Viewpoint: A Moral Obligation: Fostering Diversity and Public Trust in Research Participation
AAMC Reporter: November 2012
—By Claudia R. Baquet, M.D., M.P.H., Associate Dean for Policy and Planning, Director of the Center for Health Policy/Health Services Research and the Center for Bioethics and Health Disparities Research Center, and Professor of Medicine at the University of Maryland School of Medicine
Diversity in research participation is a national priority and holds great importance to accelerate clinical and public health advances. As researchers, our obligation is to remove the stigma and mystery surrounding research and promote literacy among the public and community health providers.
For minority, uninsured, and rural communities, persistent underrepresentation in medical research remains a dilemma. These communities experience significant health disparities, but do not benefit equitably from new discoveries. We know that when minorities are not represented in clinical trials, it will be difficult to ensure that the results are relevant to any or all racial and ethnic communities. For example, if a particular intervention is effective in treating heart disease, but the clinical trial included only white patients, can we be sure the same intervention will be effective for black or Hispanic patients?
Without greater diversity, we cannot make progress. Minority and uninsured populations face multiple barriers to research participation. Exacerbating the situation are historical research abuses, as well as design factors and trial eligibility factors, such as excluding patients with multiple chronic conditions. Also contributing to the problem are a lack of understanding about the benefits of new discoveries and regulations that protect trial participants.
Over the past 15 years, research among African-American, underserved minority, and rural communities in Maryland has identified key barriers that hinder participation and contribute to public distrust. This research also has revealed the role physicians play in encouraging their patients to participate in clinical trials.
With support from the National Institutes of Health, the Office of Policy and Planning at the University of Maryland School of Medicine in 2009 established the Bioethics Research Center to address these issues comprehensively. Through community-academic partnerships, scienceguided advocacy, and policy research, the center assesses the barriers in clinical trial participation among urban and rural communities. Our goal is to enhance public trust and understanding of research and, ultimately, to reduce health disparities.
The center uses an evidence-based model that I initially developed with oncologist Mary DeShields, M.D., to increase clinical trial participation among rural cancer patients. The model, which received a National Best Practice Award in 2004 from the Department of Health and Human Services, combines research on barriers to clinical trial participation with policy and education about clinical trials for the general public, patients, community nurses, and primary care physicians.
In partnership with community organizations, we have identified factors that can guide us as we develop educational programs and interventions. We determined that community members lack knowledge about ethical protections and regulations and the importance of research. They also are concerned about “helicopter research,” in which academics come to a community to conduct research and leave once they collect their data, rather than share the results with the community. This phenomenon perpetuates mistrust, causing community members to feel like researchers took advantage of them. On the other hand, we found that community clinicians also have concerns, including a fear they might lose control over patient care, or even lose their patients to academic providers. Many community-based providers do not understand how to refer patients to studies or how to work with investigators.
Partnerships between medical schools and teaching hospitals and community groups are essential to eliminate barriers to research participation among the public. Such partnerships also serve a vital role to researchers, helping them to translate findings into culturally appropriate interventions. At the center, we have a number of formal partnerships for research, education, and training. We work with two Area Health Education Centers—Eastern Shore and Western Maryland—which foster partnerships among students, community organizations, and academic institutions. The center also has partnerships with rural Bel Alton Community Development Corporation and High School, the National Newspaper Publishers Association, and the Eastern Shore Cancer Research Network. Through these key partnerships, we implemented training on research ethics, as well as “clinical trials 101” educational programs. Each organization brings strengths and community credibility from its respective geographic area.
In Maryland, we use a multilevel, community-partnered approach to implement many center initiatives.
The center’s signature community-tailored educational program, the Bioethics Mini Medical School, addresses barriers such as fear and historical research abuses. We solicited community feedback to develop the curriculum, course syllabus, faculty presentations, and background readings. This free, four-week educational program teaches clinical trial fundamentals, research ethics, protections for participants, and their relationship to health disparities. To date, more than 900 individuals in rural and urban communities across the state have participated.
The Mini Medical School has yielded positive outcomes. More community members have volunteered for the Institutional Review Board at the University of Maryland and have shown a greater willingness to participate in clinical trials. In view of the development of translational science and personalized medicine, we also are using this program to discuss the role of biospecimen donation, informed consent preferences, and privacy concerns of the public.
In addition, the center offers continuing education programs for community nurses, physicians, and other health care professionals. These two- to three-hour sessions have resulted in a greater willingness to refer patients to clinical trials and additional requests for continuing medical education (CME) on advances in research and clinical management. To date, more than 120 health providers have participated in our accredited CME programs.
It is essential that researchers foster public trust to increase research diversity. By facilitating research literacy among the public and community health providers, we are demystifying and destigmatizing research, while contributing to efforts that are accelerating medicine and public health.