§ Dr. CableTo ask the Secretary of State for Health what ethical guidelines are given to Government-supported medical researchers into the Alzheimer's drug Aricept about administering placebos to patients who could benefit from the drug. [84261]
§ Mr. HuttonAll research involving patients and supported by the Department, the National Health Service or the Medical Research Council is required to obtain ethical approval from the appropriate research ethics committee(s). Scientific review mechanisms also consider ethical aspects of research, including the appropriateness of randomisation and other study designs, and the use of placebos.
Guidance on research ethics is provided in the Department's Guidance for Local Research Ethics Committees and for Mulitcentre Research Ethics Committees, in conjunction with: the Royal College of Physicians' "Guidelines on the Practice of Ethics Committees in Medical Research involving Human Subjects"; and the Medical Research Council's "Guidelines for Good Practice in Clinical Trials". Copies of these will be placed in the Library.
The AD2000 trial of Aricept is being supported through the NHS research and development programme. The protocol allows for patients to be randomly assigned to Aricept or a placebo when there is uncertainty (on 422W the basis of the known effects of Aricept and the characteristics of the patient), as to whether or not Aricept would offer the patient any overall benefit. The trial has been approved by the Regional Multi-Centre Research Ethics committee and the Local Research Ethics Committee for each particular centre at which the trial is being conducted.