Community Based Participatory Research: Considerations for IRBs

Puneet Chawla Sahota, Ph.D.Post-doctoral Fellow, National Congress of American Indians

MD Candidate, Washington University in St. Louis

SACHRP MeetingDepartment of Health and Human Services

Oct. 28, 2009

Research Regulation in American Indian/ Alaska Native (AI/AN) Communities

• Many tribes have their own IRBs or research review committees

• Indian Health Service Areas have their own IRBs

• Researchers working in AI/AN communities experience a complex set of IRB review processes

• Tribal sovereignty a unique consideration– Tribal government relationship with university

CBPR and AI/AN Communities

• CBPR has become ethical gold standard for conducting research with AI/AN communities

• History of research abuses and mistrust (also for other disadvantaged communities)

• Many AI/AN communities will not approve projects without full partnership

• Data ownership a major issue• Publication review common• Whose responsibility is it to protect

community?

Challenges for University IRBs

• Protection of individual vs. community– Group risks and harms– Anonymity of individuals and communities

• Jurisdictional issues w/ tribal IRBs– Which IRB should review project first?– Changes requested by tribal vs. university

IRBs?

• Questions re: review of CBPR– When to review a project – when does the

research truly begin?– Role of community member-researchers?

Considerations for Guidance to IRBs

• How to interpret current regulations for CBPR

• Definition of “modifications” to research projects– Any change in wording of a question?– Can be burdensome in CBPR– Consider approving domains to be covered in

interviews rather than questions– Consider defining what is a significant

“modification” in CBPR projects– Requiring changes after community/IHS IRB has

already approved a project can cause problems

Considerations for Guidance to IRBs

• At which stage to review a project– Could review before any contact occurs with a

community, or once research instruments developed (more common)

– Could review at interim stages of project– Could time review based on community needs

• If tribal IRB requires university IRB approval, then review project early.

• Researcher’s role to translate community needs– e.g., appropriate compensation for study

participation

Considerations for Guidance to IRBs

• Community members as researchers– Training requirements (e.g., CITI) of all

research staff– Community members as co-researchers helps

them to understand why specific protocols need to be followed

– Cross-education of IRBs (re: CBPR) and community member-researchers (re: IRBs) helps both

– Involvement of university IRB office with community

Streamlining IRB review process

• Backlog for IRBs is a problem• “Expedited” review takes longer than full

board review in some cases• Synchronizing university and community

IRB review can be helpful• Regulatory facilitation of university IRBs

being able to accept tribal/IHS IRB review?• Guidance for university IRBs on how to

coordinate their requirements with those of tribal/IHS IRBs (e.g., changes requested)

Conclusion

• Education of IRBs is needed– Importance of CBPR for marginalized

communities– Process of collaboration with communities to

develop research instruments– Qualitative research methods

• Guidance from OHRP to IRBs on how to review CBPR may be helpful

Questions, Comments?