Protecting Human Research Participants Procedures and Regulations August 2004

TABLE OF CONTENTS Forward …………………………………………………………………………………………….1 Institutional Policy...........................................................................................................................................2 Institutional Review Board.............................................................................................................................2 Definition of Human Research Participant..................................................................................................2 Research...............................................................................................................................................2 Human Participant..............................................................................................................................3 Review Procedures ..........................................................................................................................................3 Preparation of Protocol and Application Form .............................................................................3 Review by Department Chair/Program Directors .........................................................................3 Review by IRB Designee..................................................................................................................3 IRB Review .........................................................................................................................................4 Categories of Review......................................................................................................................................4 Research Exempt From Review....................................................................................................................4 Expedited Review............................................................................................................................................5 Full Review by Institutional Review Board ................................................................................................6 Definitions of Risk .............................................................................................................................6 Provisions of Informed Consent......................................................................................................7 Questionnaire Surveys and Interviews.........................................................................................................8 Deception ..........................................................................................................................................................9 Research Involving Vulnerable Participants...............................................................................................9 NIH Guidelines on the Inclusion of Women and Minorities as Participants in Clinical Research............................................................................................................................................9 Courses with Research/Experimental Activity .........................................................................................10 Student Conducted Projects .........................................................................................................................10 Supplements to or Changes in Original Protocol.....................................................................................10 Reporting Changes in Research.....................................................................................................10 Verification of Change ....................................................................................................................11 Monitoring Research.....................................................................................................................................11 Sanctions on HHS Projects .............................................................................................................11 Reporting Requirements ...............................................................................................................................11 Investigator’s Reporting Requirements......................................................................................11 IRB Reporting Requirements .......................................................................................................11 Health Insurance Portability and Accountability Act (HIPAA) ............................................................12 Research Conducted by Non-SUNY Cortland Investigators .................................................................12 Selected References.......................................................................................................................................13

APPENDICES

IRB Members ................................................................................................................................................. A Sample Adult Consent…………………………………………………………………………….. B Sample Debriefing Statement for Adult Consent (study involved deception).....................................C Sample Debriefing Statement for Adult Consent (study involved no deception)................................D Sample Parental Consent............................................................................................................................... E Sample Passive Parental Consent............................................................................................................... F Sample Minor Consent .................................................................................................................................G Report on Research Pro jects Using Human Participants .........................................................................H

1 FORWORD

This manual has been produced to furnish a guide to faculty members and students who intend to conduct research projects involving the use of human participants. The manual cannot be comprehensive or exhaustive; we hope, however, that it will help researchers answer two questions: first, what kinds of projects must be reviewed; and second, what is the general procedure for review? The

Board of Trustees of the State University of New York has issued a clear and inclusive "General Policy Statement Concerning Procedures for Investigations Involving Human Subjects." The policy's application follows: This policy applies to all research and teaching activities involving human participants . It is designed to

protect all participants involved in such activities under the auspices, aegis, or control of the University community. Research and teaching activities are covered even though no sponsored funds are used and

would include an activity solely within a learning experiment in the classroom. It applies to all members of the University community including faculty and employees of the University and the Research Foundation, instructors, graduate and undergraduate students (emphasis added).

Projects which involve intervention in the participants’ normal activities must be reviewed. To determine if such

intervention poses any risk to the participants, the regulations mandate that an Institutional Review Board (IRB) must be formed on each local campus to review all projects involving the use of participants. The IRB, rather than the researcher, makes the final determination of risk. Further, participant involvement must always be completely voluntary. In most cases, participants’ written, informed consent must be obtained. The Trustees' Policy Statement includes among the participant rights to be protected, "the right of privacy, confidentiality of data, and the use of the findings."

The review process is initiated by completion of the form Application for the Review of Projects Using Human Participants which can be obtained from the Office of Sponsored programs or online at http://www.cortland.edu/osp/hrp.html. The completed application is submitted to the IRB Designee, Office of Sponsored Programs , Miller Building, Room 402.

Some projects may be exempt from review (see p. 4); others may be handled under an expedited review procedure (see p. 5). Projects which do not qualify for exemption or expedited review are considered for full review by the Institutional Review Board. The IRB membership, (Appendix A) meets as needed during the year and reviews submitted projects. Researchers may be invited to be present at the IRB meeting to explain details of their project. No research may be conducted until after approval is secured. The Chair of the IRB (or the Chair's designee) will send written notice of the Board's action to each applicant.

The pertinent federal regulations are available in the Office of Sponsored Programs; the New York State Public Health Laws are available in the College Library. A complete guide to the application of federal regulations, Protecting Human Research Participants: Institutional Review Board Guidebook , is also available at the Office of Sponsored Programs. Prepared by the Office for Protection from Research Ris ks of the National Institutes of Health (OPRR), it serves as an additional reference tool.

Each individual conducting or reviewing human participants research (e.g. Project Directors, department chairs, research administrators, IRB members) will be provided with a copy of the College's manual, the institutional assurance of compliance, and copies of any changes. Also available from the Office of Sponsored Programs is an excellent videotape prepared by the OPRR, Protecting Human Subjects which contains three separate instructional films: Evolving Concern, Balancing Society's Mandates and The Belmont Report.

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INSTITUTIONAL POLICY

SUNY Cortland acknowledges and accepts its responsibilities for protecting the rights and welfare of human participants of research. The institution is guided by the ethical principles regarding all research involving humans as participants as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research . In addition, the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46) will apply to

funded research and, except for the requirements for reporting information to HHS, all other research without regard to source of funding. This section of the Code was most recently revised in November 2001 and is referred to as the Common Rule. It has been adopted by HHS and other federal agencies. Briefly, the HHS requirements state: 1. The involvement of human participants in research will not be permitted until the IRB has reviewed and approved the research protocol and informed consent has been obtained.

2. The IRB will conduct a review of ongoing research at appropriate intervals but not less than once a year. In addition, SUNY Cortland is guided by the New York State Guidelines for Institutions, Institutional Review Boards, and Researchers Regarding Biomedical Research with Normal Health Subjects (March 1999). These guidelines are consistent with both the Federal CFR (noted above) as well as New York Public Health Law 2440-2446.

The institution encourages and promotes constructive communication among the research administrators, department heads, research investigators, IRB, other institutional offi cials, and human participants as a means of maintaining a high level of awareness regarding the safeguarding of the rights and welfare of the participants.

INSTITUTIONAL REVIEW BOARD

At SUNY Cortland, the IRB is composed of ten members, chaired by the Vice President for Academic Affairs. The membership includes: - both male and female members - representatives from a variety of academic areas, both scientific and non-scientific

- one repres entative from the community, not affiliated with the institution - members with experience and expertise, diverse racial and cultural backgrounds, and sensitivity to community

attitudes insuring that decisions by the IRB will safeguard the rights and welfare of human participants (current membership is listed in Appendix A).

The IRB is responsible for monitoring the performance of all research involving human participants which it approves.

Federal regulations state that "An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year (45 CFR 46.108(e)).”

DEFINITION OF HUMAN PARTICIPANT RESEARCH The federal and state governments use the following definition of human participant research:

1. Research “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (emphasis added; 45 CFR 46.102 (d)).”

3 A research project generally is described in a protocol that sets forth explicit objectives and formal procedures

designed to reach those objectives. The protocol may include therapeutic and other activities intended to benefit the

participants as well as procedures to evaluate such activities. Research objectives range from understanding normal and abnormal physiological and psychological functions or social phenomena to evaluating diagnostic, therapeutic, or preventive interventions and variations in services or practices. The activities or procedures involved in research may be invasive or non-invasive and include surgical interventions; removal of body tissues or fluids; administration of chemical substances or forms of energy; modification of diet; daily routine of service delivery; alteration of environment; observation; administration of questionnaires or tests; randomization; review of records, etc.

2. Human Participant “Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information (45 CFR, 46.102 (f)).”

Comment: Intervention includes both physical procedures by which data are gathered (for example, blood extracted

via pinpricks) and manipulations of the participant or the participant’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and participant. Private information includes 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 which has been provided for specific

purposes by an individual and which 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 participant 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 participants (45 CFR 46 Subpart A, 102 (f )).

NOTE: All references in the following text are to 45 CFR 46 Subpart A unless otherwise noted. Therefore, Subpart A

will be eliminated from the citations.

REVIEW PROCEDURES

Step 1 - Preparation of Protocol and Application Form Research investigators shall fill out an Application for Review of Projects Using Human Participants (see Appendix B) giving a complete description of the proposed research. In developing the protocol for the research project, investigators shall make provisions for the adequate protection of the rights and welfare of participants, insuring that pertinent laws and regulations are observed. This requirement is applicable even in cases where the research is

exempt from review . Research investigators shall include, where applicable, examples of proposed informed consent forms, survey instruments, and debriefing, with the application.

Step 2 - Review by Department Chair/Program Directors Department Chairs and Program Directors, through appropriate procedures established within their respective

departments, are responsible for reviewing research protocols for ethical considerations and scientific merit. Research investigators and department heads are responsible for ensuring that all research involving human participants is submitted to the IRB Designee, Office of Sponsored Programs , Miller, Room 402.

Step 3 - Review by the IRB Designee

The Director of Sponsored Programs, as the designee for the Chair of the IRB, reviews all applications and makes institutional determination whether the research protocols qualify for (1) exemption from review; (2) expedited

4 review; or (3) full IRB review. The IRB designee may provide guidance in developing a research protocol and completing the application form, when desired. At this level of review, the researcher may be asked to make revisions

in the protocol or application to make it acceptable for full IRB review. The IRB shall keep research investigators aware of the decisions and administrative processing affecting their respective applications and return all disapproved protocols to the research investigator.

Step 4 - IRB Review: The IRB makes decisions based on the following requirements:

(1) risks to participants are minimized; (2) risks to participants are reasonable in relation to anticipated benefits and knowledge that may be expected to result; (3) selection of participants is equitable; (4) informed consent will be obtained from each participant or his/her representative; (5) informed consent will be appropriately documented; (6) collected data will be monitored to ensure the safety of participants; and (7) privacy of participants and confidentiality of data is maintained.

(For in-depth explanation of IRB review standards for approval, see 45 CFR 46.111) To facilitate the review of research and the protection of the rights and welfare of human participants, research investigators and department heads are encouraged to attend IRB meetings when invited. The IRB shall notify the research investigator in writing of the Board's decisions, conditions, and requirements. The IRB provides the reasons for the decision to disapprove a protocol and gives the applicant an opportunity to respond, and in some cases, revise

and re-submit the application. Research investigators shall comply with all IRB decisions, conditions, and requirements. No research involving human participants shall be conducted without IRB approval and obtaining of informed consent from the participant or the participant’s legal representative (usually parent or guardian).

CATEGORIES OF REVIEW 1. Exempt from Review 2. Expedited Review 3. Full IRB Review RESEARCH EXEMPT FROM REVIEW Exempted research involves normal educational practices: anonymous tests, surveys, interviews, or data collection from records which poses no risk to participants. Investigators who feel their research falls into this category must still contact IRB for determination of exemption. The HHS regulations, as revised November, 2001 and effective December, 2001, list the following explicit exemptions as cited in 45 CFR 46.101 (b):

1. Research conducted in established or commonly accepted educational settings, involving normal educational

practices, such as (i) research on regular and special educational instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

2. 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 participants can be identified, directly or through identifiers linked to the participants; and (ii) any disclosure of the human participants’ responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participant’s financial standing, employability, or reputation.

5 3. 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 (b)(2) of this section, if: (i) the human participants 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.

4. 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 participants cannot be identified, directly or through identifiers linked to the participants.

5. Research and demonstration projects which are conducted by or subject to the approval of department of 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.

6. 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.

IMPORTANT: ABOVE EXEMPTIONS DO NOT APPLY TO CHILDREN OR OTHER VULNERABLE PARTICPANTS.

Research investigators and department heads shall make a determination as to whether research will involve human participants and whether such research is exempted from review as defined above. When it is not clear whether the research involves human participants or if the exemption eligibility as defined by HHS regulations applies, research investigators should seek assistance from the IRB in making this determination. All research involving human participants, even when eligible for exemption, must have protocol approved by the IRB Designee, Office of Sponsored

Programs, prior to the start of the project . EXPEDITED REVIEW The expedited review procedure involves a protocol that entails no more than minimal risk to the participants and in which the only involvement of human participants will be in one or more of the following categories. This list is

updated by HHS in consultation with other agencies and appears in the Federal Register at appropriate intervals. The most current listing includes the following:

1. Collection of: hair and nail clippings, in a nondis figuring manner, deciduous teeth; and permanent teeth if patient care indicates a need for extraction.

2. Collection of excreta and external secretions including sweat, uncannulated saliva. 3. Collection of blood samples by pinpricks from PI with appropriate experience, in amounts not exceeding 450

milliliters in an eight-week period and no more often than two times per week, from participants 18 years of age or older and who are in good health and not pregnant.

4. Voice recordings made for research purposes such as investigations of speech defects. 5. Moderate exercise by healthy volunteers; and/or moderate exercise with minor stimulates such as caffeine.

6. Any other category specifically added to this list by HHS and published in the Federal Register.

6 The IRB may use the expedited review procedure to review either or both of the following: (1) some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk and (2) minor changes

in previously approved research during the period [of one year or less] for which approval is authorized. Expedited review requires two signatures for approval. This type of review shall be conducted by the IRB Designee and IRB Chairperson and/or by one or more of the experienced IRB members designated by the chairperson to conduct the review. At Cortland, the Director of Sponsored Programs is the designee who reviews applications and submits the application to the chairperson for final approval. The Designee may confer with one or more IRB members, before

recommending an application. The IRB member(s) conducting the expedited review may exercise all of the authorities of the IRB except that the reviewer(s) may not disapprove the research. The reviewer(s) shall refer any research protocol which the reviewer(s) would have disapproved to the full committee for review. The reviewer(s) may also refer other research protocols to the full committee whenever the reviewer(s) believes that full committee review is warranted.

When the expedited review procedure is used, the IRB designee or member(s) conducting the review(s) shall inform IRB members of research protocols which have been approved under the procedure. The IRB reviews the criteria used for the approval of these projects on a semester basis. The eligibility of some research for review through the expedited procedure is in no way intended to negate or modify

the policies of this institution or other requirements of 45 CFR 46. FULL REVIEW BY THE INSTITUTIONAL REVIEW BOARD Research protocols involving human participants, which are not exempted from review or eligible for expedited review, must be reviewed by the full Institutional Review Board. Usually these protocols involve such elements as

minimal risk, deception, or a risk to the participants’ confidentiality. The IRB must be assured that:

(1) the risks have been minimized;

(2) the risks to the participants are reasonable in relation to anticipated benefits; (3) selection of participants is equitable; (4) informed consent is sought; (5) informed consent will be appropriately documented;

(6) data collection will be monitored to ensure the participants’ safety; (7) the privacy of the participants will be protected and the confidentiality of the data maintained;

(8) Appropriate debriefing is conducted.

The IRB must also be assured that when participants are likely to be vulnerable to coercion or undue influence--e.g., children--additional safeguards have been included to protect the rights and welfare of these participants.

Definitions of Risk: Risk of Harm includes any potential injury--physical, psychological, or social--that might result from participation in

the activity. "Minimal Risk means that 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 (45 CFR 46.102 (i)).”

7 Provisions of Informed Consent:

The information provided to prospective participants or their representatives must be in language they can understand. Consent should be sought under circumstances that provide the prospective participants or the participant’s representative with sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. “No informed consent, whether oral or written, may include any exculpatory language through which the participant is made to waive or appear to waive any legal rights, or releases or appears to release the

investigator, the sponsor, the institution or its agents from liability for negligence (45 CFR 46.116).” A copy of the information provided, as well as the signed consent form (if any), must be given to the participant or the participant’s representative. 1. Elements of informed consent as cited in 45 CFR 46.116:

a. An explanation of the purpose of the research and the expected duration of the participant’s involvement, a

description of the procedures to be followed, and identification of any procedures which are experimental. b. A description of any reasonably foreseeable risks or discomforts to the participant.

c. A description of any benefits to the participant or to others which may reasonably be expected from the

research. d. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advanta-

geous to the participant. e. A statement describing the extent, if any, to which confidentiality of records identifying the participant will

be maintained. f. For research involving more than minimal risk, an explanation as to whether any compensation will be

made and if any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.

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

participants’ rights, and whom to contact in the event of a research-related injury to the participant. h. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits

to which the participant is otherwise entitled and the participant may discontinue involvement at any time without penalty or loss of benefits to which the participant is otherwise entitled.

2. Additional information must be provided, when required by the IRB:

a. a statement that the particular treatment or procedure may involve risks to the participant (or to an embryo or fetus, if the participant is or may become pregnant) which are currently unforeseeable;

b. anticipated circumstances under which the participant’s involvement may be terminated by the investigator

without regard to the participant’s consent; c. any additional cost to the participant that may result from involvement in the research; d. the consequences of a participant’s decision to withdraw from the research and procedures for orderly

termination of involvement by the participant; e. a statement that significant new findings developed during the course of the research which may relate to

the participant’s willingness to continue involvement will be provided to the participant; and f. the approximate number of participants involved in the study.

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3 Documentation of informed consent: Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the participant or the participant’s legally authorized representative. A copy shall be given to the person signing

the form. Except as provided in part c below of this section, the consent form may be either of the following:

a. A written consent document that embodies the elements of informed consent as listed above. This form may be read to the participant or the participant’s legally authorized representative, regardless, the investigator shall give either the participant or the representative adequate opportunity to read it before it is signed (see Appendices B, E-G); or

b. a "short form" written consent document stating that the elements of informed consent as stated on p. 7 have

been presented orally to the participant or the participant’s legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the participant or the representative. Only the short form itself is to be signed by the participant or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the participant or the representative, in addition to a copy of the "short form";

c. an IRB may waive the requirements for the investigator to obtain a signed consent form for some or all

participants if it finds either: (1) that the only record linking the participant and the research would be the consent document and the

principal risk would be potential harm resulting from a breach of confidentiality. Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant’s wishes will govern; or

(2) that the research presents no more than minimal risk of harm to participants and involves no procedures or which written consent is normally required outside of the research context.

In cases where the documentation requirement is waived, the IRB may require the investigator to provide participants with a written statement regarding the research.

QUESTIONNAIRE SURVEYS AND INTERVIEWS

When questionnaires are freely completed, consent is assumed; thus, the return of a mail questionnaire is implicit consent and no coercion is assumed to exist. However, the project director/investigator has several obligations. The cover letter on the questionnaire must adequately and honestly explain the purposes of the survey. If the questionnaire has respondent identifiers, the project director must explain in the cover letter how identifiers will be used and how confidentiality will be assured.

Interviews are subject to the same general restrictions. The confidentiality of the interview must be assured unless permission to use personally identifiable information is explicitly granted on a written informed consent form. Additionally, in the application to the IRB, the project director must indicate how confidentiality is assured. It is not enough to say that all results will be kept confidential. The project director must say how the data will be stored and used. In most cases, any personal identifiable information within the obtained research data should be destroyed after

the purposes of the project are served. Questionnaires administered directly--as, for instance, in the classroom--are subject to the same restrictions, i.e., an explanation of the uses to which the data is to be put and explicit assurances of confidentiality. Response to a questionnaire or participation in an interview in a classroom must be completely and explicitly voluntary.

9 The following guidelines for storing consent documents are suggested:

- Non-funded research a minimum of 3 years following the completion of the study - Research following the protocol of the American Psychological Association is a minimum of 5 years after

publication

- Federally funded research a minimum of 7 years following the completion of the research

DECEPTION Federal and State agencies and the local IRB recognize that deception is inherent in the design of certain kinds of research projects, but they recommend that deception be avoided whenever alternatives are available. In any case,

deception about the degree of risk may never be practiced. The University Counsels' Office further recommends that deception be used only in innocuous, very low-risk projects. The participants must be thoroughly debriefed at the end of the project. The local IRB has made the additional requirement that debriefing be done in both oral and written forms . The written debriefing is to take the form of a Debriefing Statement (see Appendices C and D), unless otherwise approved by the

IRB.

RESEARCH INVOLVING VULNERABLE PARTICIPANTS Vu lnerable participants include minors, prisoners, persons with disabilities, and the economically or educationally disadvantaged. When research is reviewed involving a category of vulnerable participants, the IRB shall include in its

reviewing body one or more individuals who have as a primary concern the welfare of these participants. Details of the regulations regarding the use of these special populations in research are detailed in Title 45, CFR, Part 46, Subparts B-D, sections 46.201-46.409 as well as Subpart A 46.111. The IRB shall only approve research using vulnerable participants that satisfies regulations as outlined in the CFR referenced above. When a research project involves minors less than 18 years of age, the minor’s assent is required and

a parent or legal guardian’s permission is required under most circumstances. Investigators conducting research using children as participants should review SUNY Cortland’s Guide to Research Involving Minors as Participants (July 2004).

NIH GUIDELINES ON THE INCLUSION OF WOMEN AND MINORITIES AS PARTICPANTS IN

CLINICAL RESEARCH Effective March 9, 1994, National Institutes of Health (NIH) established guidelines on the inclusion of women and members of minority groups and their subpopulations in clinical research, including clinical trials, supported by the NIH. These policies were updated in August 2000 and amended in October 2001. Clinical research is defined as NIH-supported biomedical and behavioral research involving human participants.

The NIH policy requires that, in addition to the continuing inclusion of women and members of minority groups in all NIH-supported biomedical and behavioral research involving human participants, the NIH must:

- Ensure that women and members of minorities and their subpopulations are included in all human participant research unless there is a compelling rational that would impact the health of the participants, or the purpose of the research, or circumstances the NIH director may designate.

- For Phase III clinical trials, ensure that women and minorities and their subpopulations must be included; - Not allow cost as an acceptable reason for excluding these groups; and - Initiate programs and support for outreach efforts to recruit these groups into clinical studies.

10 COURSES WITH RESEARCH/ EXPERIMENTAL ACTIVITY

Certain courses routinely involve their students in a number of in-class experiments. These experimental activities require consent from the student participants, and it is further required that the experiments themselves be reviewed by the IRB. Instructors may submit individual IRB protocols or use SUNY Cortland’s simplified procedures outlined in the Guidelines for Undergraduate Student Course Activities Using Human Participants (July 2004). Instructors using the simplified procedures attest to the IRB that the classroom project(s) involve no more than minimal risk to participants, have discussed the principles of the Belmont Report with their students , and have informed students about consent/disclosure, safeguarding privacy and maintaining confidentiality. Note the simplified procedures may only be used for exempt and expedited research protocols. Special Note: In typical research studies the participants have the right to refuse to participate or withdraw from the study without penalty. However, the practice of this right becomes complicated when considering research conducted for the purpose of class demonstration/education. Thus, the instructor should have a clear statement in their course syllabus about whether participation in the classroom research is voluntary and/or how their participation is related to the goals/objectives of the course or how it might influence their grade. The instructor should be mindful of the types of situations which may occur if the student is uncomfortable with participating. For courses that either requires, or allows students to volunteer in research projects for credit (not related to in -class educational experiences), the IRB recommends the following protective steps:

1. Assuring that students understand that they will be offered reasonable alternatives which would fulfill the requirement/credit. The alternatives must be neither more onerous nor time-consuming than participation in

the research project; 2. Avoiding, whenever possible, seeking consent in physical settings in which participants may feel coerced

or unduly influenced to participate. All participants must be 18 years of age otherwise parental consent, as well as consent from the student is required. Be advised that if the instructor intends to publicly disseminate the data collected from the classroom for his/her own research purposes , the instructor must complete the normal Application for Review of Projects using Human Research Participants. STUDENT-CONDUCTED PROJECTS All student investigators must have a Cortland faculty supervisor. The faculty supervisor is responsible for ensuring that the student has received the appropriate training to minimize the risks to participants , and attesting that the student has read the Belmont Report. In addition, the faculty supervisor assures that all IRB provisions are complied with by the student investigator(s). These provisions include, but not limited to, submitting the protocol in sufficient time to the IRB for review, proper training for obtaining consent and maintaining confidentiality, adhering to the procedures outlined in the approved protocol, notifying the IRB of any changes to the protocol, and submitting a final report to the IRB upon completion of the study. The faculty supervisor and department chair must sign the Application for Review of Projects Using Human Research Participants certifying that the project is under faculty supervision. Topics of a sensitive nature should be avoided by student researchers who are not sufficiently experienced in such research. The IRB has prepared a summary of procedures to assist graduate students with the IRB application process. This summary outlines IRB review levels for classroom action research and thesis projects and can be found in the Guidelines for Graduate Student Protocols. Graduate students using minors as research participants also should review the Guide to Research with Minors.

SUPPLEMENTS TO OR CHANGES IN ORIGINAL PROTOCOL Reporting Changes in the Research

Research investigators are responsible for promptly reporting, to their department heads and to the IRB, proposed changes in a research activity.

11 Changes in research during the period for which IRB approval has already been given shall not be initiated by research investigators without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the

participant. The IRB may use the expedited review procedure to review minor changes in previously approved research during the period for which approval is authorized. Verification of Change

The IRB shall determine which projects need verification from sources other than the research investigators so that no material changes have occurred since previous IRB review. MONITORING RESEARCH

- The IRB shall conduct review of research at intervals appropriate to the degree of risk, but not less than once per

year. - The IRB shall determine, in its review of research protocols, which projects will require IRB review more often

than annually. - The IRB shall have the authority to observe or have a third party observe the consent process and the research.

- Research investigators and department heads are responsible for reporting promptly to the IRB any serious or continuing noncompliance with the requirements of this assurance or the determination of the IRB.

- The IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's decisions, conditions, and requirements or that has been associated with unexpected serious harm to participants.

SANCTIONS ON HHS PROJECTS 1. On the Local Level: An IRB shall have the authority to suspend or terminate approval of research that is not

being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to participants (45 CFR 46.113).

2. On the Federal Level: If an institution or research investigator is found to have "failed materially" to protect

human participants, the Secretary may terminate or suspend current funds or withhold further HHS research funding (whether or not HHS funds were involved in the research in which the failure to protect participants occurred; 45 CFR 46.123 (a-b)).

REPORTING REQUIREMENTS

Investigator’s Reporting Requirements

Investigators are responsible for reporting the progress of the research to the IRB as often as and in the manner prescribed by the IRB but no less than once per year. Investigators will be asked to complete a Report on Research Projects Using Human Participants form (Appendix H). Investigators also must promptly report, to their department heads and to the IRB, any injuries to human participants or any unanticipated problems that involve risks to the human participants or to others. In addition, these situations must

be included in the final Report on Research Projects form submitted to IRB. IRB Reporting Requirements

The IRB designee shall be responsible for promptly reporting informa tion on a variety of issues, as appropriate, to the IRB, to the Office for Human Research Protection (OHRP), and to research investigators and department heads.

12 Information may flow from sources such as human participants, research investigators, IRB, or other institutional staff. Specifically, the IRB shall:

(1) report promptly to the OHRP significant instances or material findings of injuries to participants and unanticipated problems involving risks to participants or others;

(2) report to the IRB information received concerning non-compliance by research investigators, injuries to participants, unanticipated problems involving risks, changes proposed in research activities, and the progress of the research;

(3) maintain information concerning the IRB's reasons for the termination or suspension of IRB approval; and (4) report promptly any changes in IRB membership to the OHRP. The IRB shall have the authority and be responsible for promptly reporting information to the OHRP. In conjunction with this requirement the IRB must be prepared to receive and to act on information received from a variety of sources, such as human participants, research investigators, the Office of Sponsored Programs or other institutional staff. For

reporting purposes, the IRB will follow the procedures described below. (1) Any serious or continuing noncompliance by research investigators with the requirements of the IRB: This

information shall be reported promptly to the IRB and the OHRP. (2) Injuries to human participants: Information received by the IRB concerning injuries to participants shall be

reported promptly to the IRB (The IRB is responsible for reporting to the OHRP). (3) Unanticipated problems: Information received by the IRB concerning unanticipated problems involving risks to

participants or others shall be reported promp tly to the IRB (The IRB is responsible for reporting to the OHRP). (4) Suspension or termination of IRB approval: Each IRB suspension or termination of approval of research proto-

cols shall include a statement of the reasons for the IRB's action; the IRB shall report the action promptly to the research investigator, the IRB, and the OHRP.

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 (HIPAA)

HIPAA regulates organizations, businesses, and health care groups’ use and handling of personal identifiable health information (PIHI). The HIPAA Privacy Rule establishes the conditions that certain entities can use or disclose PIHI –including research purposes. HIPAA preempts State laws related to privacy of health information; that is, states may do mo re, but not less than the HIPAA requirements. To be considered PIHI, the information must include the following:

1. Personal identifiable health information - Health information, including demographic information; - Relates to an individual’s physical or mental health or the provision of or payment for health care; - Sufficiently identifies the individual

2. Transmitted or maintained in any form or media, whether electronic, paper, or oral by a covered entity or business associate.

Not PIHI:

- Employment records - Family Educational Rights & Privacy Act Records

SUNY Cortland is committed to complying with all state, federal, and HIPAA rules and regulations with regards to the rights of human research participants. Thus, investigators who believe they may be dealing with medical information should read the HIPAA rules (found at: http://www.hrsa.gov/hipaa.htm ) and contact the Office of Sponsored Programs. The IRB, when considering protocols that might contain medical information, will apply and comply with the rules of HIPAA.

RESEARCH CONDUCTED BY NON-SUNY CORTLAND INVESTIGATORS

At Cortland, the IRB requires any non-Cortland investigators to have a sponsor on campus that is willing to serve as a facilitator for the research. In addition, the IRB requires a copy of the approved IRB protocol from the originating institution of the guest investigator before it will approve the research on Cortland’s campus. The IRB application and approval letter should be forwarded to the Cortland faculty sponsor for review and submission to Cortland’s IRB. This procedure assures that the research approved adheres to Cortland's IRB policies. The guest investigator will receive written authorization from the IRB Designee granting approval to conduct the study.

13 SELECTED REFERENCES

New York State Department of Health (1999). Safeguarding Health Research Subjects: Protecting Volunteers from

Harm. Guidelines for Institutions, Institutions Review Boards, and Researchers Regarding Biomedical Research with Normal Healthy Subject . Available on line at: http://www.health.state.ny.us/nysdoh/provider/volunteer/intro.htm

Office for Protection From Research Risks, Protection of Human Subjects. 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 (GPO 887-809). Washington, DC: U.S. Government Printing Office.

Office for Protection From Research Risks, Protection of Human Subjects. (2001).Code of

Protection of human subjects: Title 45, Code of Federal Regulations, Part 46. Washington, DC: U.S. Government Printing Office. Available on line at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

National Institutes of Health, Office of Extramural Research (2001). NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research. Available on line at: http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm

14 APPENDIX A

INSTITUTIONAL REVIEW BOARD MEMBERSHIP

Dr. Elizabeth Davis -Russell, Chair, Provost and Vice President for Academic Affairs Ms. Amy Henderson-Harr, Designee, Director of Office of Sponsored Programs Dr. Chris Malone, Dean of the School of Professional Studies Dr. Mark Prus, Interim Dean of the School of Arts and Sciences Dr. Edward Caffarella, Dean of the School of Education Dr. Margaret Anderson, Psychology Department Dr. Barry Batzing, Biological Sciences Department Dr. Joseph Governali, Health Department Mr. Christopher Carey, Student Health Services Dr. Charles Capanzano, Cortland County Mental Health Center

INSTITUTIONAL REVIEW BOARD MEMBERSHIP Chair: Dr. Elizabeth Davis -Russell, Chair, Provost and Vice President for Academic Affairs Designee: Ms. Amy Henderson-Harr, Designee, Director of Office of Sponsored Programs

Members: Dr. Margaret Anderson, Psychology Department Dr. Edward Caffarella, Dean of the School of Education Mr. Christopher Carey, Student Health Services Dr. Charles Capanzano, Cortland County Mental Health Center Dr. Joseph Governali, Health Department

Dr. Peter McGinnis, Exercise Science and Sports Studies

Dr. Yvonne Murnane, Graduate Studies

Dr. William Sharp, History

15 APPENDIX B

SAMPLE ADULT CONSENT State University of New York College at Cortland

The research that you have been asked to participate in is being conducted by [insert name of

investigator] of the _________ Department at SUNY Cortland. We request your informed consent to be a participant in the project described below. Please feel free to ask about the project, its procedures, or objectives.

Information and Procedures of This Research Study:

The purpose of this study is to investigate individual’s physiological responses to cognitive tasks with interaction partners. Your galvanic skin response (GSR) will be measured by connecting two of your fingers to a GSR machine. This machine poses no physical harm to you and you will not feel anything other than the metal rings around your fingers. Then you will be asked to respond to a word completion task while working with a group partner.

Before agreeing to participate you should know that: A. Freedom to withdraw

You are free to withdraw consent at any time without penalty. Even if you begin answering questions and realize for any reason that you do not want to continue, you are free to withdraw from the study. Additionally, you may ask the researcher to destroy any responses you may have given.

B. Protection of Participants’ Responses

Your responses are strictly confidential (or anonymous; it can not be both). Only the presiding faculty member and the research assistants will have access to your responses. We will use the last 4-digits of your ID number throughout the course of this study (or some other identifying info if applicable).Only your ID number will be connected with your responses. Your name will not be connected with your responses . All responses are kept in a locked cabinet in the principle investigators office and any identifying information will be destroyed at the end of the study.

C. Length of Participation and Remuneration. The study should take approximately one hour. You will receive 1 extra credit point for participating and completing this study .

D. Full Disclosure

In some experiments, it may be necessary to withhold certain information in the interests of the particular research. Should this occur, at the end of the experiment you will be furnished with a full explanation of the purpose and design of the project.

E. Risks Expected

Although you should not experience any discomforts or risk due to participating in this study, in rare cases you may learn something about yourself that might seem uncomfortable. In the event that this occurs, please discuss this with the person conducting the study. In the event this is not sufficient please contact (for Cortland Students, give contact information for the Counseling Center; otherwise, insert the appropriate contact numbers for medical or psychological treatment).

F. Benefits expected

From participating in this study you should expect to come to a greater understanding of the way in which research is conducted. Your participation should greatly enhance your understanding of research design and how scientists answer theoretical and practical research questions.

G. Contact Information

If you have any questions concerning the purpose or results of this study, you may contact [insert name of investigator at XXX-XXXX]. For questions about research or your rights as a participant, contact Amy Henderson-Harr, Office of Sponsored Programs, SUNY Cortland, at (607) 753-2511.

I __________________ have read the description of the project for which this consent is requested, understand my rights, (print name) and I hereby consent to participate in this study.

_____________________________ ____________ Signature Date

**Note to applicant: the above consent form involves some deception. Thus, full disclosure

is given via the sample debriefing found on the following page.

16 APPENDIX C

SAMPLE DEBRIEIFNG FOR SAMPLE ADULT CONSENT FORM State University of New York College at Cortland

Debriefing Earlier you were told that we were investigating physiological responses to cognitive tasks, time, and interaction partners. Although this is all true, we were not completely honest about what we were investigating. We are actually investigating whether individuals use stereotypes to reduce the arousal they feel from interacting with outgroup members. An outgroup member is someone who is identified as being from “outside” your own group. For example, if you are a women, a man would be considered in the “outgroup”. Similarly if you are white, a black/African American, Latino (a), or Asian person would be considered in the outgroup. Previous research has revealed that individuals are aroused by the presence of those who are different from them (Bodenhausen, 1990). Previous research also has revealed that we tend to stereotype members of the outgroup more than members of the ingroup. The original and predominant view of why we stereotype is to economize our thinking. That is, that stereotypes are easy to use and allow us to fill in knowledge gaps with our stored stereotypes ---thus, saving cognitive resources. However, we have hypothesized that since individuals experience arousal when exposed to outgroup members and since arousal is commonly an uncomfortable departure from homeostasis (cf. Cognitive Dissonance Theory, Festigner, 1957) than individuals might use stereotypes as a way to reduce their arousal, thus returning the individual to homeostasis (the preferred state). If the hypothesis is supported it has the potential to enhance our understanding of stereotypes, prejudice and discrimination, and may lead to different intervention strategies to combat this problem. ? Your participation in this study was vital to understanding these processes. It was necessary to deceive you as to the real purpose of the study so that we could be sure that we were studying stereotyping under the most realistic conditions as possible. That is, if we told you what we were interested in you could have responded in a way that you “think” we “wanted” you to. As we are concerned with what happens in “real life” we wanted to keep your responses as unaffected as possible by our experimental protocol. I want to once again assure you that all of your responses are confidential and that your name is in no way connected with your responses. I also want to thank you for participating in this important research. I will be happy to answer any questions you might have.

IF YOU HAVE ANY COMMENTS OR QUESTIONS I WOULD LIKE TO DISCUSS THEM WITH YOU NOW.

17

APPENDIX D SAMPLE DEBRIEFING STATEMENT (No deception involved) Semantic Memory for Sentences When a person tries to remember a sentence which s/he has recently heard or read, s/he often is unable to remember the sentence word-for-word. Instead, the person remembers the main points of the sentence, and is usually able to relate these points in some kind of paraphrased form. Forgetting for the exact words which were presented is much more rapid than forgetting for the meaning or "gist" of the information (Beck & Wickelgren, 1974). However, as a person stores the meaning of a sentence, it seems that meanings of other sentences get "blended in" or fused with each sentence (Bransford & Franks, 1971). Once the meanings become fused, it becomes very difficult to "unscramble" the fusion to remember one sentence in particular. Peterson and McIntyre (1973) have shown that this fusion takes place when sentences are closely related to each other, but not when there is little relatedness among sentences. Thus, the sentences "The house stood by the hill" and "The hill overlooked the valley" are, according to these investigators, more likely to be fused than the sentences "The boy went away" and "Bank deposits earn money." This study investigated memory for sentences and the conditions under which fusion is likely to occur. If several sentences dealing with the "house" and/or the "hill", as above, are presented in a list of sentences, the order of presentation may be an important determinant of fusion. That is, fusion may be less likely to occur if all sentences related to each other are presented together (blocked) in the list as opposed to randomly distributed throughout the list. Some of you heard the blocked presentation, while others heard a random sequence. Fusion has typically been found with random presentation on an immediate test. Little is known about the effects of blocking in this type of experiment, but we predict less fusion on an immediate test after blocked presentation. Not everybody in this experiment was given an immediate test. Although everyone returned for a second session, some of you returned 1 day later or 1 week later to take the test. We believe that with the passage of time, fusion becomes more likely. One reasonable possibility is that on delayed tests the amount of fusion will now be about the same for the blocked and random conditions. Do you have any questions? REFERENCES Begg, I. & Wickelgren, W. A. Retention functions for syntactic and lexical vs. semantic information in sentence recognition memory. Memory and Cognition, 1974, 2, 353-359. Bransford, J. D. & Franks, J. J. The abstraction of linguistic ideas. Cognitive Psychology, 1971, 2, 331-350. Peterson, R. G. & McIntyre, C. W. The influence of semantic `relatedness' on linguistic integration and retention. American Journal of Psychology, 1973, 86, 697-706. Rubenstein, J. The Study of Psychology. Pg. 434.

18 APPENDIX E

SAMPLE WRITTEN PARENTAL CONSENT Student’s Name ______________________________________________ Grade ____________

Dear Parent:

Researchers at SUNY Cortland are asking permission for your child to be in a research study on reading. The study compares children reading below grade level with those reading at or above grade level on various measures of learning and memory.

We selected your child based on the testing you agreed to when your child started school.

With your permission, s/he will work with a person from the College on six occasions for approximately 20-30 minutes each time. During each session, s/he will work on a variety of tasks designed to measure learning, memory and other things related to reading. The tasks are not difficult and in most instances the children find them quite enjoyable.

We will see each child on a one-to-one basis and arrange scheduling with his/her teacher to make sure that s/he does not miss important classroom activities.

This study has the approval and support of your child’s school district.

Your child’s responses will remain confidential (or anonymous depending on data collection procedures).

No reports about the study will contain your child’s name. We will not release any information about your child without your permission.

Taking part is voluntary.

If you choose not to have your child take part, neither you nor your child will be penalized. We will also ask your child to participate and only children who want to will take part in the study. Your child may choose to stop at any time without penalty or prejudice.

If you choose not to have your child participate, your child will complete an unrelated activity that will take a similar amount of time as the research activity so that your child’s nonparticipation will not be evident to other students in the classroom.

If you have questions about the study, please contact (insert investigator’s/faculty member’s name) at SUNY Cortland, phone ___-____. If you have questions about your rights as a parent or your child’s rights as a volunteer, please contact Amy Henderson-Harr, IRB Designee, SUNY Cortland. Call her at 753-2511or visit her at the Office of Sponsored Programs, 402 Miller Building, at SUNY Cortland College.

Below you will find a place to indicate whether or not you agree to have your child be in the study. Please have him/her return the form to school tomorrow. We would greatly appreciate your cooperation in this research.

I have read and understood the information provided to me about the research study on reading being conducted in my child’s classroom by researchers from SUNY Cortland.

I _____ give my permission to have my child ________________________participate in this study

_____ do not give (child’s name)

____________________________________ (Parent’s Signature)

19 APPENDIX F

SAMPLE PASSIVE PARENTAL CONSENT Student’s Name ______________________________________________ Grade ____________

Dear Parent:

Researchers at SUNY Cortland are asking permission for your child to be in a research study on teaching math.

During the next week, researchers from SUNY Cortland will be conducting a research study in your child’s classroom. The study compares different methods of teaching mathematical concepts. We will not interact directly with your child. His/her teacher will simply be presenting the material in two different ways to separate classes. Both teaching methods are acceptable methods for teaching these concepts and your child will receive adequate instruction in both classes. The only measure of performance will be a standard math test. This test will not be a part of your child’s record and will not affect his/her grade in any way. Your child’s responses will remain confidential (or anonymous depending on the data collection procedures). No reports about the study will contain your child’s name. We will not release any information about your child without your permission.

Taking part is voluntary. If you choose not to have your child take part, neither you nor your child will be penalized. We will also ask your child to participate and only children who want to will take part in the study. Your child may choose to stop at any time.

If you do not wish your child to be in this study, please fill out the form at the bottom of this letter and return it to me. Otherwise, a form that is not signed or returned will indicate your agreement for your child to participate.

If you choose not to have your child participate, your child will complete an unrelated activity that will take a similar amount of time as the research activity so that your child’s nonparticipation will not be evident to other students in the classroom.

If you have questions about the study, please contact (insert investigator’s/faculty member’s name) at SUNY Cortland, P.O. Box 2000, Cortland, New York 13045, phone ___-____. If you have questions about your rights as a parent or your child’s rights as a volunteer, please contact Amy Henderson-Harr, IRB Designee, SUNY Cortland. Call her at 753-2511or visit her at the Office of Sponsored Programs, 402 Miller Building, at the College. I do not wish my child ____________________________ to be in the research study on teaching math being conducted in his/her classroom. __________________________________________

(Parent’s Signature)

20 APPENDIX G

SAMPLE MINOR ASSENT (To be written in language appropriate to the age and with sufficient information for the child to understand his/her

level of involvement in the study)

Student’s Name ______________________________________ School ____________________

RESEARCH STUDY ON READING

Do you remember the permission slip you took home for your parents to sign a few days ago? (Note: The Investigator should examine whether child/s tudent understands that their parent(s) gave permission for them to participate in the study) The people I work with and I are interested in learning about reading in children. We are asking you and a lot of other kids to work with us to find out about it. If you agree to do this, I will ask you to take a reading test and solve some puzzles.

This is not a test like you usually have in school. You will not be graded on anything you do and the results will not affect your school grade. All we ask is that you try as hard as you can to do the things I ask. At any time you can ask me to stop and you do not have to continue to take the test. Your teachers and parents and the other children will not know how you do. It will be just between you and me and the people I work with. Of course, you don’t have to do this if you don’t want to, even if your parents gave their permission. If you do not want to do this or your parents asked you not to do this, just tell me and you can go back to your classroom. It is OK with me if you don’t want to be in the study and no one else, not even your teacher, will know. Do you have any questions? (The Experimenter should answer any question the child might have and insure to the best of your ability that the child understands his/her rights) Again, this will not affect your grades even if you choose not to be in the study. If you agree to do this, I would like you to sign this paper.

(If necessary, the Experimenter reads assent statement to the child)

Date_______________ The study on reading has been explained to me and any questions I had have been answered. I would like to take part in the study.

___________________________________ [signature required as appropriate to age] (Student’s Signature)

21

APPENDIX H

OSP7/04

REPORT ON RESEARCH PROJECTS USING HUMAN PARTICIPANTS Student____ Faculty____ Staff____ Final Report____ Interim Report____ Name of Investigator______________________________________________ Name of Faculty Advisor, if applicable__________________________________ Title of Project_________________________________________________ Duration of Project (dates) ____________________ to ____________________ If you are a student investigator, indicate course/class for which research was done ____________________________. If this was a multi-project effort with numerous student investigators, faculty advisor must indicate course for which research was done_____________________________________. Briefly describe the progress of your research to date. If you have completed your work, this will serve as the final report. Please answer the questions below. 1. Did you experience any unexpected problems or risks to participants? If yes, please explain below. 2. Have you made or do you intend to make any changes to your research plan? If so, please explain.

Please return to Amy Henderson-Harr, Sponsored Programs, 402 Miller Building.

Please type or print.