Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (7) - (10)

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
Scope	HM
Document part	Article 15 (7) - (10)
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Ethics committee opinion: additional conditions for vulnerable subjects

Content

Application for ethics committee opinion 15.— (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 pyschosocial 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.