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It is strongly recommended that you have a discussion with your local Institutional Review Board (IRB) if you wish to do e-Consent in REDCap.  

  • If you are working on FDA regulated study, please begin your consent process following the below course link to ensure your setup meets University of Utah CTSI REDCap FDA 21 CFR Part 11 Compliance: CFR Part 11 Validated Projects

  • For any NON-FDA studies, best practices are provided, however it may be the case that not all components mentioned are necessary for your study

  • Always capture every component that has been approved on your IRB consent within the signature block, whether that be name, dob, signature. This includes specific discrete fields captured in your consent document ie, (genetic result storing, f/u for future studies, etc)

For E-Consent to be valid, it must always be completed in ‘SURVEY MODE’ as shown below:

  • To ensure users don’t mistakenly complete in ‘data entry mode’ you may add the below branching logic to each field within your consent document:

    • [is-survey]

    • If someone opens the ‘e-consent’ instrument in ‘data entry mode’ it will not display any fields, thus a user will be unable to mistakenly complete the e-consent incorrectly.

Initial Considerations

Obtaining written consent is a critical step in the clinical research process. The type and extent of a project's e-Consent is driven by the project's IRB and is the responsibility of the Principle Investigator to ensure all IRB criteria are met and enforced. REDCap implements consent forms through an online survey.

How the e-Consent Framework functions

The REDCap e-Consent Framework provides standardized tools to obtain consent and store consent documentation with a certification screen and a storage function which automatically generates a ‘hard-copy' PDF of the signed form found in your projects ‘file repository’ application.

The below process includes steps on how you can setup your consents survey settings to automatically send the particpant a copy of their signed consent upon completion. Otherwise, if you only want to provide the signed consent upon a users request, use the ‘file repository’ to download > then send via email to participant, ensuring your email subject-line is encrypted since the document contains PHI!

Instructions on navigating the ‘file repository’ tool are linked above.

This article reviews the below topics:

  • General Setup

  • e-Consent survey formats

  • How to create & build e-Consent survey

    • How participants use e-Consent

  • Assent and Parental Permission Forms

  • Consent Modification Process (only to be used when e-consent needs updated in Production)

General Setup

If your study includes participants that are under the age of 18, additional setups are needed, see section ‘Assent and Parental Permission Forms’ for more information

  1. Determine e-Consent format to be used

  2. Create & build e-consent instrument

    1. Enable instrument as a survey

    2. Setup e-consent framework

e-Consent Survey Formats

2 Options:

  • Uploading PNG images of your consent documents

  • Converting your consent documents to a single ‘in-line’ descriptive text field

View examples below:

PNG Image uploads

**most commonly used

In-line descriptive text

No matter which format you choose, the end of each e-Consent survey should include the below fields:

How to create & build e-Consent survey:

 Click here to view the E-Conset setup process

  1. Enable surveys on the "Project Setup" page by pressing the Enable button. The line will turn green when this is complete

  2. Create survey instrument in Online Designer                                                                                                     

    1. Click Choose Action > Rename to change the instrument name from My First Instrument to an appropriate name such as:  e-Consent.  Steps shown below:

    2. Note- consent is not typically the first instrument listed in project. As a best practice we suggest creating a ‘study intro’ instrument as a landing page (if utilizing a public survey link)

    3. Rename & Save

    4. Hover on e-Consent instrument & click pencil icon to view/edit the e-Consent details

  3. Now, craft your consent based on desired format:

PNG image (or) in-line text

For PNG images:

  1. Click ‘add field’

  2. Field type: descriptive text

  3. Name field (variable name)

  4. Insert Description as (Page 1 Version 1)

  5. In same field, upload page 1 image as ‘in-line image'

  6. Save field

Repeat this process for all additional pages^

For ‘in-line’ text format:

  1. Click ‘add field’

  2. Field type: descriptive text

  3. Name field (variable name)

  4. Insert all Consent language into the Field label, click ‘Use the Rich Text Editor’ if you’d like to apply special formatting (suggested!)

  5. Save field

  • Capture every component that has been approved on your IRB consent within the signature block, whether that be name, dob, signature

** Include any discrete fields needed for you consent documentation needs, such as storing images, genetic results, etc:

  • Once your build is complete, return to the online designer to view the list of instruments

  • Enable e-consent instrument as a survey by clicking the green Enable button.  (eConsents must always be enabled as survey)

After clicking ‘enable’ you are dropped into the ‘survey settings’ page to..

a) Update Survey Title: This is what will appear at the top of the participants survey page. Note, the survey title (red) and the instrument name (blue) can be different.

b) Enable the e-consent framework, follow steps below:

  1. Scroll to very bottom of your survey settings page, locate 'e-Consent Framework' section

  2. Turn on "Auto-Archiver + e-Consent Framework"

    1. The 'Auto-Archiver + e-Consent Framework' survey option adds two things to the typical survey-taking process. 

      1. Before a participant completes the survey, an extra certification page is added to end of the survey which displays an in-line PDF copy of their survey responses where the participant must certify all information in the document is correct. Once certified, the survey will then be marked as complete.

      2. Upon completion of the survey, the framework automatically saves a PDF version of the consent in the file repository

  3. Click "Auto-Archiver + e-Consent Framework"

  4. Ensure ‘allow edits’ is unchecked (shown in black below)

  5. Provide required inputs:

    1. Version number, (you may give it a number or alpha-numeric designation to represent the current version of the consent)

    2. select name fields (first & last)

    3. select signature field

  6. You can select the optional fields like date of birth or the e-consent type.

    1. e-Consent 'type' is a free-form text field that can be used to signify the type of e-Consent that this survey represents (e.g., Pediatric versus Adult). 'Type' is often used to distinguish between multiple e-Consent forms within a project.

    2. The Optional fields will be inserted at the bottom of the page on the PDF Version 

  7. To ensure the participant receives a copy of their completed consent document:

    1. Select 'Send confirmation email?’ setting to ‘YES’

    2. Ensure the ‘from’ sender is selected as desired

    3. Ensure you’ve: Designating & Enabled a survey participant email field

    4. Encrypt the subject line to meet University Policy!!

      1. Since the consent will host PHI, you MUST encrypt the subject line

        • Subject line encryption options: PHI, [encrypt], [secure]

    5. Input desired text within the email body

    6. Select to ‘Include PDF of completed survey as attachment’

  8. Finish by clicking "Save Changes" button, found at the bottom of the survey settings page

How Participants Use e-Consent:

 Click here to expand...

The participant will open the survey and read through the consent form. When they get to the bottom, they will have the opportunity to fill in their information and sign their name if they agree to participate.

Participant will select "Next Page" and a read only copy of the consent will be generated that they can review, download, and/or print. At the bottom of the page they will need to select "I certify that all the information in the document above is correct, and I understand that signing this form electronically is the equivalent of signing a physical document."

Once this is selected they will be able to submit the survey.

Assent and Parental Permission Surveys

 Click here to expand...

  • In the case where participants are under 7 years old, only the parental permission survey is needed. This survey does not require the participant's signature, but requires the participant's name, date of birth, parent's name, parent's signature, and date signed.

  • For participants aged 7 to 17, an assent survey is needed. This requires the same information as the example above - participants name, date of birth, signature, and date of signature.

  • When participants are under the age of 18, a parent must also sign a parental permission survey.

  

Consent Modification Process

Design changes after the Production phase are discouraged but sometimes necessary. If a new version of the consent is needed, it is critical to modify the project in such a way as to not lose existing data nor compromise the audit trail of the REDCap e-Consent.

There are two ways to implement new versions of e-consent:

  1. Creation of new instruments

  2. Branching Logic

View process: Modify E-Consent: (version control)

  • Obtaining an eConsent that doesn't require a signature 

    1. Sometimes a study subject is unable to complete the signature due to physical handicap. Here are some suggestions which could be implemented to address this issue:

      1. Use attestation form as provided above

    2. Some low risk studies may not need a "wet" signature.

      1. Utilize e-consent framework, signature field is not required

  • In-Person Consenting:

    1. For non-FDA (21 CFR Part 11) regulated studies using REDCap for in-person only consent, up to 5 signatures may be added to the consent instrument and added to the e-Consent framework set up.

      1. Please note: if the coordinator signature is added to the consent instrument to reflect the document, this does not negate the need for the documentation of informed consent.

These Knowledge Articles have been developed by the University of Utah’s REDCap Analysts using data garnered from the REDCap Consortium Library and other REDCap Affiliate members’ online resources and documents. 

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