Bioethics Forum Essay
SUPPORT Update: OHRP’s Compliance Actions on Hold
In a thoughtful, nuanced letter to the University of Alabama (the home of the Principal Investigator of the SUPPORT study), the Office for Human Research Protection announced that it has “put on hold all compliance actions against UAB relating to the SUPPORT case.” Further, OHRP promises not to initiate compliance actions “in studies involving similar designs” until it clarifies the guidelines for such studies. In doing so, it acknowledges “widespread misunderstanding about the risks that are required to be disclosed in obtaining informed consent for certain types of studies.” (Previous posts on the SUPPORT controversy are here, here, here, and here.)
OHRP promises that the process of drafting new guidelines will be “as open as possible, with input from all interested parties.” To achieve this, it will “engage in the usual notice and comment process with regard to draft guidance” and “will also conduct an open public meeting on this topic.” This is a welcome development.
The letter also suggests the positions that OHRP will take in these discussions. It focuses on three main points.
First, the letter acknowledges that these discussions will focus on situations where the standard of care includes known and widespread practice variation with no reliable evidence on which practices are associated with which risks or benefits. “When the SUPPORT study was initiated,” it states, “there was no clear recent evidence indicating that different oxygenation levels with the then-current standard of care (85%- 95%) would produce differences in neurological damage or survival.”
Second, it shows that, even though all babies in the study were treated with levels of oxygen that were in common use, some babies in the studies were inevitably treated differently than they would have been treated had they not been in the study. The letter says that “every child in the SUPPORT trial experienced some change in the likelihood of being assigned to the various oxygen levels.” This is certainly true.
Third, it focuses on the different moral obligations of clinicians and researchers, saying: “Doctors are required, even in the face of uncertainty, to do what they view as being best for their individual patients. Researchers do not have that obligation.” This is a traditional view of the distinction between clinical practice and research. It is not a view that is shared by many clinical researchers who believe that studies are often safer than nonvalidated therapy and, therefore, that enrolling their patients in studies is the best thing for those patients.
The key question is whether, in these narrowly defined but not uncommon situations, research is riskier or less risky than clinical care. Put another way, are patients better protected by the perceived uncompromising loyalty of their clinicians or by the carefully designed protocols and monitoring that occur in studies? The controversy over SUPPORT brings these questions to the fore.
OHRP implicitly acknowledges that, to answer these questions, one must have a way of determining whether it is safer or more dangerous to be in a study than not to be in the study. It states that “disclosure of risk is unnecessary when study participation has no potential to increase or decrease risk compared to what would have happened had the subject not been in the study.” In order, then, to determine which risks need to be disclosed, researchers and IRBs will need to assess the likelihood that being in a study will increase or decrease risk.
This is a great first step in the right direction. We should all be grateful that OHRP has recognized the complexity of these crucial issues and taken the lead in opening a public discussion. Now, the real interesting work begins.
John B. Lantos, M.D., a Hastings Center Fellow, is director of pediatric bioethics at Children’s Mercy Hospital and the University of Missouri-Kansas City School of Medicine. He was not involved with the SUPPORT study. Children’s Mercy Hospital is now in the NICDH Neonatal Research Network but was not at the time of the SUPPORT study.
Posted by Susan Gilbert at 06/05/2013 05:15:24 PM |