On April 10, 2023, President Biden signed the bill officially ending the COVID-19 national emergency for the United States. All allowed COVID-19 deviations and reporting requirements are now discontiunued.
The following section will be retained for archival purposes.
Can I utilize Remote Consent procedures at my site due to the COVID-19 public health emergency?
These procedures must be used for any Remote Consent process implemented in response to the COVID-19 public health emergency that requires signature including initial consent, addendum consent, etc.
Remote Consent procedures are defined as follows:
- The participant or their legally-authorized representative (LAR) receives a copy of the informed consent document (e.g., via mail, fax or email) in advance of discussion regarding the study. If mailed, two copies must be mailed so the participant or LAR is able to retain a copy for reference when their signed document is returned to the site and they are waiting to receive the final copy with all necessary signatures back from the site.
- The investigator or designee discusses the study with the potential participant either via telephone or video conferencing. The investigator/designee must have the same consent discussion via telephone/video conferencing that they would have had with the participant or LAR during an in-person meeting. The investigator/designee must also implement a method to ensure the identity of the participant or LAR (e.g., verification of state identification or other identifying documents or use of personal questions or visual methods).
- If the potential participant or LAR agrees to participation, they sign the consent form and return it to the investigator (e.g., via mail, fax or email). If postal mail is used, a pre-paid, self-addressed envelope should be provided to the participant or LAR to mail the signed consent form back to the investigator.
The inclusion of a witness in the Remote Consent Procedures is dictated by local institutional policy and must follow FDA and OHRP requirements. When a witness is required, the research record must document the witness’ name and that they were present for the informed consent process. The inclusion of the witness’ signature on the consent form is dictated by local institutional policy.
- Once the research team receives the signed informed consent document from the participant or LAR, the investigator/designee who conducted the consent process must sign and date the document using the current date. Under the signature line, the investigator/designee must document whether consent was obtained over the telephone or video conferencing, the date of the telephone/video conference, and the date the signed consent was received. For example, “Discussed with [participant or LAR name] via [telephone or videoconferencing] on [insert date] and received signed consent form on [insert date].” Include a brief reason for performing the informed consent discussion over the telephone/videoconferencing.
- If the site has an informed consent policy that requires the witness to sign the consent document, the witness signs the informed consent. If the site does not have an informed consent policy that requires the signature of the witness on the consent document, then the name of the witness along with the date of the original consenting phone call is recorded in the research records to document the participation of the witness.
- The date the investigator/designee signs the informed consent document, not the date the consent discussion with the participant or LAR took place, is the official date of informed consent for the participant on the trial.
- The final informed consent document must be filed in the designated investigator/site regulatory file location. A copy of the final informed consent document, signed by the participant or LAR, the investigator, and the witness (if applicable), must be sent back to the participant via email/scan, fax, or postal mail.
- No research activities related to the study can begin until all steps of the informed consent process are complete.
Can I utilize eSignature if allowed by my local institution?
eSignatures, as defined in CIRB SOP section 126.96.36.199, are permitted to be implemented immediately for remote consenting during the COVID-19 public health emergency.
Updated: September 29, 2022