Community Engagement Picks Up Where the Usual Guidelines and Regulations Leave Off

On September 27, 2012, PRIM&R hosted a webinar titled Community Engagement in International Research: Considerations for Ethics Review. Following the webinar, I had a chance to connect with the presenters, Jim Lavery, MSc, PhD, and Katherine King, PhD, to discuss some of the questions they were unable to cover during the time allotted for the webinar.

Alexandra Shlimovich (AS): How is the framework for community engagement (CE) you presented different from the framework for research with individual participants?
Jim Lavery (JL): There are many ways to answer this question, and I’ll try to highlight a few of the differences we see and some challenges associated with focusing on communities in general. It’s important to remember that we try to start from an “interests-based” perspective. In individual-focused regulations and guidelines, the interests of the participants are paramount. One simple way to think about the CE framework is that it picks up where the usual guidelines and regulations leave off. Rather than limiting the focus to participants or the occasional third party, we work on the assumption that there are people and organizations whose legitimate interests may be affected by the research. Therefore, one way to think about the CE framework is that it is an individual-focused framework, but it applies equally to anyone with a legitimate interest in the conduct and outcomes of the research.   

Katherine King (KK): Whether it makes sense to talk about collective interests (interests that belong to the group proper) above and beyond the collected interests of individuals is a philosophical dilemma. Individual interests and/or individual harms can never be meaningfully collected. We are inclined to believe that there are some interests that people share in ways that go beyond each individual, but this would require a far lengthier discussion than space allows for today.  Moreover, this subtle distinction will not alter the importance of community engagement. As in either case, the core proposition of community engagement remains the same: -research affects the interests of people and organizations beyond the traditional research participant, and these further people and organizations should be given a voice in the research program.

AS: What is the power balance between communities and researchers through CE (especially with regard to knowledge)?
JL: The issue of power often comes up when we discuss CE, and in some respects, CE is all about power. One way of thinking about power is that the interests of investigators, or sponsors, or funders, or host institutions, tend to be prioritized over the interests of the poor people who are often the end targets for new treatments or technologies. Just because certain interests tend to be given priority over others doesn’t mean they aren’t legitimate, so an ideal approach would facilitate a fair and reasonable balancing of all interests. This is what we’d like to see in a CE framework eventually, but there are lots of details to be worked out before that is likely.

AS:  Have you had any experience with establishing a community ombuds or bridge leader to address the changing relationships during the trial?
JL: We have not personally had the experience of establishing these kinds of roles, but we have seen different forms of representation used s, in various contexts. The whole question of “representation” is itself an extremely complex.  We have also been doing some  other work related to “brokering” engagements between and among various interest-holders. I think we need more case examples of how these roles work.

AS: What is the relevance of ownership in CE from the perspectives of both communities and researchers? How does CE transform power relations between investigators and the communities?
JL: The term “ownership” is often used in discussions about CE. We have seen many examples of community members (i.e., those participating in trials, or those living and working in the immediate vicinity of a trial or study, or participating in other direct ways) explaining to us how their sense of “ownership” of a project, or their stakes in the project, has been enhanced because of CE. For example, in a study with sex workers in Kenya, the women talked about the profound impact on them when the investigators provided them with a dedicated meeting space. This very concrete gesture made the women feel that they were much more a part of the study than they had ever felt previously. The downside of relying too heavily on the term “ownership,” is that it is usually meant more figuratively than literally. This takes us back to the power issue. In our interests-based model, ownership (i.e., having the final control over key aspects of a study and the necessary resources at your disposal to effect the necessary decisions and actions) may ultimately matter less than whether your legitimate interests in the conduct and outcomes of the research are acknowledged and addressed fairly. 

AS: When should an IRB require the development of a CE plan?
JL: An IRB should develop a CE plan when the IRB suspects there may be people or organizations with legitimate interests in the research and whose interests could be affected by the research, but who have not been accounted for in any way in the research plan. Our CE framework provides a decent starting place. It was designed to be short and digestible and provides 12 “points to consider” rather than a long document that is difficult to navigate.

If you’re interested in learning more about community engagement and did not have a chance to participate in last week’s webinar, the archive is available for purchase. PRIM&R members can also access additional readings related to this topic on our Knowledge Center.