Protection of Research Subjects

To the Editor: Regarding the study by the Acute Respiratory Distress Syndrome (ARDS) Network, discussed by Steinbrook (April 3 issue),¹ some may wonder whether the institutional review boards (IRBs) had enough information to evaluate the risks of this study properly. As a member of an IRB that reviewed this protocol, I want to assure readers that there was indeed a very diligent review. The local consent form carefully and properly represented the risks involved in the study. There was ongoing review of adverse events, which were assiduously reported by the investigators. The public overall and the research subjects in particular . . .