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Compliance In Focus
Posted by Brandy Chittester on Tue, Sep 3, 2013

Consent by Phone - Revisited

Several months ago, we wrote the above blog about consent by phone. Recently, I discoveredConsent by Phone the following guidance from a FAQ document:

“35. May informed consent be obtained by telephone from a legally authorized representative?"

A verbal approval does not satisfy the 21 CFR 56.109(c) requirement for a signed consent document, as outlined in 21 CFR 50.27(a). 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.” (Last updated 08/08/2011).

So it appears there is guidance on the consent by phone… I am still looking for the video chat guidance!

Photo Credit:Images_of_Money

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Topics: Consent by Phone, Guidance, FDA

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