The Medicines for Human Use (Clinical Trials) Regulations 2004

Membership U.K.

3.—(1) An ethics committee shall consist of—

(a) expert members; and

(b) lay members.

(2) An ethics committee shall have no more than 18 members.

(3) [F1 The] members of an ethics committee shall be appointed by the appointing authority.

(4) A person shall not be eligible for appointment as a lay member of an ethics committee if, in the course of his employment or business, he—

(a) provides medical, dental or nursing care, or

(b) conducts clinical research.

(5) An appointing authority shall, in relation to an ethics committee, exercise their power under sub-paragraph (3) so as to ensure that—

(a) at least one third of the total membership shall be lay members; and

(b) at least half of the lay members must be persons who are not, or who never have been—

(i) health care professionals,

(ii) persons involved in the conduct of clinical research, other than as a subject of such research, or

(iii) a chairman, member or director of—

(aa) a health service body, or

(bb) a body, other than a health service body, which provides health care[F2 ; or

[F3 (cc) an integrated care board.]]

[F4 (6) References in sub-paragraph (5) to a health service body include—

(a) a Strategic Health Authority,

(b) a Primary Care Trust,

(c) the National Institute for Health and Care Excellence, F5 ...

(d) the Health and Social Care Information Centre.]

[F6 (e) Health Education England, and

(f) the Health Research Authority.]

Textual Amendments

F1 Word in Sch. 2 para. 3(3) substituted (1.5.2008) by The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008 (S.I. 2008/941), regs. 1(1), 5(3)

F2 Sch. 2 para. 3(5)(b)(iii)(cc) and preceding word inserted (1.10.2012) by The NHS Commissioning Board Authority (Abolition and Transfer of Staff, Property and Liabilities) and the Health and Social Care Act 2012 (Consequential Amendments) Order 2012 (S.I. 2012/1641), art. 1(2)(b), Sch. 3 para. 8(3)(a)

F3 Sch. 2 para. 3(5)(b)(iii)(cc) substituted (1.7.2022) by The Health and Care Act 2022 (Consequential and Related Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/634), regs. 1(2), 19(2)(a)

F4 Sch. 2 para. 3(6) inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), arts. 1(2), 11, Sch. 2 para. 66(3)

F5 Word in Sch. 2 para. 3(6)(c) omitted (1.4.2015) by virtue of The Care Act 2014 (Health Education England and the Health Research Authority) (Consequential Amendments and Revocations) Order 2015 (S.I. 2015/137), art. 1, Sch. 2 para. 3(a)

F6 Sch. 2 para. 3(6)(e)(f) added (1.4.2015) by The Care Act 2014 (Health Education England and the Health Research Authority) (Consequential Amendments and Revocations) Order 2015 (S.I. 2015/137), art. 1, Sch. 2 para. 3(b)