Appendix S.I. 2004/1031: memorandum from
the Department of Health
Medicines for Human Use (Clinical Trials) Regulations
2004 (S.I. 2004/1031)
1. The Committee has requested a memorandum on the
following points concerning the above Regulations:
(1) Does the Department agree that -
(a) the reference to paragraph (5), in regulation
7(5)(c), should have been a reference to paragraph (4);
(b) the reference to regulation 13, in regulation
16(1), should have been a reference to regulation 14;
(c) in regulation 23(1), "paragraphs (1)
and (2)" should have read "paragraphs (2) and (3)";
(d) the reference to regulation 24(4), in regulations
26(1)(c), 29(c) and 31(1)(a)(ii), should have been a reference
to regulation 24(5);
(e) the reference to regulation 15(6) and to
regulation 16(5), in paragraph 4(2)(d and (f)) of Schedule 4,
should have been a reference to regulation 15(5) and to regulation
16(6) respectively;
(f) the reference to regulation 11(3)(a), in
paragraph 5 of Schedule 4, should have been a reference to regulation
12(3)(a)?
(2) Paragraph 1 of Schedule 4 deals with the
case where the Authority receives a notice pursuant to regulation
16(3) or (7) that a chief investigator wishes to appeal against
an ethics committee opinion which is not favourable. Explain
why paragraph 1 is not expressed to apply to the case where the
Authority receives a notice pursuant to regulation 16(4)(b), given
that regulation 16(8) provides that Schedule 4 is to have effect
to regulate the procedure where the Authority receives a notice
in accordance with paragraph (3), (4) or (7) of regulation 16.
2. In relation to the first point, the Department
agrees that the references should have been as stated by the Committee.
3. In relation to the second point, paragraph 1(1)
of Schedule 4 should have been expressed to apply to the case
where the Authority receives a notice pursuant to regulation 16(4)(b).
The reference was omitted in error.
4. The errors will be corrected at the earliest opportunity.
11th May 2004
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