Customer Reviews

Ethics and Regulation of Clinical Research: Second Edition

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This is not an easy read, but there is a good reason it is still in print from 1988 - it is a classic, or ought to be. I am a mid-level institutional administrator and had to read it for a class in research management, and unlike many in the class, I actually read it cover to cover once I became engaged with it being history as much as philosophy. Meaning it turns out to be more concrete than abstract. The best parts are about the creation and workings of the National Commission for the Protection of Human Subjects, back in the day, and about the emergence of the Belmont Report from the nothingness of a really crummy prior human subject history combined with the usual messiness of committee-style group process. I think, and Dr. Levine thinks too, that the Belmont Report is a beautiful thing. It turns out to be pretty interesting where it came from, how it got there. This is what I recall the book to be mostly about, or at least most engagingly about.