1.—(1) Subject to the following sub-paragraphs, where the United Kingdom Ethics Committee Authority (“the Authority”) receive a notice pursuant to regulation 16(3) [F1, (4)(b)] or (7) that a chief investigator wishes to appeal against an ethics committee opinion which is not favourable, the Authority shall, subject to sub-paragraph (2)—U.K.
(a)direct that the application for that opinion may be considered by another ethics committee specified in the direction; or
(b)appoint a panel in accordance with paragraph 3 (“an appeal panel”) and refer the opinion to that panel.
(2) Subject to sub-paragraph (4), the Authority may refuse to give a direction or appoint a panel pursuant to sub-paragraph (1) where it considers that the grounds for appealing against the opinion are unfounded.
(3) Where the Authority refuse to give a direction or appoint a panel pursuant to sub-paragraph (1), the Authority shall send a notice to the chief investigator setting out their reasons for refusal.
(4) Where the opinion was given by the Gene Therapy Advisory Committee, the Authority must appoint a panel in accordance with paragraph 3 and refer the opinion to that panel.
Textual Amendments
F1Word in Sch. 4 para. 1(1) inserted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 30(a)