Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (1) - (6)

Document information
Reference	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
Validity area	GBR
Scope(s)	HM
Document name	The Medicines for Human Use (Clinical Trials) Regulations 2004
Version / Revision	01-May-2004
Status	Current
Document type	Legal act
Language(s)	EN
Description	The Medicines for Human Use (Clinical Trials) Regulations 2004
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 1 — Unit 1.5.4
Scope	HM
Document part	Article 15 (1) - (6)
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Ethics committee, Regulatory submission, Reporting timeline
Comment	Ethics committee opinion: assessment criteria and timelines

Content

Application for ethics committee opinion 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 paragraph 2 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; (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 persons incapable of giving informed consent, whether the research is justified having regard to the conditions and principles specified in Part 5 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.