The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025
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Change 1
9 Substitution of regulation 9
For regulation 9 (constitution and operation of ethics committees) substitute— Operation of ethics committees 9 (1) This regulation does not apply in relation to an Ethics Committee constituted by regulations made by the Scottish Ministers under section 51(6) of the Adults with Incapacity (Scotland) Act 2000. (2) An ethics committee established under regulation 6 must— (a) be constituted of 5 or more members, appointed by the Authority, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial; and (b) include one member appointed by the Authority to be a Chairperson. (3) An ethics committee may— (a) establish sub-committees consisting of members of the committee; and (b) make arrangements for the exercise, on behalf of the committee, of any of its functions by such a sub-committee, in accordance with the standing orders and standard operating procedures adopted under paragraph (4). (4) An ethics committee— (a) must, subject to the approval of the Authority, make standing orders, and adopt standard operating procedures for the regulation of its proceedings and business; and (b) may, subject to the approval of the Authority, vary or revoke such orders or procedures. (5) The meetings and proceedings of an ethics committee and its sub-committees must be conducted in accordance with the standing orders made, and the standard operating procedures adopted, under paragraph (4). (6) All applications for an ethics committee opinion must be considered by a full meeting of an ethics committee. (7) In this regulation— “a full meeting of an ethics committee” means a meeting at which— at least 5 members of the committee are in attendance, which may include attendance in person or remote attendance; the members present collectively satisfy the requirement in paragraph (2); and one of the members present is a lay member; “lay member” means an individual who does not have a formal qualification related to, or professional experience in, the field of clinical research or healthcare. .
9 Substitution of regulation 9
For regulation 9 (constitution and operation of ethics committees) substitute— Operation of ethics committees 9 (1) This regulation does not apply in relation to an Ethics Committee constituted by regulations made by the Scottish Ministers under section 51(6) of the Adults with Incapacity (Scotland) Act 2000. (2) An ethics committee established under regulation 6 must— (a) be constituted of 5 or more members, appointed by the Authority, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial; and (b) include one member appointed by the Authority to be a Chairperson. (3) An ethics committee may— (a) establish sub-committees consisting of members of the committee; and (b) make arrangements for the exercise, on behalf of the committee, of any of its functions by such a sub-committee, in accordance with the standing orders and standard operating procedures adopted under paragraph (4). (4) An ethics committee— (a) must, subject to the approval of the Authority, make standing orders, and adopt standard operating procedures for the regulation of its proceedings and business; and (b) may, subject to the approval of the Authority, vary or revoke such orders or procedures. (5) The meetings and proceedings of an ethics committee and its sub-committees must be conducted in accordance with the standing orders made, and the standard operating procedures adopted, under paragraph (4). (6) All applications for an ethics committee opinion must be considered by a full meeting of an ethics committee. (7) In this regulation— “a full meeting of an ethics committee” means a meeting at which— at least 5 members of the committee are in attendance, which may include attendance in person or remote attendance; the members present collectively satisfy the requirement in paragraph (2); and one of the members present is a lay member; “lay member” means an individual who does not have a formal qualification related to, or professional experience in, the field of clinical research or healthcare. .
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