The Cambridge Handbook of Health Research Regulation

ISBN-13: 9781108475976 / Angielski / Twarda / 2021 / 436 str.

Graeme Laurie (University of Edinburgh);Edward Dove (University of Edinburgh);Agomoni Ganguli-Mitra (University of Edinburgh)

Opis

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.

Recenzje

'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

Spis treści

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?