Critical care research and informed consent.
The doctrine of informed consent severely limits the ability of medical researchers to develop, evaluate, and refine investigational technologies for the treatment of patients suffering from heart attacks, strokes, and other "critical care" conditions. In this Article, Mr. Saver examines the current doctrine of informed consent as applied to critical care research and its various deficiencies. In addition, he analyzes recent reforms proposed by the Food and Drug Administration, which are intended to remove certain obstacles to critical care research posed by informed consent. While the proposed reforms address several of the current deficiencies, he asserts that they lack the breadth and scope necessary to advance the progress of critical care research in an ethical and sensible manner. Mr. Saver proposes several complementary and alternative reforms that would better accomodate the interests of all affected parties: the patients, their families, the researchers, and the general public.
Saver
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McDermott, Will & Emery, Washington, D.C.
D016887:Cardiopulmonary Resuscitation; D016638:Critical Illness; D028744:Ethics Committees, Research; D005190:Family; D035082:Federal Government; D033161:Government Regulation; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D026684:Personal Autonomy; D036302:Therapeutic Human Experimentation; D020458:Third-Party Consent; D014481:United States; D014486:United States Food and Drug Administration