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Regulatory Stewardship of Health Research: Navigating Participant Protection and Research Promotion

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ISBN: 9781788975346 9781788975353 Year: Pages: 232 DOI: 10.4337/9781788975353 Language: English
Publisher: Edward Elgar Publishing
Subject: Law
Added to DOAB on : 2020-02-18 17:14:37
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This timely book examines the interaction of health research and regulation with law through empirical analysis and the application of key anthropological concepts to reveal the inner workings of human health research. Through ground-breaking empirical inquiry, Regulatory Stewardship of Health Research explores how research ethics committees (RECs) work in practice to both protect research participants and promote ethical research. This thought-provoking book provides a new perspective on the regulation of health research by demonstrating how RECs and other regulatory actors seek to fulfil these two functions by performing a role of ‘regulatory stewardship’.

Ethics Dumping: Case Studies from North-South Research Collaborations

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Book Series: SpringerBriefs in Research and Innovation Governance ISSN: 2452-0519 ISBN: 9783319647302 9783319647319 Year: Pages: 134 DOI: https://doi.org/10.1007/978-3-319-64731-9 Language: English
Publisher: Springer Nature Grant: University of Central Lancashire
Subject: Philosophy
Added to DOAB on : 2018-06-26 16:01:58
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This book provides original, up-to-date case studies of “ethics dumping” that were largely facilitated by loopholes in the ethics governance of low and middle-income countries. It is instructive even to experienced researchers since it provides a voice to vulnerable populations from the forementioned countries. Ensuring the ethical conduct of North-South collaborations in research is a process fraught with difficulties. The background conditions under which such collaborations take place include extreme differentials in available income and power, as well as a past history of colonialism, while differences in culture can add a new layer of complications. In this context, up-to-date case studies of unethical conduct are essential for research ethics training.

GDPR and Biobanking

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Book Series: Law, Governance and Technology Series ISBN: 9783030493882 Year: Pages: 434 DOI: 10.1007/978-3-030-49388-2 Language: English
Publisher: Springer Nature
Subject: Law --- Computer Science --- Medicine (General)
Added to DOAB on : 2021-01-15 00:49:51
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This open access book focuses on the discrepancies in biobank research regulations that are among the most significant hurdles to effective research collaboration. The General Data Protection Regulation (GDPR) has established stringent requirements for the processing of health and genetic data, while simultaneously allowing considerable multi-level exceptions for the purposes of scientific research. In addition to directly applicable exceptions, the GDPR places the regulatory responsibility for further defining how the Member States strike a balance between the individuals' rights and the public interest in research within their national legal orders. Since Member States' approaches to the trade-off between data subjects' rights on the one hand, and appropriate safeguards on the other, differ according to their ethical and legal traditions, their data protection requirements for research also differ considerably. This study takes a comprehensive approach to determine how the GDPR affects regulatory regimes on the use of personal data in biobanking research, with a particular focus on the balance between individuals' rights, public interest and scientific research. In this regard, it has two main goals: first, to scrutinize the GDPR research regime, its objective and constitutive elements, the impact it has on biobanking, and its role in a changing EU landscape post-Brexit; and second, to examine how various exceptions have been operationalized nationally, and what challenges and opportunities this diversification entails. The book not only captures the complexity GDPR creates for biobanking, but also sheds light on various approaches to tackling the corresponding challenges. It offers the first comprehensive analysis of GDPR for biobanking, and the most up-to-date overview of the national biobank regulatory frameworks in Europe.

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