PART 2ETHICS COMMITTEES
Recognition of ethics committees7
1
Subject to paragraph (3), the Authority may, by a notice in writing, recognise a committee as an ethics committee for the purposes of these Regulations if—
a
an application in relation to that committee has been made in accordance with paragraph (2); and
b
they are satisfied that the proposed arrangements for the membership and operation of that ethics committee would—
i
enable that committee to perform the functions of an ethics committee adequately; and
ii
comply with the provisions of Schedule 2.
2
An application for recognition of an ethics committee shall be—
a
made in writing to the Authority; and
b
accompanied by such information, documents and particulars as are necessary to enable the Authority to determine the application.
3
If any committee—
a
was established or recognised by—
i
the Secretary of State,
ii
the Scottish Ministers,
iii
the National Assembly for Wales,
iv
the Department of Health, Social Services and Public Safety, or
v
a Strategic Health Authority, Health Board or Health and Social Services Board,
for the purpose of advising on the ethics of research investigations on human beings, and
b
was in existence on 30th April 2004,
the Authority may recognise that committee in accordance with paragraph (1) without an application for recognition being submitted.
4
When recognising a committee the Authority shall specify—
a
whether the committee may act for the entire United Kingdom or only for a particular area of the United Kingdom;
b
the description or class of clinical trial in relation to which it may act as an ethics committee; and
c
any other conditions or limitations that apply to that committee.
5
The Authority may—
a
vary the area for which a committee recognised under this regulation acts,
b
vary the description or class of clinical trial in relation to which it may act as an ethics committee, or
c
vary or revoke any conditions or limitations imposed under paragraph (5),
where it considers it necessary or appropriate to do so.