Two University of Missouri-Kansas City School of Medicine professors have published an article in the New England Journal of Medicine critical of proposed new guidelines for disclosing risks to research study participants.
The federal Office for Human Research Protections recently issued draft guidance on disclosing reasonably foreseeable risks to participants in comparative effectiveness research studies. The UMKC professors argue that the new guidelines are confusing and represent a “radical reinterpretation” of the ethical foundations of research, as codified in the historic Belmont Report.
John Lantos, M.D., professor of pediatrics and director of the Children’s Mercy Bioethics Center, and John Spertus, M.D., M.P.H., the Daniel J. Lauer, M.D., Chair in Metabolism and Vascular Disease Research and clinical director of outcomes research at Saint Luke’s Mid America Heart Institute, wrote the commentary.
In the article, Lantos and Spertus argue that the new guidelines will make comparative effectiveness research seem riskier than it is. The draft guidelines call for disclosures that would classify any difference in treatment as a risk, even if the harm comes from treatments that are routinely used for patients, and not from participating in a trial to see which treatment is better.
Spertus said that he welcomed the consideration of new guidelines. “We want to see revisions to these consent processes so that they’re practical and so that we can learn how to deliver better care,” he said. “It’s just that what they’re wanting to disclose as risks aren’t really risks.”
The article draws an example of “disease X” that’s treated one of two ways. In the example, 50 percent of doctors always prescribe treatment A, and 50 percent of doctors always prescribe treatment B. “The doctors in each group do so because they think that the other drug does not work as well and that patients who take it are more likely to get headaches,” the article states.
The commentary asks readers to consider a randomized trial to determine which treatment is, in fact, riskier. Half the patients would receive treatment A, and half the patients would receive treatment B — just as in practice. According to the new guidelines, the participants in the study would be seen as facing risks greater than the risks of patients outside the study if you had to disclose the potential risks of treatment in the trial, but not in routine clinical care. Moreover, as the article notes, the treatment for patients outside the study is based on the “unsubstantiated beliefs of their physicians” — hardly a risk-free proposition.
“There’s a very important and underappreciated fact that the exact same patient going to two random doctors would be treated differently,” Spertus said. “We don’t want to confuse that with the research itself.”
Spertus said he is optimistic the Office of Human Research Protections will consider the feedback generated by the New England Journal of Medicine commentary.
“It’s not easy to know if you are going to make a difference or not,” he said. “So we’re hoping that we will be able to have some influence on the office’s deliberations before they firmly develop a rule.”