Needed: A More Diverse Pool of Biomedical Research Subjects
By Susanne B. Haga
As the country grapples with the past and ongoing effects of systemic racism on top of a global pandemic, the scientific community has an opportunity to take action on a critical issue: the under-representation of minorities in biomedical research. Most biomedical research participants are white. As a result, the safety and efficacy of drugs and other medical interventions for diverse communities may not be revealed early. As all sectors of society review policies to promote inclusion and prohibit discriminatory practices, now is an opportune time to consider how to effectively recruit individuals of color to participate in biomedical research.
Biomedical research has always lacked diversity among study participants. Current FDA statistics show African-Americans make up an average of only 9% of clinical trial participants, compared to 72% who are white. The same disease and treatments can affect different people in different ways due to social health determinants and access to care, differences in disease severity and disease etiology and the impact of co-morbidities, environmental factors, diet and culture. Therefore skewed study populations may pose health risks to those under-represented populations. While steps can be taken to reduce noise in the data when a study involves a single race or group, such research will never fully reflect real-world patients who need that medical intervention.
Individuals of color may choose not to participate in research because they feel it’s too time-consuming, they see no perceived benefit, it seems risky, or they are not compensated. Others may not participate because they lack resources like high-speed Internet access, time or transportation. Yet if they are never even approached or made aware of the research, the choice to decline is not theirs to make.
Also, members of minority communities may not participate because they simply don’t trust the researcher, the institution or the funder of the project. The legacy of Tuskegee, Henrietta Lacks and others lingers in communities’ collective memories. The benefits of a diverse study team cannot be underestimated, as such a team can help develop a well-received plan and make community connections. Researchers and institutions also need to partner with trusted individuals or community groups to begin to earn their confidence and respect. Building positive long-term relationships based on trust and mutual respect will yield more returning study participants and referrals. This approach is far preferable to swooping in and out in order to boost minority recruitment for a single study.
Developing and implementing a community-based recruitment plan will require more time, effort and funding than a more passive recruitment campaign that relies on posters or is limited to patients at a certain clinic. For example, researcher teams can recruit within diverse communities at local libraries, farmers markets, or the YMCA. Everyone is operating under budget constraints, but this is not a place to cut corners. Funders or research sponsors should require a carefully developed recruitment plan as part of the overall project costs. A study’s success often depends on recruiting a large and diverse population. Thousands of dollars and precious time can be lost if only a handful of people enroll.
Some researchers have successfully establishing relationships with under-represented communities and are increasing participation in biomedical research. In Lancaster, Pennsylvania, the University of Maryland established a clinic to care for members of the Amish community and provide them an opportunity to participate in research that they otherwise would not be able to access. Meanwhile, in Jackson, Mississippi, the Jackson Heart Study has enrolled more than 5,000 Black men and women in the last 20 years.
The lack of diverse study populations has not gone unnoticed. Funders like the National Institutes of Health and regulatory bodies like the FDA have worked to develop guidance and support research on this issue. And a program at Duke’s Clinical and Translational Science Institute is working to train more researchers on how to ensure more diversity among research participants. But we can and need to do better. As leading research institutions, pharmaceutical companies and other groups examine their diversity practices and policies, we must take advantage of this time of reflection to improve biomedical research to benefit of all members of society. We need creative approaches to help spread the word about research and to promote informed decision-making by study participants that is inclusive and just.
Susanne Haga is an associate research professor at Duke University School of Medicine.