1. The Role of IRBs and Ethics Susan Kornetsky, MPH Children’s Hospital, Boston

2. My Position Ethical considerations regarding human subject protection are the primary responsibility of the IRB Ethical considerations regarding human subject protection are the primary responsibility of the IRB We should not take the “ethics” out of IRB review We should not take the “ethics” out of IRB review Institutions that conduct human subject research are responsible for making sure that IRB’s have the resources and support for ethical decision making Institutions that conduct human subject research are responsible for making sure that IRB’s have the resources and support for ethical decision making IRB are responsible for establishing collaborative relationships with investigators to assure the ethical conduct of the research IRB are responsible for establishing collaborative relationships with investigators to assure the ethical conduct of the research

3. Why are we even discussing this? 45 CFR 46.103(b)(1) Regarding Assurances 45 CFR 46.103(b)(1) Regarding Assurances Assurances applicable to federally supported or conducted research shall at a minimum include: (1) A statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution, regardless of whether the research is subject to Federal regulation. This may include an appropriate existing code, declaration, or statement of ethical principles, or a statement formulated by the institution itself. (1) A statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution, regardless of whether the research is subject to Federal regulation. This may include an appropriate existing code, declaration, or statement of ethical principles, or a statement formulated by the institution itself.

4. Why are we even discussing this? Why are we even discussing this? Many institutions established IRBs before they were even required to consider the new ethics issues, not set up to comply with regulations because they did not exist Many institutions established IRBs before they were even required to consider the new ethics issues, not set up to comply with regulations because they did not exist Bioethics as a recognized discipline has developed and matured at the same time as human subject protections, we now have more players in the field Bioethics as a recognized discipline has developed and matured at the same time as human subject protections, we now have more players in the field The regulatory environment has caused a shift of focus to compliance and checklists, but has never relinquished responsibility of ethical review. The regulatory environment has caused a shift of focus to compliance and checklists, but has never relinquished responsibility of ethical review. Institutions have devoted resources to increased compliance functions. Institutions have devoted resources to increased compliance functions. Role of IRB administrative offices /chairs are under transition Role of IRB administrative offices /chairs are under transition

5. Why are we even discussing this? Regulations are not separate from ethical principles Regulations are not separate from ethical principles Autonomy – Informed consent and special protections for vulnerable Autonomy – Informed consent and special protections for vulnerable Beneficence - Risk/benefit assessments Beneficence - Risk/benefit assessments Justice- Burdens and benefits of research distributed fairly Justice- Burdens and benefits of research distributed fairly Regulations were written to serve as a roadmap for ethical considerations by IRBs. Regulations were written to serve as a roadmap for ethical considerations by IRBs.

6. Why IRBs need to remain a focal point of ethics review. Why IRBs need to remain a focal point of ethics review. IRBs share the knowledge of ethics and regulations. Bottom line is before a research can begin both need to be satisfied IRBs share the knowledge of ethics and regulations. Bottom line is before a research can begin both need to be satisfied A well constituted IRBs is multidisciplinary and collectively brings all types of expertise to consider and address ethical and regulatory issues at the same time A well constituted IRBs is multidisciplinary and collectively brings all types of expertise to consider and address ethical and regulatory issues at the same time IIRBs are in a position to see “trends’ in new ethical issues, because they review all research IIRBs are in a position to see “trends’ in new ethical issues, because they review all research Applying just the regulations will make no sense without the ethical considerations Applying just the regulations will make no sense without the ethical considerations

7. Why IRBs need to remain a focal point of ethics review IRBs are in a position to advise PIs IRBs are in a position to advise PIs Ethical consultations offer options, but at the end of the day a decision needs to be made. Ethical consultations offer options, but at the end of the day a decision needs to be made. IRBs are in a position to affect institutional norms and policies, important for reoccurring ethical issues IRBs are in a position to affect institutional norms and policies, important for reoccurring ethical issues IRBs are required to consider the community perspective through the voice of the unaffiliated and outside members IRBs are required to consider the community perspective through the voice of the unaffiliated and outside members

8. Concerns about Research Ethics Consultation Services Promulgates concept; IRB’s purpose is regulatory; Promulgates concept; IRB’s purpose is regulatory; Even with caveat of “consultation only” potentially creates conflict between IRB and “ethics” specialist Even with caveat of “consultation only” potentially creates conflict between IRB and “ethics” specialist Can potentially limit scope of education and knowledge that bioethics professionals can provide to all Can potentially limit scope of education and knowledge that bioethics professionals can provide to all

9. Concerns about Research Ethics Consultation Services From some publications appears that issues being considered are role of IRB ( dissemination of research results) From some publications appears that issues being considered are role of IRB ( dissemination of research results) IRB membership will become undesirable IRB membership will become undesirable What makes a bioethics consultant(s) any more expert than IRBs? What makes a bioethics consultant(s) any more expert than IRBs?

10. What does an IRB need: What can they do better? Educated IRB chairs and members on ethical considerations as it applies to research Educated IRB chairs and members on ethical considerations as it applies to research Include bioethics specialists on the IRB; why work separately? Include bioethics specialists on the IRB; why work separately? Resist the “checklist only approach”; refocus from just compliance Resist the “checklist only approach”; refocus from just compliance IRB administrators/members require bioethics training IRB administrators/members require bioethics training

11. What does an IRB need: What can they do better? Avoid approach “ we raise the issue” you resolve them Avoid approach “ we raise the issue” you resolve them IRBs need to be available for pre and post- consultation IRBs need to be available for pre and post- consultation Utilize and collaborate with bioethics specialists as: Utilize and collaborate with bioethics specialists as: consultants consultants educators educators

12. Conclusion IRBs should IRBs should serve as the focal point for ethical review serve as the focal point for ethical review resist only regulatory and compliance functions resist only regulatory and compliance functions utilize the increase interest and expertise of bioethics specialists utilize the increase interest and expertise of bioethics specialists educate themselves educate themselves view their role as consultants with bioethicists investigators view their role as consultants with bioethicists investigators