The Medicines for Human Use (Clinical Trials) Regulations 2004

Ethics committee opinion U.K.

15.—(1) Subject to paragraphs (3) and (4), an ethics committee shall within the specified period following receipt of a valid application, give an opinion in relation to the clinical trial to which the application relates.

(2) Where following receipt of a valid application it appears to the committee that further information is required in order to give an opinion on a trial, the committee may, within the specified period and before giving its opinion, send a notice in writing to the applicant requesting that he furnishes the committee with that information.

(3) Where the committee sends a request in accordance with paragraph (2), the specified period shall be suspended pending receipt of the information requested.

(4) If the clinical trial involves a medicinal product for xenogenic cell therapy, the time limits referred to in paragraphs (1) to (3) shall not apply and the ethics committee may give an opinion in relation to that trial or send a notice under paragraph (2) at any time after receipt of the valid application.

(5) In preparing its opinion, the committee shall consider, in particular, the following matters—

(a) the relevance of the clinical trial and its design;

(b) whether the evaluation of the anticipated benefits and risks as required under [F1 paragraph 10] of Part 2 of Schedule 1 is satisfactory and whether the conclusions are justified;

(c) the protocol;

(d) the suitability of the investigator and supporting staff;

(e) the investigator’s brochure [F2 or, where the investigational medicinal product has a marketing authorization and the product is to be used in accordance with the terms of that authorization, the summary of product characteristics relating to that product];

(f) the quality of the facilities for the trial;

(g) the adequacy and completeness of the written information to be given, and the procedure to be followed, for the purpose of obtaining informed consent to the subjects' participation in the trial;

(h) if the subjects are to include [F3 minors or] persons incapable of giving informed consent, whether the research is justified having regard to the conditions and principles specified in [F4 Part 4 or Part 5 respectively] of Schedule 1;

(i) provision for indemnity or compensation in the event of injury or death attributable to the clinical trial;

(j) any insurance or indemnity to cover the liability of the investigator or sponsor;

(k) the amounts, and, where appropriate, the arrangements, for rewarding or compensating investigators and subjects;

(l) the terms of any agreement between the sponsor and the owner or occupier of the trial site which are relevant to the arrangements referred to in sub-paragraph (k); and

(m) the arrangements for the recruitment of subjects.

(6) If—

(a) any subject of the clinical trial is to be a minor; and

(b) the committee does not have a member with professional expertise in paediatric care,

it shall, before giving its opinion, obtain advice on the clinical, ethical and psychosocial problems in the field of paediatric care which may arise in relation to that trial.

(7) If—

(a) any subject to the clinical trial is to be an adult incapable by reason of physical and mental incapacity to give informed consent to participation in the trial; and

(b) the committee does not have a member with professional expertise in the treatment of—

(i) the disease to which the trial relates, and

(ii) the patient population suffering that disease,

it shall, before giving its opinion, obtain advice on the clinical, ethical and psychosocial problems in the field of that disease and patient population which may arise in relation to that trial.

(8) The ethics committee shall consider, and give an opinion on, any other issue relating to the clinical trial, if—

(a) the committee has been asked by the applicant to consider the issue;

(b) it is, in the committee’s opinion, relevant to the other matters considered by the committee in accordance with this regulation.

(9) Where an ethics committee gives an opinion in accordance with this regulation, it shall publish a summary of that opinion.

(10) In this regulation—

“the specified period” means—

(a)

in the case of a clinical trial involving a medicinal product for gene therapy or somatic cell therapy or a medicinal product containing a genetically modified organism—

(i)

where a specialist group or committee is consulted, 180 days, or

(ii)

where there is no such consultation, 90 days; or

(b)

in any other case, 60 days;

“specialist group or committee” means a group or committee whose functions include the provision of advice on ethical or scientific issues in relation to—

(a)

in the case of medicinal products for gene therapy or somatic cell therapy, the use of such therapies in the treatment of humans; or

(b)

in the case of medicinal products containing genetically modified organisms, the administration of such products to humans.

Textual Amendments

F1 Words in reg. 15(5)(b) substituted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 9(a)

F2 Words in reg. 15(5)(e) inserted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 9(b)

F3 Words in reg. 15(5)(h) inserted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 9(c)(i)

F4 Words in reg. 15(5)(h) substituted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 9(c)(ii)