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The University of Southampton
Southampton Law School

Healthcare Research Ethics and Law

Published: 1 December 2009

Professor Hazel Biggs, School of Law, University of Southampton, UK New Publication: Healthcare Research Ethics and Law - Regulation, Review and Responsibility

This 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, professionals involved with medical research and those with an academic interest in the subject.

Publication Date October 2009

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.


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

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