Use of REDCap for Electronic Consent

Obtaining written consent is a critical step in the clinical research process, but managing paper forms can be a major hassle and many workflows necessitate the ability to perform the process virtually. REDCap offers an electronic method to acquire and store participant consent through a new e-Consent Framework and PDF Auto-Archiver. It is important to note that the consent process and investigator responsibilities remain the same regardless of the media/format used to obtain consent.

What is e-Consent?

Electronic-Consent (e-Consent) is a platform for consenting research participants using a computer-based consent form rather than traditional paper documentation. REDCap now has a feature that implements consent forms through an online survey which can be accessed on a computer, mobile phone, or tablet.

Participants can ‘sign’ their consent by typing in their name or by utilizing REDCap’s ‘Signature’ field type on the survey. There are two main ways e-consent can be collected via REDCap: In-Person and Virtual.

In-person consent occurs when you have direct in-person contact with the participant and consent is collected via an electronic device. Virtual consent occurs when you are in a different physical location from the participant and consent is collected via a link sent to the participant. This usually occurs via an HHC Zoom account, over phone, or via email.

The REDCap e-Consent Framework has been developed to provide standardized tools for secure and compliant e-Consent processes. The ‘Auto-Archiver + e-Consent Framework’ survey option adds a certification screen and a storage function which automatically generates a ‘hard-copy’ PDF of the signed form.

Using REDCap Electronic Consent

Any use of REDCap for e-Consent, must be IRB approved. If you are looking to create a new study using REDCap e-Consent, please follow the instructions below to use the HHC templates. Once a draft project has been created, and the research team has tested the process end-to-end, email or complete this form for REDCap Admin review. It is best to complete this process before IRB submission. The team can also help guide you in what additional elements will be needed for submission.

Template Instructions:
REDCap Electronic Consent - In-Person Instructions
REDCap Electronic Consent - Virtual Instructions

For assistance with using these templates, please contact

REDCap Login:  

If you wish to convert a current IRB approved consent to the REDCap e-Consent template, you will need to submit a modification to the IRB. For adjustment of a current REDCap project please contact

IRB requirements for approval of an e-consent process include:

  • Submission of a paper (Word) consent document to facilitate the review process.
  • Describing the use of REDCap for consent included in the protocol or standard operating procedure
  • Describe the consent process – nature of consent discussion (phone, virtual, live or asynchronous opportunity to ask questions).
  • How participants will be directed to REDCap (e.g. secure email with link to REDCap – indicate whether the link will be unique to the participant or generic).
  • Any revisions/additions to the consent language necessary to implement REDCap.
  • Consent introduction message/participant instructions.
  • Use of the HHC developed templates
  • The IRB must approve the final REDCap e-Consent prior to using it.

Please note: At HHC, we are not allowing the use of REDCap’s e-Consent for studies that require 21 CFR Part 11 compliance. Any questions regarding which studies qualify, please contact

eConsent Contact