§ Baroness Finlay of Llandaffasked Her Majesty's Government:
What action they have taken or are planning regarding the Thrombolysis in Cardiac Arrest Study in the light of the approval in principle of the relevant Multi-centre Research Ethics Committee and the requirements of the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031). [HL3925]
§ The Parliamentary Under-Secretary of State, Department of Health (Lord Warner)The Government recognise the importance that ethical and necessary research in emergency situations continues to develop184WA and improve treatment and care. The Medicines for Human use (Clinical Trials) Regulations 2004 apply to clinical trials in emergency situations. Guidance is being considered on how informed consent can be obtained from a legal representative in an emergency situation where the individual affected is incapable of giving consent. The Government are considering as a matter of urgency whether any changes to the regulations are needed or whether further guidance for clinical trials in emergency situations will suffice.
The Department of Health is committed to improving and developing strategies for treatment of patients suffering from heart attack and cardiac arrest. The National Defibrillator Programme and funding of paramedic thrombolysis are examples of this commitment.