The Cambridge handbook of health research regulation /

The Cambridge handbook of health research regulation

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Bibliographic Details
Corporate Author: Cambridge University Press ()
Language:English
Published: Cambridge : Cambridge University Press, 2021.
Subjects:
Zagadnienia prawa administracyjnego państw obcych
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Online Access:Zobacz publikację w Cambridge Core (Open Access)
Description:
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.


Table of Contents:
  • Laurie, Graeme Introduction : Towards a Learning Health Research Regulation System (s. 1-10) https://doi.org/10.1017/9781108620024.001
  • Annie, Sorbie Section IA – Concepts : Introduction (s. 13-15) https://doi.org/10.1017/9781108620024.003
  • Rogers, Wendy A. Vulnerability (s. 17-26) https://doi.org/10.1017/9781108620024.004
  • Stoljar, Natalie Autonomy : Relational Conceptions (s. 27-36) https://doi.org/10.1017/9781108620024.005
  • Schaefer, Owen Proportionality in Health Research Regulation (s. 37-45) https://doi.org/10.1017/9781108620024.006
  • Delden, Johannes J. M. van Graaf, Rieke van der Social Value (s. 46-55) https://doi.org/10.1017/9781108620024.007
  • Kieslich, Katharina Prainsack, Barbara Solidarity in Health Research Regulation (s. 56-64) https://doi.org/10.1017/9781108620024.008
  • Sorbie, Annie The Public Interest (s. 65-72) https://doi.org/10.1017/9781108620024.009
  • Townend, David Privacy (s. 73-80) https://doi.org/10.1017/9781108620024.010
  • Kerasidou, Angeliki Trustworthy Institutions in Global Health Research Collaborations (s. 81-89) https://doi.org/10.1017/9781108620024.011
  • Brassington, Iain Vulnerabilities and Power : The Political Side of Health Research (s. 90-98) https://doi.org/10.1017/9781108620024.012
  • Dove, Edward Nayha, Sethi Section IB - Tools, Processes and Actors : Introduction (s. 99-101) https://doi.org/10.1017/9781108620024.013
  • Kaye, Jane Prictor, Megan Consent (s. 103-111) https://doi.org/10.1017/9781108620024.014
  • Aitken, Mhairi Cunningham-Burley, Sarah Forms of Engagement (s. 112-120) https://doi.org/10.1017/9781108620024.015
  • Chuong, Kim H. O’Doherty, Kieran C. Participatory Governance in Health Research : Patients and Publics as Stewards of Health Research Systems (s. 121-129) https://doi.org/10.1017/9781108620024.016
  • Coleman, Carl H. Risk-Benefit Analysis (s. 130-138) https://doi.org/10.1017/9781108620024.017
  • Nicol, Dianne Nielsen, Jane The Regulatory Role of Patents in Innovative Health Research and Its Translation from the Laboratory to the Clinic (s. 139-147) https://doi.org/10.1017/9781108620024.018
  • Simm, Kadri Benefit Sharing : From Compensation to Collaboration (s. 148-157) https://doi.org/10.1017/9781108620024.019
  • Flear, Mark L. Taking Failure Seriously : Health Research Regulation for Medical Devices, Technological Risk and Preventing Future Harm (s. 158-166) https://doi.org/10.1017/9781108620024.020
  • Sethi, Nayha Rules, Principles and the Added Value of Best Practice in Health Research Regulation (s. 167-176) https://doi.org/10.1017/9781108620024.021
  • Dove, Edward Research Ethics Review (s. 177-186) https://doi.org/10.1017/9781108620024.022
  • Shabani, Mahsa Thorogood, Adrian Murtagh, Madeleine Data Access Governance (s. 187-196) https://doi.org/10.1017/9781108620024.023
  • Nicholls, Stuart G. Is the Red Queen Sitting on the Throne? : Current Trends and Future Developments in Human Health Research Regulation (s. 197-204) https://doi.org/10.1017/9781108620024.024
  • McMahon, Aisling M. Regulatory Authorities and Decision-Making in Health Research : The Institutional Dimension (s. 205-214) https://doi.org/10.1017/9781108620024.025
  • Meslin, Eric M. The Once and Future Role of Policy Advice for Health Regulation by Experts and Advisory Committees (s. 215-224) https://doi.org/10.1017/9781108620024.026
  • Graeme, Laurie Section IIA - Private and Public Dimensions of Health Research Regulation : Introduction (s. 227-228) https://doi.org/10.1017/9781108620024.028
  • Postan, Emily Changing Identities in Disclosure of Research Findings (s. 229-238) https://doi.org/10.1017/9781108620024.029
  • Taylor, Mark Whitton, Tess Health Research and Privacy through the Lens of Public Interest : A Monocle for the Myopic? (s. 239-247) https://doi.org/10.1017/9781108620024.030
  • Burgess, Michael M. Mobilising Public Expertise in Health Research Regulation (s. 248-256) https://doi.org/10.1017/9781108620024.031
  • Vayena, Effy Blasimme, Alessandro Towards Adaptive Governance in Big Data Health Research : Implementing Regulatory Principles (s. 257-265) https://doi.org/10.1017/9781108620024.032
  • Brownsword, Roger Regulating Automated Healthcare and Research Technologies : First Do No Harm (to the Commons) (s. 266-274) https://doi.org/10.1017/9781108620024.033
  • Agomoni, Ganguli-Mitra Section IIB - Widening the Lens : Introduction (s. 275-276) https://doi.org/10.1017/9781108620024.034
  • Ho, Calvin W. L. When Learning Is Continuous : Bridging the Research–Therapy Divide in the Regulatory Governance of Artificial Intelligence as Medical Devices (s. 277-286) https://doi.org/10.1017/9781108620024.035
  • Lipworth, Wendy Wiersma, Miriam Ghinea, Narcyz Hendl, Tereza Kerridge, Ian Lysaght, Tamra Munsie, Megan Rudge, Chris Stewart, Cameron Waldby, Catherine The Oversight of Clinical Innovation in a Medical Marketplace (s. 287-295) https://doi.org/10.1017/9781108620024.036
  • Urquiza Haas, Nayeli The Challenge of ‘Evidence’ : Research and Regulation of Traditional and Non-Conventional Medicines (s. 296-305) https://doi.org/10.1017/9781108620024.037
  • Pickersgill, Martyn Experiences of Ethics, Governance and Scientific Practice in Neuroscience Research (s. 306-314) https://doi.org/10.1017/9781108620024.038
  • Ganguli-Mitra, Agomoni Hunt, Matthew Humanitarian Research : Ethical Considerations in Conducting Research during Global Health Emergencies (s. 315-323) https://doi.org/10.1017/9781108620024.039
  • Arzuaga, Fabiana A Governance Framework for Advanced Therapies in Argentina : Regenerative Medicine, Advanced Therapies, Foresight, Regulation and Governance (s. 324-331) https://doi.org/10.1017/9781108620024.040
  • McMillan, Catriona Section IIC - Towards Responsive Regulation : Introduction (s. 333-334) https://doi.org/10.1017/9781108620024.041
  • Isasi, Rosario Human Gene Editing : Traversing Normative Systems (s. 335-343) https://doi.org/10.1017/9781108620024.042
  • Chan, Sarah Towards a Global Germline Ethics? : Human Heritable Genetic Modification and the Future of Health Research Regulation (s. 344-355) https://doi.org/10.1017/9781108620024.043
  • Hinterberger, Amy Bea, Sara Cells, Animals and Human Subjects : Regulating Interspecies Biomedical Research (s. 356-364) https://doi.org/10.1017/9781108620024.044
  • McMillan, Catriona When Is Human? : Rethinking the Fourteen-Day Rule (s. 365-372) https://doi.org/10.1017/9781108620024.045
  • Jackson, Emily A Perfect Storm : Non-evidence-Based Medicine in the Fertility Clinic (s. 373-381) https://doi.org/10.1017/9781108620024.046
  • Harmon, Shawn H. E. Medical Devices Regulation : New Concepts and Perspectives Needed (s. 382-390) https://doi.org/10.1017/9781108620024.047
  • Laurie, Graeme Afterword : What Could a Learning Health Research Regulation System Look Like? (s. 391-400) https://doi.org/10.1017/9781108620024.048