Frequently Asked Questions

May informed consent be obtained by telephone from a legally authorized representative?

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Clinical Trials
Clinical: MedTech
Clinical: Biopharma
Guidelines & Standards

A verbal approval does not satisfy the 21 CFR 56.109(c) requirement for a signed consent document. However, it is acceptable to send the informed consent document to the legally authorized representative (LAR) by facsimile and conduct the consent interview by telephone when the LAR can read the consent as it is discussed. If the LAR agrees, he/she can sign the consent and return the signed document to the clinical investigator by facsimile.