The Role of IRBs The Role of IRBs and Ethicsand EthicsSusan Kornetsky, MPHSusan Kornetsky, MPH

Children’s Hospital, BostonChildren’s Hospital, Boston

My PositionMy Position Ethical considerations regarding human subject Ethical considerations regarding human subject

protection are the primary responsibility of the protection are the primary responsibility of the IRBIRB

We should not take the “ethics” out of IRB reviewWe should not take the “ethics” out of IRB review Institutions that conduct human subject research Institutions that conduct human subject research

are responsible for making sure that IRB’s have are responsible for making sure that IRB’s have the resources and support for ethical decision the resources and support for ethical decision makingmaking

IRB are responsible for establishing collaborative IRB are responsible for establishing collaborative relationships with investigators to assure the relationships with investigators to assure the ethical conduct of the research ethical conduct of the research

Why are we even Why are we even discussing this?discussing this?

45 CFR 46.103(b)(1) Regarding Assurances45 CFR 46.103(b)(1) Regarding Assurances

Assurances applicable to federally supported or Assurances applicable to federally supported or conducted research shall at a minimum include:conducted research shall at a minimum include:

(1) A statement of principles governing the (1) A statement of principles governing the institution in the institution in the discharge of its responsibilitiesdischarge of its responsibilities for protecting the rights and welfare of human for protecting the rights and welfare of human subjects of research conducted at or sponsored subjects of research conducted at or sponsored by the institution, regardless of whether the by the institution, regardless of whether the research is subject to Federal regulation. This research is subject to Federal regulation. This may include an appropriate existing code, may include an appropriate existing code, declaration, or declaration, or statement ofstatement of ethical principlesethical principles, or , or a statement formulated by the institution itself.a statement formulated by the institution itself.

Why are we even Why are we even discussing this?discussing this?

Many institutions established IRBs before they Many institutions established IRBs before they were even required to consider the new ethics were even required to consider the new ethics issues, not set up to comply with regulations issues, not set up to comply with regulations because they did not existbecause they did not exist

Bioethics as a recognized discipline has developed Bioethics as a recognized discipline has developed and matured at the same time as human subject and matured at the same time as human subject protections, we now have more players in the fieldprotections, we now have more players in the field

The regulatory environment has caused a shift of The regulatory environment has caused a shift of focus to compliance and checklists, but has never focus to compliance and checklists, but has never relinquished responsibility of ethical review.relinquished responsibility of ethical review.

Institutions have devoted resources to increased Institutions have devoted resources to increased compliance functions. compliance functions.

Role of IRB administrative offices /chairs are under Role of IRB administrative offices /chairs are under transition transition

Why are we even Why are we even discussing this?discussing this?

Regulations are not separate from Regulations are not separate from ethical principles ethical principles Autonomy – Informed consent and Autonomy – Informed consent and

special protections for vulnerablespecial protections for vulnerable Beneficence - Risk/benefit assessmentsBeneficence - Risk/benefit assessments Justice- Burdens and benefits of Justice- Burdens and benefits of

research distributed fairlyresearch distributed fairly Regulations were written to serve as Regulations were written to serve as

a roadmap for ethical considerations a roadmap for ethical considerations by IRBs. by IRBs.

Why IRBs need to remain a Why IRBs need to remain a focal point of ethics review.focal point of ethics review.

IRBs share the knowledge of ethics and IRBs share the knowledge of ethics and regulations. Bottom line is before a research regulations. Bottom line is before a research can begin both need to be satisfiedcan begin both need to be satisfied

A well constituted IRBs is multidisciplinary A well constituted IRBs is multidisciplinary and collectively brings all types of expertise and collectively brings all types of expertise to consider and address ethical and to consider and address ethical and regulatory issues at the same timeregulatory issues at the same time

IIRBs are in a position to see “trends’ in new IIRBs are in a position to see “trends’ in new ethical issues, because they review all ethical issues, because they review all researchresearch

Applying just the regulations will make no Applying just the regulations will make no sense without the ethical considerations sense without the ethical considerations

Why IRBs need to remain a Why IRBs need to remain a focal point of ethics reviewfocal 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 Ethical consultations offer options, but at

the end of the day a decision needs to be the end of the day a decision needs to be made. made.

IRBs are in a position to affect IRBs are in a position to affect institutional norms and policies, institutional norms and policies, important for reoccurring ethical issuesimportant for reoccurring ethical issues

IRBs are required to consider the IRBs are required to consider the community perspective through the community perspective through the voice of the unaffiliated and outside voice of the unaffiliated and outside membersmembers

Concerns about Research Concerns about Research Ethics Consultation Ethics Consultation

ServicesServices Promulgates concept; IRB’s purpose Promulgates concept; IRB’s purpose

is regulatory;is regulatory; Even with caveat of “consultation Even with caveat of “consultation

only” potentially creates conflict only” potentially creates conflict between IRB and “ethics” specialistbetween IRB and “ethics” specialist

Can potentially limit scope of Can potentially limit scope of education and knowledge that education and knowledge that bioethics professionals can provide bioethics professionals can provide to allto all

Concerns about Research Concerns about Research Ethics Consultation Ethics Consultation

ServicesServices From some publications appears From some publications appears

that issues being considered are role that issues being considered are role of IRB ( dissemination of research of IRB ( dissemination of research results)results)

IRB membership will become IRB membership will become undesirable undesirable

What makes a bioethics What makes a bioethics consultant(s) any more expert than consultant(s) any more expert than IRBs? IRBs?

What does an IRB need: What does an IRB need: What can they do better?What can they do better?

Educated IRB chairs and members Educated IRB chairs and members on ethical considerations as it on ethical considerations as it applies to researchapplies to research

Include bioethics specialists on the Include bioethics specialists on the IRB; why work separately? IRB; why work separately?

Resist the “checklist only approach”; Resist the “checklist only approach”; refocus from just compliancerefocus from just compliance

IRB administrators/members require IRB administrators/members require bioethics trainingbioethics training

What does an IRB need: What does an IRB need: What can they do better?What can they do better?

Avoid approach “ we raise the issue” Avoid approach “ we raise the issue” you resolve themyou resolve them

IRBs need to be available for pre and IRBs need to be available for pre and post-consultationpost-consultation

Utilize and collaborate with Utilize and collaborate with bioethics specialists as:bioethics specialists as: consultantsconsultants educatorseducators

ConclusionConclusion

IRBs should IRBs should serve as the focal point for ethical reviewserve as the focal point for ethical review resist only regulatory and compliance resist only regulatory and compliance

functions functions utilize the increase interest and utilize the increase interest and

expertise of bioethics specialistsexpertise of bioethics specialists educate themselves educate themselves view their role as consultants with view their role as consultants with

bioethicists investigators bioethicists investigators