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Validated Projects, part 3: Electronic Consent
- Ashley O'Connor
- Alyssa Hill
- Randy Madsen
Version: 3
Digital Signature Requirements
In order to comply with digital signature requirements for electronic consent, researchers are responsible for the following:
The identity of the participant signing has been verified.
Electronic consent signatures will be unique to each participant and shall not be reused or reassigned to anyone else.
Electronic consent signatures will be certified by the participant that they are intended to be the legally binding equivalent of handwritten signatures prior to signing.
Additional certification or testimony that electronic signatures are the legally binding equivalent of handwritten signatures obtained before submission.
Signed electronic records must include:
The printed name of the signer.
The date and time of when the signature was executed.
Note: Time of signature will be tracked within REDCap logging and does not need to be recorded on the form itself.
The meaning (review, approval, responsibility, authorship, etc) associated with the signature.
Note: This requirement is covered by the certification of the signature by the participant, as well as the signature of the coordinator on the documentation of informed consent.
How to Implement Electronic Consent in REDCap
Researchers must follow procedures to meet compliance as outlined in the eConsent REDCap Template project templates. There are 2 to start from when requesting a project:
eConsent REDCap Extensive Template: Includes contact info, adult, children, LAR, witness, and interpreter electronic consents, manual (paper) consent upload, and documentation of informed consent instruments.
eConsent REDCap Simple Template: Includes contact info, adult electronic consent, manual (paper) consent upload, and documentation of informed consent instruments.
Fields and forms may be amended based on study requirements. For FDA regulated studies, the e-consent and documentation of informed consent instruments should be used as is.
Note: For FDA regulated studies, only one signature may be captured for each e-consent instrument.
Gathering Participant Contact Info
Initial participant contact information should be collected by study personnel and entered into the Participant Contact Info instrument. This instrument will collect the date, participant’s name, email, DOB, and preferred language, consent type, age group, and a field that will trigger the e-Consent form to be sent electronically.
e-Consent Instruments
Build your consent instrument to include every component that has been approved on your IRB consent within the signature block, such as name, DOB, and signature. This includes specific discrete fields captured in your consent document ie, (genetic result storing, f/u for future studies, etc).
Include a descriptive text ‘placeholder’ field for the consent form.
Ensure the consent date field has a minimum and maximum validation set to ‘today’.
Enable the consent instrument as a survey. All electronic consent instruments MUST be enabled as surveys.
Enable the e-Consent framework by selecting the e-Consent and PDF Snapshots tab.
+Enable the e-Consent Framework for a survey.
Select your consent instrument.
Configure your settings. The ability to edit responses MUST be left unchecked and name and signature fields MUST be designated. You may optionally add the custom tag/category for the PDF footer, designate date of birth, and/or add a custom label for the PDF header.
+ Add consent form.
Enter the version number in the Consent form version field.
Select the descriptive field for placement of consent form.
If configuring specific consent forms for DAGs or multiple languages, make those settings here.
On the Consent Form (Inline PDF), Choose File to upload a PDF of your consent document.
Using e-Consent
e-Consent surveys can be sent through Automated Survey Invitations (ASI) or opened as a survey in the REDCap project by a coordinator and handed over to the participant.
To send e-Consent through an ASI, the link is sent to the participant using information provided in the Participant Contact Info instrument. Conditional logic and settings should be defined to designate to who and when to send e-Consent.
To open the consent form as a survey from within the project for a participant, navigate to the e-Consent instrument to be used from their record. In the Survey options dropdown, select “Open as a Survey”.
When the participant opens the survey, they will see a form similar to the one shown below.
On the next page, the participant reviews their consent document, and they will check the box certifying their electronic signature.
Assent and Parental Permission Surveys
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. 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)/guardian(s) name(s), parent(s)/guardian(s) signature(s), and date signed.
Additional Electronic Consent
There are instruments included in the template for situations where legally authorized representative (LAR), witness, and/or interpreter consent documents are needed.
File Repository
To view PDFs of locked records, signed e-consent surveys, and other uploaded files, navigate to the "File Repository" under Applications in the left navigation bar.
To view signed e-Consent PDFs, navigate to the “PDF Snapshot Archive” folder.
You will see a list of signed e-consent surveys.
Version Control
When informed consent documents are updated, it is important to track new versions. To update consent documents in a project, navigate to the e-Consent and PDF Snapshots from the Online Designer.
+ Add consent form.
Enter the next version number in the Consent form version field.
Ensure the descriptive field for placement of consent form is selected.
If configuring specific consent forms for DAGs or multiple languages, make those settings here.
On the Consent Form (Inline PDF), Choose File to upload a PDF of your newest versioned consent document.
NOTICE: After clicking the "Add new consent form" submit, the consent form will GO LIVE IMMEDIATELY on the e-Consent survey.
Additionally, make sure to update Automated Survey Invitations (ASIs) or modify Alerts depending on your distribution method.
Old versions of consent forms can be viewed by selecting “View all versions”
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