Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 7-10

Document information
Reference	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
Validity area	GBR
Scope(s)	HM
Document name	The Medicines for Human Use (Clinical Trials) Regulations 2004
Version / Revision	01-May-2004
Status	Current
Document type	Legal act
Language(s)	EN
Description	The Medicines for Human Use (Clinical Trials) Regulations 2004
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 1 — Unit 1.5.3
Scope	HM
Document part	Article 7-10
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Ethics committee, Requirements
Comment	Recognition of committees as ethics committees

Content

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 (5), where it considers it necessary or appropriate to do so.

Revocation of recognition 8. The Authority may revoke a recognition of an ethics committee if they are satisfied that—

(a)the provisions of Schedule 2 are not complied with in relation to that committee; (b)the committee is failing to perform its functions under these Regulations adequately or at all; or (c)it is otherwise necessary or expedient to do so. Constitution and operation of ethics committees 9. The provisions of Schedule 2 have effect in relation to ethics committees.

Other functions of the Authority 10.—(1) The Authority shall monitor the extent to which ethics committees adequately perform their functions under these Regulations.

(2) The Authority may provide advice and assistance to ethics committees with respect to the performance of their functions.