Working as team boosts community engagement
IRBs can't do it alone
While considering the "community" in community-engaged research may add new issues for IRBs to consider, they're not in this job alone.
Lainie Freedman Ross, MD, PhD, a professor of clinical medical ethics at the University of Chicago, says that the nine key functions of human subjects protection are ideally performed by a team of players that includes representatives from the community.
Among them: Investigators, conflict of interest committees, research ethics consultation programs, research subject advocacy programs, data safety monitoring plans (and committees, in some cases) and community advisory boards (CABs).
In a paper published recently in the Journal of Empirical Research on Human Research Ethics, Ross and her colleagues delineate the potential roles of all of these groups in ensuring protection of both individuals and communities.
Recommendations specifically for IRBs reviewing community-engaged research include:
Minimizing risk IRBs can work with CABs to help determine whether a formal data safety monitoring plan is necessary and whether there should be explicit stopping rules.
Determining the risk-to-benefit ratio Here, the IRB's role is key, although it may consult with other entities, including the CAB, to identify potential risks and benefits, especially to the community. IRBs should revisit this issue on continuing review to make sure emerging risks are identified.
Fair selection of subjects IRBs can work with CABs to ensure that their perspective is included on this issue. They also help determine whether vulnerable groups should be included, based on potential benefits to those groups.
Informed consent, training of research personnel In addition to its mandated role of ensuring all required elements of informed consent are present, the IRB can mandate human subjects protection training for any research personnel.
Ross says proper training is especially important in studies that enlist community volunteers to recruit their neighbors. She says one unresolved issue is who should be responsible for monitoring the process to make sure that consent is voluntary and informed.
"IRBs are not required to monitor consent, but from a broader human subjects protection standpoint, we really need to be thinking about how we monitor the things we're asking for," she says. "When we take this into the community and we train lay people to get consent from their peers, whose responsibility is it to monitor and insure that risks and benefits and alternatives are being clearly articulated?"
Data monitoring While fulfilling its normal role in reviewing adverse events, the IRB should also consider in its continuing review whether the risk-benefit ratio has changed.
Privacy and confidentiality As in all research it reviews, the IRB must ensure there are sufficient safeguards of participants' privacy and that the data is secure. In community research, it's important that community members who aid in data collection be trained so that they understand privacy and confidentiality issues.
Conflicts of interest IRBs should insist on a conflict-of-interest management plan to oversee any reported conflicts. They should be aware that these conflicts may apply to both researchers and to the community partners.
Vulnerable populations IRB should consider whether the community partner involved in a proposed study is accurately representing those of its members who may be in vulnerable populations.
Ross LF, et al. Nine Key Functions for a Human Subjects Protection Program for Community-Engaged Research: Points to Consider. J Empir Res Hum Res Ethics. 2010 Mar;5(1):33-47.