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Ethical and Scientific Concerns about the MRC PACE Trial

Posted Apr 15 2010 3:22pm
Ethical and Scientific Concerns about the MRC PACE Trial

West Midlands MREC reference: MT/MREC/02/7/89

Chief Investigator: Professor Peter D White  (Psychiatrist, St Bartholomew’s Hospital, London)

“PACE” is the acronym for Pacing, Activity, and Cognitive behavioural therapy, a randomised Evaluation  (a randomised, controlled trial of adding cognitive behaviour therapy, graded exercise, or adaptive pacing to usual medical care, compared to usual medical care alone, for Chronic Fatigue Syndrome [ME] ).

The Governance arrangements for NHS Research Ethics Committees, 2001, state:

“9.7 The primary task of a REC lies in the ethical review of research proposals and their supporting documents, with special attention given to the nature of any intervention and its safety for participants, to the informed consent process, documentation, and to the suitability and feasibility of the protocol”.

In relation to the MRC PACE Trial on “CFS/ME”, there are serious concerns about all these issues.

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