by Elisa A. Hurley, PhD, Executive Director, and Avery Avrakotos, Education and Policy Manager
On Friday, October 24, the Office for Human Research Protections (OHRP) released a draft guidance document titled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” The draft guidance follows more than a year of deliberation and public consultation prompted by the controversy surrounding the Surfactant, Positive Pressure, and Oxygenation Trial (SUPPORT).
SUPPORT was a multisite randomized trial that took place from 2005 to 2009 and sought to determine, in part, the optimal oxygen saturation for extremely premature infants. Subjects enrolled in the study were randomized to one of two arms: a low oxygen arm, in which the level of oxygen they received was maintained between 85% and 89%, and a high oxygen arm, in which the level of oxygen they received was maintained between 91% and 95%. At the time the study took place, the recognized standard of care was for infants to receive oxygen saturation between 85% and 95%.
In a determination letter dated March 7, 2013, OHRP stated that the informed consent process did not meet the requirements set forth at 45 CFR 46 and that the risks of the research, which measured retinopathy and death as outcomes, were not properly disclosed to the parents of the infants enrolled in the study. As described in previous posts, considerable public debate ensued, and it quickly became apparent that there were real differences in understanding about how the regulations at 45 CFR 46 should apply to research studying interventions that fall within what is referred to as the “standard of care,” including how determinations about which risks are “research risks” should be made, and, accordingly, what risks should be disclosed to potential subjects during the research consent process.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.