African-Americans are disproportionately enrolled in studies that don’t require informed consent

African-Americans are enrolled in clinical trials that do not require patients to give individual consent at a disproportionately high level, according to a study published Monday.

Scientists are allowed to conduct these experiments without obtaining consent from each individual participant because they are testing emergency medical procedures, and often the patients physically can’t respond. For example, scientists might be comparing two different methods of CPR, or examining the effect of different drug cocktails to treat a heart attack. So, the Food and Drug Administration allows researchers to test out the treatment anyway, as long as they meet certain conditions beforehand.

Twenty-nine percent of the people enrolled in trials for which the researchers could find data were identified as African-American. That stands in contrast to the fact that African-Americans or blacks make up about 13 percent of the U.S. population and about 14 percent of total clinical trial participants, according to the US Census Bureau and the FDA, respectively.

The study, published in Health Affairs, also found that researchers who conduct these consent-free trials often do not publish information about the demographics of the trial participants.

“To the extent that there are risks and burdens associated with clinical trials, justice requires that those be spread fairly and evenly across populations,” said Dr. Steven Joffe, director of medical ethics at the University of Pennsylvania Perelman School of Medicine.

The large number of African-Americans in studies exempted from typical consent requirements contrasts with their low participation rates in some other kinds of trials. Clinical trials can present unique opportunities for patients, giving them an early shot at experimental treatments that might extend their lives, though many therapies turn out not to work and can also carry worrisome risks. A recent ProPublica investigation found that African-Americans are underrepresented in clinical trials for new cancer drugs, denying them the opportunity for potentially lifesaving treatment.

Consent for participation in medical research is an issue that resonates especially deeply for blacks. In the infamous Tuskegee study, conducted by the U.S. government from 1932 to 1972, African-American sharecroppers with syphilis were left untreated, without their consent. Since then, rules governing informed consent have become much tighter, but one legacy of Tuskegee is lingering distrust of the medical establishment among many African-Americans.

Researchers who conduct consent-free trials are supposed to make public their “demographic” data from the studies, according to federal regulations. But the rules don’t say exactly which data should be made available.

“We do think it’s important to the extent possible to have the utmost transparency when it comes to race and consent in these trials,” said Dr. William Feldman, a fellow at Brigham and Women’s Hospital who led the study.

Feldman said that his team has not shared the names of scientists who did not publish such data with the FDA.

“It just hasn’t come up,” Feldman said. He added that the regulations don’t specify exactly how scientists have to make these data available.

The FDA declined to comment on the paper. An FDA spokesperson, Jeremy Kahn, said that the agency “evaluates [studies] as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”

To conduct his analysis, Feldman reached out to the researchers who did not publish their data individually. He was able to acquire data on the race of 17,302 individuals in the U.S. who were part of these trials, out of 23,833 total enrolled individuals. Feldman only looked at completed trials, and excluded some because they enrolled the same participants.

While the researchers can’t say for sure why African-Americans are overrepresented in these trials that do not require consent, the paper provides a possible explanation: Large academic medical centers where these studies are conducted are located in places where many African-Americans suffer from the particular health conditions being studied.

For example, two consent-exempt studies for trauma enrolled a proportion of African-American individuals “comparable to the overall portion of African-Americans who suffered from the conditions under investigation” in the area of the trials, the paper read.

Dr. Jennifer Miller, an assistant professor at the Yale School of Medicine who was not involved in the research, said in an email that it’s difficult in general to determine if clinical trial participants are representative of individuals afflicted with the diseases in question.

“We lack demographic information and patient profiles for many diseases, making it hard to understand if we are enrolling the right types of patients in trials,” Miller said, adding that by “right,” she meant “demographically and clinically representative patients.”

The paper’s authors also noted in the paper that many of the trials did not find significant benefits from the experimental procedures, and in some cases, patients were worse-off with the new therapy.

But Joffe said that he doesn’t want to jump to the conclusion that this means these studies should no longer be conducted. Consider what might happen if that were the case: medical professionals could just change how they practice without testing it. Paramedics could, for example, change the way they do CPR without rigorously testing it. Nobody would know if patients were better off or worse off.

Feldman said that his team is working on a follow-up paper to look at how researchers consult with the community before launching one of these consent-free trials, and how this is related to who ends up being tested in the trials.