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Clinical Trial Regulations

Volume 448: debated on Tuesday 11 July 2006

To ask the Secretary of State for Health when she will bring forward the proposed amendment to the Clinical Trials Regulations of 2004 on consent; and what steps she is taking (a) to halt and (b) to reverse the reductions in emergency care research in the meantime. (83472)

The Government are committed to the support for emergency care research. Following detailed consultation with those involved in emergency research, a provision was included in the UK Clinical Trials Regulations1 which precludes incapacitated adults participating in trials without the prior consent of their legal representative. However, after the regulations came into force, researchers involved in a large trial requiring immediate administration of a clot busting drug to resuscitate patients following a heart attack found it was impracticable to obtain consent using the provisions of the regulations. This was because the patient had usually lost capacity to consent and the limited time available for administering the trial drug did not allow contact to be made with the legal representative.

The Government therefore consulted on a proposed amendment to the regulations which would enable incapacitated adults to be entered into trials prior to the consent of a legal representative having been obtained where the trial was of a medicine to be used in emergency situations. Consent would subsequently need to be obtained. The proposal received wide support.

However, the occurrence of serious adverse reactions in a drug trial in healthy volunteers in March has led to heightened scrutiny of all clinical trial regulation, including a re-examination of this proposal to ensure that it can be justified. That re-examination is ongoing.

1 The Medicines for Human Use (Clinical Trials) Regulations 2004 [SI 20004/1031].