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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.
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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
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REDCap
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implements consent forms through an online
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survey.
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How the e-Consent Framework
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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
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‘hard-copy' PDF of the signed form
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found in your projects 'file repository’ application
This article reviews the below topics:
General Setup
e-Consent
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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.
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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:
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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 |
Determine e-Consent format to be used
Create & build e-consent instrument
Enable instrument as a survey
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
PNG Image uploads
In-line descriptive text
*may be preferred if you wish for participants to make text larger/smaller as this cannot be done with png images.
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:
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3. Now, craft your consent based on desired format: PNG image (or) in-line text For PNG images:
Repeat this process for all additional pages^  For ‘in-line’ text format:
 4. Capture every competent that has been approved on your IRB consent within the signature block, whether that be name, dob, sig, etc. Do this by adding new fields for each component needed:  5. Once your build is complete, return to the online designer to view the list of instruments  6. Enable e-consent instrument as a survey by clicking the green Enable button. (eConsents |
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must always be enabled as survey) After clicking ‘enable’ you are dropped into the ‘survey settings’ page to enable the e-consent framework, see steps below:
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7. Finishby clicking "Save Changes" button, found at the bottom of the |
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survey settings page you are currently in |
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. |
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Assent and Parental Permission Surveys
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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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Utilize e-consent framework
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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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, signature field is not required
eConsents and 21 CRF Part 11 Compliance
The University of Utah's REDCap instance is not currently CFR part 11 compliant. We are aggressively working toward completing the compliance requirements of a protected environment and verification. We hope to achieve this in
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2023
If you are interest in running your project on a REDCap Part 11 compliant environment, and would like to be added to our list of interested groups, please email https://utahccts.atlassian.net/servicedesk/customer/portal/3/group/16/create/41
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.