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Obtaining 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. |
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This article reviews the below topics:
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Initial Considerations
REDCap implements consent forms through an online survey
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- Before a participant completes the survey, an extra certification page is added to the end of the survey that displays an in-line PDF copy of the document in which they will be asked to confirm that all information in the document is correct.
- The survey will not be considered complete until they fulfill the certification step.
- Upon completion of the survey, a static copy of their responses in the form of a consent-specific PDF will be stored in the project's File Repository.
- The consent-specific PDF will have the values of the e-Consent Framework Options inserted at the bottom of each page in the PDF.
- These values (i.e., name, date of birth, etc.) are added to the PDF as extra documentation of the identity of the person who is consenting.
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There is a template in the REDCap template library if you would like to use it, or you can build your on instruments.
instrument, however it’s the surveys instrument’s "Auto-Archiver + e-Consent Framework", survey setting, that allows the real-time copy to be auto-saved within the project.
It’s important to understand that the survey instrumentand e-consent framework are 2 separate functions, working together! When these 2 functions are combined, REDCap provides a standardized method to obtain electronic consent.
For E-Consent to be valid the below must always be true:
Consent is always captured in ‘SURVEY MODE’ :
Signature fields are stand alone, and never embedded!
Embedding signature fields will result in an invalid consent as the file that is then saved to your file repository will not host the participants signature!
The e-consent framework is correctly enabled. When the e-consent is correctly enabled it ensures:
A verification measure is added to e-consent survey, so the participant can review and verify their provided information is correct before submitting.
Upon e-consent survey completion, the system automatically stores an exact, real-time, ‘hard-copy' PDF of the participants consent documentation within the project’s ‘file repository’ tool.
Redcap project users cannot edit the captured consent, after initial capture.
The file repository tool should be used for consent tracking/auditing purposes.
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Don’t want to build your E-Consent from scratch? Use the template!
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Configuration Summary:
Build your consent survey instrument(s)
Accurately enable the framework via survey settings, for each consent survey instrument
Test process as if you were the participant
Review your ‘file repository’ tool after testing to confirm validity of setup/capture
How to build your e-consent survey instrument
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NOTE: This article covers how to build your e-consent instrument. When gathering e-consent you must ensure you capture Documentation of Informed Consent within in separate instrument! |
Expand below for instructions on how to build your e-consent survey instrument:
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WARNING: If you consent document is not saved with the correct PDF export setting, you will NOT have a valid audit trail as the document will appear black, as shown below. 
Ensure your PDF consent document is saved correctly before proceeding to below instructions, then test afterward to confirm validity of display in file repo.
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- Click Choose Action > Rename to change the instrument name from My First Instrument to an appropriate name such as: e-Consent. Steps shown below:
- Rename and press SAVE
- Click on pencil to build (or Modify) the e-Consent form
- Click on ADD Field
- Select Field Type = Descriptive Text
- Add other fields as desired
- Return to main page list of instruments
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How to enable the e-consent framework
Expand below for instructions on how to enable:
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- Before a participant completes the survey, an extra certification page is added to end of the survey that displays an in-line PDF copy of their survey responses in which they will be asked to confirm that all information in the document is correct. Once they confirm all is correct, the survey will then be marked as complete. The survey will not be considered complete until they fulfill the certification step.
- Upon completion of the survey, a static copy of their responses in the form of a consent-specific PDF will be stored in the project's File Repository.
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How to automatically send a copy of the consent form to participant
NOTE: the below process only works if you first Designating & Enable a survey participant email field AND the email field is captured in the project before the consent survey instrument is completed!
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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. |
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 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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If your study will included Assent/PPF, we highly suggest initiating your project creation using our template: |
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:
Creation of new instruments
Branching Logic
View process: Modify E-Consent: (version control)
Additional Considerations Related to e-Consent
Obtaining an eConsent that doesn't require a signature
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:
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Use attestation form as provided above
Some low risk studies may not need a "wet" signature
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- The e-consent framework settings can only be set for 1 arm.
- In order to allow you to use the same eConsent for the other arm of the study, you'll have to copy the 2 consent documents and rename with a _v2 suffix for example and assign the originals to arm 4 and the _v2 to arm 5. Then the e-consent settings will be set for each, specific to their arm
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- In order to access and download the consent ensure you have full data set export rights under User Permissions, then follow these steps:
- From the Left Menu, select Filer Repository
- Select PDF Survey Archive:
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, in that case you should still include your consent verbiage and IRB stamp of approval within a consent survey instrument.
We suggest you still utilize e-consent framework, however 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.