Community engagement is increasingly becoming an integral part of research. “Community-engaged research” (CEnR) introduces new stakeholders as well as unique challenges to the protection of participants and the integrity of the research process. We—a group of representatives of CTSA-funded institutions and others who share expertise in research ethics and CEnR—have identified gaps in the literature regarding (1) ethical issues unique to CEnR; (2) the particular instructional needs of academic investigators, community research partners, and IRB members; and (3) best practices for teaching research ethics. This paper presents what we know, as well as what we still need to learn, in order to develop quality research ethics educational materials tailored to the full range of stakeholder groups in CEnR.

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Purpose The goal of this study is to examine participant responses to disclosure of genetic results in a minority population at high-risk for depression and anxiety. Methods 82 subjects in a genetic study of nicotine dependence were offered personalized genetic results: all were nicotine dependent and 64% self-identified as African American. Pathway Genomics was used to evaluate genetic risks for 5 complex diseases. Participants returned 4–8 weeks following enrollment for in-person genetic counseling interviews and evaluation of baseline measures. A telephone follow-up was performed 4–8 weeks later to assess responses to results. Results 50 of the 82 subjects (61%) were interested in receiving genetic results. These participants had multiple risk factors, including high baseline measures of depression (66%) and anxiety (32%), as well as low rates of employment (46%), adequate health literacy (46%), and health insurance (45%). Pathway Genomics reported “increased risk” for at least one disease in 77% of subjects. 95% of participants reported that they appreciated the genetic results, and receiving these results was not associated with changes in symptoms of depression or anxiety. Furthermore, after return of genetic results, smoking cessation attempts increased (p=0.003). Conclusion Even in an underserved population at high-risk for adverse psychological reactions, subjects responded positively to personalized genetic results.

Scholars and policymakers continue to struggle over the meaning of the word “vulnerable” in the context of research ethics. One major reason for the stymied discussions regarding vulnerable populations is that there is no clear distinction between accounts of research vulnerabilities that exist for certain populations and discussions of research vulnerabilities that require special regulations in the context of research ethics policies. I suggest an analytic process by which to ascertain whether particular vulnerable populations should be contenders for additional regulatory protections. I apply this process to two vulnerable populations: the cognitively vulnerable and the economically vulnerable. I conclude that a subset of the cognitively vulnerable require extra protections while the economically vulnerable should be protected by implementing existing regulations more appropriately and rigorously. Unless or until the informed consent process is more adequately implemented and the distributive justice requirement of the Belmont Report is emphasized and operationalized, the economically disadvantaged will remain particularly vulnerable to the harm of exploitation in research.

While funders increasingly support research that partners with communities, community partners still must submit to a regulatory oversight structure that does not reflect their unique research ethics challenges and needs. In recognition of the importance of collaborative research endeavors, the authors engaged in a process of reconnaissance and negotiations with local community partners and research ethics boards (REBs) at the University of Michigan to begin to address the mismatch between regulatory demands and community-based research realities. This preliminary process yielded both changes in the REB oversight structure and training required of community partnered research. While the ultimate impact of these changes remains to be seen, the process itself yielded insights and materials of use to both our local REBs, and hopefully those at other institutions as well. This article will present those insights and provide links to those materials.