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The Mental Capacity Act 2005 will be implemented during 2007, joining the Human Tissue Act 2004 and the European Union Clinical Trials Directive 2004 in contributing to new legislation that affects clinical research. Input from researchers and academics at the consultation stage has ensured that the resulting legislation will not prohibit vital research in incapacitated patients, as had been originally feared.1 The National Research Ethics Service has recently provided guidance for conducting research in incapacitated subjects.2
The guidance has one important omission. The Data Protection Act 1998 provides important safeguards to protect the privacy of individuals, but overly restrictive interpretations of the act by local data protection officers have been a major hindrance to the conduct of legitimate clinical research in critically ill patients.3
We have been in contact with the Information Commissioner's Office and confirmed that research in incapacitated patients can fulfil the requirements of the Data Protection Act. Our standard research practice is to obtain assent from a patient representative before data processing to ensure that the patient's prior wishes are taken into account. We then obtain consent from the patient, as soon as is practicable, once they regain capacity. We have been advised that this fulfils the requirements of the Data Protection Act ensuring fair processing of information, provided that such processing is essential for the purpose of research, and that such research could not be undertaken with non-identifiable personal data (D Evans, Information Commissioner's Office, personal communications, April 2005 and August 2007).
We urge the National Research Ethics Service to include advice on this topic on their website after appropriate consultation with the Information Commissioner's Office.
On behalf of the Intensive Care Society, UK
Competing interests: CLR is a member of the Cambridgeshire 4 Research Ethics Committee.