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footnote 19. Contains Nonbinding Recommendations 18 Options for returning the document to the clinical investigator may include facsimile, a photographic image sent through electronic means, scanning the consent form and returning it through a secure email account, or posting it to a secure Internet address, especially if there are concerns about having the participant mail a potentially contaminated consent document. Alternatively, the trial participant may bring the signed and dated consent form to his/her next visit to the clinical site, if restrictions on traveling to the clinical trial site are alleviated or mail it to the clinical investigator. The case history for each trial participant must document that informed consent was obtained prior to participation in the trial. 29 In addition, the person signing the consent form must receive a copy of the consent form. 30 Although FDA regulations do not require the trial participant’s copy to be a signed copy, FDA recommends that a copy of the signed consent form be provided. The trial participant or their legally authorized representative must sign and date the informed consent form before the investigator may conduct any study-related procedures involving the participant. 31 Where it is not feasible for investigators to receive the signed consent form prior to beginning study-related procedures, the investigators should have the prospective trial participant or legally authorized representative confirm verbally during the consent interview that the participant or legally authorized representative has signed and dated the form. In addition, the overseeing IRB must review and approve the planned informed consent process.32 Q13. How can informed consent be obtained and documented from a prospective trial participant (or legally authorized representative) when they cannot print and sign a paper copy of the consent form provided electronically by the investigator/designee, they cannot electronically sign the informed consent form, and providing a paper copy of the consent form via mail/courier is not feasible within the time frame for enrollment into the clinical trial? Where a prospective trial participant (or legally authorized representative) is unable to print the informed consent document provided electronically by the investigator/designee, an electronic signature process is not available, and the prospective trial participant must meet time-sensitive eligibility criteria, the investigator may consider using the following alternative process to satisfy FDA requirements for obtaining and documenting informed consent: 1. The investigator/designee provides the prospective participant (or legally authorized representative) with an electronic version of the informed consent document. 2. The investigator/designee arranges a telephone call or video conference call with the prospective participant (or legally authorized representative), the investigator/designee, a witness who is not otherwise connected with the clinical investigation and, if desired and feasible, additional participants requested by the 29 See 21 CFR 312.62(b) and 812.140(a)(3) 30 See 21 CFR 50.27(a). 31 See 21 CFR 50.20 and 50.27(a). 32 See 21 CFR 50.27(a), 56.103(a), and 56.111(a). Contains Nonbinding Recommendations 19 prospective participant (e.g., next of kin). Alternatively, in lieu of using a witness, a recording of the conversation can be made. 33 3. To ensure that the prospective participant (or legally authorized representative) is approached in a consistent fashion, a standard process should be used that will accomplish the following: a. Identification of who is on the call. b. Review of the informed consent document with the prospective participant (or legally authorized representative) by the investigator/designee and response to any questions the prospective participant (or legally authorized representative) may have. c. Verbal confirmation by the prospective participant (or legally authorized representative) that their questions have been answered and that they would like to participate in the trial. 4. Verbal confirmation by the participant (or legally authorized representative) that they signed and dated a blank piece of paper with a written statement that they voluntarily agree to participate in the protocol, noting both the Protocol ‘NUMBER’ and brief protocol title. 5. After signing and dating the newly created document, the trial participant (or legally authorized representative) sends a photograph of the signed and dated statement by facsimile, text message, or email to the investigator/designee; OR returns the document to the investigator by mail at a later date, or at a future study visit that might occur in person. 6. When using a witness, documentation in the trial records includes a signed and dated attestation by the witness who participated on the call that the patient confirmed their agreement to participate in the trial and signed the document referenced above. 7. When using a recording in lieu of using a witness, documentation in the trial records includes the recording of the conference call. 8. After the signed and dated document is received by trial staff, it should be appended to a copy of the consent document that was reviewed with the trial participant (or their legally authorized representative) and retained in the trial records as would normally be done for a signed informed consent document. 

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