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Validated Projects, part 3: Electronic Consent
Version: 2
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 template. 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
Electronic consent instruments MUST be enabled as surveys, with Auto-Archiver + e-Consent Framework enabled in the survey settings for the instrument. The ability to edit responses MUST be left unchecked. Enter the version number in the e-Consent version field, and you may optionally add the type in the e-Consent type field. Best practice is to include the version number and IRB approval date in the e-Consent version field.
The consent date field has a minimum and maximum validation set to ‘today’.
Always capture every component that has been approved on your IRB consent within the signature block, whether that be name, dob, signature. This includes specific discrete fields captured in your consent document ie, (genetic result storing, f/u for future studies, etc)
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 survey from within the project for a participant, navigate to the Econsent 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 Survey 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, enter DRAFT mode and follow 1 of 2 options:
OPTION 1. Use branching logic within the instrument
If using images of the consent document, add descriptive text field(s) with new version with variable names appended with _v2. Apply branching logic to show field depending on conditions.
If using inline descriptive text with the consent document information, simply copy the field, append _v2 to the new field, make edits where necessary, and apply branching logic to show field versions depending on conditions as shown above.
In the survey settings, make sure to edit the e-Consent version field to the new version number with the new IRB approval date. In the Optional fields, you can enter the type (i.e. Adult, Assent, Parental Permission Form). Make sure to save your changes.
Submit your changes for review.
OPTION 2. Create new instrument
Copy the consent instrument, and rename it with the version number appended and suffix _v2 added to variables.
In the survey settings, make sure to edit the e-consent Framework fields to the new v2 variables and the new version number with the new IRB approval date. In the Optional fields, you can enter the type (i.e. Adult, Assent, Parental Permission Form). Make sure to save your changes.
Make sure to inactivate old Automated Survey Invitations (ASIs), modify Alerts, or modify the Survey Queue depending on your distribution method.
It may be beneficial to add form display logic for your new consent instruments. In this example, if v1 is being used up to 12/10/2022, I will update the logic for both instruments to follow that.
Inactivate the old version of the consent survey by turning the status to “Survey Offline” in the survey settings.
Submit your changes for review. Once the changes have been approved, don’t forget to add user rights to your new instrument(s). For further instructions see the Add, Edit, Remove Users From Your Own Project knowledge article.
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