Neonatal research ethics after SUPPORT

Abstract

The SUPPORT study (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments), sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development to evaluate different oxygen saturation targets for extremely premature babies, led to a national controversy that was surprisingly public, intense, and polarizing. This article describes the study design, the study outcomes, and the key issues. I conclude that the controversy was based on two different views of the clinical investigator. One, held by investigators themselves, is that investigators are primarily committed to the patient's well-being. The other sees the investigator as unable to disentangle his conflicting loyalties and as inevitably prioritizing the goals of research over the goals of patient care. I suggest that our current oversight systems overstate the risks of research and understate the risks of idiosyncratic practice variation. A better system would treat the relative risks of these two phenomena as comparable.

Keywords: Ethics; Neonatal; Regulation; Research.