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 Meeting Department 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?