Amendment of the Clinical Trials Regulations2
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.