e-Consent 2.0: Enhanced e-Consent Framework and PDF Snapshot Functionality Setup

Electronic-Consent (e-Consent) is a platform for consenting patients or research subjects either on site or at home using a computer-based consent form rather than traditional paper documentation. Consent forms can be implemented in a REDCap survey via computer, mobile phone, or tablet.

To use the e-consent module, please request a project by completing the request form: https://rc.med.ubc.ca/redcap/surveys/?s=HEAXHW4LW7

If your research project needs to be de-identified as per the REB, you must request a separate project to host your e-consent data. E-consent data, as it contains identifiers, should be hosted separately from your research project data; hence your team will have two REDCap projects. This will better protect identifiers and increase the security of your data. In addition, we recommend coding your consent question as a "yes/ no" question (ie. 1, I consent / 0, I do not consent), as recommended by the REB.

It is the responsibility of the research team to get the use of e-consenting in their project approved by the Research Ethics Board prior to implementation. In your ethics application, we suggest adding this statement to your consent form: "Your electronic consent form will be stored in the UBC Faculty of Medicine's secured network in Vancouver, BC. Only authorized personnel will be able to access it."

1) Enabling Surveys

Step 1: Enable surveys on the "Project Setup" page.

Step 2: Set up a survey instrument. Fields in this instrument should include:

a descriptive field with the consent language
a consent statement checkbox / radiobutton
identifier fields (name, signature, etc.)

2) Enabling e-Consent Framework

Step 1: Enable the instrument as a survey by clicking "Enable".

Step 2: To enable e-Consent, select the "e-Consent and PDF Snapshots" button

Step 3: Click the "+ Enable the e-Consent Framework for a survey" button and select the surveys you'd like to enable from the dropdown menu

Step 4: Fill out the e-Consent Framework Options that appear such as the:

Primary Settings (mandatory)
Additional Settings
- REB Consent version under the Custom tag/category for PDF footer
Forced signature fields
Location(s) to save the signed consent snapshot
Snapshot file name

NOTE: For forced signature fields please check with your REB what specific field type will be acceptable as the signature for your e-consent.

Select "Save settings" to save the form as an e-Consent survey

Step 5: Your e-Consent survey should now show up under the "e-Consent Framework Settings" page with information listed such as the location(s) to save the signed consent snapshot, custom tag/category, and notes.

If various versions of the consent form are required we can add a new consent form by selecting the "+ Add consent form".

Step 6: Complete the following information:

Consent form version (mandatory)
Placement of consent form (mandatory)
Display for specific DAG (optional)
Display for specific language (optional)
Consent form (as rich text) (mandatory) - This is the text specific to the DAG, MLM, or combination of both DAG and MLM

**Note: eConsent 2.0 versioning designates a REDCap version, not the project's Consent form version which was designated in Step 4**

Once a consent instrument has been designed and added to the eConsent 2.0 framework, this version can no longer be edited. To make edits, a new consent version must be assigned and saved. To capture the REB approved e-Consent paper version, please add it to the custom tag/category for PDF viewer.

PDF View: the pdf footer will contain the mandatory identifier fields (ie. first name and last name) along with other optional fields specified in the e-Consent framework such as date of birth and custom tag/category (ie. pediatric)

If a consent form was added to the framework and a version was specified, the REDCap eConsent version number will also be included in the footer.

3) What it looks like for participants

Certification Page:

Before a participant completes the survey, an extra certification page is added to the end of the survey that displays a PDF copy of the document in which they will be asked to confirm that all information in the document is correct. The survey will not be complete until they confirm and "submit" this certification step.

Static copies of survey responses will be stored in the File Repository and in the project field if one was specified in Step 4.

4) Combining multiple e-Consents or countersign documents

Step 1: Navigate to the "PDF Snapshots of Records" tab from the Online Designer, and select the green "+ Add new trigger" button

Step 2: Fill out the following snapshot trigger options:

Name of snapshot trigger
Snapshot trigger conditions (every time the survey is completed or dependent on logic conditions)
Specific instruments/events to be included in PDF snapshot
Location(s) to save snapshot
Snapshot file name

Select the "save" button to complete your snapshot trigger.

Below is an example on how you would combine an e-Consent with a countersign document:

PDF snapshots saved to the "PDF Snapshot Archive" in the File Repository will be displayed alongside a copy of the e-Consent PDF without the values: identifier, version, or type as seen below. The countersign document will contain both the e-Consent and the countersign elements combined into one document.

You have selected an option that triggers this survey to end right now.

To save your responses and end the survey, click the 'End Survey' button below. If you have selected the wrong option by accident and/or wish to return to the survey, click the 'Return and Edit Response' button.