Customer Reviews

The Oxford Textbook of Clinical Research Ethics

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1 star:		(1)

 

 

Excellent book covering the ethics that are part of the clinical research process. Similar to the previous book by the authors, but much better organized and better written.

This book is okay for a class for NIH / federally funded research, but it is certainly not a comprehensive guide to the research.

Pharmaceutical or device research are almost entirely neglected. The book works pretty much exclusively in 45 CFR 46 and rarely touches anything in 21 CFR or FDA-regulated research (except for one short chapter). Additionally, the authors critique the regulations, but never give the reader an opportunity to read them for themselves. In my opinion, no amount of education or critiques could ever substitute actually reading the regulations themselves and this book neglected even including a passage or appendix with the federal regulations. I also feel the book showed clear bias on the side for federally funded research and painted for-profit (pharma/device) research in a negative fashion and, on occasion, included misleading and incorrect information. The book is approachable on a college or graduate level and covers a wide range of topics, if you are only considering NIH-style research and you are willing to put its biased view of for-profit industry aside.

The book arrived quickly and in perfect condition. The book quality is rather low. It does not use any color and the few images included are of a low quality. The paper is thin and transparent which makes highlighting and underlining unadvisable.

A book review in the New England Journal of Medicine for Aug. 28, 2008, called this textbook "a gem"...."an accessible synthesis and discussion of the many facets of research ethics"...."a resource suitable for a course in research ethics [that] would also be helpful for those starting a career in clinical research." The review -- by Gary L. Chadwick, Pharm.D., M.P.H., of the University of Rochester (NY) -- also said, "This book supports physicians who seek to perform real-world research in the most ethical way," and that "readers will gain a better understanding of complex issues, which will hold them in good stread in discussions with peers, with research subjects, and with people thinking of becoming participants in clinical research." In addition to which, said the New England Journal review, "The writing is consistently top-drawer." This reader concurs.