1. 1 Wheaton College INSTITUTIONAL REVIEW BOARD (IRB)

2. 2 What is an IRB? The Institutional Review Board (IRB) is a committee established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The Institutional Review Board (IRB) is a committee established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. Office for Human Research Protections (OHRP) Office for Human Research Protections (OHRP)

3. 3 OHRP Definitions RESEARCH: A systematic investigation designed to develop or contribute to generalizable knowledge RESEARCH: A systematic investigation designed to develop or contribute to generalizable knowledge HUMAN SUBJECT: An individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information HUMAN SUBJECT: An individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information

4. 4 Why does Wheaton have an IRB? There is increasing research activity at Wheaton. There is increasing research activity at Wheaton. We need to comply with federal regulations for the protection of human subjects and data privacy We need to comply with federal regulations for the protection of human subjects and data privacy e.g., 45 CFR 46 and 42 CFR; HIPAA e.g., 45 CFR 46 and 42 CFR; HIPAA We need to comply with standards of professional conduct and practice. We need to comply with standards of professional conduct and practice. Not all research proposals are pre-approved by another IRB; and even if they are, the other IRB may not apply all standards relevant to Wheaton. Not all research proposals are pre-approved by another IRB; and even if they are, the other IRB may not apply all standards relevant to Wheaton.

5. 5 Historical Significance 1947: Nuremberg Trials Twenty-six Nazi physicians are tried at Nuremberg, Germany, for research atrocities performed on prisoners of war Twenty-six Nazi physicians are tried at Nuremberg, Germany, for research atrocities performed on prisoners of war Nazi War Crimes Tribunal issues first internationally recognized code of research ethics Nazi War Crimes Tribunal issues first internationally recognized code of research ethics

6. 6 Nuremberg Code Basic principles of voluntary consent Basic principles of voluntary consent Capacity of subjects to consent Capacity of subjects to consent Freedom of subjects from coercion Freedom of subjects from coercion Comprehensive analysis of risks and benefits Comprehensive analysis of risks and benefits Minimization of risk and harm to subjects Minimization of risk and harm to subjects Favorable risk/benefit ratio Favorable risk/benefit ratio Qualified investigators Qualified investigators Appropriate research design Appropriate research design Freedom of subjects to withdraw at any time Freedom of subjects to withdraw at any time

7. 7 Tuskegee Studies: 1932-1972 Study of natural history of untreated syphilis in Tuskegee, Alabama Study of natural history of untreated syphilis in Tuskegee, Alabama Poor, black males uninformed about presence of disease and denied a treatment discovered in 1947 Poor, black males uninformed about presence of disease and denied a treatment discovered in 1947 Abuses revealed in 1972 Abuses revealed in 1972

8. 8 1974: National Commission Established and Act Passed National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research established National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research established National Research Act passed by Congress National Research Act passed by Congress Established IRBs and required review of federally funded research involving human subjects Established IRBs and required review of federally funded research involving human subjects

9. 9 Autonomy Give respect, time, and opportunity to subjects to make own decisions Give respect, time, and opportunity to subjects to make own decisions No pressure to participate No pressure to participate Protection for potentially vulnerable populations such as Protection for potentially vulnerable populations such as Children Children Elderly Elderly Cognitive or emotionally impaired Cognitive or emotionally impaired Prisoners Prisoners

10. 10 Beneficence Obligation to secure well-being of research participants Obligation to secure well-being of research participants Protection of subjects from harm Protection of subjects from harm Maximization of benefits Maximization of benefits Careful balancing of risks and benefits Careful balancing of risks and benefits

11. 11 Justice Distribute benefits and burdens of research fairly and without bias Distribute benefits and burdens of research fairly and without bias Selection of subjects not based on Selection of subjects not based on convenience convenience subject availability subject availability compromised position of subjects compromised position of subjects subject manipulability subject manipulability language barrier language barrier

12. 12 What does the IRB do? Reviews research proposals involving direct contact with Wheaton students, or release of Wheaton staff or student data to researcher(s) outside of Wheaton; Reviews research proposals Reviews research proposals involving direct contact with Wheaton students, or release of Wheaton staff or student data to researcher(s) outside of Wheaton; Reviews research proposals Approves, suggests specific revisions, or disapproves these proposals Approves, suggests specific revisions, or disapproves these proposals Provides Continuing Review of approved research projects (at least annually) Provides Continuing Review of approved research projects (at least annually) Provides in-service training about human participant protection in research to Wheaton students and staff Provides in-service training about human participant protection in research to Wheaton students and staff Responds to participant inquiries or concerns about their participation in Wheaton research Responds to participant inquiries or concerns about their participation in Wheaton research Provides technical assistance to researchers Provides technical assistance to researchers

13. 13 When does research need IRB review? All prospective projects that pertain to research and human subjects as defined earlier, that involve Wheaton students, staff, or data, must be reviewed by the Wheaton IRB. All prospective projects that pertain to research and human subjects as defined earlier, that involve Wheaton students, staff, or data, must be reviewed by the Wheaton IRB. Internal data analysis undertaken by Wheaton staff exclusively for purposes of Wheaton needs assessment, program planning, program evaluation, or other administrative requirements is exempt from need for DHS IRB review. Internal data analysis undertaken by Wheaton staff exclusively for purposes of Wheaton needs assessment, program planning, program evaluation, or other administrative requirements is exempt from need for DHS IRB review.

14. 14 What does the IRB look for? Protection of participant rights Protection of participant rights Adequate Informed Consent to participate Adequate Informed Consent to participate Procedures which are not harmful – psychologically or physically Procedures which are not harmful – psychologically or physically Procedures which assure maintenance of confidentiality of sensitive data Procedures which assure maintenance of confidentiality of sensitive data Right to refuse to participate without adverse consequence such as denial of services Right to refuse to participate without adverse consequence such as denial of services Scientific merit of the proposed study Scientific merit of the proposed study Is the design minimally adequate to answer the research questions? Are benefits worth the risks? Is the design minimally adequate to answer the research questions? Are benefits worth the risks?

15. 15 Who is on the IRB? At least five members At least five members At least one nonscientific member and one not otherwise affiliated with the institution At least one nonscientific member and one not otherwise affiliated with the institution Must include member “primarily concerned” with the welfare of vulnerable subjects, e.g., children, prisoners, pregnant women, or mentally ill Must include member “primarily concerned” with the welfare of vulnerable subjects, e.g., children, prisoners, pregnant women, or mentally ill Professional competence necessary to review specific research activities, and knowledge of standards of professional conduct and practice (1+ scientist- practitioners) Professional competence necessary to review specific research activities, and knowledge of standards of professional conduct and practice (1+ scientist- practitioners) Know what is acceptable research in terms of institutional commitments and regulations (a senior management representative) Know what is acceptable research in terms of institutional commitments and regulations (a senior management representative) Know legal requirements Know legal requirements

16. 16 Current Membership Chair: Michael Berg (2012-15) Dept. of Psychology Chair: Michael Berg (2012-15) Dept. of Psychology Teresa Celada (2010-13) Dept. of Philosophy Teresa Celada (2010-13) Dept. of Philosophy Karen McCormack (2012-15) Dept. of Sociology Karen McCormack (2012-15) Dept. of Sociology Shawn McCafferty (2012-15) Dept. of Biology Shawn McCafferty (2012-15) Dept. of Biology Charles (Chuck) Kennedy (2010-13)(Outside Member) Charles (Chuck) Kennedy (2010-13)(Outside Member) M. Gabriela Torres (2012-15) Dept. of Anthropology M. Gabriela Torres (2012-15) Dept. of Anthropology Executive Secretary: Joel Relihan (2010-14) Associate Provost Executive Secretary: Joel Relihan (2010-14) Associate Provost

17. 17 Wheaton IRB Website Information and rights for potential research participants Information and rights for potential research participants IRB policy and guidelines IRB policy and guidelines IRB submission instructions and forms IRB submission instructions and forms IRB terms and definitions IRB terms and definitions Contact information Contact information

18. 18 For additional information contact Joel C. Relihan, Associate Provost Joel C. Relihan, Associate Provost IRB Executive Secretary Human Protections Administrator Phone: 508.286.3497 relihan_joel@wheatoncollege.edu