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Regulating Risk: Values and Law in Health Research Governance


ISBN13: 9780415816007
To be Published: January 2026
Publisher: Routledge
Country of Publication: UK
Format: Hardback
Price: £90.00



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.

Subjects:
Medical Law and Bioethics
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

Series: Biomedical Law & Ethics Library

Assisted Suicide and the European Convention on Human Rights ISBN 9780367628437
Published January 2023
Routledge
£37.99
Out of print
Assisted Suicide and the European Convention on Human Rights ISBN 9780367628222
Published April 2021
Routledge
£135.00
£135.00
Revisiting Landmark Cases in Medical Law ISBN 9780367498764
Published February 2020
Routledge
£39.99
Revisiting Landmark Cases in Medical Law ISBN 9781138808331
Published October 2018
Routledge
£135.00
Health Research Governance in Africa ISBN 9781138036772
Published September 2018
Routledge
£135.00
Health Research Governance in Africa (eBook) ISBN 9781351713054
Published September 2018
Routledge
Out of print
The Umbilical Cord Blood Controversies in Medical Law (eBook) ISBN 9781317555445
Published January 2017
Routledge
Out of print
The Umbilical Cord Blood Controversies in Medical Law ISBN 9781138840881
Published January 2017
Routledge
£145.00
The Voices and Rooms of European Bioethics ISBN 9781138701984
Published January 2017
Routledge
£44.99
Revisiting the Regulation of Human Fertilisation and Embryology
Edited by: Kirsty Horsey
ISBN 9781138713055
Published January 2017
Routledge
£49.99
Revisiting the Regulation of Human Fertilisation and Embryology (eBook)
Edited by: Kirsty Horsey
ISBN 9781317664802
Published June 2015
Routledge
Out of print
Revisiting the Regulation of Human Fertilisation and Embryology
Edited by: Kirsty Horsey
ISBN 9781138021891
Published June 2015
Routledge
£145.00
Out of print
The Voices and Rooms of European Bioethics ISBN 9780415737197
Published May 2015
Routledge
£130.00
Bioethics: Methods, Theories, Domains ISBN 9781138789937
Published April 2014
Routledge
£53.99
Medical Ethics in China: A Transcultural Interpretation ISBN 9780415724562
Published September 2013
Routledge
£43.99
Coercive Care: Rights, Law and Policy (eBook) ISBN 9781135016579
Published June 2013
Routledge
Out of print
Coercive Care: Rights, Law and Policy ISBN 9780415628198
Published June 2013
Routledge
£145.00
The Connected Self: The Ethics and Governance of the Genetic Individual ISBN 9781107008601
Published January 2013
Cambridge University Press
£100.00
£43.99
Medical Ethics in China: A Transcultural Interpretation ISBN 9780415689496
Published December 2011
Routledge
£150.00
Medical Ethics in China: A Transcultural Interpretation (eBook) ISBN 9781136491245
Published December 2011
Routledge
Out of print
Bioethics: Methods, Theories, Domains ISBN 9780415609913
Published October 2011
Routledge
£145.00
Bioethics: Methods, Theories, Domains (eBook) ISBN 9781136190070
Published October 2011
Routledge
Out of print
Healthcare Research Ethics and Law: Regulation, Review and Responsibility ISBN 9780415429177
Published October 2009
Routledge-Cavendish
£49.99
The Body in Bioethics ISBN 9781844720569
Published April 2009
Routledge-Cavendish
£49.99
Values in Medicine: What are we Really Doing to Patients? ISBN 9780415424684
Published December 2007
Routledge-Cavendish
£135.00
Values in Medicine: What are we Really Doing to Patients? ISBN 9780415424691
Published December 2007
Routledge-Cavendish
£45.99
Medicine, Malpractice and Misapprehensions ISBN 9780415428095
Published December 2007
Routledge-Cavendish
£44.99
Assisted Dying: Reflections on the Need for Law Reform ISBN 9781844720545
Published November 2007
Routledge-Cavendish
£49.99
Euthanasia, Ethics and the Law: From Conflict to Compromise ISBN 9781844721061
Published November 2007
Routledge-Cavendish
£49.99
The Best Interests of the Child in Healthcare ISBN 9781844720422
Published October 2007
UCL Press
£49.99
Bioethics and the Humanities: Attitudes and Perceptions ISBN 9781844720521
Published March 2007
Routledge-Cavendish
£44.99
Impairment and Disability: Law and Ethics at the Beginning and End of Life ISBN 9781844720408
Published February 2007
Routledge-Cavendish
£44.99
The Harm Paradox: Tort Law and the Unwanted Child in an Era of Choice ISBN 9781844721085
Published January 2007
Routledge-Cavendish
£49.99
Publication Abandoned
Publication Abandoned