By Bill Snyder
The public’s mistrust of medical science, including vaccination, is being driven in part by a top-down research enterprise that does not give human subjects a voice in the studies that affect them, according to a national leader in biomedical ethics at Vanderbilt University Medical Center.
“Investigators, legislators, lawyers, doctors, funders — all have a say in what research gets done,” said Ellen Wright Clayton, MD, JD, co-founder of VUMC’s Center for Biomedical Ethics and Society. “The people who it’s going to affect are below the line, and for the most part they don’t have a voice.”
As a result, “the populations that are affected may simply not believe what the research says, and boy, we are seeing that a lot now in our society,” Clayton said Sept. 29 during a symposium celebrating the 20th anniversary of the Department of Biostatistics at VUMC.
Clayton, Craig-Weaver Professor of Pediatrics and professor of Law, was among 12 speakers who addressed the symposium’s topic: “Ethical healthcare through innovations in biostatistics.”
The term “human subjects” is an accurate one, Clayton said, because for the most part, they have little control over how the information collected about them is used.
Mistrust can develop when information collected from research subjects is used in a way that does not benefit them or in a way that may harm them, for example, by reinforcing instead of dispelling entrenched societal biases that contribute to health care disparities.
That can set up a vicious cycle, fueling a reluctance among understudied minority and marginalized groups to enroll in research studies and stunting the potential of research to address the nation’s most pressing health challenges, including alarming disparities in health outcomes between Black and white Americans.
Breaking the cycle will require investigators to engage with the subjects of their research to understand what questions they want answered and what matters most to them.
“It’s important for researchers to identify what people want,” Clayton said. “This is a change from a top-down research enterprise to at least a bottom-up or bottom-inclusive approach, where we actually work with the people we’re trying to help.
“Having investigators at the table working with these communities changes the work that we do,” she said. “Having a greater inclusion in our research teams actually helps us avoid mistakes and leads to better science.”
A member of the National Academy of Medicine, Clayton is a founding member of its Standing Committee on Reproductive Health, Equity and Society. She has been involved in the national Electronic Medical Records and Genomics (eMERGE) network, which works at the intersection of DNA biorepositories and electronic medical record systems.
With Bradley Malin, PhD, professor of Biomedical Informatics, Biostatistics and Computer Science at Vanderbilt, she co-directs a center funded by the National Institutes of Health called GetPreCiSe (Genetic Privacy and Identity in Community Settings), which is researching genetic privacy issues.
Clayton also is working on ethical issues involved in the development and use of artificial intelligence and machine learning through the NIH-funded Artificial Intelligence/Machine Learning Consortium to Advance Health Equity and Researcher Diversity (AIM-AHEAD), and the Ethics Core of the NIH Common Fund’s Bridge2AI consortium.
