Online Program

Research ethics reconsidered in the context of community-engaged research

Wednesday, November 4, 2015

Nancy Shore, PhD, Community-Campus Partnerships for Health, Seattle, WA
Kelly Edwards, PhD, Department of Bioethics and Humanities, University of Washington, Seattle, WA
Eric Wat, MA, Special Service for Groups, Los Angeles, CA
Lola Sablan-Santos, Guam Communications Network, Long Beach, CA
Mei-Ling Isaacs, MPH, Ka Meheu ‘Ohu O Ka Honu, Wailuku, HI
Elmer Freeman, MSW, PhD(c), Center for Community Health Education Research and Service, Inc., Boston, MA
John Cooks, Galveston Island Community Research Advisory Committee, Houston, TX
Paige Castro, Community-Campus Partnerships for Health, Seattle, WA
Alice Park, MPH, United Way of King County, Seattle, WA
Elaine Drew, PhD, Community-Campus Partnerships for Health, Seattle, WA
Sarena D. Seifer, MD, Community Campus Partnerships for Health, Seattle, WA
As community engagement in research is increasingly expected by funding agencies and community organizations, the limitations of federal research ethics regulations and the predominant model of research ethics review are evident. Institution-based Institutional Review Board (IRB) reviews of research adhere to Federal regulations for the protection of human subjects, informed by the 1979 Belmont Report ethical principles. These principles emphasize the protection of individual study participants, but not communities.

To address the limitations of research review practices, our community-academic team examined existing guiding principles and regulations in light of current best practices for community-engaged research (CEnR) identified through literature review and our NIH funded case studies of community-based research review processes.  Our analysis informed a re-conceptualized set of ethical principles for research that we applied to revisions to the Belmont Report and the federal regulations, as well as to scenarios for systems of research ethics review.  We sought feedback from diverse stakeholders including community members and others vested in CEnR and research ethics through community-based meetings and an online survey.

Our proposed changes include: 1) expanding research ethics considerations from individuals to communities; 2) including core researcher capacities (humility, accountability, relational integrity); 3) providing guidance regarding IRB composition and decision-making; and 4) creating a blended system of community-based and institution-based ethics review.

Research practice and societal expectations have changed since the development of guiding ethical principles and regulations.  Our proposed revisions to the foundational federal policy documents governing research ethics review ensure their responsiveness to communities and relevance to CEnR.

Learning Areas:

Ethics, professional and legal requirements
Public health or related laws, regulations, standards, or guidelines
Public health or related organizational policy, standards, or other guidelines
Public health or related public policy

Learning Objectives:
Explain why the Belmont Report and Federal regulations for the protection of human participants in research do not adequately address community-level risks and benefits Explain the rationale for proposed revisions to the Belmont Report and Federal regulations for the protection of human participants (and their communities) in research Compare and contrast different scenarios for a research ethics review system in the U.S. that would adequately assess community level risks and benefits Identify strategies that community-based organizations engaged in research can use to ensure that research involving their communities is ethical

Keyword(s): Community-Based Research (CBPR), Ethics

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I have been the principal investigator on one NIH and co-principal investigator on two Greenwall Foundation funded grants focused on community-engaged research and ethical review.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.