Healthcare Research Ethics and Law

Regulation, Review and Responsibility

By Hazel Biggs

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About the Book

The book explores and explains the relationship between law and ethics in the context of medically related research in order to provide a practical guide to understanding for members of research ethics committees (RECs), professionals involved with medical research and those with an academic interest in the subject.

Healthcare Research Ethics and Law sets out the law as it relates to the functions of Research Ethics Committees (RECs) within the context of the process of ethical review and aims to be accessible and readily understood by REC members. Each chapter begins by locating the material within the practical context of ethical review and then provides a more theoretical and analytical discussion detailing how the theory and practice fit together. The key legal issues of confidentiality, consent and negligence are addressed in detail, alongside practical guidance as to how and when liability may be incurred in these areas. In addition, the practical and legal implications of the implementation of European Directive 2001/20/EC, the Human Tissue Act 2004 and the Mental Capacity Act 2005 are considered alongside a discussion of their socio-political background and relevance for medical research in the UK.

Reviews

" This is a timely publication which provides a useful source for those wishing to find out more about how the regulation of healthcare research operates in the United Kingdom. It will prove particularly helpful as a portable source of reference for members of research ethics committees, or RECs." - Robin Mackenzie, University of Kent, Research Ethics Review (2010) Vol.6, No 1

Table of Contents

1. Introduction Part 1 2. Brief History of Research Ethics 3. Research Ethics in Theory & Practice 4. Legal Liabilities of RECs 5. Consent 6. Confidentiality Issues in Research Part 2: Specialist Concerns 7. Researching Vulnerable Groups 8. Human Tissue 9. Conclusions and Thorny Issues

About the Author(s)

Professor Hazel Biggs is Professor of Medical Law at the University of Southampton, UK.