The Cambridge Handbook of Health Research Regulation: Cambridge Law Handbooks
Editat de Graeme Laurie, Edward Dove, Agomoni Ganguli-Mitra, Catriona McMillan, Emily Postan, Nayha Sethi, Annie Sorbieen Limba Engleză Hardback – 23 iun 2021
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Specificații
ISBN-13: 9781108475976
ISBN-10: 1108475973
Pagini: 436
Dimensiuni: 181 x 259 x 28 mm
Greutate: 0.95 kg
Editura: Cambridge University Press
Colecția Cambridge University Press
Seria Cambridge Law Handbooks
Locul publicării:Cambridge, United Kingdom
ISBN-10: 1108475973
Pagini: 436
Dimensiuni: 181 x 259 x 28 mm
Greutate: 0.95 kg
Editura: Cambridge University Press
Colecția Cambridge University Press
Seria Cambridge Law Handbooks
Locul publicării:Cambridge, United Kingdom
Cuprins
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?
Recenzii
'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
'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
'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
Descriere
The definitive reference guide to designing scientifically sound and ethically robust medical research, considering legal, ethical and practical issues.