Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 5-6

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 5-6
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Ethics committee, Competent authority, Responsibilities
Comment	Ethics committee authority and recognition

Content

ETHICS COMMITTEES United Kingdom Ethics Committees Authority 5.—(1) The body responsible for establishing, recognising and monitoring ethics committees in the United Kingdom in accordance with these Regulations is the United Kingdom Ethics Committees Authority, which is a body consisting of—

(a)the Secretary of State for Health; (b)the National Assembly for Wales; (c)the Scottish Ministers; and (d)the Department for Health, Social Services and Public Safety for Northern Ireland. (2) The functions of the Authority—

(a)may, by agreement between them, be performed by any one of the Secretary of State for Health, the National Assembly for Wales, the Scottish Ministers and the Department for Health, Social Services and Public Safety for Northern Ireland acting alone, or any two or more of them acting jointly; and (b)may be performed by any one of the Secretary of State for Health, the National Assembly for Wales, the Scottish Ministers and the Department for Health, Social Services and Public Safety for Northern Ireland acting alone solely in relation to a part of the United Kingdom with respect to which the Secretary of State, the Assembly, the Ministers or the Department, as the case may be, have responsibilities. (3) In accordance with the preceding provisions of this regulation, in these Regulations “the United Kingdom Ethics Committees Authority” (“the Authority”) means any one or more of the Secretary of State for Health, the National Assembly for Wales, the Scottish Ministers and the Department for Health, Social Services and Public Safety for Northern Ireland, and, in the case of anything falling to be done by the Authority, means any one or more of them acting as mentioned in paragraph (2).

(4) The Authority may appoint such persons as they think necessary for the proper discharge by them of their functions, and those persons shall be appointed on such terms and conditions (including conditions as to remuneration, benefits, allowances and reimbursement for expenses) as the Authority think fit.

(5) Arrangements may be made between the Authority and any relevant authority for—

(a)any functions of the Authority to be exercised by, or by members of staff of, the relevant authority; or (b)the provision of staff, premises or administrative services by the relevant authority to the Authority. (6) Any arrangements under paragraph (5) for the exercise of any functions of the Authority shall not affect the responsibility of the Authority.

(7) In this regulation, “relevant authority” means any government department, local or public authority or holder of public office.

Establishment of ethics committees 6.—(1) The Authority may establish ethics committees to act—

(a)for the entire United Kingdom or for such areas of the United Kingdom; and (b)in relation to such descriptions or classes of clinical trials, as the Authority consider appropriate.

(2) The Authority may—

(a)vary the area for which any committee they have established acts or, as the case may be, the descriptions or classes of clinical trials in relation to which such a committee acts; and (b)abolish any such committee. Recognition of ethics committees