Dr. Stephen I. ANKIER is the founder and principal consultant of Ankier Associates (established 1993). He originally qualified as a pharmacist and, after successfully completing postgraduate studies, he was awarded a PhD in pharmacology and the equivalent of an MSc in biochemistry. In 2001, the University of Hertfordshire awarded Stephen a Master of Laws degree in Medical Law (LLM) with distinction.
While Statutory Instrument (S.I.) 2004/1031 provides the most important pivotal framework for conducting medical and clinical research (Phase I through to Phase IV) on medicinal substances in the United Kingdom (UK) it is not the only legal basis for conducting bioresearch on humans.
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In fact, there are several long-standing general Acts of Parliament, many other relevant S.I. and a long tradition of common law precedent that combine with S.I. 2004/1031 to form the current legal foundation for performing research on volunteers and patients. In addition, there have been some important statutory developments in the UK that impinge on the medico-legal background against which human research must be conducted. These include the Freedom of Information Act 2000, the Mental Capacity Act 2005 and the National Health Service Redress Act 2006. On 1st December 2011, the Health Research Authority Regulations 2011 (S.I. 2011/2341) came into force that makes provision for the Health Research Authority (HRA) to be established as a Special Health Authority. Its central purpose is to protect and promote the interests of patients and the public in health research. The second edition of the HARD COPY BOOK of 'Medical Law and Research' incorporates comprehensive updates in the ever changing medico-legal environment in which research on humans is performed. Nevertheless, the basic concept of 'Medical Law and Research' remains a focus on those core areas of medical law that specifically relate to medical and clinical research. In addition, there is now discussion on attempts at the national implementation of European Community (EC) Clinical Trials Directive 2001/20/EC across Europe that has resulted in a confusingly wide divergence of interpretations and practices – despite the original intention of harmonisation. 'Medical Law and Research' remains a comprehensive and indispensable medico-legal reference text reference work for healthcare, managerial, administrative and research professionals involved in bioresearch, whether they work within hospitals, general practice, the pharmaceutical industry, contract research, public research, academia or members of ethics committees , that explains the implications of medical and scientific interventions on volunteers and patients recruited for clinical or medical research.
It is clear that medical law is continuing to develop very quickly with new statutory regulations and case law continually impacting on how medical and clinical research must be conducted. In an attempt to keep abreast of such changes, the primary format for publishing ‘Medical Law and Research' remains the Internet where a fully searchable ONLINE WEB-BOOK is available at www.medreslaw.com. Annual subscriptions include periodical electronic updates integrated into the online text to include the most recent advances specifically applicable to clinical research. Although it is impossible to be certain that all relevant information has been presented, hopefully this educational facility will help professionals to increase their level of awareness about legal issues and also help researchers with “due diligence” when they seek to conduct research to appropriate standards. The HARD COPY BOOK of the ‘Medical Law and Research' remains available as a convenient alternative format that merits its place on the bookshelf for the easy reference of anyone interested in or directly involved in bioresearch. Stephen Ankier has many successful years of extensive experience at a senior level within medical and clinical research and has been awarded a Masters degrees in medical law in addition to several other academic awards and Fellowships. He remains an enthusiast about the impact of medical law on bioresearch and continues to use his experience and knowledge to lucidly explain the consequences of developments in medical law on human research in an interesting and thought-provoking manner. The text is written using plain English and in a ‘non-legalese’ style that is accessible to those without a legal background.
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