This multi-disciplinary Handbook examines human health research and its regulation. It uses real world examples - research using patient data, tissue and other human materials - to explore current challenges in delivering good medical research for the public good. Practical recommendations for real-world situations are a key feature of the book.
This multi-disciplinary Handbook examines human health research and its regulation. It uses real world examples - research using patient data, tissue and other human materials - to explore current challenges in delivering good medical research for the public good. Practical recommendations for real-world situations are a key feature of the book.
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?
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?
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