Updated FDA Guidance Allows Photographs of Isolated Patients’ Informed Consent Form
A photograph of a signed informed consent form of a patient in isolation is an acceptable proof of consent, according to the FDA’s latest update to its guidance on conducting clinical trials during the COVID-19 crisis.
In the latest update to its March 2020 guidance, the agency clarifies its previous advice and outlines steps for producing a compliant photograph of a consent form. In addition to conducting a phone or video conference to explain the consent form and answer the patient’s questions, the patient or someone else in the room with the patient may take a photograph of the signed form and a trial team member may file an attestation that explains how the photograph was obtained and that it is a photograph of the document signed by the patient.
An alternative method may be used, the guidance says, in which a witness to the call may provide a signed and dated attestation to the fact that the patient confirmed his or her consent and signed the document. The investigator also must provide a signed and dated statement that the patient’s signed consent form could not be retained due to potential contamination of the document. A recording of the call may be used in place of a witness, the guidance says.
The FDA also added to the guidance advice on obtaining consent from an isolated patient if he or she cannot print and sign an electronic copy of the consent form and providing a paper copy of the form via mail or courier would delay consent beyond the enrollment timeframe. In this situation, a patient may verbally confirm that he or she signed and dated a blank piece of paper with a written statement consenting voluntarily to participate in the trial. The patient or legally authorized representative must send a photograph of the signed statement to the investigator via fax, text message or email, or return the document by mail at a later date or at a future study visit.
The agency cautions, however, that this approach to documenting informed consent must first be approved by the IRB overseeing the trial.
To read the guidance, click here: https://bit.ly/3221qlm.