The New England journal of medicine
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To the Editor: We are a group of physicians, bioethicists, and scholars in allied fields who agree with the Office for Human Research Protections (OHRP) that the informed-consent documents that were used in the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) were seriously inadequate.(1) The aims of the SUPPORT study were commendable, and the study addressed important clinical issues. Nevertheless, however complex and important a study may be, the consent process must be clear enough to enable informed decision making. ⋯ S. Code of Federal Regulations (45CFR46.116) includes the following requirements for informed consent: "A statement that the study . . .