Home >
Law >
Medical Law >
The Cambridge Handbook of Health Research Regulation

The Cambridge Handbook of Health Research Regulation

Author: Graeme Laurie; Edward Dove; Agomoni Ganguli-Mitra, McMillan Catriona; Emily Postan; Nayha Sethi; Annie Sorbie
Publisher: Cambridge University Press
ISBN: 9781108475976
Published In: June 2021
Format: Hardback
Jurisdiction: U.K. ? Disclaimer:
Countri(es) stated herein are used as reference only

List Price: HKD 2,236.00

HKD 2,168.92 Save HKD 67.08 (3%)

Download Order Form

Add to Wishlist
| Add to Compare

Description
Contents

Details

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.

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?

Browse Books

The Cambridge Handbook of Health Research Regulation

Free delivery Hong Kong?

Details

You may also be interested in these books:

What Our Customers Say?

Browse Books

The Cambridge Handbook of Health Research Regulation

Free delivery Hong Kong?

Details

You may also be interested in these books:

What Our Customers Say?

video title