Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 7-10: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 | ||
| | |module=1 | ||
| | |unit=1.5.3 | ||
| | |scope=HM | ||
| | |doc_part=Article 7-10 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
Β | |tags=TAG-00134-Eth-kom ++ TAG-00340-Req-nfo | ||
|tags_display=[[Glossary:TAG-00134-Eth-kom|Ethics committee]], [[Glossary:TAG-00340-Req-nfo|Requirements]] | |||
Β | |comment=Recognition of committees as ethics committees | ||
|content=7.β(1) Subject to paragraph (3), the Authority may, by a notice in writing, recognise a committee as an ethics committee for the purposes of these Regulations ifβ | |||
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7.β(1) Subject to paragraph (3), the Authority may, by a notice in writing, recognise a committee as an ethics committee for the purposes of these Regulations ifβ | |||
(a)an application in relation to that committee has been made in accordance with paragraph (2); and | (a)an application in relation to that committee has been made in accordance with paragraph (2); and | ||
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(2) The Authority may provide advice and assistance to ethics committees with respect to the performance of their functions. | (2) The Authority may provide advice and assistance to ethics committees with respect to the performance of their functions. | ||
}} | |||
Latest revision as of 13:49, 16 July 2026
| 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 β Unit 1.5.3 |
| Scope | HM |
| Document part | Article 7-10 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Ethics committee, Requirements |
Content
7.β(1) Subject to paragraph (3), the Authority may, by a notice in writing, recognise a committee as an ethics committee for the purposes of these Regulations ifβ
(a)an application in relation to that committee has been made in accordance with paragraph (2); and (b)they are satisfied that the proposed arrangements for the membership and operation of that ethics committee wouldβ (i)enable that committee to perform the functions of an ethics committee adequately; and (ii)comply with the provisions of Schedule 2. (2) An application for recognition of an ethics committee shall beβ
(a)made in writing to the Authority; and (b)accompanied by such information, documents and particulars as are necessary to enable the Authority to determine the application. (3) If any committeeβ
(a)was established or recognised byβ (i)the Secretary of State, (ii)the Scottish Ministers, (iii)the National Assembly for Wales, (iv)the Department of Health, Social Services and Public Safety, or (v)a Strategic Health Authority, Health Board or Health and Social Services Board,for the purpose of advising on the ethics of research investigations on human beings, and (b)was in existence on 30th April 2004, the Authority may recognise that committee in accordance with paragraph (1) without an application for recognition being submitted.
(4) When recognising a committee the Authority shall specifyβ
(a)whether the committee may act for the entire United Kingdom or only for a particular area of the United Kingdom; (b)the description or class of clinical trial in relation to which it may act as an ethics committee; and (c)any other conditions or limitations that apply to that committee. (5) The Authority mayβ
(a)vary the area for which a committee recognised under this regulation acts, (b)vary the description or class of clinical trial in relation to which it may act as an ethics committee, or (c)vary or revoke any conditions or limitations imposed under paragraph (5), where it considers it necessary or appropriate to do so.
Revocation of recognition 8. The Authority may revoke a recognition of an ethics committee if they are satisfied thatβ
(a)the provisions of Schedule 2 are not complied with in relation to that committee; (b)the committee is failing to perform its functions under these Regulations adequately or at all; or (c)it is otherwise necessary or expedient to do so. Constitution and operation of ethics committees 9. The provisions of Schedule 2 have effect in relation to ethics committees.
Other functions of the Authority 10.β(1) The Authority shall monitor the extent to which ethics committees adequately perform their functions under these Regulations.
(2) The Authority may provide advice and assistance to ethics committees with respect to the performance of their functions.
