Emergency research and the interests of participants

Abstract

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.