How to setup and use eConsent
How to setup eConsent
Step 1: Enable surveys in your project
Surveys are required to use REDCap’s eConsent features, even if you are collecting signatures in-person on a tablet.
Step 2: Create your eConsent instrument(s) in REDCap
With the 2.0 version of REDCap’s eConsent Framework, it is preferred to upload the consent form as a PDF with version control. This means you do not need to copy/paste the entire contents of the consent form into REDCap.
Create REDCap fields for any questions asked of the participant, such as their name and signature.
In a sample eConsent form, the following is the signature page for the participant:
The page is created in REDCap’s online designer using descriptive, radio, text, and signature fields. Some fields are marked as required and/or as identifiers. Text Validation and Action Tags are used to control data entry.
Step 3: Create a location for the consent form’s contents
REDCap’s eConsent Framework will insert a copy of the consent form PDF below a specified descriptive field. In the example below, a blank descriptive field has been added to the top of the instrument to act as a location for the inserted PDF.
This field does not need to be blank. For example, it can be used to contain instructions/information for the participant.
Step 3: Enable the eConsent instrument as a survey
Surveys are required to use REDCap’s eConsent features. You can use the Survey Settings page customize the survey’s appearance and behavior.
Note: If you are using the feature to “Send confirmation email”, do not use “Include PDF of completed survey as attachment”. Email is not considered a secure means of communication and should not be used when sending identifying information.
At the bottom of the Survey Settings page there is an option to send an email to the participant once they complete the survey. This includes the ability to send a PDF copy of the survey they had just completed.
Completed eConsent forms contain identifying information and should not be sent via email.
Step 4: Enable the eConsent Framework
Click the “e-Consent“ button in the header of the Data Collection Instruments table.
In the Frameworks Settings page, click “+ Enable the e-Consent Framework for a survey”
Select your eConsent instrument
In the “Enable e-Consent” window, you can customize the features of your eConsent form.
Once the Settings page is saved, the Framework Settings page will update. You can use this page to enable multiple eConsent forms (ex. assent, surrogate).
Step 5: Add the consent form
Each eConsent form has version control available. Click ‘Add consent form’ to create (or add) a new version of the consent form.
In the “Add consent form” window, you can customize the features of this version of the consent form. A version number is required. If your project uses Data Access Groups (DAGs) or the Multi-Language Module (MLM), you can specify different forms for each site/language.
The placement of the consent form will use the descriptive field created in Step 3. The consent form is then uploaded as an “Inline PDF”
At this time it is possible, but not recommended, to use the “Rich Text” version of the Consent Form.
Copy/Pasting consent form contents from a Word document, PDF, or other source will often require careful editing and reformatting within REDCap to ensure it was copied correctly and readably. However, the contents of the Rich Text box do not persist between consent versions. If there is a typo or other error to be corrected, a new version of the Rich Text consent form will need to be created from scratch and given a new version number.
Once the version page is saved, the Framework Settings page will update. You can return to this page to add another version of the consent form.
The completed example eConsent form in form view (i.e., within REDCap. A PDF copy of the consent form has been inserted at the top of the form and has PDF reader features such as zoom, download, and print.
The fields at the bottom of the form were marked with the Action Tag @READONLY-FORM to ensure they cannot be used/edited in REDCap. This forces the form to be filled out as a survey, which ensures the eConsent Framework is being used.
How to use eConsent
eConsent surveys can be accessed the same way as other surveys in REDCap:
using a public survey link or QR code
emailed via composing the survey invitation, using Automated Survey Invitations (ASIs), or using Alerts & Notifications
opening a participant record in REDCap and using the “Survey options” to open the survey.
eConsent forms must be filled out as surveys to make use of REDCap’s eConsent Framework
Below is a sample eConsent form using default survey settings
After selecting “Next Page >>” the participant will be asked to review the completed form and ensure everything is correct before submitting.
In-Person eConsent
If your eConsent forms are being signed in-person (ex. using a tablet), you are likely using options 1 or 3 listed above.
For option 3, remember to Log out of REDCap before allowing the participant to use the device.
If multiple signatures are required (ex. witness, persons obtaining consent), an in-person eConsent form can easily be setup with fields for multiple signatures that are obtained at the same time.
In-person eConsent also allows for the completed form to be printed and given to the participant.
Remote eConsent
If your eConsent forms are being signed remotely (i.e., the participant is sent a survey invitation link via email, SMS, or QR code), you are likely using options 1 or 2 listed above.
If multiple signatures are required, it may not be possible to gain all the signatures at the same time. It is best practice to split the eConsent form into two or more instruments (ex. one for the participant, one for the person obtaining consent) that each use the eConsent framework. In this case, the participant submits their portion of the eConsent form without the additional signatures, then the study team completes their portion in a second instrument. The two parts can then be merged together into one PDF using editing software or automatically captured and stored using REDCap’s Snapshot module.
Remote eConsent also presents an additional challenge when attempting to securely send the completed consent form to the participant. It is possible for the participant to download a copy of the completed form on the Certification Screen before submitting their eConsent survey. Otherwise, you may want to consider mailing a printed copy of the form or using one of the methods outlined here.
Contact us if you are having any trouble implementing eConsent or have any questions.
We also offer build services for eConsent, which can be requested using our intake survey.
View completed consent forms
eConsent forms can be viewed in the participant’s REDCap record.
If you are using the eConsent Framework’s version control (i.e., uploading a PDF copy of the consent form into the Framework), The consent form displayed on this page will match the version that the participant signed.
If the survey response is editable (using the option in the eConsent Settings page “allow e-consent responses to be edited by users”), then it is possible for the form to be different than the one signed by the participant. eConsent forms that were created in older versions of REDCap or were created without using the Framework’s version control features, the version seen in the participant's record may not match what they had signed.
To guarantee that the copy of the participant’s consent form is exactly what was seen at the time of submission, a copy of all completed eConsent forms are automatically saved to the File Repository. These forms can be found under the “PDF Snapshot Archive”. Features of the eConsent Settings (such as name, date of birth, custom tags), when used, can improve searchability in this archive.
Use our checklist Does my eConsent form meet best practice requirements? to help ensure your eConsent is implemented securely