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  • 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. 

 

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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.

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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.

Info

Note: For FDA regulated studies, only one signature may be captured for each e-consent instrument.

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Excerpt
namevalidated_contact_info

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.

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e-Consent Instruments

  1. Build your consent instrument to includeevery 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).

    1. Include a descriptive text ‘placeholder’ field for the consent form.

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    2. Ensure the consent date field has a minimum and maximum validation set to ‘today’.

  2. Enable the consent instrument as a survey. All electronic consent instruments MUST be enabled as surveys.

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  3. Enable the e-Consent framework by selecting the e-Consent and PDF Snapshots tab.

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    1. +Enable the e-Consent Framework for a survey.

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      1. Select your consent instrument.

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      2. 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.

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    2. + Add consent form.

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      1. Enter the version number in the Consent form version field.

      2. Select the descriptive field for placement of consent form.

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      3. If configuring specific consent forms for DAGs or multiple languages, make those settings here.

      4. On the Consent Form (Inline PDF), Choose File to upload a PDF of your consent document.

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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.

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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”.

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When the participant opens the survey, they will see a form similar to the one shown below.

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On the next page, the participant reviews their consent document, and they will check the box certifying their electronic signature.

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Assent and Parental Permission Surveys

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