VCU Center for Clinical and Translational Research1 Looking at CBPR Through the Lens of the IRB Cornelia Ramsey, PhD, MSPH Community Research Liaison,

VCU Center for Clinical and Translational Research 1

Looking at CBPR Through the Lens of the IRB

Cornelia Ramsey, PhD, MSPHCornelia Ramsey, PhD, MSPHCommunity Research Liaison, Center for Clinical and Translational Community Research Liaison, Center for Clinical and Translational

Research, Division of Community Engagement, Department of Research, Division of Community Engagement, Department of Epidemiology & Community HealthEpidemiology & Community HealthVirginia Commonwealth UniversityVirginia Commonwealth University

October 30, 2008October 30, 2008


Seeds for Thought and Discussion…

CBPR design & methods

Ethical issues for the IRB – the current debate

Key points from leaders in the field


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 – http://nihroadmap.nih.gov Long-term plan to strengthen linkages between

research and practice and practice and communities

One strategy – community engaged research


Community Engaged ResearchContinuum

(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


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)


Comparison:Traditional Academic Research vs. Community Research

Traditional Research Community Research

Goal of research Advance knowledge Betterment of community

Source of research question Theoretical work Community-identified problem

Designer of research Trained researcher Trained researcher & community

Role of researcher Outside expert Collaborator, learner

Role of community Subject of study Collaborator, learner

Relationship of researcher to participants

Short-term, task-oriented, detached

Long-term, multifaceted, connected

Value of research Acceptance by peers (e.g., publication)

Contribution to community change

Ownership of data Academic researcher Community

Means of dissemination Academic conference, journal

Any and all forums, media, meetings,

community

(Strand K, et al. 2003)


CER strategies build capacity but…

… also create opportunities for risk to communities


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)


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)


Specific Risks to Communities

Stigmatization Discrimination Research related community identity Fractured social structure

(Dickert et al 2005)


Two Possible ApproachesEstablishment 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


Examples of Existing Guidelines for Communities


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 under taken”;

(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.”


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


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)


First Steps…


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)


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


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)


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)


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)



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



Questions & Discussion


ReferencesBall 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) 33-52.

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. 2005 vol 95 no.7 2005.

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, 2008.

Israel A et al. Review of Community-Based Research: Assessing Partnership Approaches to Improve Public Health. Annual Review of Public Health. 1998 19:173-202.

Israel B, et al (Eds.). Methods in Community-Based Participatory Research for Health. San Francisco: Jossey-Bass & Co., 2005.

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., 2003.

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.

Documents

VCU Center for Clinical and Translational Research1 Looking at CBPR Through the Lens of the IRB Cornelia Ramsey, PhD, MSPH Community Research Liaison,