The Cambridge Handbook of Health Research Regulation

Graeme Laurie is Professorial Fellow and Founding Director of the J. Kenyon Mason Institute, Edinburgh Law School, University of Edinburgh. He was the Principal Investigator on the Liminal Spaces Project (2014-2021). Edward Dove is Lecturer in Health Law and Regulation and a Deputy Director of the Mason Institute. Agomoni Ganguli-Mitra is Lecturer in Bioethics and Global Health Ethics at the Mason Institute. Catriona McMillan is a Senior Research Fellow in Medical Law and Ethics and a Deputy Director of the Mason Institute. Emily Postan is Senior Research and Teaching Fellow in Bioethics and a Deputy Director of the Mason Institute. Nayha Sethi is Chancellor's Fellow in Data Driven Innovation and a Deputy Director of the Mason Institute. Annie Sorbie is Lecturer in Medical Law and Ethics and a Deputy Director of the Mason Institute.

'This is an excellent book … I learned a great deal by reading it, gained much food for thought and know that I will return to it often, and hence I can highly recommend it.' Lyn Horn, Bioethics

• 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?