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Community Based Participatory Research: Considerations for IRBs

Community Based Participatory Research: Considerations for IRBs. SACHRP Meeting Department of Health and Human Services Oct. 28, 2009. Puneet Chawla Sahota, Ph.D. Post-doctoral Fellow, National Congress of American Indians MD Candidate, Washington University in St. Louis.

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Community Based Participatory Research: Considerations for IRBs

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  1. Community Based Participatory Research: Considerations for IRBs SACHRP Meeting Department of Health and Human Services Oct. 28, 2009 Puneet Chawla Sahota, Ph.D. Post-doctoral Fellow, National Congress of American Indians MD Candidate, Washington University in St. Louis

  2. 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

  3. 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?

  4. 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?

  5. 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

  6. 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

  7. 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

  8. 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)

  9. 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

  10. Questions, Comments?

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