Regulation 28(1) of, and Schedule 1 to, the Clinical Trials Regulations implement, among other provisions, article 5(a) of that Directive, which requires that an incapacitated adult cannot be included in a clinical trial of a medicine without the consent of his legal representative.

Regulation 2 amends Schedule 1 to creates an exception to the general rule that an incapacitated adults cannot be included in a clinical trial unless the conditions in paragraphs 1 to 5 of Part 5 of Schedule 1 have been met; in particular that the adult’s legal representative (as defined) has given informed consent. The exception applies only when the following conditions are met: (i) treatment is required urgently; (ii) the nature of the trial also requires urgent action; (iii) it is not reasonably practicable to meet the conditions in paragraphs 1 to 5 of Part 5 (obtaining consent etc); and (iv) an ethics committee has given approval to the procedure under which the action is taken.

Regulation 3 amends the Adults with Incapacity (Scotland) Act 2000 consequentially.

A full regulatory impact assessment of the effect that this instrument will have on the costs of business is available from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London, SW8 5NQ and copies have been placed in the library of both Houses of Parliament.