Part 4Amendment to Part 3 (Authorisation for Clinical Trials and Ethics Committee Opinion)

Amendment to regulation 12

regulation 12 + 12.—(1) Regulation 12 (requirement for authorisation and ethics committee opinion) is amended as follows.

(2) In paragraph (2)—

regulation 12 2 a + (a)in sub-paragraph (a), for “subject” substitute “participant”;

regulation 12 2 b + (b)in sub-paragraph (b), for “subjects” substitute “participants”.

(3) For paragraph (3)(1) substitute—

“(3) The conditions referred to in paragraphs (1) and (2) are—

(a)an ethics committee has given a favourable opinion in relation to the clinical trial; and

(b)the clinical trial has been authorised by the licensing authority,

in accordance with these Regulations.”.

(4) Omit paragraph (4).