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28. In Schedule 2 to the principal Regulations (additional provisions relating to ethics committees)—
(a)in paragraph 1 (interpretation), in the definition of “appointing authority”—
(i)in sub-paragraph (b), omit “or”,
(ii)in sub-paragraph (c), for “the Authority;” substitute “the Authority, or”,
(iii)after sub-paragraph (c), insert the following sub-paragraph—
“(d)in relation to the Gene Therapy Advisory Committee, the Secretary of State;”;
(b)in paragraph 6 (committees, meetings and proceedings), after sub-paragraph (4), insert—
“(5) An ethics committee shall retain all the documents relating to a clinical trial on which it gives an opinion for—
(a)where the trial proceeds, at least three years from the conclusion of the trial; or
(b)where the trial does not proceed, at least three years from the date of the opinion.”; and
(c)in paragraph 8 (deputies and co-opted members), in sub-paragraph (6), for “(4)” substitute “(5)”.
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