Amendment of Schedule 2 to the Clinical Trials Regulations5
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.
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).