OpenLegislation

Regulation 5 United Kingdom Ethics Committees Authority

(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)

F1the Health Research Authority;

(b)

the F2Welsh Ministers;

(c)

the Scottish Ministers; and

(d)

the F3Department of Health in Northern Ireland.

(2)

The functions of the Authority—

(a)

may, by agreement between them, be performed by any one of F4the Health Research Authority, the F5Welsh Ministers, the Scottish Ministers and the F6Department of Health in Northern Ireland acting alone, or any two or more of them acting jointly; and

(b)

may be performed by any one of the Health Research Authority, the Welsh Ministers, the Scottish Ministers and the Department of Health in Northern Ireland acting alone solely in relation to a part of the United Kingdom with respect to which F7the Health Research Authority, 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 F8the Health Research Authority, the F9Welsh Ministers, the Scottish Ministers and the F10Department of Health in 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 F11... 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; F12...

(b)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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.

Annotations

Textual amendments

F1

Words in reg. 5(1) substituted (1.1.2015) by Care Act 2014 (c. 23), ss. 116(a), 127 (with s. 119(3)); S.I. 2014/2473, art. 5(h)

F2

Words in reg. 5(1) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 6(2)(a)

F3

Words in reg. 5(1) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 6(2)(b)

F4

Words in reg. 5(2) substituted (1.1.2015) by Care Act 2014 (c. 23), ss. 116(a), 127 (with s. 119(3)); S.I. 2014/2473, art. 5(h)

F5

Words in reg. 5(2) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 6(2)(a)

F6

Words in reg. 5(2) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 6(2)(b)

F7

Words in reg. 5(2) substituted (1.1.2015) by Care Act 2014 (c. 23), ss. 116(b), 127; S.I. 2014/2473, art. 5(h)

F8

Words in reg. 5(3) substituted (1.1.2015) by Care Act 2014 (c. 23), ss. 116(a), 127 (with s. 119(3)); S.I. 2014/2473, art. 5(h)

F9

Words in reg. 5(3) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 6(2)(a)

F10

Words in reg. 5(3) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 6(2)(b)

F11

Words in reg. 5(4) omitted (28.4.2026) by virtue of The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 6(3)

F12

Reg. 5(5)(b) and word omitted (28.4.2026) by virtue of The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 6(4)