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For E-Consent to be valid, consent 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.

  • If you are working on FDA regulated study, please begin your consent process following: 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 specific study

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:

  • e-Consent survey formats & Notes

  • 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)

e-Consent Survey Formats & Notes

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  • Best practice is to upload each page of your consent document as an ‘in-line' displayed PNG or JPEG image.

    • WARNING: While the system will technically allow you to upload a single PDF that hosts all consent pages, this should NOT be done as it may cause the signed copy that gets saved to your project and/or sent to the participant to be blank! Example:

  • You may also create your e-consent by using a ‘in-line’ descriptive text field, however this does leave room for error and may be more difficult to update/version later on.

PNG or JPEG Image uploads

(best practice)

In-line descriptive text

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

Additionally, be sure to include any discrete fields needed for your consent, such as storing images, genetic results, etc:

  • Consenting in multiple languages:

    • There are advanced features that can be used to ensure the participant is displayed only the consent images that are in their language using the MLM tool and branching logic. If you have questions on this setup, submit a REDCap help ticket.

How to create & build e-Consent survey:

Expand
titleClick 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^

  • Capture your consent signature block components as shown below, however, for a true contactless e-consent, you will NOT capture the study teams name/signature on this instrument. This instrument is used to capture ONLY the participants part of the consent process. The study team will perform their sign-offs in a different instrument.

** 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) UpdateSurvey 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. Finishby clicking "Save Changes" button, found at the bottom of the survey settings page

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Don’t want to build your E-Consent from scratch?

  • ‘eConsent REDCap Template' is now available for use when requesting a new project be created:

How Participants Use e-Consent:

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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

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  • 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. In this case you should still utilize e-consent framework, but the selection of the signature field is not required

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.