Regulation 24 Review and appeal relating to ethics committee opinionF1

(1)

This regulation applies where—

(a)

a sponsor has been notified under regulations 18(2) or 18B(2) that—

(i)

the trial is not approved and the grounds for not approving the trial relate to the ethics committee opinion, or

(ii)

the trial is approved subject to specified conditions and those conditions relate to the ethics committee opinion;

(b)

the ethics committee has modified a clinical trial approval under regulation 21; or

(c)

the sponsor has been notified under regulation 22A(3) or 22C(2) that—

(i)

a proposed substantial modification is not approved and the grounds for not approving the modification relate to the ethics committee opinion, or

(ii)

the proposed substantial modification is approved subject to conditions and those conditions relate to the ethics committee opinion.

(2)

This regulation does not apply in relation to an opinion given by—

(a)

an Ethics Committee constituted by regulations made by the Scottish Ministers under section 51(6) of the Adults with Incapacity (Scotland) Act 2000; or

(b)

an ethics committee pursuant to paragraph 2 of Schedule 4.

(3)

Where this regulation applies, the sponsor may, within the period of 28 days beginning with the day on which notice is given or such extended period as the Authority may in any particular case allow, give notice in writing to the Authority—

(a)

stating the sponsor’s wish to appeal against the opinion; and

(b)

setting out their representations with respect to that opinion.

(4)

Schedule 4 has effect to regulate the procedure where the Authority receives a notice in accordance with paragraph (3).

Annotations

Textual amendments

F1: Regs. 14-26 substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 14