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Applied Clinical Trials
Stephen I. Ankier and Angus E. Donald (Ankier Associates, 2004), 213 pages, £145
Medical Law and Research
Stephen I. Ankier and Angus E. Donald (Ankier Associates, 2004), 213 pages, 145
Medical Law and Research includes chapters on the following topics: liability in clinical research; trial approval and regulatory affairs; confidentiality; informed consent (including children and vulnerable subjects); negligence; misconduct and fraud; and publications.
Based mostly on the laws of England and Wales, the book expertly guides the reader through the latest regulations affecting clinical research. Thus, EU Directive 2001/20/EC together with UK implementing legislation (SI 2004/1031) are frequently referred to. There is a wealth of illustrative legal case histories. Some international rulings are also referred to where this is helpful in explaining particular issues.
One learns about the Bolam test, whereby "a doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art." It is interesting to see that in the context of clinical research this test is not the only criterion for consideration, as research isn't exclusively a medical discipline.
The ethical problems involved in the use of placebo, and the need to have a no-effect comparator in trials, are discussed in chapter 2.
Medical Law and Research is easy to read, enjoyable, and thought-provoking. There is good advice such as the 10-year side effects limitation period rule.
Three of the chapters address consent. Not discussed, though, is inadequate consent documentation, especially in the case of children. The need to capture the relationship of the legal representative of the subject is overlooked by both ethics committees and research institutions. The assumption is taken that "if a child subject has the same surname as the person signing the form, then this must be the parent" should be challenged.
The book is up to date, and throughout there is a plentiful supply of supportive references and illustrative legal cases (583 footnotes and references).
On the whole, Medical Law and Research is strongly recommended for anyone wishing to better understand the background and present position of medical law in the context of clinical research.
Nigel J. Crossland is QA director with the Crossland Consultancy, Swettenham Village, UK, email: firstname.lastname@example.org.
SIDEBAR: Med Law Online
Medical law, especially in clinical research, is moving forward into an environment influenced by both case law and the unremitting introduction of new regulations. In order to keep pace with changes, the authors have launched a fully searchable, Web-based version of Medical Law and Research (www.MedResLaw.com).