Regulation 12 Requirement for authorisation and ethics committee opinion

United Kingdom

(1)

No person shall—

(a)

start a clinical trial or cause a clinical trial to be started; or

(b)

conduct a clinical trial,

unless the conditions specified in paragraph (3) are satisfied.

(2)

No person shall—

(a)

recruit an individual to be a F1participant in a trial;

(b)

issue an advertisement for the purpose of recruiting individuals to be F2participants in a trial,

unless the condition specified in paragraph (3)(a) has been satisfied.

F3(3)

The conditions referred to in paragraphs (1) and (2) are—

(a)

an ethics committee has given a favourable opinion in relation to the clinical trial; and

(b)

the clinical trial has been authorised by the licensing authority,

in accordance with these Regulations.

F4(4)

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

Annotations

F1: Word in reg. 12(2)(a) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 12(2)(a)
F2: Word in reg. 12(2)(b) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 12(2)(b)
F3: Reg. 12(3) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 12(3)
F4: Reg. 12(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), 12(4)