Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Introduction: Difference between revisions
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| | |has_document=Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 | ||
| | |module=1 | ||
| | |unit=1.5.3 | ||
| | |scope=HM | ||
| | |doc_part=3.2 - Introduction | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00134-Eth-kom ++ TAG-00341-Res-ben ++ TAG-00051-Eth-ngs ++ TAG-00329-Saf-lne | |||
|tags_display=[[Glossary:TAG-00134-Eth-kom|Ethics committee]], [[Glossary:TAG-00341-Res-ben|Responsibilities]], [[Glossary:TAG-00051-Eth-ngs|Ethics]], [[Glossary:TAG-00329-Saf-lne|Safety]] | |||
|comment=Role of the ethics committee in trial oversight | |||
|content=3.2 Ethics committee | |||
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3.2 Ethics committee | |||
The role of the ethics committee (or other board responsible for reviewing the trial) is to ensure the protection of the rights and welfare of human subjects participating in clinical trials, as defined by the current revision of the Declaration of Helsinki and national and other relevant regulations, and to provide public reassurance, inter alia, by previewing trial protocols, etc. (see Section 2). | The role of the ethics committee (or other board responsible for reviewing the trial) is to ensure the protection of the rights and welfare of human subjects participating in clinical trials, as defined by the current revision of the Declaration of Helsinki and national and other relevant regulations, and to provide public reassurance, inter alia, by previewing trial protocols, etc. (see Section 2). | ||
The ethics committee should be constituted and operated so that its tasks can be executed free from bias and from any influence of those who are conducting the trial. | The ethics committee should be constituted and operated so that its tasks can be executed free from bias and from any influence of those who are conducting the trial. | ||
The ethics committee should have documented policies and procedures as a basis for its work, which should be available to the public. These should set out the authority under which the committee is established, the number of members elected and their qualifications, a definition of what it will review and its authority to intervene and maintain records of its activities. The documents should also state how frequently the committee will meet and how it interacts with the investigator and/or sponsor. | The ethics committee should have documented policies and procedures as a basis for its work, which should be available to the public. These should set out the authority under which the committee is established, the number of members elected and their qualifications, a definition of what it will review and its authority to intervene and maintain records of its activities. The documents should also state how frequently the committee will meet and how it interacts with the investigator and/or sponsor. | ||
[...] | [...] | ||
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Latest revision as of 13:49, 16 July 2026
| Document information | |
|---|---|
| Reference | WHO WHO - Guidelines for GCP for trials on
pharmaceutical products* 1995 |
| Validity area | WHO |
| Scope(s) | HM |
| Document name | WHO - Guidelines for GCP for trials on
pharmaceutical products* |
| Version / Revision | 1995 |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | World Health Organization
WHO Technical Report Series, No. 850, 1995, Annex 3 Guidelines for good clinical practice (GCP) for trials on pharmaceutical products* |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 — Unit 1.5.3 |
| Scope | HM |
| Document part | 3.2 - Introduction |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Ethics committee, Responsibilities, Ethics, Safety |
Content
3.2 Ethics committee The role of the ethics committee (or other board responsible for reviewing the trial) is to ensure the protection of the rights and welfare of human subjects participating in clinical trials, as defined by the current revision of the Declaration of Helsinki and national and other relevant regulations, and to provide public reassurance, inter alia, by previewing trial protocols, etc. (see Section 2). The ethics committee should be constituted and operated so that its tasks can be executed free from bias and from any influence of those who are conducting the trial. The ethics committee should have documented policies and procedures as a basis for its work, which should be available to the public. These should set out the authority under which the committee is established, the number of members elected and their qualifications, a definition of what it will review and its authority to intervene and maintain records of its activities. The documents should also state how frequently the committee will meet and how it interacts with the investigator and/or sponsor. [...]
