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.
Related Questions
- When may a legally authorized representative provide consent on behalf of an adult with diminished decision-making capacity?
- What are the differences between a legally authorized representative (LAR) and a caregiver?
- May informed consent be obtained by telephone from a legally authorized representative?
