NIH researchers recently reported several trust-enhancing strategies identified through a process of community engagement that may help researchers successfully recruit clinical research participants in medically underserved communities. To help secure the trust of potential participants, the report says, researchers should openly disclose all information to enhance informed decisionmaking, and ensure that research teams include members who can relate to participants in terms of cultural, racial/ethnic, and language backgrounds. Patient advocates, primary care physicians or trusted church members, they add, can be helpful in promoting trust in the research and the researchers.
The community engagement process was conducted by Christine Grady, Ph.D., R.N., and her colleagues at NIH Department of Clinical Bioethics, the NIH Department of Nursing, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). In September 2004, they invited members of a community-based research program called the Health Partnership Program (HPP) to a meeting to discuss issues in ethics of clinical research involving participants with limited access to health care. Ten HPP partners representing various community organizations participated in the discussion. During the meeting, the researchers presented three research case examples for the community partners to discuss. Afterwards, the scientists performed data analysis based on the meeting transcript.
The community partners perceived clinical research as valuable, and did not suggest excluding individuals from research because of limited health care access. On the other hand, they emphasized that there is a common and pervasive distrust in minority communities of research and researchers stemming from a history of abuse and exploitation in many areas (and not simply from the legacy of the infamous Tuskegee Syphilis Study in African Americans). Therefore, to increase participation in clinical trials by participants from underserved communities, it is crucial to enhance trust between patients and researchers.
A key strategy to enhance trust, according to Dr. Grady and her colleagues, is to improve communication. Prospective participants should not only have the information they need to make decisions about whether or not to participate in research, but should have the opportunity for ongoing communication with the research team. Advocates that can help explain study-related information and support participants were seen as a way to enhance communication and trust. Besides improving communication, researchers should address the concerns of people with limited access to health care so that barriers to participation can be reduced. Scientists should be attentive to the rights, values, needs and welfare of research participants, both during and after the study. It is also crucial for researchers to ensure confidentiality of patient data.
In 2000, as part of its effort to facilitate research on health disparities in rheumatic diseases, the NIAMS established the Health Partnership Program (HPP) to examine disparities in arthritis and other rheumatic diseases among local area African Americans and Hispanics/Latinos. The HPP involves approximately 68 community partners representing various sectors of the African American and Hispanic/Latino communities in the Washington, D.C. area. A major component of the HPP is the NIAMS Community Health Center (CHC), located in an established community health facility operated by Unity Health Care, Inc. The CHC serves as a venue for community-based research on clinical aspects of rheumatic diseases in urban populations, provides a community base for health education, and offers training opportunities for health professionals. Since the CHC opened in July 2001, more than 1,400 patients have been enrolled in a NIAMS natural history study of rheumatic diseases in minority communities.
The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a part of the Department of Health and Human Services' National Institutes of Health, is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases; the training of basic and clinical scientists to carry out this research; and the dissemination of information on research progress in these diseases. For more information about NIAMS, call the information clearinghouse at (301) 495-4484 or (877) 22-NIAMS (free call) or visit the NIAMS Web site at http://www.niams.nih.gov.
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Grady C, et. al. Exploring the ethics of clinical research in an urban community. Amer. J. Public Health 2006;96(11):1996-2001.