Regulation 12 Amendment to regulation 12I1
United Kingdom As made
(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
Commencement
Footnotes
- f1
-
Regulation 12(3) was amended by S.I. 2006/1928.