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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.






Statutory Instrument (S.I.) 2004/1031 has had an important impact on medical research by providing an important statutory framework for the legally enforceable conduct of trials in accordance with good clinical practice while also creating a statutory role for ethics committees. More recently, European Clinical Trials Regulations 536/2014/EU was approved by the European Parliament and replaces EU Clinical Trials Directive 2001/20/EC with the aims of simplifying, streamlining and harmonising clinical trial authorisation and procedural requirements throughout the EU.. However, it is not the only legal basis for conducting bioresearch on humans.



In fact, there are several Acts of Parliament, and a long tradition of common law precedent that combined with S.I. 2004/1031 and its amendments to form the current legal foundation for performing research on volunteers and patients. Moreover, there have been some other important statutory developments in the UK that impinge on the medico-legal background against which human research must be conducted. For example, the Health and Social Care Act 2012 recognises the importance of promoting research and the use of research evidence for patient care and empowers the Secretary of State, the NHS Commissioning Board, commissioning groups and local authorities to conduct, commission and assist the conduct of research.

Meanwhile, 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 this context, the HARD COPY BOOK of 'Medical Law and Research' included comprehensive updates at the time of publication in the ever changing medico-legal environment in which research on humans is performed.

This publication still remains an 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.

Each of nine chapters is supported by explanatory footnotes that summarise historical developments, cites illustrative case law and discusses seminal legal landmarks. The chapters cover the key areas of :

  • liability and indemnity,
  • negligence,
  • approval systems and regulatory affairs,
  • confidentiality,
  • consent in adults with or without capacity and in children,
  • publication,
  • misconduct and fraud in clinical trials.

However, it is clear that medical law has continued to develop very quickly with the new statutory regulations and case law often impacting on how medical and clinical research must be conducted. In an attempt to remain current with such significant changes, the primary format for publishingMedical Law and Research' has remained 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 included, 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 the principles of bioresearch.

Further developments are expected early next year when we anticipate launching an electronic book version of ‘Medical Law and Research' in formats that can be used by Kindles and other e-readers.

Stephen Ankier has many successful years of extensive experience at a senior level within scientific, medical and clinical research and has been awarded a Masters degree 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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