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The Medicines for Human Use (Clinical Trials) Regulations 2004
Performing emergency medical research in situations where patients are unable to give their own informed consent has long been a thorny issue. For example, a common problem is whether or not a patient in the middle of having an acute myocardial infarction can really weigh up the information in a few minutes and give properly informed consent for a trial of a thrombolytic.1 The legal basis for consent for research in the incapacitated patient changed profoundly on 1 May 2004. On this date the Medicines for Human Use (Clinical Trials) Regulations 2004 came into force, the UK implementation of Directive 2001/20/EC of the European Parliament.
These laws may seem remote in everyday practice but they should be of interest to all emergency physicians, as even those not involved in research will be directly affected by the consequences of these changes. We can only provide effective, evidence based emergency care if evidence is available from well structured clinical trials. If new regulations do not take account of emergency research, or clinical trials in emergency medicine are inhibited or prevented by an over burdensome bureaucracy, we will not be able to advance our knowledge or provide high quality care.
From the outset it should be emphasised that the changes in the law discussed in this article only apply to consent to participation in medical research. For the latest regulations in consent for normal medical treatment, emergency physicians should be familiar with the implications of the Mental Capacity Act 2005.
The new legal framework
The detailed legislation is found in Schedules 1 and 2 of the Medicines for Human Use (Clinical Trials) Regulations 2004.2 Key issues are contained within Part 5 “Conditions and principles which apply in relation to an incapacitated adult” (see box 1 …