By Emily E. Anderson, Stephanie Solomon Cargill, and Ryan Spellecy
Engaging communities in research beyond mere enrollment is not new and, in fact, has a long history in public health, education, and citizen science. While community engagement originated as a response to abuse and exploitation of marginalized communities by researchers, and thus as a means to better protect research participants, there has historically been some tension between community-engaged researchers and IRBs.
We – as research ethicists who also chair or serve on IRBs and have experience conducting community-engaged research ourselves – believe that the relationship between IRBs and community-engaged researchers is improving, but challenges persist.
Increasingly, community engagement is required by sponsors for research grant funding and is being recognized as a crucial approach to increasing diversity in clinical trials, addressing potential community risks and harms, promoting trust in participant populations, and many other benefits. At the same time, community engagement poses challenges to the traditional approach IRBs take to oversight and review.
More than 25 years ago, our community research partners struggled to complete the human research protections training required by our university. This training assumed existing knowledge of research methods and terminology and used many examples from clinical research that did not resonate with the studies they were working on.
Some communities have created their own research ethics oversight mechanisms. Some, like the Special Services for Groups IRB, are IRBs registered with the Office of Human Research Protections. Others, like the Bronx Community Research Review Board (BxCRRB), are meant to be an adjunct to IRB review at the academic researcher’s own institution, providing input that is not constrained by the parameters of the Common Rule. Community-based research review mechanisms will likely continue to grow as a means of additional protection for research participants and for communities, and IRBs at academic research institutions should recognize and learn about these mechanisms.
Community-engaged research raises unique ethical considerations, such as how to appropriately select community research partners who are representative of the community’s interests, how to adequately pay research partners for their time and talents, how to identify and mitigate risks to identifiable communities, and how to ensure equity in terms of power and decision-making between academic and community partners. Many of these questions do not necessarily fall under IRBs’ narrow purview, but they are important for HRPP professionals and members of IRBs who review community-engaged research to be aware of.
HRPP professionals and members of IRBs should also be aware that there are resources available to support ethical community-engaged research. For example, in response to the need for tailored human subjects training for community partners, one of us (Emily Anderson) eventually developed CIRTification, which is freely available; there other similar programs such as Research Ethics for All, which was recently developed by people with developmental disabilities along with disability service providers, researchers, and IRB administrators and members.
On Tuesday, November 14, we will present a PRIM&R Webinar on Community Engagement in Research: Ethical Considerations for HRPPs. At this session, we will review the overlapping goals of community engagement and human research protections programs, discuss unique ethical and structural considerations this research presents to IRB review, and recommend best practices and resources for reviewing research that engages community partners. We hope you can join us!
Emily E. Anderson, PhD, MPH, is a Professor of Bioethics at the Loyola University Chicago Stritch School of Medicine. Stephanie Solomon Cargill, PhD, MSPH, is Associate Professor of Health Care Health and Public Health at Saint Louis University. Ryan Spellecy, PhD, is the Ursula von der Ruhr Chair in Bioethics, Professor of Bioethics and Medical Humanities, and Psychiatry and Behavioral Medicine at Medical College of Wisconsin, where he is also Assistant Provost for Research and Director, Human Research Protections Program.