Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - informed consent: Difference between revisions
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| | |has_document=Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 | ||
| | |module=3 | ||
| | |unit=3.1.1 | ||
| | |scope=HM | ||
| | |doc_part=Glossary - informed consent | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
 | |tags=TAG-00029-Inf-rte ++ TAG-00244-Def-ini ++ TAG-00043-Goo-tek ++ TAG-00343-Doc-ten | ||
|tags_display=[[Glossary:TAG-00029-Inf-rte|Informed consent]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00343-Doc-ten|Documentation]] | |||
 | |comment=Definition of informed consent (GCP/ICH) | ||
|content=informed consent | |||
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informed consent | |||
A subject's voluntary confirmation of willingness to participate in a particular trial, and the documentation thereof. This consent should only be sought after all appropriate information has | A subject's voluntary confirmation of willingness to participate in a particular trial, and the documentation thereof. This consent should only be sought after all appropriate information has | ||
been given about the trial including an explanation of its status as research, its objectives, potential benefits, risks and inconveniences, alternative treatment that may be available, and of | been given about the trial including an explanation of its status as research, its objectives, potential benefits, risks and inconveniences, alternative treatment that may be available, and of | ||
the subject’s rights and responsibilities in accordance with the current revision of the Declaration of Helsinki (see Appendix 1) | the subject’s rights and responsibilities in accordance with the current revision of the Declaration of Helsinki (see Appendix 1) | ||
}} | |||
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 3 — Unit 3.1.1 |
| Scope | HM |
| Document part | Glossary - informed consent |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Informed consent, Definition, Good clinical practice, Documentation |
Content
informed consent A subject's voluntary confirmation of willingness to participate in a particular trial, and the documentation thereof. This consent should only be sought after all appropriate information has been given about the trial including an explanation of its status as research, its objectives, potential benefits, risks and inconveniences, alternative treatment that may be available, and of the subject’s rights and responsibilities in accordance with the current revision of the Declaration of Helsinki (see Appendix 1)
