Regulation 12 Amendment to regulation 12

(1)

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

(2)

In paragraph (2)—

(a)

in sub-paragraph (a), for “subject” substitute “participant”;

(b)

in sub-paragraph (b), for “subjects” substitute “participants”.

(3)

For paragraph (3)^f1 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).

Annotations

Footnotes

f1: Regulation 12(3) was amended by S.I. 2006/1928.