MHRA Consultation on Amendment to Clinical Trials Regulations

Proposed amendment to legislative requirements in emergency situations.

The Secretary of State for Health is proposing to amend the legislative requirements of 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/her participation in trials of medicines.

See the consultation document in full at http://medicines.mhra.gov.uk/inforesources/publications/MLX326.pdf

College Response:  Coordinated through Heads of Division, please send comments to your HoD.
End of consultation: 24 Oct 05