The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008

Amendment of Schedule 2 to the Clinical Trials Regulations

5.—(1) Schedule 2 to the Clinical Trials Regulations (additional provisions relating to ethics committees) shall be amended as follows.

(2) In paragraph 1 (interpretation), in the definition of “expert member”, in sub-paragraph (b), for “clinical trials” substitute “clinical research”.

(3) In paragraph 3 (membership), in sub-paragraph (3), for “Subject to paragraph 7, the” substitute “The”.

(4) In paragraph 6 (committees, meetings and proceedings)—

(a) in sub-paragraph (2), for “sub-paragraph (4)” substitute “sub-paragraphs (4) and (4A)”;

(b) for sub-paragraph (4) substitute the following sub-paragraphs—

“(4) All valid applications for an ethics committee opinion must be considered by a full meeting of an ethics committee.

(4A) Where a full meeting of an ethics committee has considered a valid application and reached a provisional opinion, it may delegate the final determination of its opinion in accordance with regulation 15 to the Chairman of the ethics committee or a sub-committee of specified members.”; and

(c) after sub-paragraph (5) insert the following sub-paragraph—

“(6) For the purposes of this paragraph, a “full meeting of an ethics committee” is one at which at least seven members of the committee (including any members co-opted under paragraph 8) are present, including at least—

(a) one lay member who is not and never has been—

(i) a health care professional, or

(ii) a chairman, member, director, officer or employee of a health service body; and

(b) one expert member.”.

(5) In paragraph 7 (deputies and co-opted members), in sub-paragraph (1), for “An ethics committee” substitute “The appointing authority”.

(6) In paragraph 8 (co-opted members)—

(a) in sub-paragraph (3) for “an ethics committee” substitute “a committee that advises or has advised on the ethics of research involving human subjects”; and

(b) for sub-paragraph (5) substitute the following sub-paragraph—

“(5) A co-opted member shall hold and vacate office in accordance with the ethics committee’s standing orders and operating procedures adopted under paragraph 6(3).”.