Scientists are grappling with historic inequities in medical research in light of racial justice protests gripping the U.S.
Breaking through decades of mistrust from the Black community to ensure medical research adequately reflects the U.S. population means scientists need to think more about how they engage with minority groups. With more than $16.5 billion pegged for clinical research in fiscal 2020, the National Institutes of Health could use its deep pockets to encourage researchers to improve their outreach to minority populations when readying studies, bioethicists said.
“Now is the time for us to really consider: How do we actively engage with communities and think about our own biases—not just those scientific biases that we talk about in the research literature but our personal biases that impact how we design our research?” said Joyce E. Balls-Berry, an assistant professor at the Mayo Clinic who works to make health research more diverse.
Diversity in medical research needs to be more than a box-checking exercise because various diseases and medications can affect populations differently. Adding only healthy minority volunteers to a clinical study isn’t real equity because that won’t reflect existing social and health challenges facing some minority groups, Elisa A. Hurley, executive director of Public Responsibility in Medicine & Research, said.
Improving outreach means the research institutions will have to work more closely with minority communities to understand their unique health challenges and concerns when recruiting study volunteers. But that work is difficult and often thankless, discouraging researchers from reaching out, Balls-Berry said.
“Recent decades have seen more participation of women and racial and ethnic minority groups in research,” the agency said. “NIH’s goal is to ensure that these trends continue so that the knowledge gained from research is applicable to everyone affected by the disease or condition under study.”
NIH Director Francis S. Collins acknowledged the need to do more at a recent meeting of his advisers. Doing that “is going to require continued energy and determination and commitment by all of us.”
Grappling With History
Better outreach means confronting and learning from a history of racist medical policies under which Black people were used for research, often without their consent.
Cervical cancer patient Henrietta Lacks’ cells have been used in research for decades even though she never gave consent. As part of the Tuskegee experiment, hundreds of poor Black men were denied access to adequate syphilis treatments or lied to about their treatment so researchers could study the disease’s progress over four decades. That revelation in 1972 laid the ethical foundation for the human research subject protection regulations known as the Common Rule.
Keisha S. Ray, a bioethicist who works on justice questions related to biomedical enhancement at the University of Texas Health Science Center at Houston, draws a direct line from those violations to the current protests against police violence.
“It’s this tiredness of just government-sanctioned murder in the same way that we started getting regulations in biomedical research because it was this tiredness of using black bodies just for gain—and a lot of times it wasn’t for the benefit of the black community,” Ray said.
Power of the Purse
The NIH can keep those historic biases from creeping into new studies by using its funding to encourage studies that feature interdisciplinary research teams rather than one researcher, said Vickie M. Mays, a University of California, Los Angeles professor and director of the school’s minority health disparities center.
That could mean including an anthropologist who can talk about community narratives or a computational sociologist to eliminate bias in algorithms, Mays said. For example, a hypertension study that only treats symptoms with medication may overlook how external forces like stress can affect how well the drug works, Mays said.
“If you bring the right people to the table, you actually will have greater insight into the problem you’re trying to discuss,” she said.
Funding Black Voices
Better outreach to minority populations also means ensuring minority scientists have access to necessary funding, which is another area where the NIH can use its clout to improve representation. Black scientists are much less likely to get NIH grant funding than their white counterparts, according to a recent study. That disparity is primarily due to scoring during the peer-review process.
Mays wants a commission to examine unequal treatment in science, similar to how the National Academy of Medicine examined racial and economic disparities in health care.
These changes have the potential to benefit all underserved communities. A JAMA Oncology study from 2019 found studies used to approve new cancer therapies consistently underrepresented Black and Hispanic cancer patients. Mays said research institutions need to rethink how they implement the requirement to have a community member on an ethics board and how far that representation goes.
“We need to rethink the expertise that’s needed to actually ensure that there is adequate protection,” she said. For example, institutional review boards may need the perspective of Spanish-speaking Latinos, or they may lack insight into Native American communities.
Do It Right From the Start
Ensuring a diverse pool of participants needs to be part of a study’s design from the beginning, said Barbara E. Bierer, co-founder and faculty director of the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University. The center will soon issue a report with actionable steps, including a set of resources and case studies of success in clinical trial diversity.
“What we’ve done to date is not OK,” Bierer said. “But you can’t just say that. You have to figure out how to change it. And in order to change it, you’ve got to get into all those details that are troublesome, difficult, and take commitment—and at least initially, will take resources.”
Medical research needs to improve because abuses still happen although they don’t rise to the level of the Tuskegee study, Ray said.
“It’s not overt as much anymore. You’re not going to see the research equivalent of George Floyd’s death,” she said. “But it’s still some of the same principles of leaving Black voices out of research.”