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Letters |

Protection for Human Subjects in Medical Research

Harold T. Shapiro, PhD; Eric M. Meslin, PhD
JAMA. 2000;283(18):2387-2390. doi:10.1001/jama.283.18.2387.
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To the Editor: Dr Woodward's1 article draws incorrect conclusions from 2 reports2,3 published by the National Bioethics Advisory Commission (NBAC).

We are puzzled by Woodward's comment that "NBAC has recently taken steps both to strengthen and to weaken the consent requirement," referring to the report on decision-making capacity2 as an instance of the former and the report on human biological materials3 as an example of the latter. When advising the president, NBAC does not presume that its role is always to recommend stricter (or looser) protections. It is not, as Woodward claims, a "noteworthy departure" for NBAC to have resolved as a matter of principle that "no person should be enrolled in research without the twin protections of informed consent and independent review of the research," nor to have recommended that federal regulations be changed to allow IRBs to grant waivers of the consent process even if it is practicable to obtain consent. Like any comprehensive ethical analysis, NBAC's reports begin with no such presumptions; rather, we identify the relevant issues, the context in which the issues occur, and the relevance of particular ethical considerations and principles. Indeed, we consider it a virtue of this commission that the deliberations on these 2 very different topics—the involvement of persons with specific mental disorders and the use (rather than involvement) of tissue specimens remaining from medical and surgical procedures—could lead to different conclusions and recommendations regarding the adequacy of existing federal protections.


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