Skip to main content

Research Repository

Advanced Search

Emergency Research and the Interests of Participants

Pattinson, Shaun D.

Emergency Research and the Interests of Participants Thumbnail



The UK Clinical Trials Regulations were amended in 2006 and 2008 to facilitate research on medicinal products administered in emergency situations. The Regulations, which implement the EU Clinical Trials Directive, had previously required prior consent to participation in a clinical trial from either the participant or the participant’s legal representative. These amendments put emergency research on medicinal products on a similar footing to research on other types of invasive emergency treatment. This article argues that this was a positive development from the perspective of science and society and one for which there is a strong ethical basis. Nonetheless, it is argued that the UK Regulations cannot be interpreted consistently with European law without distortion contrary to the rule of law. It is also argued that the Directive needs to be amended or replaced to ensure a proper balance between the interests of participants and the interests of science and society. A number of specific suggestions are made, and the proposals made by the European Commission in July 2012 are supported. It is, however, argued that more needs to be done to protect the conduct of emergency trials from the conflicts of interests and biases that generally beset clinical trials.


Pattinson, S. D. (2012). Emergency Research and the Interests of Participants. Medical Law International, 12(2), 121-141.

Journal Article Type Article
Publication Date Jun 1, 2012
Deposit Date Oct 1, 2012
Publicly Available Date Mar 22, 2013
Journal Medical Law International
Print ISSN 0968-5332
Electronic ISSN 2047-9441
Publisher SAGE Publications
Peer Reviewed Peer Reviewed
Volume 12
Issue 2
Pages 121-141
Keywords Emergency research, Medical research, Clinical Trials Directive, UK Clinical Trials Regulations, Mental Capacity Act.


Accepted Journal Article (495 Kb)

Copyright Statement
The final definitive version of this article has been published in the Journal Medical law international, 12/2, 2012 © SAGE Publications Ltd 2012 by SAGE Publications Ltd at the Medical law international page: on SAGE Journals Online:

You might also like

Downloadable Citations