By Lois Shepherd
The Hastings Center Bioethics Forum
Originally posted May 17, 2013
The clinical research community and a number of prominent bioethicists have swiftly come to the defense of investigators conducting the SUPPORT study, in which approximately 1,300 premature infants were randomly assigned to be maintained at higher or lower levels of oxygen saturation. The study took place between 2005 and 2009, involved 22 sites and was reviewed by at least as many institutional review boards. In March, the Office of Human Research Protection (OHRP) concluded that investigators had violated the informed consent provisions of the federal regulations governing research by failing to inform parents of infants enrolled in the study about risks of retinopathy, neurological injury, and death. Results from the study revealed that infants assigned to receive the lower range of oxygen suffered higher rates of death than infants assigned to the upper range, while the latter suffered higher rates of retinopathy than the former. Defenders accuse OHRP of faulting the investigators for failing to inform parents of risks they learned about only through the study.
The central point of disagreement between defenders and critics of the study appears to be whether participants in the study were receiving medical care that was different from the care they would have received outside the study and whether participation in research therefore carried any medical risks that required risk/benefit scrutiny by IRBs or disclosure to parents of the infants enrolled. This would appear to be a factual matter about which one could obtain some clarity, but discussions of this issue have been somewhat opaque.
Part of the reason for this may be different, but unacknowledged, understandings of the concept of “standard of care,” a term used – both in the informed consent forms and the commentary about them – but rarely defined in this debate.
The entire article is here.