Citation, commencement and interpretation

1. —(1) These Regulations may be cited as the Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006 and shall come into force on 12th December 2006.

(2) In these Regulations, the “Clinical Trials Regulations” means the Medicines for Human Use (Clinical Trials) Regulations 2004( 3 ).

Amendment of the Clinical Trials Regulations

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. ” .

Amendment of the Adults with Incapacity (Scotland) Act 2000

3. In section 51 of the Adults with Incapacity (Scotland) Act 2000( 4 ) (authority for research) in subsection (3A)—

(a) omit “and” at the end of paragraph (a); and

(b) after paragraph (b), insert—

“ (c) without the consent of any guardian or welfare attorney, or the adult’s nearest relative, if—

(i) treatment is being, or is about to be, provided for an adult who is incapable in relation to a decision about participation in the research as a matter of urgency;

(ii) having regard to the nature of the clinical trial and of the particular circumstances of the case it is necessary to take action for the purposes of the clinical trial as a matter of urgency;

(iii) it has not been reasonably practicable to obtain the consent of any such person;

(iv) it has not been reasonably practicable to obtain the consent of any of the persons mentioned in paragraph (b)(ii)(A) or (B); and

(v) the action to be taken is carried out in accordance with a procedure approved by the Ethics Committee or any other ethics committee or by an appeal panel appointed under Schedule 4 of the Medicines for Human Use (Clinical Trials) Regulations 2004 ( S.I. 2004/1031 ) at the time it gave its favourable opinion in relation to the clinical trial. ” .