Values and Institutions in Health Research Regulation The Case of Regenerative Medicine Biomedical Law and Ethics Library Series

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.

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