2. In Schedule 1 to the Clinical Trial Regulations (conditions and principles of good clinical practice and for the protection of clinical trial subjects), in Part 1 (application and interpretation), in paragraph 1—
(a)in sub-paragraph (4), for “If” substitute “Subject to sub-paragraphs (6) and (7), if”; and
(b)after sub-paragraph (5), insert the following sub-paragraphs—
“(6) Sub-paragraph (7) applies if treatment is being, or is about to be, provided for a subject who is an incapacitated adult as a matter of urgency and, having regard to the nature of the clinical trial and of the particular circumstances of the case—
(a)it is also necessary to take action for the purposes of the clinical trial as a matter of urgency; but
(b)it is not reasonably practicable to meet the conditions set out in paragraphs 1 to 5 of Part 5.
(7) Where this sub-paragraph applies, paragraphs 1 to 5 of Part 5 shall not apply in relation to the subject if the action specified in sub-paragraph (6) is carried out in accordance with a procedure approved by an ethics committee or by an appeal panel appointed under Schedule 4 at the time it gave its favourable opinion.”.