摘要：Objectives. Institutional review boards (IRBs), designed to protect individual study participants, do not routinely assess community consent, risks, and benefits. Community groups are establishing ethics review processes to determine whether and how research is conducted in their communities. To strengthen the ethics review of community-engaged research, we sought to identify and describe these processes. Methods. In 2008 we conducted an online survey of US-based community groups and community–institutional partnerships involved in human-participants research. We identified 109 respondents who met participation criteria and had ethics review processes in place. Results. The respondents' processes mainly functioned through community–institutional partnerships, community-based organizations, community health centers, and tribal organizations. These processes had been created primarily to ensure that the involved communities were engaged in and directly benefited from research and were protected from research harms. The primary process benefits included giving communities a voice in determining which studies were conducted and ensuring that studies were relevant and feasible, and that they built community capacity. The primary process challenges were the time and resources needed to support the process. Conclusions. Community-based processes for ethics review consider community-level ethical issues that institution-based IRBs often do not. Community-engaged research (CEnR) is increasingly recognized by national health organizations, funding agencies, researchers, and community groups as critical to addressing our nation's pressing health concerns. 1 – 7 CEnR's emphasis on community engagement raises ethical considerations that go beyond individual-level protections to include those at the community level. This focus on communities creates challenges for the institutional review board (IRB) system in the United States. IRBs, designed to protect the rights and welfare of individual study participants, may be less equipped to protect the rights and welfare of communities involved in research. The Belmont principles 8 that guide IRBs do not explicitly address the scope of ethical considerations that arise in CEnR; thus, IRB application of these principles may not provide a thorough ethical analysis. 9 – 11 For example, in a review of 30 application forms from university-based IRBs, Flicker et al. found that community considerations were often missing. 10 Although all forms inquired about scientific rationale, none asked about the involved community's input regarding study justification. Only 4 forms asked about community- or society-level risks and benefits, and only 5 asked how findings would be disseminated. Additionally, Deeds et al. analyzed IRB feedback on a multisite community-based HIV prevention proposal and found that only 17% of the IRB comments focused on direct or indirect community issues. 12 Studies of CEnR researcher experiences with IRBs reveal deep concerns about the need to expand the ethical analysis to include community-level considerations of social justice, risks, and benefits. 13 – 20 Some researchers have questioned whether community-based review processes are better situated to understand actual risks and benefits, as compared with institution-based IRBs. 21 A growing number of community groups have implemented ethics review processes to determine how (and whether) research is conducted in their communities. These processes operate independently, parallel to or in partnership with institution-based IRBs, and in some cases they are structured as community IRBs. 22 – 28 With the exception of federally recognized community IRBs, community-based review processes are not mandated or regulated, and little is known about them beyond reports on individual experiences. 25 – 27 To gain insight into how ethics review of CEnR can be enhanced, we sought to systematically describe community-based processes for ethics review of research in the United States. Such understanding is essential given the increasingly frequent occurrence of CEnR and the growing body of literature indicating that institution-based IRBs cannot always provide a thorough and relevant ethical assessment of such research.
