Human subjects research regulation: perspectives on the future.

Vosper, Helen

Abstract

This book is the 43rd in a series entitled ‘Basic bioethics’, and is intended to make work in bioethics accessible to a broad audience. This volume looks at the regulations safeguarding research involving human participants, and explores the legislative framework governing research in the US, in particular the ‘Common Rule for the Protection of Human Subjects’. The reason for this focus is that there have been a number of proposed changes (described within the Advanced Notice for Proposed Rulemaking, or ANPRM) which aim to take a risk-based approach to targeting regulatory oversight, as well as modifying regulations to keep pace with research, particularly regarding multi-site trials and the challenges facing research involving use of biological specimens. One of the points made in the introduction is that at the time of writing (late 2013) little progress had been made in terms of this legislative review. Indeed, at the time of writing this review, the process is far from complete. The aim of the book, therefore, is to stimulate dialogue around the proposed changes.

Citation

VOSPER, H. 2017. Human subjects research regulation: perspectives on the future. Ergonomics [online], 60(12), pages 1766-1767. Available from: https://doi.org/10.1080/00140139.2017.1332803

• Journal Article Type: Book Review
• Acceptance Date: May 23, 2017
• Online Publication Date: May 29, 2017
• Publication Date: Dec 31, 2017
• Deposit Date: May 3, 2022
• Publicly Available Date: May 3, 2022
• Journal: Ergonomics
• Print ISSN: 0014-0139
• Electronic ISSN: 1366-5847
• Publisher: Taylor and Francis
• Peer Reviewed: Peer Reviewed
• Volume: 60
• Issue: 12
• Pages: 1766-1767
• Item Discussed: COHEN, G. and LYNCH, H.F. (eds.). 2014. Human subjects research regulation: perspectives on the future. Cambridge, MA: Instutute of Technology. ISBN 9780262526210
• DOI: https://doi.org/10.1080/00140139.2017.1332803
• Keywords: Bioethics; Safeguarding; Human participants; Human factors; Ergonomics
• Public URL: https://rgu-repository.worktribe.com/output/983705