摘要：Belmont Report principles focus on the well-being of the research subject, yet community-engaged investigators often eschew the role of subject for that of participant. We conducted semistructured interviews with 29 community and academic investigators working on 10 community-engaged studies. Interviews elicited perspectives on ethical priorities and ethical challenges. Interviewees drew on the Belmont Report to describe 4 key principles of ethical community-engaged research (embodying ethical action, respecting participants, generalizing beneficence, and negotiating justice). However, novel aspects of the participant role were the source of most ethical challenges. We theorize that the shift in ethical focus from subject to participant will pose new ethical dilemmas for community-engaged investigators and for other constituents interested in increasing community involvement in health research. Patients, family members, health advocates, and health care agency leaders play substantially different roles in health services and public health research than they did just a few decades ago. 1–3 Many major US health research funders today expect community involvement in research design, execution, or dissemination. 4–7 For instance, engaging communities in research is a key goal of the National Center for Advancing Translational Science at the National Institutes of Health. The Patient-Centered Outcomes Research Institute prioritizes patient involvement in the development, governance, oversight, and dissemination of research. 8 A report the Agency for Healthcare Research and Quality commissioned found that stakeholder involvement . . . helps ensure that [Agency for Healthcare Research and Quality research] responds to relevant and important issues, . . . develops products that are accessible and user-friendly, and . . . ultimately reaches its intended audiences. 9 (pi) On the whole, community-engaged research asks community members with lived experience of the health problem under study—or with responsibility for populations with this lived experience (e.g., community-based agencies, advocates, payers)—to participate in planning, designing, conducting, interpreting, or disseminating research. Community engagement in research can take numerous forms, from limited advisory roles in early stages (e.g., input on research priorities) to key leadership responsibilities at every stage, as in community-based participatory research. 10–13 Consensus-building activities, shared control of data, and long-term partnerships can be key elements of community-engaged projects. These research approaches reflect the growing prominence of patient advocacy groups and the concept of participatory science. 1,14,15 Until the latter decades of the 20th century, community members primarily participated in research as subjects. Indeed, the construction of the role of the research subject is inextricable from the historical development of the human sciences generally and health research specifically. 16–19 Researchers defined the research situation with reference to 3 aspects of the subject role. First, the role of the subject is context dependent: an individual becomes a subject by consenting to provide data for a specific study (e.g., in a particular laboratory). Second, the role of the subject is task focused: it centers on completing activities that generate data, such as giving biological samples or completing tests. Third, the role of the subject is time limited: once data collection is complete, the subject role ends, as does, typically, the researcher’s relationship with the individual. Once specified, the subject position allowed researchers to elaborate and refine key intellectual assumptions about research rigor, reliability, and validity. Among these were that one can generalize from data on individuals (e.g., those with particular diseases) to larger populations (e.g., others with the same disease); that an individual can be studied in isolation from social context; and that abstract attributes (e.g., intelligence, conscientiousness) can be reliably measured in artificial experimental settings. The specification of the subject role also structured the concept of research ethics codified in the Belmont Report. The distinction between researcher and subject set the stage for “trust-based obligations” that are the foundation for what we understand as research ethics 20 (p542) with the “protection of human subjects” as a core ethical goal. 21 (p5) The experimental situation should maximize benefits and reduce risks to subjects as much as possible (the Belmont Report’s basic ethical principle of beneficence), 22 individuals should participate voluntarily (principle of respect for persons), and risks and benefits to potential research subjects should be fairly distributed (principle of justice). To preserve the voluntarism at the heart of this relationship, both parties should expect the experiment to generate useful knowledge that could not be otherwise obtained, 23 and they should expect this knowledge to be free of fabrication and falsehood. 24 Institutional review boards (IRBs) assess whether subjects are adequately protected and insist on extra protections for those from vulnerable groups who may experience unusual constraints on voluntary decision-making or who may be less likely to receive the research benefits. 25 By contrast, community-engaged investigators enlist individuals in research as participants, advocating a transformation “from regarding individual community members as research subjects to engaging community members and the organizations that represent them as research partners.” 10 (p1) Community-engaged investigators prefer the participant role because it “increases the possibility of overcoming the understandable distrust of research on the part of communities that have historically been the ‘subjects’ of such research.” 26 (p181) To community-engaged investigators, words like “subject” and “researcher” can signal exploitation rather than ethical protection because the subject role is seen to require passive acquiescence to others’ agendas. 27,28 Community-engaged investigators also eschew the sharp distinction between subject and researcher and seek to minimize the distance between community and academic participants through the mutual exchange of knowledge and skills. 29 Community-engaged research is understood to be “‘with’ [the] community . . . rather than ‘for’ [the] community.” 28 (p321) Community-engaged research participants may include enrolled individuals, research partners, social and constituent groups, funders and payers, study site staff, and others with some stake in the project. Many investigators recognize the ethical implications of these new research relationships, but the theory and practice of ethical community-engaged research remain inchoate. 30 Although community-engaged investigators accept the continued relevance of the 3 Belmont principles, 31 they articulate novel ethical priorities 30 and encounter new ethical challenges. 32–34 Community-engaged investigators have developed innovative approaches to support ethical conduct, 35 yet investigators’ opinions about ethical priorities can vary. 36 Although many investigators view community engagement as a means for achieving ethical ends, 30 the field lacks objective criteria and shared guidelines for implementing ethical practices in community-engaged research. 37 Conceptualizing ethics in community-engaged research is important for developing normative guidelines, educating investigators, and monitoring research conduct. 38,39 We used interview data from community and academic investigators working on community-engaged projects to describe the ethical priorities and dilemmas in community-engaged research. We compared projects to outline 4 principles of ethical community-engaged research and to advance theory that accounts for common ethical challenges. We have shown that most ethical challenges emerge as a result of the collapse of the subject position. Community-engaged investigators’ ethical focus on the participant—a role that is less time limited, setting dependent, and task focused than is that of the subject—raises ethical dilemmas that resist resolution through traditional ethical frameworks. By directing attention to this shift from subject to participant, we characterize sources of ethical challenge, propose strategies that can support ethics in research engaging community members, and raise a set of fundamental questions for further study.
