How should we regulate risk in biomedical research? An ethical analysis of recent policy proposals and initiatives

Annette Rid

Health Policy, 2014, vol. 117, issue 3, 409-420

Abstract: The existing regulatory framework for research is increasingly attacked for its “one-size-fits-all” approach. Many stakeholders contend that existing regulations formulate the same regulatory requirements for research involving very different levels of risk, and thereby unnecessarily stifle medical progress. To address this criticism, regulators are currently developing more risk-adapted approaches to regulating research. A key feature of these approaches is that they aim to calibrate subject protections, including ethical review and safety monitoring, to the risks that studies pose to participants.

Keywords: Research/drug regulation; Risk; Risk-adapted regulation; Research ethics; Subject protection; Ethical review; Informed consent; Safety monitoring; Comparative policy analysis (search for similar items in EconPapers)
Date: 2014
References: View complete reference list from CitEc
Citations:

Downloads: (external link)
http://www.sciencedirect.com/science/article/pii/S0168851014001109
Full text for ScienceDirect subscribers only

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:eee:hepoli:v:117:y:2014:i:3:p:409-420

DOI: 10.1016/j.healthpol.2014.04.011

Access Statistics for this article

Health Policy is currently edited by Katrien Kesteloot, Mia Defever and Irina Cleemput

More articles in Health Policy from Elsevier
Bibliographic data for series maintained by Catherine Liu () and ().