Potential Strategies for Strengthening Community Engagement in Ethical Oversight of Human Research: Results from an Exploratory, Mixed-Methods Study

BACKGROUND: Engagement of community, patient, and research participant perspectives is critical to ethical research. While community engagement is now widely practiced in the design, implementation, and dissemination of health-related research, it is less prevalent in the activities of human research protections programs (HRPP), including but not limited to review of research protocols by institutional review boards (IRBs). METHODS: Here we report on findings from a mixed-methods empirical study consisting of in-depth interviews with institutional HRPP directors and community engagement experts to generate a list of strategies for engaging community perspectives in research ethics review and oversight, followed by a two-round Delphi panel with diverse experts in research to identify consensus regarding recommended strategies that are both highly feasibly and have potential for high impact. RESULTS: Our interviews with HRPP directors and community engagement experts generated 63 potential strategies for engaging community perspectives in HRRP research review and oversight activities. After two Delphi panel rounds, 17 strategies across eight themes achieved consensus on both high impact and high feasibility (agreement by at least 75% of panelists). The 17 recommended strategies clustered in several patterns: general board membership, and specifically non-scientist and unaffiliated members; review of individual protocols; research participant experience; engagement with institution-based community engagement experts; and supporting institutional investigators in community engagement. CONCLUSIONS: This research is a critical first step towards identifying best practices and promoting their implementation to inform future policy directions on community, patient, and research participant representation and engagement in the ethical review and oversight of human research. Future work could explicitly examine the barriers and facilitators to implementing strategies that support community engagement in IRBs and HRPPs.