Our goal, with the information covered on this page, is to call attention to considerations specific to using e-consent in REDCap.

Topics covered:

Start with the Paper Consent Document

A REDCap e-consent survey is based on a digital transformation of the study's paper or physical consent document that was approved by the IRB. To simplify the transformation, OCTRI has created e-consent templates that include specific REDCap features that comply with institutional and legal requirements for obtaining a valid consent electronically. 

This means that the paper consent and the e-consent survey in REDCap will have the same requirements, i.e. if the paper consent requires the participant's signature, the e-consent survey in REDCap will be set up with the IRB approved electronic approach for REDCap for capturing the participant's signature.

For creating your paper consent document, you can find the OHSU consent templates on the IRB site.

Studies with External IRB Oversight:

Note, the OCTRI e-consent templates were developed based on the OHSU IRB consent templates. The OHSU IRB uses a combined consent and HIPAA Authorization format. Some external IRBs may not follow the same pattern. If your study has an external IRB of record, we highly recommend pursuing a combined consent and HIPAA Authorization format that mimics the OHSU IRB templates. Deviation from this will result in requiring extra custom assistance from the REDCap team and related charges. Please contact us if you have questions about this.  

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Applying IRB Requirements for Using E-Consent to REDCap

OCTRI worked closely with the IRB to apply the IRB's Guide for the Use of Electronic Consent and Electronic Means to Support Consent to e-consents in REDCap. For your connivence, we've outlined below some of the key requirements from this guidance as it applies to a study team using REDCap for e-consent.

Important reminders:

• An Information Sheet is a type of consent form.

• In practical terms within the context of e-consent, a waiver of the documentation of consent means the participant's signature is not required on the consent form.

• If your study collects Personal Health Information (PHI) your consent must include HIPAA language and/or you must have a HIPAA Waiver of Authorization approved for your study. For more information, please discuss with the OHSU IRB or request a regulatory consultation by contacting octri@ohsu.edu. 

IRB Required Signatures that Impact e-Consent Implementation:

Your e-consent is a digitally transformed version of your IRB approved paper form. It should be a one-to-one match for all language and other elements that make up the paper document, such as signatures and optional components that require initials. When building your e-consent please be mindful of the following:

• Participant signature:
  • Does your project require a signature? In some cases, the IRB can waive the requirement to obtain written consent. Note: waiving written consent, or documentation of consent is not the same as waiving consent entirely. Please review the IRB Guidance document related to Waiver and Alterations of consent 
• Additional signatures:
  • Does your project involve a Legally Authorized Representative (LAR), child assent or the signature of an interpreter? These more complex implementations require assistance from the REDCap team, for which there are charges. Please contact REDCap@ohsu.edu to obtain a quote. 
• Consenting staff signature:
  • Does your project require the signature of the staff who are completing the consent (often called an "attestation"). 
• Reconsent: 
  • Will your project require participants to reconsent to the project? This is frequently required for projects enrolling minors who will reach adulthood during the course of the study or for projects enrolling incapacitated participants who will regain consciousness after enrolling. If your project has needs like these assistance from the REDCap team will be needed and charges will apply. Contact REDCap@ohsu.edu to request a quote. 
• Optional participation in some portions of the research (i.e. agreement to be contacted for future research): Some studies offer different levels of involvement which can appear as questions with boxes for initials to indicate agreement or declination. These questions should also appear in your e-consent.   

Study Team Responsibilities

In REDCap:

Ensure only trained, IRB approved staff are managing e-consent in REDCap

In the protocol:

• Describe the use of REDCap for e-consent as part of the study's consent process.

• Describe how participants will be directed to the e-consent survey in REDCap, such as an email with link to the e-consent survey and indicate whether the link will be unique to the participant or generic link. 

• Describe how a copy of the consent will be provided to the participant, such as mail, secure email, a download REDCap, and for consents that require participant signature, describe how participants will be given a copy of the e-consent the participant signed and submitted. 
  • The participant must be given a copy of the signed eConsent, or, if applicable, a signed document that combines eConsent and HIPAA authorization. This can be provided electronically (via encrypted/secure email, system provided copy, etc.) or by paper (physical mail, hand delivered to participant during clinic visit, etc.).

Submit the following material for IRB approval:

• A paper (Word) consent document.

  • Indicate if you are obtaining signatures or requesting a waiver of written consent and waiver of HIPAA authorization signature.

• All patient facing messages that will be generated by REDCap including:

  • The introduction message and instructions for the participant at the start of the e-consent survey.

  • The completion message at the end of e-consent survey for both 1) eligible participants who agreed to participate, and 2) potential participants who did not agree to participate.

  • The email message and the subject line, if the study is sending participants an email with a link to the e-consent survey.

• Any hyperlinks, video, audio, images, or other electronic media attached to or embedded in the e-consent survey or e-consent survey invitation.
• A PDF of the final e-consent survey built in REDCap.

• Any revisions/additions to the consent language necessary to implement REDCap.

• If your project will be under the oversight of a non-OHSU IRB (i.e. a single IRB) also submit this document outlining how eConsenting in OHSU's REDCap is done. This document should be acknowledged by the IRB of record to ensure they understand OHSU's method of eConsenting in the REDCap software as this can be different from institution to institution. Note, you may also submit this document to the OHSU IRB as a means of explaining how REDCap is set up for e-consent.