The Ethics of Community Engaged Research
Debates about the ethics of clinical research are not new (Chen et al., 2006; Emanuel et al., 2000; Levine, 1988), but community-engaged research (CEnR) raises additional questions and challenges. Community engagement is about relationships between and among communities, researchers, and research institutions. What ethical code should we use to assess the conduct of those relationships, and how should that code be monitored and enforced? As CEnR has become more prevalent and more varied, this fundamental question has generated a number of specific questions and ideas (Khanlou et al., 2005; Silverstein et al., 2008).
A well-accepted ethical code concerning research that involves living human beings already exists, and a regulatory process based in this code has been developed for all federally funded “human subjects research.” The need for this ethical code stems from the nature of research — by definition, that which is being researched has not yet been “proven.” Accordingly, there is uncertainty about the results of research activities, including the possibility of harm to participants. In this ethical framework, studies are understood to fall into two general categories: those that present minimal risk to participants, and those that may subject participants to more than minimal risk (see Common Rule 45 CFR [Code of Federal Regulations] 46.102(h)(i)).
All federally funded research that involves living people requires review by an institutional review board (IRB); the people who serve on IRBs and review research have a responsibility to ensure that risk to participants is minimized. The issues that IRBs consider include the risks to participants, the procedures for collecting and protecting research data, the strength of the scientific design, and the process by which individuals give their informed consent to participate in research.
Should there be a process for determining whether a CEnR collaboration is based on trust and whether each partner has successfully fulfilled his or her responsibilities to the other partners and to the project? If there should be such a process or similar processes, should they be the responsibility of the IRB? In their reviews, IRBs typically have not considered many activities and principles of community engagement. For example, although IRBs may require letters of support from community partners, they are not concerned with how well the researcher knows the community or whether trust has been established. Once research has been approved, the IRB will not typically obtain community input for its regular reviews of research protocols. Furthermore, studies demonstrate that IRBs generally do not incorporate the principles of CEnR into their considerations, even for studies that are community engaged (Flicker et al. 2007), and some have questioned whether the current IRB system is appropriate to provide oversight for all forms of CEnR (Brugge et al., 2003; Malone et al., 2006; Ross et al., 2010a, 2010b, 2010c; Shore, 2007). Finally, the majority of IRBs do not want to take on this additional task, and researchers and others are wary of “IRB mission creep” as these boards take on more and more regulatory responsibility (Center for Advanced Study, 2004).
The Yale University CTSA’s Community Alliance for Research and Engagement (CARE) Ethical Principles of Engagement Committee (2009) developed an expanded set of principles that is relevant to this discussion. The committee’s view is that ethical review applies “not only to individual research subjects but also to interactions between the research partners” (p. 2). The committee explains: “Each partner has certain responsibilities. Among the most important of these is that each should recognize the other’s needs and empower the other to assert its unique rights within the relationship” (CARE, 2009, p. 9).
Part of ethical conduct is developing a legitimate and serious dissemination plan for the findings of the proposed research that will meet the needs of both communities and researchers. In addition to its emphasis on ethical and empowering practice among partnership organizations, the CARE Committee extends the principles and protections of the Belmont Report to communities:
University Researchers should involve Community partners as early as possible in discussions about the potential uses of all data to be collected, including a dissemination plan for the sharing of the research findings with the wider [non-academic] Community, and should develop a process for handling findings that may reflect negatively and thus cause harm to one or both partners (CARE, 2009, p. 3).
Others have called for ethical review to consider the risks and benefits for both individual participants and entire communities and are asking whether it should be required that communities, as well as individuals, consent to research. This issue is particularly relevant for research into the relationship between the environment and health because the discovery and dissemination of environmental information may affect the well-being of an entire community (Brown et al., 2006; Gbadegesin et al., 2006; Shore, 2006; Wing, 2002). There is also uncertainty about the roles and authority of community advisory boards and what ethical principles, if any, govern these boards (Blumenthal, 2006; Gilbert, 2006; Quinn, 2004).
Developing a comprehensive list of ethical questions for CEnR is challenging because the purpose, approach, and context for such research varies greatly from one project to another (Green et al., 2001b; Israel et al., 1988). As both the volume and range of CEnR activities that focus on health expand, ideas about the ethical review of such research, both inside and outside the health field, will continue to develop.