The Medicines for Human Use (Clinical Trials) Regulations 2004

Transfer of functions

13.—(1) This paragraph applies where—

(a) recognition of an ethics committee is revoked in accordance with regulation 8; or

(b) an ethics committee is abolished or ceases operation.

(2) If the person who was the appointing authority before revocation, abolition or the ceasing of operation of the committee (“the old committee”) is the Authority, that person may nominate another ethics committee as responsible for the work of the committee.

(3) If the person referred to in sub-paragraph (2) was not the Authority, that person may only nominate an ethics committee with the approval of the Authority.

(4) If the person referred to in sub-paragraph (2) no longer exists or if that person fails to nominate another ethics committee, the Authority shall nominate such a committee.

(5) Where an ethics committee is nominated in accordance with the preceding sub-paragraphs—

(a) that committee shall consider any applications made to the old committee in accordance with regulation 14, if the old committee had not given an opinion before the date of revocation, abolition or ceasing of operation;

(b) that committee shall be the relevant ethics committee for any clinical trial in relation to which the old committee had given a favourable opinion in accordance with regulation 15.