Part 12Amendment to the Schedules

Amendment to Schedule 4

regulation 40 + 40.—(1) Schedule 4 (appeal against unfavourable ethics committee opinion) is amended as follows.

(2) In paragraph 1—

regulation 40 2 a + (a)in sub-paragraph (1)(1)—

regulation 40 2 a i + (i)for “regulation 16(3), 4(b) or (7)” substitute “regulation 24(3)”;

regulation 40 2 a ii + (ii)for “chief investigator” substitute “sponsor”;

regulation 40 2 a iii + (iii)omit paragraph (b) and the “or” preceding it;

regulation 40 2 b + (b)in sub-paragraph (2) omit—

regulation 40 2 b i + (i)“Subject to sub-paragraph (4),”;

regulation 40 2 b ii + (ii)“or appoint a panel”;

regulation 40 2 c + (c)in sub-paragraph (3)—

regulation 40 2 c i + (i)omit “or appoint a panel”;

regulation 40 2 c ii + (ii)for “chief investigator” substitute “sponsor”;

regulation 40 2 d + (d)omit sub-paragraph (4).

(3) In paragraph 2—

regulation 40 3 a + (a)in sub-paragraph (a)—

regulation 40 3 a i + (i)for “ethics committee which gave the unfavourable opinion” substitute “Authority”;

regulation 40 3 a ii + (ii)for “chief investigator” substitute “sponsor”;

regulation 40 3 a iii + (iii)at the end, omit “and”;

regulation 40 3 b + (b)in sub-paragraph (b), for “regulation 15,” substitute “regulation 17; and”;

regulation 40 3 c + (c)after sub-paragraph (b), insert—

“(c)that committee shall within 30 days beginning with the day on which the application is sent to the committee under paragraph (a), or such extended period as the Authority may in any particular case allow, either confirm the opinion or give a favourable opinion.”.

(4) Omit paragraphs 3 to 6.