10/16/06

Who owns human tissue?
Halachic parallels welcome. (זכין לאדם שלא בפניו?)
Federal regulations are based on a notion of voluntarism, but the right to refuse participation in research is based more on ensuring that subjects can be the ones to judge how to protect their own interests than on a pure form of autonomous decision making, which would include a right to refuse for any reason or no reason at all. Hence, no consent is required for research deemed to pose minimal risk to subjects — or for research in which identifying information is obscured or from which it has been deleted (which protects privacy and minimizes social risks such as stigmatization or discrimination, but does nothing to recognize subjects' autonomy). And when patients' preferences regarding the kinds of research that may be performed on their tissue are ascertained, this is done as a courtesy, rather than as recognition of patients' rights to prohibit the use of their tissues for purposes of which they disapprove.
From R. Alta Charo, Body of Research -- Ownership and Use of Human Tissue. NEJM 2006;355(15):1517-1519.





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