Content Comparison

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.

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)

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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.