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

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
Comment	Renewing consent and special informed consent situations

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.