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BMJ 2007;335:415 (1 September), doi:10.1136/bmj.39311.480949.3A
| The first 150 words of the full text of this article appear below. |
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.
Clare L Reid, research associate, David K Menon, head
Division of Anaesthesia, University of Cambridge, Box 93, Addenbrooke's Hospital, Cambridge CB2 2QQ
clr42@cam.ac.uk
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