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Children in Care: Clinical Trials

Volume 479: debated on Thursday 17 July 2008

To ask the Secretary of State for Children, Schools and Families what regulations and guidelines govern the participation of children in care in drug trials. (218463)

I have been asked to reply.

Clinical Trials in the European Union are undertaken in accordance with the requirements of Directive 2001/20/EC of the European Parliament and of the European Council on the approximation of the laws, regulations and administrative provisions of the member states relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. The Directive provides for the protection of clinical trial subjects, including minors, and sets out requirements for the ethical review of clinical trials. The Directive provides for a general rule that minors may only be included in a clinical trial if the informed consent of the parents or legal representative has been obtained.

The Directive was transposed into United Kingdom legislation as the Medicines for Human Use (Clinical Trials) Regulations on 1 May 2004. Two further Commission Directives setting out the detailed principles and guidelines of good clinical practice have been agreed and implemented into UK law. On 1 May 2008 the Government amended UK legislation, following a public consultation, to allow minors to be entered into a trial prior to consent having been obtained from a person with parental responsibility or legal representative in trials of emergency medicines where and while certain conditions are met.