Versions Compared

Version Old Version 49 New Version Current
Changes made by

Alyssa Hill

Alyssa Hill

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

  • 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. 

 

Excerpt
namevalidated_econ_implement

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.

Image Modified

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.

...

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.

Screen Shot 2024-03-28 at 2.38.17 PM.pngImage Modified

 

Excerpt
namevalidated_1econ_instruments

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.

      157aa39b-c6dd-499a-8f9a-02bc46c85953.png

    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.

    430e7806-2b16-4d5a-aee1-a293ad0de450.png

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

    f1c7edd9-569c-49ee-b52d-3082d0ace6fb.png

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

      e3f8b047-5dbc-4b3c-b01b-38fbd12b35cd.png

      1. Select your consent instrument.

        7011ed81-b61a-4551-bd93-208ea6c8d023.png

      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.

        bb040b51-4bd7-4ddb-abe6-c03205608597.png

    2. + Add consent form.

      4446fa69-edaa-48d9-86c1-71f4a98dfcf2.png

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

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

        645426ad-864a-4689-8cb9-61639b12c680.png

      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.

        bfa8e7f5-c35e-4a17-9328-af8bebd62f90.png

Excerpt
namevalidated_econ_distribute

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.

Image ModifiedImage Modified

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”.

Image Modified

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

Image Modified

 

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

Image Modified

...

Assent and Parental Permission Surveys

...

You will see a list of signed e-consent surveys.

...

true
Excerpt
hidden
namevalidated_2version_control

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.

  1. + Add consent form.

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

    2. Ensure the descriptive field for placement of consent form is selected.

    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 newest versioned consent document.

Note

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”

a

Go to Next Page, or return to Table of Contents.