Regulation 28 Amendment of Schedule 2 to the principal Regulations

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)”.