- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
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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).”.
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