2015
DOI: 10.2515/therapie/2014234
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The European “Clinical Trial” Regulation: Relationship with the Jardé Act: a Giens Workshop

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“…Oral consent is sufficient because according to French law (the Jardé Act), this is a minimal-risk research project. 30 If the patient does not have the cognitive or physical capacity to read the information sheet, the investigator will address the patient's trusted person and/or family member, who will consent orally on behalf of the patient. A copy of the information sheet and consent form for the patient or the patient's trusted person and/ or family member (translated into English) is provided as online supplemental file 1.…”
Section: Consent and Inclusionmentioning
confidence: 99%
“…Oral consent is sufficient because according to French law (the Jardé Act), this is a minimal-risk research project. 30 If the patient does not have the cognitive or physical capacity to read the information sheet, the investigator will address the patient's trusted person and/or family member, who will consent orally on behalf of the patient. A copy of the information sheet and consent form for the patient or the patient's trusted person and/ or family member (translated into English) is provided as online supplemental file 1.…”
Section: Consent and Inclusionmentioning
confidence: 99%