Ethics of Health Research in Communities: Perspectives From the Southwestern United States

Abstract

PURPOSEThe increasing attention paid to community-based research highlights the question of whether human research protections focused on the individual are adequate to safeguard communities. We conducted a study to explore how community members perceive low-risk health research, the adequacy of human research protection processes, and the ethical conduct of community-based research.METHODS Eighteen focus groups were conducted among rural and urban Hispanic and Native American communities in New Mexico using a semistructured guide. Group transcriptions were analyzed using iterative readings and coding, with review of the analytic summary by group members.RESULTS Although participants recognized the value of health research, many also identifi ed several adverse effects of research in their communities, including social (community and individual labeling, stigmatization, and discrimination) and economic (community job losses, increased insurance rates, and loss of community income). A lack of community benefi cence was emphasized by participants who spoke of researchers who fail to communicate results adequately or assist with follow-through. Many group members did not believe current human research and data privacy processes were adequate to protect or assist communities.CONCLUSIONS Ethical review of community-based health research should apply the Belmont principles to communities. Researchers should adopt additional approaches to community-based research by engaging communities as active partners throughout the research process, focusing on community priorities, and taking extra precautions to assure individual and community privacy. Plans for meaningful dissemination of results to communities should be part of the research design. Ann Fam Med 2010;8:433-439. doi:10.1370/afm.1138. INTRODUCTIONC onverging organizational, conceptual, and funding developments during the last decade have raised the profi le of health and medical research conducted in communities. At the same time, the number of practice-based research networks, organizations that specifi cally undertake research in primary care and community settings, has grown rapidly. [1][2][3][4][5] With these developments, there has been increasing interest in the concept of community-based participatory research, whereby community members have more involvement in all stages of the research process. 6,7 More recently, the National Institutes of Health's Clinical and Translational Science Awards program has included explicit expectations for community engagement in research and for development of research that can directly benefi t communities. E T HIC S OF HE A LT H R ESE A RCH IN COMMUNIT IESThis growing interest in conducting research that directly or indirectly involves communities raises a concern about the adequacy of research protections. Human research protections established and expanded during the last 60 years have centered on the rights and safety of the individual in the research process. Indeed, the 3 principles of The Belmont Report (re...

Cultivating a Cycle of Trust With Diverse Communities in Practice-Based Research: A Report From PRIME Net

“…4,12,15,24 We note as well the parallels between action steps derived from our participants' comments and those of the community-based participatory research and other participatory research models 13,15,25,26 that are increasingly featured in PBRN research studies. 11,16,27 PBRNs are in a unique position to actualize the strategies we outline and to ensure that clinical research more equitably serves the needs of all peoples.…”

“…11,16,24 The dominant model of research funding does not account for the resources needed to nurture this trust, especially before and after the data collection phases-the first and fourth stages in the cycle of trust presented herein. The effort and resources required to develop community applications of research results-to close the loop-as part of the cycle of trust are well outside the scope of the current research funding model.…”

“…Another implication of these findings related to trust is the need for research participants' protections to engage at a community, rather than an individual, level. 24,28,29 Current review processes do not necessarily include communities as active partners in the development of research topics and protocols. Our findings suggest that new models for funding and participant protection are needed if participation of underrepresented groups in clinical research is to be expanded and maintained.…”

Transformation and Renewal

“…27 Do existing ethical guidelines provide adequate protection for community-based research? According to a recent study of ethnic minority communities, 28 more is needed, including expansion of the Belmont Report (the ethical foundation for human subjects research). 29 A commenter agreed, calling for new language and a new research framework: …engaging communities require[s] researchers to reframe their research as research "with" and not "in," "on" or "about" communities….…”

In This Issue: Longitudinal Follow-up Yields New Insights

“…9 An important study by Williams et al 10 shows that from the perspective of community members, current research participant protection criteria do not match the nature of community-based health research.…”