The Medicines for Human Use (Clinical Trials) Regulations 2004

Recognition of ethics committeesU.K.

7.—(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 [F1(4)],

where it considers it necessary or appropriate to do so.

Textual Amendments