§ Lord WarnerI am today notifying Parliament of the Government's proposals to amend the requirements of the Medicines for Human Use (Clinical Trials) Regulations 2004 for consent in emergency situations.
The Clinical Trials Directive(1)" requires that before an incapacitated person is entered into a clinical trial his or her legal representative must give consent. Our implementing regulations include specific provision for establishing who should act as the legal representative. Since the implementing regulations came into force on 1 May 2004, researchers conducting a large international trial in cardiac arrest (the TROICA trial) have concluded that the scheme for establishing the legal representative and obtaining his or her consent is unworkable for clinical trials set in the context of emergency medicine. Thus, it would prove impossible to include United Kingdom patients in such trials unless the UK's requirements were amended.
The Medicines and Healthcare Products Regulatory Agency will consult on a proposal to amend the regulations so that an incapacitated person can be entered into a clinical trial involving emergency treatment prior to consent being obtained from his or her legal representative. This exception to the requirement for prior consent would be subject to strict safeguards. The proposed approach would be consistent with the accepted international standards for conducting clinical trials in emergency situations as set out in the International Conference on Harmonisation guidelines(2) on good clinical practice, and with the approach for research envisaged in the Mental Capacity Bill.
25WSIt is the Government's view that the proposed amendment would ensure that the rights, safety and well-being of those participating in clinical trials of medicines are protected while also ensuring that new treatments for medical emergencies can be developed in the UK.
1Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. OJ L 121 1.5.2001 p. 34
2Note for guidance on good clinical practice CPMP/ICH 135/95