View source for Reference:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 23

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{{:Document:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016}}

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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Document part
| Page 23
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! Language
| EN
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! Original entry by
| Florian Adragna
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! Comment
| Renewing consent and special informed consent situations
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== 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.