VCU Center for Clinical and Translational Research1 Looking at CBPR Through the Lens of the IRB Cornelia Ramsey, PhD, MSPH Community Research Liaison, Center for Clinical and Translational Research, Division of Community Engagement, Department of Epidemiology & Community Health Virginia Commonwealth University October 30, 2008

VCU Center for Clinical and Translational Research2 Seeds for Thought and Discussion… CBPR design & methods Ethical issues for the IRB – the current debate Key points from leaders in the field

VCU Center for Clinical and Translational Research3 Why the Emphasis on CBPR now? Need for translational research US health outcomes are no better than outcomes for other industrialized countries Even though the US is a leader in biomedical research, there is a gap between this research and practice, and ultimately health outcomes NIH Roadmap – Long-term plan to strengthen linkages between research and practice and practice and communities One strategy – community engaged research

VCU Center for Clinical and Translational Research4 Community Engaged Research Continuum (clinical & social/behavioral) Investigator- Driven Research Community- Driven Research Community Based Participatory Research Community Placed Research Community Based Research Less Community involvement Complete Community involvement

VCU Center for Clinical and Translational Research5 Key Strategies – For CBPR: Active engagement and shared decision-making of community members, academic researchers and funders Integrated sources of knowledge (e.g., formal & informal) Iterative data collection and analysis using multiple methods (e.g., qualitative and quantitative etc.) Utilization of multiple channels for knowledge dissemination Achievement of common goals: social change, improved health and well-being (Israel et al 1998)

VCU Center for Clinical and Translational Research6 Comparison:Traditional Academic Research vs. Community Research Traditional ResearchCommunity Research Goal of researchAdvance knowledgeBetterment of community Source of research questionTheoretical workCommunity-identified problem Designer of researchTrained researcherTrained researcher & community Role of researcherOutside expertCollaborator, learner Role of communitySubject of studyCollaborator, learner Relationship of researcher to participants Short-term, task-oriented, detached Long-term, multifaceted, connected Value of researchAcceptance by peers (e.g., publication) Contribution to community change Ownership of dataAcademic researcherCommunity Means of disseminationAcademic conference, journal Any and all forums, media, meetings, community (Strand K, et al. 2003)

VCU Center for Clinical and Translational Research7 CER strategies build capacity but… … also create opportunities for risk to communities

VCU Center for Clinical and Translational Research8 Why are there Community Risks? Structure and function of communities Communities have unique politics, beliefs, and values - research may affect these elements Communities may make decisions collectively, and informed consent from individuals may conflict with the political structure, social networks Disease treatments may conflict beliefs regarding traditional healing (Weijer 1999)

VCU Center for Clinical and Translational Research9 Why risks (continued) … “ Belmont principles… do not appear to cover the scope of ethical considerations that arise in CBPR and thus the IRB’s application of these principles may not provide a relevant or thorough ethical analysis” In CBPR human protections are not just about individuals but the respect, beneficence and justice for the community. (Grignon, Wong and Seifer 2008 ) “The ethical issues raised by communities in research are not adequately captured by the current ethical framework for human subjects research as articulated in the Belmont Report.” (Weijer 1999)

VCU Center for Clinical and Translational Research10 Specific Risks to Communities Stigmatization Discrimination Research related community identity Fractured social structure (Dickert et al 2005)

VCU Center for Clinical and Translational Research11 Two Possible Approaches Establishment of New Set of Guidelines Document view that promotes community’s values Add new principle of “respect for communities” or “respect for cultures” Miller, 1995 Enrichment of Existing Principles Reinterpretation of the view of the individual in research Consider the community… Childress, 1994

VCU Center for Clinical and Translational Research12 Examples of Existing Guidelines for Communities

VCU Center for Clinical and Translational Research13 International Guidelines for Ethical Review of Epidemiological Studies (1) “Investigators must respect the ethical standards of their own countries and the cultural expectations of the societies in which epidemiological studies are under­taken”; (2) when individual informed consent cannot be obtained, consent may be sought from a community representative; (3) if the study is objectionable to the community, individual informed consent may not be sufficient to render a study ethical; (4) wherever possible, investigators should not expose groups to harm, including the harm of disruption of social mores; (5) healthcare may be provided to the community as a benefit; (6) when possible, investigators should train local health workers; and (7) the community should be represented in the ethics review process.”

VCU Center for Clinical and Translational Research14 The Australia National Health and Medical Research Council Both parties are accorded equal moral status. Community is involved from research genesis to publication of findings. Community must be consulted in the preparation of the research proposal Study must be potentially useful to the community Study conducted with sensitivity to the community’s culture and politics through face-to-face meetings & adequate time to reflect Written informed consent of the community must be obtained before individual subjects are approached for consent Community will be involved in the actual conduct of the study Community will be reimbursed for any community resources used Use of data and biological samples must be negotiated and requires the consent of the community. Always credit the community

VCU Center for Clinical and Translational Research15 However… in the NHMRC All communities were considered more or less the same as First Nations communities - this is a mistake. It is an error to blindly apply guidelines written for one community to another community. (Weijer 1999)

VCU Center for Clinical and Translational Research16 First Steps…

VCU Center for Clinical and Translational Research17 Clearly Define the Community Collectivities are “population groups with social structures, common customs, and acknowledged leadership.” Collectivities include nations, cultural groups, small indigenous communities and some neighborhood groups. The definition is also explicitly intended to include families. (Canada Tri-Council Working Group on Ethics, 1996)

VCU Center for Clinical and Translational Research18 Identify Implications of Strategies- for CBPR Active engagement and shared decision-making of community members, academic researchers and funders  Community involvement BEFORE IRB approval  Community ownership of data, findings, results Iterative data collection and analysis using multiple methods Necessitates changes throughout study – implications for study revisions  Timeline of research  Timeliness of revisions  Qualitative research data monitoring, analysis plan Utilization of multiple channels for knowledge dissemination  Community ownership, community credit Achievement of common goals: social change, improved health and well-being  Impact on risk benefit analysis – not just individual but community level benefit and risks

VCU Center for Clinical and Translational Research19 Think About Informed Consent Information about programs, trainings and materials representing community language & culture & context Full disclosure about how research incorporates knowledge and strengths of community in recruitment plan, instrument development, intervention development & research design Confidentiality – for individuals and community relationships and trust Voluntary participation – no coercion (Viswanathan et al. 2004)

VCU Center for Clinical and Translational Research20 Think About Benefits & Risks Maximize benefits Advance common goals – social action & research goals Build capacity of community partners in research – research design to data collection, interpretation & dissemination Minimize risks Avoid “collaborating with the enemy” Be sensitive to causes of potential fractures in the community Be aware of how research could further stigmatize vulnerable communities (Ball & Janyst 2008)

VCU Center for Clinical and Translational Research21 Think About Justice Community “insiders” can identify vulnerable individuals emotionally charged topics appropriate cultural perspectives on research Equitable distribution of benefits and burdens of research Who is included? Excluded? Why? Who shares resources? (e.g., money) (Ball & Janyst 2008)

VCU Center for Clinical and Translational Research22 Review - Clarifying Expectations Initiate the relationship with awareness of ethical issues for communities Identify people community members trust including governing bodies and work & spend time in the community to identify & connect with community-defined representatives Memorandum of Agreements detail everything Expect the draft plan will be revised! For some communities - oral consents are used – written consent has history of deception and misuse (Ball & Janyst 2008)

VCU Center for Clinical and Translational Research23 Questions & Discussion

VCU Center for Clinical and Translational Research24 References Ball J, Janyst P. Enacting Research Ethics in Partnerships with Indigenous Communities in Canada: Do it in a good Way”. Journal of Empirical Research on Human Research Ethics 2008 vol.3 (2) Canada Tri-Council Working Group on Ethics,Code of Conduct for Research Involving Humans {draft}: Ottawa: Minister of Supply and Services, 1996 Childress JF, Fletcher JC. Respect for autonomy. Hastings Center Report 1994;24(3):34–5. Dickert N and Sugarman J Ethical Considerations of Community Consultation in Research. American Journal of Public Health vol 95 no Grignon J, Wong KA, Seifer SD. Ensuring Community-level Research Protections. Proceedings of the 2007 Educational Conference Call Series on Institutional Review Boards and Ethical Issues in Research. Seattle, WA:Community-Campus Partnerships for Health, Israel A et al. Review of Community-Based Research: Assessing Partnership Approaches to Improve Public Health. Annual Review of Public Health : Israel B, et al (Eds.). Methods in Community-Based Participatory Research for Health. San Francisco: Jossey-Bass & Co., Miller B. Autonomy. In: Reich WT, ed.Encyclopedia of Bioethics, Rev. ed. New York: Simon & Schuster MacMillan, 1995:215–20. Minkler M, Wallerstein N (Eds.). Community-Based Participatory Research for Health. San Francisco: Jossey-Bass & Co., 2003 Strand K, et al. Community-Based Research and Higher Education: Principles and Practices. San Francisco: Jossey-Bass & Co., Weijer, C. Protecting Communities in Research: Philosophical and Pragmatic Challenges Cambridge Quarterly of Healthcare Ethics (1999), 8, 501–513. Cambridge University Press Viswanathan M, Ammerman A, Eng E, Gartlehner G, Lohrk N, Griffith D, Rhodes S, Samuel-Hodge C, Mary S, Lux L, Webb L, Sutton SF, Swinson T, Jackman A, Whitener L, Community-Based participatory Research: Assessing the Evidence Evidence Report Technology Assessment No. 00 AHRQ Publication 04-E022-2 Rockville, MD: Agency for Healthcare Research and Quality. July 2004.