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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: I suspect that many investigators were surprised by Dr Woodward's1 claim that human research subjects are now threatened with increasing risks because of pressures to reduce the protections offered by current procedures for reviewing and approving research protocols. On the contrary, the system created to assure that we protect human research subjects is increasingly difficult to navigate, with little evidence of a commensurate increase in the protection of human subjects. Furthermore, I believe it is the manner in which existing regulations are being interpreted and enforced that is creating some of the problems described by Woodward, particularly the increasing inability of IRBs to handle the avalanche of protocols they now receive.