It appears that the PACE Trial did not conform to the Declaration of Helsinki in full, for example:
participants and others have asserted that coercion was used (breaching A5,
A8, B20 and B22): it is understood that the policy at the now-closed Fatigue Clinic at the Royal Free Hospital was that patients who were asked but declined to enter the PACE Trial were to be discharged from the Clinic and would have no further access to a Clinic doctor for medical advice (access which, apart from symptomatic medical care, they might need in order to support a claim for State benefits, as a GP cannot endorse an application for
Disability Living Allowance). Having to choose between the option of an inappropriate intervention or no intervention plus no further access to a clinic doctor is not true consent. If Professor White (who was in overall charge of
the RFH Fatigue clinic) was recruiting patients attending the Royal Free Fatigue Service Clinic to the PACE Trial on the basis that non-compliers would be discharged from the Clinic raises the possibility that he was recruiting only CBT/GET-compliant patients to his MRC trial, which would decrease the number of trial drop-outs at a stroke, and this would be to his advantage (see
http://www.meactionuk.org.uk/COERCION_AS_Cure.htm); furthermore, as noted above, a Minister of State confirmed that GPs were offered financial inducements to procure participants for the trial, and those GPs may have brought undue pressure on patients to enter the trial, which in turn may have compromised their own relationship with patients.