Who regulates trials?
Clinical research in the UK is a highly regulated industry; clinical studies must comply with the EU Clinical Trials Directive which is enforced in the United Kingdom by two governmental bodies, The Medicines and Healthcare products Regulatory Agency (MHRA) and by Approved Ethics Committees. The Clinical Trials Directive dictates that written consent from a volunteer is mandatory. As a volunteer you have to be fully informed about all aspects, risks and possible side effects of a trial before you give written consent.
