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Drug Trials

Volume 79: debated on Monday 20 May 1985

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asked the Secretary of State for Social Services if he will introduce legislation to require drug companies to use the same procedures to gain informed consent to participation in drug trials as is used to gain the informed consent of patients.

The guidelines issued by the Royal College of Physicians recommend that volunteers be given a full explanation of the proposed procedure, including the risks, and that they should ordinarily give written consent to all but trivial procedures. We will consider the need for legislation on this and other aspects of drug trials involving healthy volunteers in the light of the updated advice we are awaiting from the College, the Association of British Pharmaceutical Industries and the Medicines Commission.