Research Ethics Reconsidered in the Context of Community-Engaged Research

Due to PRIM&R’s unique position in the research ethics field, we are often approached by organizations and investigators who wish to tap into the PRIM&R community for their specialized skills, unique perspective, and dedication to conducting research with human subjects to the highest standards. This post is one such example of that. Nancy Shore, PhD, senior consultant at Community-Campus Partnerships for Health (CCPH) and principal investigator, and her study team would like the assistance of the PRIM&R community in furthering their research, which is co-sponsored by CCPH and the University of New England (UNE) with support from a grant from the Greenwall Foundation. Read on to see how you can help.

The trend toward community-engaged research enlarges the role of the community beyond an individual institutional review board (IRB) member, or participants in a research study. Specifically, community-engaged research (CEnR) represents a shift away from traditional research approaches that identified individual community members as research subjects to engaging with community members and the organizations that represent or serve them as research partners and participants.

Additionally, some researchers and certain communities have grown dissatisfied with the regulations designed to protect the rights and welfare of individual study participants, arguing that such regulations do not sufficiently consider these communities’ interests.

These developments require an updated regulatory framework, and therefore, CCPH and UNE invite you to share feedback on their proposed revisions to the Belmont Report and Department of Health and Human Services (HHS) research ethics regulations.

The genesis of these changes stem from the team’s earlier work, which found that the Belmont Report does not cover a wide range of ethical issues that arise in CEnR. Thus IRBs may not provide a complete ethical analysis. For example, the Belmont Report does not include the CEnR commitment to community benefit nor do most university-based IRB application forms ask for the community’s perspectives regarding the justification for the study or what the benefits may be, if any, for the involved community.

CCPH and UNE share the goal of revising the ethical framework and regulations for research involving humans in light of the realities of CEnR. Their proposed revisions build off of their National Collaborative Study Team’s cross-case study of five diverse community-based research ethics review processes (CRPs), feedback sessions held with each of the team partners’ CRP reviewers and other local stakeholders, as well as a review of the literature.

They are now seeking feedback on their draft revisions. Please follow this link to learn more and to share your thoughts. By providing this feedback, you will contribute to a greater understanding of how members of different key stakeholder groups might react and respond to a new human research ethics framework. Your feedback, combined with others, will help CCPH and UNE revise and finalize their revised Belmont Report and HHS regulations with a wide variety of stakeholder considerations in mind.

If you have questions or comments, please contact CCPH and UNE at or 206.666.3406.

Study Team:

  • Paige Castro-Reyes, Community-Campus Partnerships for Health, Seattle, WA 
  • John Cooks, Galveston Island Community Research Advisory Committee, Galveston, TX
  • Elaine Drew, PhD, University of Alaska Fairbanks, Fairbanks, AK
  • Kelly Edwards, PhD, University of Washington, Seattle, WA
  • Elmer Freeman, MSW, Center for Community Health Education Research and Service, Boston, MA
  • Mei-Ling Isaacs, Ka Meheu ‘Ohu O Ka Honu, Honolulu, HI
  • Lola Sablan-Santos, Guam Communications Network, Long Beach, CA
  • Sarena Seifer, MD, Community-Campus Partnerships for Health, Seattle, WA
  • Nancy Shore, PhD (Principal Investigator), University of New England/Community-Campus Partnerships for Health, Seattle, WA
  • Eric Wat, Special Service for Groups IRB, Los Angeles, CA