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Mental Capacity Act (2005) versus Clinical Trial Regulations (2004)
Researchers in emergency medicine will face another major change in the law when the provisions of the Mental Capacity Act 2005 come into force in England and Wales in April 2007. This act gives a framework for consent for emergency care research in cases where patients are incapacitated and cannot consent themselves.1 Research in Scotland has a different set of regulations contained in the Adults with Incapacity (Scotland) Act 2000.
The new law
There will now be two major legal frameworks for emergency medicine research. The Mental Capacity Act will be applied if the research involves non-drug interventions, procedures, devices, investigations or service organisation. Within the Act, sections 30–34 relate to research. This Act does not apply if a “medicine” is being studied, in which case the research must be conducted under the Medicine for Human Use (clinical trials) Regulations 2004 (the UK implementation of Directive 2001/20/EC of the European Parliament).2 Despite the difference in the name, the Medicines Regulations and the Mental Capacity Act have the same status in law.
A number of circumstances within the Mental Capacity Act have to be fulfilled to be able to carry out medical research on incapacitated patients. Firstly, there should be no potential to answer the research question in patients who possess capacity. Secondly, the research must be connected with the condition that underlies the mental incapacity (trauma research on patients with trauma, stroke research on patients with stroke, etc). Thirdly, the research should have “the potential to benefit the patient without imposing on the patient a burden that is disproportionate to the potential benefit”. This means that only small risks will be tolerated with interventions that have small potential benefit, but that large risks can be tolerated if there is potential for a …
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