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that they have signed and dated the informed consent document that is in their possession. 4. The patient (or an individual in the room) takes a photograph of the signed informed consent document and sends it to the investigator/designee. 5. A trial team member enters the photograph into the trial records along with an attestation that states how that photograph was obtained and that it is a photograph of the informed consent document signed by the patient. Method 2: A witness can attest to the signature, but a photograph of the signed informed consent document cannot be transmitted 1. An unsigned consent form is provided to the patient by a person who has entered the room. 2. The investigator/designee arranges a three-way telephone call or video conference call with the patient, a witness who is not otherwise connected with the clinical investigation, and, if desired and feasible, additional individuals requested by the patient (e.g., next of kin). Alternatively, in lieu of using a witness, a recording of the conversation can be made.25 3. To ensure that patients are approached in a consistent fashion, a standard process should be used that will accomplish the following: • Identification of who is on the call. • Review of the informed consent document with the patient by the investigator/designee and response to any questions the patient may have. • Verbal confirmation by the patient that their questions have been answered, that they would like to participate in the trial, and that they have signed and dated the informed consent document that is in their possession. 25 If an investigator wants to record the telephone or video conference call, the investigator/designee should ensure that the recording is done in a manner consistent with applicable State and local laws and that all parties agree to being recorded. Contains Nonbinding Recommendations 17 4. When using a witness, documentation in the trial records includes: (1) 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 informed consent document; and (2) a signed and dated attestation by the investigator/designee stating why the informed consent document signed by the patient was not retained (e.g., due to potential contamination of the document by infectious material). When using a recording in lieu of a witness, documentation in the trial records includes: (1) the recording of the conference call; and (2) a signed and dated attestation by the investigator/designee who participated on the call stating why the informed consent document signed by the patient was not retained (e.g., due to potential contamination of the document by infectious material). When either Method 1 or 2 is used to document informed consent, the resulting documentation should be: (1) collected and archived, as either original paper copies or appropriately certified electronic copies (e.g., using a validated process for scanning paper copies),26 and (2) retained according to applicable FDA record retention requirements as part of the trial record. 27 If the patient is unable to provide informed consent and there is a legally authorized representative, investigators must obtain written consent from the patient’s legally authorized representative in accordance with 21 CFR 50.27(a). Q12. How do I obtain informed consent from a patient unable to travel to a clinical trial site where electronic informed consent is not an option? Investigators may also need to obtain informed consent from a potential trial participant or their legally authorized representative when these individuals are unable to travel to the site where the investigator is located due to COVID-19 illness or travel restrictions. When investigators do not have electronic informed consent (eIC) capabilities, 28 methods of obtaining informed consent other than a face-to-face consent interview may still be acceptable if those methods allow for an adequate exchange of information and documentation, and a method to ensure that the signer of the consent form is the person who plans to enroll as a participant in the clinical investigation or is the legally authorized representative of the trial participant. For example, the consent form may be sent to the trial participant or their legally authorized representative by facsimile or email, and the consent interview may then be conducted by telephone when the trial participant or their legally authorized representative can read the consent form during the discussion. After the consent discussion, the trial participant or their legally authorized representative can sign and date the consent form. 26 FDA guidance on good clinical practice developed with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) defines a certified copy as “[a] copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original.” See the ICH guidance for industry E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) (March 2018), available on the FDA guidance web page. 27 See 21 CFR 312.57, 312.62, and 812.140. 28 See 

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