Reference:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 23: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 | ||
| | |module=3 | ||
| | |unit=3.1.1 | ||
| | |scope=G | ||
| | |doc_part=Page 23 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00029-Inf-rte ++ TAG-00032-Inf-ngs ++ TAG-00025-Sub-mer | |||
|tags_display=[[Glossary:TAG-00029-Inf-rte|Informed consent]], [[Glossary:TAG-00032-Inf-ngs|Consent process]], [[Glossary:TAG-00025-Sub-mer|Trial participant]] | |||
|comment=Renewing consent and special informed consent situations | |||
|content=Guideline 4: Individual informed consent | |||
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Guideline 4: Individual informed consent | |||
[...] | [...] | ||
Commentary on Guideline 4 | Commentary on Guideline 4 | ||
| Line 50: | Line 17: | ||
Renewing consent. | Renewing consent. | ||
When material changes occur in the conditions or the procedures of a study, and also periodically in long-term studies, the investigator should once again seek informed consent from the subjects. For example, new information may have come to light, either from the study or from other sources, about the risks or benefits of products being tested or about alternatives to them. Subjects should be given such information promptly. In many clinical trials, results are not disclosed to subjects and investigators until the study is concluded. This is ethically acceptable if an ethical review committee has approved their nondisclosure. | When material changes occur in the conditions or the procedures of a study, and also periodically in long-term studies, the investigator should once again seek informed consent from the subjects. For example, new information may have come to light, either from the study or from other sources, about the risks or benefits of products being tested or about alternatives to them. Subjects should be given such information promptly. In many clinical trials, results are not disclosed to subjects and investigators until the study is concluded. This is ethically acceptable if an ethical review committee has approved their nondisclosure. | ||
}} | |||
Latest revision as of 13:49, 16 July 2026
| Document information | |
|---|---|
| Reference | CIOMS CIOMS - International Ethical Guidelines for Biomedical Research
Involving Human Subjects 2016 |
| Validity area | CIOMS |
| Scope(s) | G |
| Document name | CIOMS - International Ethical Guidelines for Biomedical Research
Involving Human Subjects |
| Version / Revision | 2016 |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | Council for International Organizations of Medical Sciences (CIOMS)
International Ethical Guidelines for Biomedical Research Involving Human Subjects |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 3 — Unit 3.1.1 |
| Scope | G |
| Document part | Page 23 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Informed consent, Consent process, Trial participant |
Content
Guideline 4: Individual informed consent [...] Commentary on Guideline 4 [...] Renewing consent. When material changes occur in the conditions or the procedures of a study, and also periodically in long-term studies, the investigator should once again seek informed consent from the subjects. For example, new information may have come to light, either from the study or from other sources, about the risks or benefits of products being tested or about alternatives to them. Subjects should be given such information promptly. In many clinical trials, results are not disclosed to subjects and investigators until the study is concluded. This is ethically acceptable if an ethical review committee has approved their nondisclosure.
