Trial Design and Patient Safety — The Debate Continues

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Abstract
On July 3, 2003, nearly a year after it first became involved, the Office for Human Research Protections (OHRP) of the Department of Health and Human Services released its decision about two disputed multicenter clinical trials of treatment for the acute respiratory distress syndrome (ARDS).1,2 In a 15-page letter, the office seems to substantiate the ethical appropriateness and research design of both trials and to refute concern that participants were subjected to unnecessary risks. The OHRP does this by referring to the opinions of outside consultants whom it retained, without taking a position on the controversy itself. However, the . . .