What guidance is available on
Remote Informed Consent?

The ORI Remote Informed Consent guide outlines steps and options for obtaining remote consent for minimal risk, greater than minimal risk, and
FDA-regulated research. Options described include paper consent, electronic consent, and hybrids.

When reviewing remote consent proposals, refer to the applicable category for regulatory requirements. For instance, FDA regulations do not offer a waiver of documentation, so signed/dated documents must be obtained. However for situations such as consenting patients in isolation, FDA provides alternative methods for documenting consent.

For the IRB application, researchers are advised to:
  • describe the process, including how the form is presented/reviewed, signatures are obtained, and copies provided to participants;
  • Include a link, screenshots, or demo showing final formatting & features subject would see;
  • Include PDF representation of the e-consent for the IRB stamp; and
  • Obtain IRB review & approval for subsequent modifications.
E-consent refers to use of electronic systems and processes to convey information and obtain and document informed consent. E-Consent may take place remotely or in-person.

REDCap provides an e-consent template that researchers may use to conduct an e-consent process for Non-FDA-regulated research. (For details see attached or view the REDCap mobile app and consent feature webinar or CCTS Biobank video demo.)

E-consent used in FDA-regulated studies must comply with FDA Part 11 regulations which add
extra requirements for systems and e-signatures. While FDA has issued some flexibility when Part 11 compliant systems are not available, during the COVID-19 pandemic, (see Q 26 on FDA COVID-19 Guidance), the Remote Informed Consent guide provides links to products and resources to facilitate study compliance with Part 11.