The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006

Amendment of Schedule 2 to the principal Regulations

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)”.