The Cambridge Handbook of Health Research Regulation

The definitive reference guide to designing scientifically sound and ethically robust medical research, considering legal, ethical and practical issues.

Graeme Laurie (Edited by), Edward Dove (Edited by), Agomoni Ganguli-Mitra (Edited by), Catriona McMillan (Edited by), Emily Postan (Edited by), Nayha Sethi (Edited by), Annie Sorbie (Edited by)

9781108475976, Cambridge University Press

Hardback, published 24 June 2021

436 pages
25.9 x 18.1 x 2.8 cm, 0.97 kg

'a rigorously edited, multidisciplinary handbook that has it all: from a solid conceptual framework that comprehends the axiological foundations of health research to the corresponding regulatory and procedural safeguards for the subjects involved … This volume in the "Cambridge Handbook" series is the perfect tool for students of health research regulation; biomedical investigators, industry regulators, or those seeking justice before a court of law; and professionals charged with administering justice … Highly recommended.' P. Rodriguez del Pozo, Choice Connect

The first ever interdisciplinary handbook in the field, this vital resource offers wide-ranging analysis of health research regulation. The chapters confront gaps between documented law and research in practice, and draw on legal, ethical and social theories about what counts as robust research regulation to make recommendations for future directions. The Handbook provides an account and analysis of current regulatory tools - such as consent to participation in research and the anonymization of data to protection participants' privacy - as well as commentary on the roles of the actors and stakeholders who are involved in human health research and its regulation. Drawing on a range of international examples of research using patient data, tissue and other human materials, the collective contribution of the volume is to explore current challenges in delivering good medical research for the public good and to provide insights on how to design better regulatory approaches. This title is also available as Open Access on Cambridge Core.

Introduction
Part I. Concepts, Tools, Processes
Section A. Concepts
Introduction
1. Vulnerability
2. Autonomy
3. Proportionality
4. Social Value
5. Solidarity
6. Public Interest
7. Privacy
8. Trust and Institutions: Global Health Research Collaborations
9. Vulnerabilities and Power: The Political Side of Health Research
Section B. Tools and Processes
Introduction
10. Consent
11. Forms of Engagement
12. Participatory Governance in Health Research: Patients and Publics as Stewards of Health Research Systems
13. Risk-Benefit Analysis
14. The Regulatory Role of Patents in Innovative Health Research and Its Translation from the Laboratory to the Clinic
15. Benefit Sharing – From Compensation to Collaboration
16. Taking Failure Seriously: Health Research Regulation for Medical Devices, Technological Risk and Preventing Future Harm
17. Rules, Principles and the Added Value of Best Practice in Health Research Regulation
18. Research Ethics Review
19. Data Access Governance
20. Is the Red Queen Sitting on the Throne? Current Trends and Future Developments in Human Health Research Regulation
21. Regulatory Authorities and Decision-Making in Health Research: The Institutional Dimension
22. The Once and Future Role of Policy Advice for Health Regulation by Experts and Advisory Committees
Part II: Reimagining Health Research Regulation
Section A: Private and Public Dimensions of Health Research Regulation
Introduction
23. Changing Identities in Disclosure of Research Findings
24. Health Research and Privacy through the Lens of Public Interest: A Monocle for the Myopic?
25. Mobilising Public Expertise in Health Research Regulation
26. Towards Adaptive Governance in Big Data Health Research: Implementing Regulatory Principles
27. Regulating Automated Healthcare and Research Technologies: First Do No Harm (to the Commons)
Section B: Widening the Lens
Introduction
28.When Learning is Continuous: Bridging the Research-Therapy Divide in the Regulatory Governance of Artificial Intelligence as Medical Devices
29. The Oversight of Clinical Innovation in a Medical Marketplace
30. The Challenge of 'Evidence': Research and Regulation of Traditional and Non-Conventional Medicines
31. Experiences of Ethics, Governance, and Scientific Practice in Neuroscience Research
32. Humanitarian Research: Ethical Considerations in Conducting Research during Global Health Emergencies
33. Governance Framework for Advanced Therapies in Argentina
Section C: Towards Responsive Regulation
Introduction
34. Human Gene Editing: Traversing Normative Systems
35. Towards a Global Germline Ethics? Human Heritable Genetic Modification and the Future of Health Research Regulation
36. Human Organs and Animal Bodies: Regulating Interspecies Research
37. When is Human? Rethinking the 14-day Rule
38. A Perfect Storm: Non-Evidence-Based Medicine in the Fertility Clinic
39. Margins or Mainstream? Enhancement and the Need for a New Regulatory Perspective
Afterword: What Could a Learning Health Research Regulation System Look Like?

Subject Areas: Medical anthropology [PSXM], Bio-ethics [PSAD], Forensic medicine [MMQ], Medical sociology [MBS], Medical ethics & professional conduct [MBDC], Medical & healthcare law [LNTM], Social law [LNT], Laws of Specific jurisdictions [LN], Law [L]