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May 10, 2000

Protection for Human Subjects in Medical Research

Author Affiliations

Phil B.FontanarosaMD, Deputy EditorIndividualAuthorStephen J.LurieMD, PhD, Contributing EditorIndividualAuthor

JAMA. 2000;283(18):2387-2390. doi:10.1001/jama.283.18.2387

To the Editor: Dr Woodward1 notes that there are efforts under way to alter US federal regulations that govern medical research, and she expresses concern that these changes may be influenced by pressures that "subordinate the interests of the subject to those of science and society." Her fears may be justified and should be heeded. However, I take issue with her argument that the concept of "minimal risk" is a prime victim in this scenario and that it is critical to the health of the current system for protecting human subjects. I would like to propose that it is, instead, one of the causes of the illness.