Review of Human Subjects Research Regulation: Perspectives on the Future image

IRB: Ethics & Human Research, July-August 2015, Vol. 37, No. 4
Christine Grady


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Christine Grady, MSN, PhD, the chief of the Department of Bioethics in the Clinical Center of the National Institutes of Health, recently published a review of Faculty Director I. Glenn Cohen & Executive Director Holly F. Lynch's book, Human Subjects Research Regulation: Perspectives on the Future, in the journal IRB: Ethics & Human Research.

From the review:

My favorite part of the book is the final section on paradigm shifts in research ethics, the section that seeks to reimagine what research ethicsshouldbe. The innovative proposals in this section engage the reader with a variety of ideas, including more clearly defining the realm of research covered by the regulations, basing reforms on the model of employment and labor laws, and delegating the risk-benefit analysis to individual prospective participants. For me, the most radical and yet perhaps most important proposal comes from Greg Koski, former director of OHRP. Koski notes that the regulatory apparatus for research oversight was built on an “implicit assumption, if not an explicit accusation, that . . . scientists will harm their human subjects . . . [and] are somehow irresponsible, bad people.” [...]

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bioethics fda health care reform health law policy holly fernandez lynch human subjects research i. glenn cohen pharmaceuticals regulation