The Pharmaceutical Journal
Vol 277 No 7419 p373
23 September 2006

Second edition maintains impressive currency and command of its subject

‘Medical law and research’, by Stephen I. Ankier. 2nd edition. Pp302. Price £150. Middlesex: Ankier Associates; 2005

Published little more than a year after the first edition, this book maintains an impressive currency and command of its subject. It is aimed at regulators and directors of clinical research, research ethics committees, health bodies and students of medical law. The text opens with chapters on liability and negligence, continues with clear expositions of the law on approval of clinical trials, on confidentiality, capacity and consent for all research subjects, and finishes with chapters on problems of publication, and on fraud and misconduct in research.

Nearly every chapter has been expanded to accommodate developments such as the Mental Capacity Act 2005, new clinical trial regulations in 2004 (SI No 1031) and fuller implementation of the European Clinical Trials Directive (2001/20/EC). Tables of statutes and cases used to support the text have been added together with a glossary of abbreviations and comparison of progress in implementing the directive across the EU and beyond. This book may be a little daunting for the reader who is unused to reading legal textbooks; the references and footnotes are massive, in one case occupying a whole page.

Is it worth buying another copy so soon after the first? Yes, if you absolutely have to be up to date and like your information printed and collated, but for the same price you can subscribe to updates on the website (www.MedResLaw.com) run by Ankier Associates.


Joy Wingfield (professor of pharmacy law and ethics at the school of pharmacy, University of Nottingham)