Review of “e-Consent” (electronic consent) Forms

Electronic consent (“e-consent”) via web applications and/or electronic tablets such as an iPad is growing in popularity. FDA has issued guidance titled Use of Electronic Informed Consent.

Electronic consent is a broad term and can describe the exact representation of the IRB-approved document on an electronic device as well as refer to a consent process using electronic devices and audio-visual aids.

WCG reviews the electronic (e-consent) platform at the study level, where approved consent forms are uploaded as participant material templates. Sites that intend to use the platform are not required to submit the platform with their site-specific consent forms. The platform is reviewed once at the study level, with the expectation that each site will upload its own IRB-approved consent form. Exact representation of the IRB-approved document on an electronic device does not require IRB review of screen shots of the consent form on the device. The IRB need only approve the static version. (This is also true of other participant-facing forms that require IRB review, such as participant diaries and eCOAs.)

For all FDA-regulated electronic consents, including exact representation of an IRB-approved document on an electronic device, the IRB requires the signatures be confirmed to be 21 CFR part 11 compliant and requires a certificate of authenticity.

Electronic consent processes that are not just exact electronic representations require further details to be submitted. WCG IRB reviews e-consent technologies during development and in their final form to ensure that they meet the regulatory requirements for the elements and documentation of consent. This section provides some simple best practices on how to prepare an informed consent IRB submission so that it is suitable for use in an electronic consent tool. 

e-Consent Submission Timing

Sponsors and investigators considering e-consent may wish to obtain IRB approval of the consent document text prior to developing the electronic consent tool. Revisions based on IRB feedback are easier to implement before e-consent programming and animation has begun. 

e-Consent Submission Items

For a typical e-consent IRB submission, the sponsor and e-consent vendor will jointly prepare the IRB submission of materials. Typical submissions include:

1. Scripts for any video or audio files.
2. Storyboards for any planned video creation.
3. Content for any screens on the e-consent tool that will be viewed by the participant.