Values and Institutions in Health Research Regulation

The Case of Regenerative Medicine

By Shawn H.E. Harmon

© 2017 – Routledge

296 pages

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Hardback: 9780415816007
pub: 2017-04-01

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About the Book

This book undertakes an exploration of the key concept of ‘values’ and particularly examines the significance of socio-moral values to the advancement of the field of biomedical law and research governance. Values serve as a touchstone throughout the book and the author seeks to identify the values which are present in the core international instruments relevant to biomedicine and considers the ways in which those values are defined and ranked. In the process, he critiques those core international instruments from a value perspective and demonstrates the policy tensions that exist in the biomedical field.

This book is international in scope but many of the examples cited are drawn from biomedical practise in the UK and Argentina. The UK is one of the most active jurisdictions in the field of biomedical research governance and often serves as a model for other jurisdictions. It is referenced here with a view to providing examples of the adoption of values influenced legal and ethical mechanisms which are now actively in force. By contrast, Argentina is an emerging economy relying on biomedicine as a means of sustainable development and national re-imagining, and in the process it is actively redesigning its regulatory environment. Argentina is a useful example of the challenges faced by, and potential courses open to, developing or emerging countries with obvious relevance to countries across Latin America. Harmon pulls together examples of values informing regulation in the UK and Argentina and from them offers a framework for regulating this dynamic field. The emphasis of the analysis of the regulation of the life sciences and biotechnology is on how that regulation puts into practise (or fails to put into practise) claimed socio-moral values.

Table of Contents

1. Introduction Part 1: Health, Law and Socio-Moral Values 2. Our Confrontation with Reality 3. Our Summoning of the Law 4. Our Better Angels and the Value of Values Part 2: Value Rhetoric in International Instruments Relevant to Biomedicine 5. Values in the International Human Subject Research Instruments 6. Values in the International Biomedical Research Instruments 7. Values in the International Commercial Instruments Part 3: Case Study I – Values in the Operational Setting: A Case Study on Narrowing and Preferencing Values in the UK 8. Paradigms and Mechanisms in the Research Context: UK Biobank and Consent 9. Paradigms and Mechanisms in the Treatment Context: UK Courts and Tissue Control 10. Paradigms and Mechanisms in the Commercial Context: European Patent Cases and Ownership Part 4: Case Study II – Values in the Pre-Law Setting: A Case Study on Values Held and Regulatory Objectives in Argentina 11. Argentina’s Evolving Legal Framework in Biomedicine 12. Values Claimed by Argentina’s Science and Policy Elites 13. Shaping Argentina’s Science Environment: Vindicating the Democracy Value Part 5: A Value-Conscious and Value-Based Framework 14. Conclusion: Operationalising Values in the Biomedical Context

About the Author

Shawn H.E. Harmon is a Lecturer in Regulation & Risk, School of Law, University of Edinburgh and Deputy Director, J Kenyon Mason Institute for Medicine, Life Sciences and Law and also serves as Co-Editor-in-Chief, Medical Law International.

About the Series

Biomedical Law and Ethics Library

Scientific and clinical advances, social and political developments and the impact of healthcare on our lives raise profound ethical and legal questions. Medical law and ethics have become central to our understanding of these problems, and are important tools for the analysis and resolution of problems – real or imagined.

In this series, scholars at the forefront of biomedical law and ethics will contribute to the debates in this area, with accessible, thought-provoking, and sometimes controversial ideas. Each book in the series will develop an independent hypothesis and argue cogently for a particular position. One of the major contributions of this series is the extent to which both law and ethics are utilised in the content of the books, and the shape of the series itself.

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Subject Categories

BISAC Subject Codes/Headings:
LAW / General
LAW / Ethics & Professional Responsibility
LAW / Health
LAW / Medical Law & Legislation