To the Editor: Drazen et al. (Oct. 8 issue)(1) suggest that Judge Bowdre's summary judgment in a recently dismissed SUPPORT (the Surfactant, Positive Pressure, and Oxygenation Randomized Trial) lawsuit highlights a "key concept in the SUPPORT controversy" - the mischaracterization of a risk that is inherent to the patient's condition as being a risk of research. We believe that meaningful informed consent in research comparing standard-of-care treatments, like all consent in intervention research, must rest on a clear explanation to the patient of the differences between treatment that is provided in the context of research and treatment that is not. . . .
AbstractTo the Editor: Drazen et al. (Oct. 8 issue)(1) suggest that Judge Bowdre's summary judgment in a recently dismissed SUPPORT (the Surfactant, Positive Pressure, and Oxygenation Randomized Trial) lawsuit highlights a "key concept in the SUPPORT controversy" - the mischaracterization of a risk that is inherent to the patient's condition as being a risk of research. We believe that meaningful informed consent in research comparing standard-of-care treatments, like all consent in intervention research, must rest on a clear explanation to the patient of the differences between treatment that is provided in the context of research and treatment that is not. . . .