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Taylor & Francis




We agree with Mark Rothstein's goal of giving tissue donors control over their donated tissues. But we think using the research model as the basis for attaining this goal, while widely employed and accepted, should be abandoned.

The research regulations were originally adopted to deal with interventions on living human beings, not on the tissue of human beings. The Nuremberg Code (a reaction to concentration camp experiments), the Willowbrook experiment, the Tuskegee syphilis experiment, and the other examples of the abuse of research subjects that provided the rationale for regulating research on human subjects clearly had nothing to do with research on their tissues. The regulations were directed at protecting the safety and welfare of the living human beings who are being intervened upon by researchers.

Moreover, most of the concern over tissue collection has little, if anything, to do with research. For example, the creation of a tissue repository, regardless of the Office for Human Research Protections (OHRP 1997) position and guidance, is not research at all. There is no hypothesis, no methodology, no statistical design, and so forth. It is a mere warehouse of tissues, and all the tissue could be discarded without anyone ever doing anything to them resembling research. Nonetheless, the fact that tissue banking per se is not research doesn't mean that there should be no rules for the donation of tissue to tissue banks. But rules for the donation of tissue to banks should not be dictated by inapt research regulations.

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