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After publication of the Belmont Report in 1978, it became common to distinguish research, in which human subjects receive the full set of protections provided by the U.S. Common Rule (45 CFR 46), from innovative medical care, in which they do not. This distinction faces two major difficulties: it relies on a sharp differentiation between research and innovative medical care without a proper basis for drawing it, and it does not address the question of what sort of protections are appropriate for patients who receive innovative medical care. This book represents the thinking of a group that was convened by
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