Research ethics reconsidered in the context of community-engaged research

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.