MRC response to Draft Amendment to UK Regulations for Emergency Situations
In August 2005 the Medicines and Healthcare products Regulatory Agency (MHRA) published a consultation on a proposed amendment to the Medicines for Human use (Clinical Trials) Regulations 2004. The amendment would provide, in certain emergency situations, an exception to the general requirement that informed consent must be obtained from an incapacitated patient’s legal representative prior to his or her enrolment in clinical trials of medicines.
Read the MRC’s response to the MHRA.