The Cambridge Handbook of Health Research Regulation (Cambridge Law Handbooks)

Cambridge University Press, 6/24/2021
EAN 9781108475976, ISBN10: 1108475973

Hardcover, 436 pages, 25.7 x 19.8 x 2.8 cm
Language: English

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?