In Support of SUPPORT — A View from the NIH

In the wake of extensive scientific and public discussions since our March 7, 2013, determination letter in the SUPPORT study, OHRP has become aware of widespread misunderstanding about the risks that are required to be disclosed in obtaining informed consent for certain types of clinical trials.Our goal in this letter is to clarify several issues related to our determination.At the outset, we wish to emphasize that OHRP does not and has never questioned whether the design of the SUPPORT study was ethical.It was a study that asked important questions and produced information that promises to advance both scientific knowledge and clinical care.Rather, consistent with OHRP's mission to protect human subjects of research, the overarching concern of our determination was the adequacy of informed consent, a bedrock principle of research involving human subjects.To make truly informed decisions about whether or not to participate in a research study, potential volunteers or their parents or guardians are entitled to certain information, including a description of reasonably foreseeable risks.We acknowledge that the UAB consent form included language that reflected then-current research suggesting that lower saturation targets reduced the risk of retinopathy of prematurity (ROP), as well as language about the potential risks of ROP with prolonged use of supplemental oxygen.However, the "Risks" section of that form failed to mention and appropriately describe, as it should have, that relationship.More