In the UK informed consent has long been accepted as an important safeguard for protecting the interests of participants in medical research. Consent was declared to be ‘absolutely essential’ by the first principle of the 1947 Nuremberg Code. It was not until the fifth revision of the Helsinki Declaration in 2000 that this was modified to support research in an emergency situation, where it is not possible to obtain consent from the participant or a proxy before entry into the trial. This article considers the legal and ethical issues raised by research into emergency treatment for which prior informed consent is not feasible. It argues for reform of the EU legislation addressing emergency research on medicinal products and supported the relevant provisions of the Regulation proposed by the European Commission in July 2012. The prevalence principle, and the precautionary principle argued to underpin it in ‘The rights and interests of the participant’ section, requires that we at least trial more radical policies specifically directed at the distorting influence of the commercial interests of pharmaceutical companies. Such policies are particularly important in the context of emergency research given the prospective removal of the safeguard of informed consent.
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. (2012). Emergency research and the interests of participants Medical Law International DOI: 10.1177/0968533212465615