Aboriginal Community Participation in Research Ethics Review: Issues in Community Consent

1. Aboriginal Community Participation in Research Ethics Review:Issues in Community Consent Joseph Kaufert Department of Community Health Sciences and Centre for Aboriginal Health Research, University of Manitoba October 18, 2005

2. Background Paper on Issues of Group, Community or First Nation Consent in Health Research By : Joseph Kaufert, Professor, University of Manitoba Kathleen Cranley Glass, Director Biomedical Ethics Unit, McGill University William L. Freeman, Director of Community Health Programs, Northwest Indian College

3. Objectives: Community Consent Working Paper • To analyze current literature and case materials applying frameworks for group, community or First Nation consent; identifying the impact of cultural and historical context and prospects for consensus and divergence. • To review international policy documents and other relevant literature on the concept and application of community consent in Indigenous research ethics policy in Canada, Australia, the United States and New Zealand. • To examine the roles of external REBs and Community Advisory Committees

5. Community Harms • Physical (distrust of all research and care interventions) • Psychological (self-stigmatization, disruption of group values) • Social (external stigma and external genetic determinism) (Freeman, Romero, Kanade, 2005)

6. Example • In 1985, Dr. Richard Ward took blood samples of 833 Nuu-Chah-nulth people under the auspices of carrying out research to explore the high rate of arthritis in that nation. • After the original study, the blood samples were kept. • Without consent, the samples were then used to isolate DNA and carry out research relating to Dr. Ward’s own research in genetic anthropology.

7. Added Principal: Respect for and Protection of the Rights of Communities • “A reasonable formulation of the principle of respect for communities confers on the researcher an obligation to respect the values and interests of the community in research and , wherever possible, protect the community from harm.” (Weijer et.al 1999)

8. Figure 1 – International, National and Local Frameworks for Determining Community Consent

9. Problems in Community-Based Health Research Problems of defining the “community” • Self-definition versus political or demographic boundary • Problems of communities within urban centres • Political representation of communities through First Nations or Tribes • Problems of multiple communities including conflicting stakeholder perspectives based on gender, lineage or genetic interest

10. Problems in Community-Based Health Research • Problem of defining who speaks for the community? • Problem of consensus formation by private social units or decision-making by elected leaders or leaders with traditional authority • Problem of representing community interests in research ethics review structures and determining the legitimacy of expressions of community consent.

11. CIHR Guidelines Health Research Involving Aboriginal Peoples

12. Aboriginal Nation or Community? • Community is a structure of support mechanisms that include the personal responsibility for the collective and reciprocally, the collective concerns for individual existence.

13. Community Jurisdiction and Approval Process • Authority in the area of research is based on the assumption that Aboriginal communities have Aboriginal or treaty rights to regulate research within the community; • Research involves the activity of seeking knowledge, an activity that is culturally specific and fundamental to all societies;

14. Hierarchy of Jurisdiction • Aboriginal communities have a ground-up structure of political authority • Researchers and participants cannot assume that one political body has the authority over research.

15. Complex Authority Structures • Legal authorities of a community may include: • Band elders • Traditional leaders • Municipal leaders • Tribal leaders • Confederation leaders • Regional leaders

16. Free, Prior and Informed Consent • Research conducted in an Aboriginal community must obtain free, prior and informed consent from the Aboriginal community and individual participants as appropriate.

17. Community Research Ethics Review • Aboriginal communities may have their own “Ethics Review Board” established. • In this case, the Aboriginal community has jurisdiction to require research conducted in their territory to comply with such procedures.

18. Evaluation of Barriers in Current University-Based Research Ethics Review:K. GlassJ. Kaufert

19. Issues for University-Based Research Ethics Boards in Evaluation of Community Consent • REB culture and emphasis on external science context • External REB knowledge gaps related to historical and cultural context of Aboriginal relationships with researchers

20. External REB Issues • Problems of external REB engagement of local knowledge and interpretation of local perspectives on harms and benefits of proposed research. • Limited capacity to address local harms and assess just resource allocation

21. External REB Issues • Protecting Confidentiality • Ownership and Interpretation of Data (Conflicting values involving OCAP and academic independence) • Publishing Rights • Representation of Communities in REB Membership

22. Research as a Partnership • Relevant communities and individuals should be involved at all stages of the research process, from formulating projects and methods, to determining research outcomes and interpreting results.

23. Parallel Systems • A researcher would not only have to submit their proposal to their own institution’s Research Ethics Board (likely a university) but also the Aboriginal community’s Research Ethics Board [REB].

24. Ownership and Cultural Knowledge • There must be clear guidelines stating that Indigenous peoples and their respective communities retain ownership of any traditional knowledge, cultural practices and traditions that are shared with the researcher(s).

25. Comparing Conventional and Participatory Models of Research Collaboration Between First Nations and University Based Researchers CONVENTIONAL PARTICIPATORY

26. Partnership Development for Aboriginal Health Research Step 1 Pilot Development Funding Review for Development of Community Relations STOP No Yes Relationship Building: -Respect traditional values/beliefs -PAR -OCAP Representative Model continues…

27. Step 1 – Continued… Representative Model… Review for Community Research Priorities Submission to Granting Agency Referral to Community Authority or Local REB Review by Local REB Community REB Recommendations to Local Authority Stop Community Acceptance No Yes Researcher Submission to Funding Agency

28. AMC/CAHR ConsultationReviewing the CIHR Draft Guidelines: 1. Review of guidelines from the perspective of members of working health information and ethics review committee

29. AMC/CAHR ConsultationReviewing the CIHR Draft Guidelines (Continued): 2.Review of operational issues in the system of review necessary to implement guidelines

30. AMC/CAHR ConsultationReviewing the CIHR Draft Guidelines (Continued): 3. Review of guidelines from the perspective of other Aboriginal Communities

31. Methods: • Key Informant Interviews • Focus Groups • Elders Consultation

32. New CIHR 5 Year Project on Understanding Research Ethics Communication From the Perspective of All “Participants”: • Partnership with UBC Centre for Applied Ethics Co-Investigators: S. Cox; M. McDonald J. Kaufert P. Kaufert

33. New CIHR 5 Year Project: (Continued) • Emphasis on documenting all research participant’s perspectives on research participation • Alternative perspectives of individual participants (“subjects”), community participants, researchers, REBs, ethicists, science and research policy-makers

34. New CIHR 5 Year Project: (Continued) • Methods: - Key informant interviews - 4 Case studies of actual research 5. Opportunities for collaborative research