cause confusion. If a separate project description is given to subjects, the actual

consent form will not need to exceed one page.

f. Submission to the IRB: Researchers must include copies of any proposed consent

form(s) with the proposal. Researchers must also submit copies of any written or

verbal explanation of the project that will be given to Subjects. The approved

Consent Form is valid for a maximum of one year. In cases where a project is

continuing beyond one year, permission to continue use of the Consent Form

must be applied for at least one month in advance of the one-year anniversary

date. Such permission is granted in conjunction with the application for

Continuing Review.

Research with Vulnerable Populations

a. For research with children, the elderly, the disabled, and other vulnerable

populations, additional protections are required. Permission must be obtained

from parents/guardians for all vulnerable subjects as well as assent from subjects

themselves. No subject can provide consent unless they are over 18 years of age

unless they are a college/university student, the research is done on a

college/university, and a waiver for consent has been granted. If subjects are

under 18 years, they will require a family member/guardian to provide permission


for them to participate. Tusculum students under 18 years cannot participate

without parental permission. Pregnant women and prisoners also are considered

vulnerable populations, though not the only ones, so special considerations apply.

Researchers should review the material in the CITI, NIH, or Tusculum’s training

modules and consult with the IRB for further details.

b. Assent and Permission: Be sure to include copies of materials to be sent home to

families/guardians and the Permission Forms they would sign. Be sure that

procedures for gaining and maintaining Assent are clear. For example, teenagers

under 18 require parental permission, but they themselves must also provide

Assent. This can be accomplished by having them read and sign something. For

younger children, the elderly or disabled, ongoing assent must be obtained before

the research commences, then continually determined verbally and behaviorally.

You will need to make it clear how this will be done.

c. For research in institutions (schools, nursing homes, hospitals, prisons):

Researchers will need to provide written documentation to the IRB chair that the

institution approves of your research project before you begin to collect data.

Researchers may also include this information as an appendix if they have

contacted an institution before submitting to the IRB. However, the IRB makes

the final decisions regarding all procedures and instruments, so it is reasonable to

obtain formal IRB approval before obtaining approval from an institution.


Instruments for Data Collection

If used, please include a copy of all instruments that will be used in the research study. If

the instrument is commercially available, please provide a representative sample of questions

from the instrument. Research instruments include, but are not limited to the following: surveys,

interview guides, observation tools, psychometric tests, or any data collection tool.

Recruitment Materials

If used, please include a copy of all recruitment materials used in the research study. If

the research involves cooperating institutions, organizations, or agencies, please include

authorization from those entities to use the recruitment materials as well. Recruitment materials

include such things as flyers, recruitment advertisements, survey monkey descriptions.

IRB Training Verification

IRB training verification is required for Expedited and Full IRB review. Please note that

while IRB training verification is not required for Exempt research, if the IRB determines that

your research is not Exempt or that there are risks to the subjects, the researcher will be required

to provide IRB training verification prior to beginning the study.

All investigators leading or assisting with any phase of a research project (design, data

collection, data analysis, presentation) must complete IRB Training and provide documentation

of completion to the IRB. Researchers may complete Tusculum’s Online IRB Training3. The

IRB Committee also recognizes previously completed “Protecting Human Research Subjects”

3 https://ws.tusculum.edu/survey/index.php/184947

https://ws.tusculum.edu/survey/index.php/184947


NIH Extramural Research Training course4 or the CITI Program training course5 that was

completed within the last five years. Each investigator is responsible for registering for the

course, reading the content, passing the review quizzes, and printing a copy of the certificate of

completion. The IRB Training must be completed and submitted by the lead investigator and the

faculty supervisor (if applicable) before submitting an IRB application. Certificate(s) of

Completion must be submitted for any additional investigators before the project is approved. All

researchers must provide verification of current IRB training at a frequency no less than every

five years.

4 http://phrp.nihtraining.com/users/login.php 5 https://about.citiprogram.org/en/homepage/

http://phrp.nihtraining.com/users/login.php

https://about.citiprogram.org/en/homepage/


Important Additional Considerations

Safeguarding Information

Safeguarding information about an individual that has been obtained in the course of

investigation is a primary obligation of the researcher. When the researcher is a student,

responsibility for the conduct of the research and the supervision of human subjects lies with the

faculty / staff sponsor. Such information shall not be communicated to others unless explicit

permission for the release of identifying data is provided by the individual. Information about

individuals may be discussed only for professional purposes and only with persons clearly

concerned with the project. Written and oral reports should present only data germane to the

purposes of the project, and every effort should be made to avoid invasion of privacy.

Provisions must also be made for the maintenance of confidentiality in the preservation

and ultimate disposition of any data collected. Adequate security measures must be described to

the IRB and carried out by the principal researcher until the records are destroyed. Records

containing personal information shall be destroyed as soon as possible in keeping with the long-

range goals of the project.

Signed copies of informed consent forms must be maintained by the principal researcher

and be stored in a secure manner. Unless otherwise specified by Federal and/or state regulations,

retention shall be for a period of at least three years beyond the termination of the study. If the

investigator resigns from Tusculum before the end of the designated period, the informed consent

forms must be submitted to the IRB unless otherwise specified.

The one exception to provisions of confidentiality however concerns the federal

government. Unless the researcher files a form with the federal government requesting


confidentiality before data is collected, federal officials concerned with protection of subjects are

allowed to request data collected by an investigator.

Certificate of Confidentiality

A Certificate of Confidentiality may sometimes be required by granting agencies such as

NIH to provide additional protection for vulnerable populations. The following is a summary of

policies from Health and Human Services6.

The Public Health Service Act §301(d), 42 U.S.C. §241(d), "Protection of privacy of

individuals who are research subjects," states:

The Secretary may authorize persons engaged in biomedical, behavioral, clinical, or other

research (including research on mental health, including research on the use and effect of alcohol

and other psychoactive drugs) to protect the privacy of individuals who are the subject of such

research by withholding from all persons not connected with the conduct of such research the

names or other identifying characteristics of such individuals. Persons so authorized to protect

the privacy of such individuals may not be compelled in any Federal, State, or local civil,

criminal, administrative, legislative, or other proceedings to identify such individuals.

The privacy of the research subjects referred to in §301(d) is protected through the

issuance of Certificates of Confidentiality. These certificates of Confidentiality provide

protection against compelled disclosure of identifying information about subjects enrolled in

sensitive biomedical, behavioral, clinical, or other research. This protection is not limited to

federally supported research.

Guidance: OHRP does not issue Certificates of Confidentiality. Certificates of

Confidentiality are issued by the National Institutes of Health (NIH) and other HHS agencies to

6 https://humansubjects.nih.gov/coc/index


protect identifiable research information from forced or compelled disclosure7. They allow the

investigator and others who have access to research records to refuse to disclose identifying

information on research participants in civil, criminal, administrative, legislative, or other

proceedings, whether federal, state, or local. Certificates of Confidentiality may be granted for

studies collecting information that, if disclosed, could have adverse consequences for subjects,

such as damage to their financial standing, employability, insurability, or reputation. By

protecting researchers and institutions from being compelled to disclose information that would

identify research subjects, Certificates of Confidentiality help to minimize risks to subjects by

adding an additional level of protection for maintaining confidentiality of private information.

Certificates of Confidentiality protect subjects from compelled disclosure of identifying

information but do not prevent the voluntary disclosure of identifying characteristics of research

subjects. Researchers, therefore, are not prevented from voluntarily disclosing certain

information about research subjects, such as evidence of child abuse or a subject's threatened

violence to self or others.

However, if a researcher intends to make such voluntary disclosures, the consent form

should clearly indicate this. Furthermore, Certificates of Confidentiality do not prevent other

types of intentional or unintentional breaches of confidentiality. As a result, investigators and

IRBs must ensure that other appropriate mechanisms and procedures are in place to protect the

confidentiality of the identifiable private information to be obtained in the proposed research.

7 CoC Contacts at NIH and Other HHS Agencies that Issue Certificates https://humansubjects.nih.gov/coc/contacts


Changes to the Protocol

If a research procedure changes after a research project has been approved, the researcher

must not proceed with the proposed changes without written approval of the IRB.

In cases where a researcher is seeking approval for a project essentially identical to a

project previously approved by the IRB, renewed approval should be obtained generally through

an expedited review. Full reviews are required when an investigator submits a previously

approved proposal to other funding agencies.

Adverse Effects on Subjects

It is the researcher’s responsibility to notify the IRB in writing of any adverse effects to

research Subjects within one week of such event(s). If a researcher should encounter any

unexpected and serious adverse effects on human Subjects, research should be immediately

discontinued and the IRB must be notified.

Renewed Approval

Any project which exceeds a period of one year in duration must be reviewed and receive

IRB approval prior to the beginning of the second and any successive years of the research project.

Renewed Approval must be sought at least one month prior to the anniversary date of approval for

the research study.

The Consent Form is also valid for a maximum of one year after its approval. In cases

where a project is continuing beyond one year, permission to continue use of the Informed Consent

Form must be applied for at least one month in advance of the one-year anniversary date. Such

permission is granted in conjunction with the application for Continuing Review.


IRB Divisional Tracking for Research Course Assignments

The IRB Divisional Tracking Form for Research Course Assignments is the Appendix.

The form may be copied from the appendix and submitted electronically, along with relevant

documents, to the chair of the IRB committee.

After the IRB Divisional representatives have approved a project, the Tracking Form will

be returned to the faculty person for his/her records and a copy will be submitted to the IRB

chair.


Appendix: Definitions of Terms

Anonymized data — Lacking “identifiers or codes that can link a particular sample to an

identified specimen or a particular human being.” The data is unidentified. (i.e.,

personally identifiable information was not collected, or if collected, identifiers were not

retained and cannot be retrieved). Information or materials (e.g., data or specimens) that

cannot be linked directly or indirectly by anyone to their source(s). Source: 2000.

Research Involving Human Biological Materials: Ethical Issues and Policy Guidance,

Executive Summary. Rockville, MD: National Bioethics Advisory Committee, p. 2.

(http://bioethics.georgetown.edu/nbac/hbm_exec.pdf)

Assent — “...affirmative agreement to participate in research. Mere failure to object should not,

absent affirmative agreement, be construed as assent.”

Source: 45 CFR 46.402(b)

Autonomous person — “An individual capable of deliberation about personal goals and of

acting under the direction of such deliberation.” Source: National Commission for the

Protection of Human Subjects of Biomedical and Behavioral Research. 1979. The

Belmont Report — Ethical Principles and Guidelines for the Protection of Human

Subjects of Research. Washington, D.C.: U.S. Department of Health and Human

Services: Part B, section 1, “Respect for Persons”

(http://ohsr.od.nih.gov/guidelines/belmont.html)

Children — Some federal definitions define all minors as children. Tusculum differentiates

between children and minors. A minor thirteen and under.

Clinical trial — “...a prospective biomedical or behavioral research study of human subjects that

is designed to answer specific questions about biomedical or behavioral interventions

(drugs, treatments, devices, or new ways of using known drugs, treatments, or devices).”

Source: US Department of Health and Human Services Grant Application (PHS 398) Part

II: Supplemental Instructions for Preparing the Human Subjects Section of the Research

Plan (http://grants.nih.gov/grants/funding/phs398/phs398.pdf#page=109)

http://bioethics.georgetown.edu/nbac/hbm_exec.pdf


http://grants.nih.gov/grants/funding/phs398/phs398.pdf#page=109


Coded Data — Direct personal identifiers have been removed (e.g., from data or specimens) and

replaced with words, letters, figures, symbols, or a combination of these (not derived

from or related to the personal information) for purposes of protecting the identity of the

source(s); but the original identifiers are retained in such a way that they can be traced

back to the source(s) by someone with the code. Note: A code is sometimes also referred

to as a “key,” “link,” or “map.”

Coercion — Influencing an individual’s decision about whether or not to do something by using

explicit or implied threats (loss of good standing in a job, poor grades, etc.). Coercion and

be unintentional, (i.e. a supervisor asking a subordinate to participate in a research study).

Source: Faden, RR, and Beauchamp, TL. 1986. A History and Theory of Informed

Consent. New York: Oxford University Press, p. 339.

Compensation — May include money, other material compensation, such as a coupon or gift

certificate, or other non-monetary rewards (e.g. extra credit).

Deception — Misleading research subjects about the research purpose or procedures.

De-identified — All direct personal identifiers are permanently removed (e.g., from data or

specimens), no code or key exists to link the information or materials to their original

source(s), and the remaining information cannot reasonably be used by anyone to identify

the source(s). Note: For purposes of HRPP policy, protected health information is de-

identified when it does not contain any of the 18 identifiers specified by the HIPAA

Privacy Rule at 45 CFR Part 164 (or has been determined to be de-identified by a

statistician in accordance with the standards established by the Privacy Rule). For more

information, including the list of identifiers that must be removed to de-identify health

information, see HIPAA and Human Subjects Research.

Delivery — “Complete separation of the fetus from the woman.” Source: 45 CFR 46.202(b)

Diminished autonomy — An individual with restricted capability of deliberation about personal

goals and of limited ability to act under the direction of their deliberations. Developed in

contrast to the concept of the “autonomous person” in The Belmont Report. Source:

National Commission for the Protection of Human Subjects of Biomedical and

http://orrp.osu.edu/irb/irbforms/hipaa/


Behavioral Research. 1979. The Belmont Report — Ethical Principles and Guidelines for

the Protection of Human Subjects of Research. Washington, D.C.: U.S. Department of

Health and Human Services: Part B, section 1, “Respect for Persons.”


Equipoise — Substantial scientific uncertainty about which treatments will benefit subjects

most, or a lack of consensus in the field that one intervention is superior to another.

Fetus — “The product of conception from implantation until delivery.” Source: 45 CFR

46.202(c)

Human Participant — A living individual about whom an investigator (whether professional or

student) conducting research obtains a) data through intervention or interaction with the

individual or b) identifiable, private information. Tusculum utilizes the term subjects and

human participants interchangeably.

Incomplete disclosure — Withholding some information in order to conduct an unbiased study,

with the understanding that the information could be material to a decision by prospective

subjects about whether or not to participate in the study.

Informed consent — A legally-effective, voluntary agreement that is given by a prospective

research subject following comprehension and consideration of all relevant information

pertinent to the decision to participate in a study.

Institutional Review Board — The committee at Tusculum given the authority to approve or

disapprove research projects involving subjects.

Interaction — Communication or interpersonal contact between researcher and subject.

Intervention — Both physical procedures by which data are gathered (for example,

venipuncture) and manipulations of the subject or the subject's environment that are

performed for research purposes.

Investigator — “OHRP considers the term investigator to include anyone involved in

conducting the research. OHRP does not consider the act of solely providing coded



private information or specimens (for example, by a tissue repository) to constitute

involvement in the conduct of the research. Note that if the individuals who provide

coded information or specimens collaborate on other activities related to the conduct of

this research with the investigators who receive such information or specimens, then

OHRP would consider such additional activities to constitute involvement in the conduct

of the research. Examples of such additional activities include, but are not limited to: (1)

the study, interpretation, or analysis of the data resulting from the coded information or

specimens; and (2) authorship of presentations or manuscripts related to the research.”

Source: OHRP, HHS. 2004. Guidance on Research Involving Coded Private Information

or Biological Specimens. (http://www.hhs.gov/ohrp/policy/cdebiol.html). Tusculum

utilizes the term researcher and investigator interchangeably.

Legally Authorized Representative — “An individual or judicial or other body authorized

under applicable law to consent on behalf of a prospective subject to the subject’s

participation in the procedure(s) involved in the research.” Source: 45 CFR 46.102(c)

Minimal risk — “The probability and magnitude of harm or discomfort anticipated in the

research are not greater in and of themselves than those ordinarily encountered in daily

life or during the performance of routine physical or psychological examinations or

tests.” Source: 45 CFR 46.102(i)

Minor — “Persons who have not attained the legal age for consent to treatments or procedures

involved in the research, under the applicable law of the jurisdiction in which the

research will be conducted.” Source: 45 CFR 46.402(a)

Neonates — “A newborn.” Source: 45 CFR 46.202(d)

Permission — “The agreement of parent(s) or guardian to the participation of their child or ward

in research.” Source: 45 CFR 46.402(c)

Placebo — An inactive intervention designed to resemble, as much as possible, its active

counterpart in clinical research.

http://www.hhs.gov/ohrp/policy/cdebiol.html


Pregnancy — “Encompasses the period from the implantation until delivery. A woman shall be

assumed to be pregnant if she exhibits any of the pertinent presumptive signs of

pregnancy, such as missed menses, until the results of a pregnancy test are negative or

until delivery.” Source: 45 CFR 46.202(f)

Prisoner — “Any individual involuntarily confined or detained in a penal institution. The term

is intended to encompass individuals sentenced to such an institution under a criminal or

civil statute, individuals detained in other facilities by virtue of statutes or commitment

procedures which provide alternatives to criminal prosecution or incarceration in a penal

institution, and individuals detained pending arraignment, trial, or sentencing.” Source:

45 CFR 46.303

Private Information — information about behavior that occurs in a context in which an

individual can reasonably expect that no observation or recording is taking place, and

information that has been provided for specific purposes by an individual and that the

individual can reasonably expect will not be made public (for example, a medical record).

Private information must be individually identifiable (i.e., the identity of the subject is or

may readily be ascertained by the investigator or associated with the information) in

order for obtaining the information to constitute research involving human Subjects.

Research — systematic investigation designed to develop or contribute to generalizable

knowledge. Under this definition some demonstration, service and training projects may

be considered to include research activities

Researcher — “OHRP considers the term investigator to include anyone involved in conducting

the research. OHRP does not consider the act of solely providing coded private

information or specimens (for example, by a tissue repository) to constitute involvement

in the conduct of the research. Note that if the individuals who provide coded information

or specimens collaborate on other activities related to the conduct of this research with

the investigators who receive such information or specimens, then OHRP would consider

such additional activities to constitute involvement in the conduct of the research.

Examples of such additional activities include, but are not limited to: (1) the study,

interpretation, or analysis of the data resulting from the coded information or specimens;


and (2) authorship of presentations or manuscripts related to the research.”

Source: OHRP, HHS. 2004. Guidance on Research Involving Coded Private Information

or Biological Specimens. (http://www.hhs.gov/ohrp/policy/cdebiol.html). Tusculum

utilizes the term researcher and investigator interchangeably.

Subjects — A living individual about whom an investigator (whether professional or student)

conducting research obtains a) data through intervention or interaction with the individual

or b) identifiable, private information. Tusculum utilizes the term subjects and human

participants interchangeably.

Therapeutic Misconception — The tendency for research subjects to: “downplay or ignore the

risks posed to their own well-being by participation ... [due to] the subjects’ deeply held

and nearly unshakeable conviction that every aspect of their participation in research has

been designed for their own individual benefit.” Source: Emanuel, EJ et al., eds. 2003.

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary.

Baltimore, MD: The Johns Hopkins University Press, p.194.

Undue Burden — Research populations must not be subject to undue burden, wherein they are

“systematically selected simply because of their easy availability, their compromised

position, or their manipulability, rather than for reasons directly related to the problem

being studied.” Source: National Commission for the Protection of Human Subjects of

Biomedical and Behavioral Research. 1979. The Belmont Report — Ethical Principles

and Guidelines for the Protection of Human Subjects of Research. Washington, DC: U.S.

Department of Health and Human Services: Part B, section 3, “Justice”


Undue influence — “An offer of an excessive, unwarranted, inappropriate, or improper reward

or other overture in order to obtain compliance.” Source: Emanuel, EJ et al., eds. 2003.

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary.

Baltimore, MD: The Johns Hopkins University Press, p.37.

http://www.hhs.gov/ohrp/policy/cdebiol.html



Appendix: Template for Consent/Permission Form

The template available on the IRB website as well on the Tusculum IRB Moodle Site

under Tusculum Governance is designed to help Tusculum Faculty, Staff, and Students as they

design the consent process and prepare a consent form. All researchers are STRONGLY

ENCOURAGED to make use of this template. If this template is not appropriate for a particular

study or if you have any consent questions, contact the IRB Chair.

Remember that what is included here relates to consent, designed for adults. For children,

assent needs to be obtained as well as permission from parent or guardian. For the IRB, assent

should be a few simple paragraphs that you include as a separate document in your submission

(outlining what you will tell each child before they take part in your study. It should explain

everything you will be asking them to do and that they can stop at any time. You are expected to

get their personal permission to participate (assent) before you use them as Subjects. If they are

able, they can assent in writing, as well as verbally. When working with young children, you must

describe how on-going assent will be assessed – what behavioral or verbal cues will be used to

determine whether continuing is appropriate or not.


Appendix: IRB Divisional Tracking Form

The template available on the IRB website as well on the Tusculum IRB Moodle Site under

Tusculum Governance is designed to help Tusculum Faculty get research with minimal risk

approved that will only occur within the classroom and is not for publication.

To Be Completed by the Faculty Person Submitting the Research Assignment


General Categories of IRB Submissions

Exempt

Category 1

o Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

o Examples: Evaluating the use of accepted or revised standardized tests Testing or comparing a curriculum or lesson A program evaluation of pharmacy continuing education

Category 2

o Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.

o Examples: Surveying teachers, nurses, or doctors about a technique or an outcome Interviewing managers about a management style or best practice Conducting a focus group about an experience or an opinion of a

community program

Category 3

o Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

o Example: Interviewing public officials about a local or global issue.


Category 4

o Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

o Example: Analyzing existing tissue samples or data set which are recorded by the

investigator without identifiers

Category 5

o Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

o See OHRP’s guidance regarding this category

Category 6

o Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. (See also FDA’s Exempt Category)

Expedited

Category 1

o Clinical studies of drugs and medical devices only when condition (a) or (b) is met: Research on drugs for which an investigational new drug application (21

CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)

http://www.hhs.gov/ohrp/policy/exmpt-pb.html

https://irb.northwestern.edu/process/new-study/reviews/exempt-categories-examples#FDA


Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

Category 2

o Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: from healthy, nonpregnant adults who weigh at least 110 pounds. For

these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or

from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

Category 3

o Prospective collection of biological specimens for research purposes by noninvasive means.

o Examples: hair and nail clippings in a nondisfiguring manner; deciduous teeth at time of exfoliation or if routine patient care indicates a

need for extraction; permanent teeth if routine patient care indicates a need for extraction; excreta and external secretions (including sweat); un-cannulated saliva collected either in an unstimulated fashion or

stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue;

placenta removed at delivery; amniotic fluid obtained at the time of rupture of the membrane prior to or

during labor; supra- and subgingival dental plaque and calculus, provided the collection

procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;

mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;

sputum collected after saline mist nebulization.


Category 4

o Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)

o Examples: physical sensors that are applied either to the surface of the body or at a

distance and do not involve input of significant amounts of energy into the subject or an invasion of the subjects privacy;

weighing or testing sensory acuity; magnetic resonance imaging; electrocardiography, electroencephalography, thermography, detection of

naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;

moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

Category 5

o Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).

o Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4).

o This category includes materials that were previously collected for either non-research or research purposes, provided that any materials collected for research were not collected for the currently proposed research.

o The phrase “…or will be collected solely for non-research purposes” pertains to the origin of the materials. For example, blood samples that were collected for a clinical test or the results of a course driven exam given in a history class.

Category 6

o Collection of data from voice, video, digital, or image recordings made for research purposes.

o Expedited Review does not apply if identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability,


reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

Category 7

o Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

Full Review

• Studies that involve more than minimal risk require full board review at a convened meeting at which a quorum of IRB members is present. For the research to be approved, it must receive the approval of a majority of those members.

• While federal regulations do not specifically list categories that require full board review, studies such as those listed below are normally sent to full board for review when part of the study design involves greater than minimal risk procedures:

o studies involving clinical procedures with drugs, devices, or biologics, or innovative research into new medical or surgery procedures

o studies taking place internationally (particularly countries with little or no provisions for protection of human subjects) where subjects may be at physical, psychological or legal risk

o studies in which disclosed information could require mandatory legal reporting (e.g., child/elder abuse, etc.)

o studies involving deception which raise the risk to subjects or others o studies in which the IRB staff, chair, member, or designee determines risk to

subjects or others to be greater than minimal risk o studies using “vulnerable populations”* and thus requiring extra protections

*Children, prisoner, pregnant women and neonates


Appendix: Online Resources for IRBs

Office of Human Research Protections; links to other resources http://www.hhs.gov/ohrp/

APA research ethics page, links to other resources http://www.apa.org/ethics/

Office of Research Integrity https://ori.hhs.gov/

https://ori.hhs.gov/human-subject-research-0

45CFR 46

https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

Nuremberg Code

https://history.nih.gov/research/downloads/nuremberg.pdf

National Research Act of 1974

https://history.nih.gov/research/downloads/PL93-348.pdf

Belmont Report

https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html

http://www.hhs.gov/ohrp/

http://www.apa.org/ethics/

https://ori.hhs.gov/

https://ori.hhs.gov/human-subject-research-0

https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

https://history.nih.gov/research/downloads/nuremberg.pdf

https://history.nih.gov/research/downloads/PL93-348.pdf

https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html


U.S. Department of Education, Protection of Human Subjects in Research

http://www.ed.gov/about/offices/list/ocfo/humansub.html

American Association for Public Opinion Research http://www.aapor.org/additionalirbresources

IRB Review of the Use of Social Medium in Research

https://www.quorumreview.com/wp-content/uploads/2012/12/IRB-Review-of-the-Use-of-Social-Media-in-Research_Gearhart_Quorum-Review_Monitor_2012_12_01.pdf

ORI Introduction to Responsible Conduct of Research

https://ori.hhs.gov/sites/default/files/rcrintro.pdf

http://www.ed.gov/about/offices/list/ocfo/humansub.html

http://www.aapor.org/additionalirbresources



https://ori.hhs.gov/sites/default/files/rcrintro.pdf

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