Page Comparison

1. 1. 1. the participants consent documentation within the project’s ‘file repository’

1. 1. 1. tool.

      2. Redcap project users cannot edit the captured consent, after initial capture.

The below process includes steps on how you can setup your consents survey settings to automatically send the particpant a copy of their signed consent upon completion. Otherwise, if you only want to provide the signed consent upon a users request, use the ‘file repository’ to download > then send via email to participant, ensuring your email subject-line is encrypted since the document contains PHI!

Instructions on navigating the ‘file repository’ tool are linked above.

This article reviews the below topics:

• e-Consent survey formats & Notes

• How to create & build e-Consent survey

  • How participants use e-Consent

• Assent and Parental Permission Forms

• Consent Modification Process (only to be used when e-consent needs updated in Production)

e-Consent Survey Formats & Notes

• Best practice is to upload each page of your consent document as an ‘in-line' displayed PNG or JPEG image.

  • WARNING: While the system will technically allow you to upload a single PDF that hosts all consent pages, this should NOT be done as it may cause the signed copy that gets saved to your project and/or sent to the participant to be blank! Example:

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• You may also create your e-consent by using a ‘in-line’ descriptive text field, however this does leave room for error and may be more difficult to update/version later on.

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Additionally, be sure to include any discrete fields needed for your consent, such as storing images, genetic results, etc:

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• Consenting in multiple languages:

  • There are advanced features that can be used to ensure the participant is displayed only the consent images that are in their language using the MLM tool and branching logic. If you have questions on this setup, submit a REDCap help ticket.

How to create & build e-Consent survey:

1. 1. 1. Image Added

      2. The file repository tool should be used for consent tracking/auditing purposes.

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• Configuration Summary:

  1. Build your consent survey instrument(s)

  2. Accurately enable the framework via survey settings, for each consent survey instrument

  3. Test process as if you were the participant

  4. Review your ‘file repository’ tool after testing to confirm validity of setup/capture

How to build your e-consent survey instrument

Expand below for instructions on how to build your e-consent survey instrument:

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title Click here for instrument build instructions
WARNING: If you consent document is not saved with the correct PDF export setting, you will NOT have a valid audit trail as the document will appear black, as shown below. Image Added If working on a PC, when saving your file as a pdf choose… ‘optimize for: minimum size, (publishing online)’ If working on a MAC, when saving your file as a pdf choose… ‘Best for printing’ Image Added Image Added Ensure your PDF consent document is saved correctly before proceeding to below instructions, then test afterward to confirm validity of display in file repo. INSTRUCTIONS: Click on image to expand 1 Enable surveys on the "Project Setup" page by pressing the Enable button. The line will turn green when this is completeImage Removed Create survey instrument in Online Designer                                                                                                      Image Removed Click Choose Action > Rename to change the instrument name from My First Instrument to an appropriate name such as:  e-Consent.  Steps shown below: Image Removed Note- consent is not typically the first instrument listed in project. As a best practice we suggest creating a ‘study intro’ instrument as a landing page (if utilizing a public survey link) Rename & Save Image Removed Hover on e-Consent instrument & click pencil icon to view/edit the e-Consent details Image Removed Now, craft your consent based on desired format: PNG image (or) in-line text For PNG images: Click ‘add field’ Field type: descriptive text Name field (variable name) Insert Description as (Page 1 Version 1) In same field, upload page 1 image as ‘in-line image' Save field Repeat this process for all additional pages^ Image Removed Capture your consent signature block components as shown below, however, for a true contactless e-consent, you Image Added 2 Create e-consent instrument via Online Designer page Image Added 3 Create the consent document field: Field type: Descriptive field Select ‘upload file’, select pdf file, confirm upload Switch the display from ‘x' to 'in-line’ (shown in image 3) Image AddedImage Added 4 Create any fields needed to capture your consent signature block components. You will NOT capture the study teams name/signature on this instrument. This instrument is used to capture ONLY the participants part of the consent process. The study team will perform their sign-offs in a different instrument. Image Added Image Removed 5 ** Include any discrete fields needed for you consent documentation needs, such as storing images, genetic results, etc:Image Removed Once your build is complete, return to the online designer to view the list of instruments Image Removed future contact, etc. Image Added 6 Now it’s time to enable your instrument with the e-consent framework! This step is CRITICAL for auditing. Proceed to next section below!

How to enable the e-consent framework

Expand below for instructions on how to enable:

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title Click here to enable e-consent framework settings
INSTRUCTIONS: click on image to expand 1 Enable e-consent instrument as a survey by clicking the green Enable button.   ( eConsents must always be enabled as survey )Image Removed to be valid! Image Added 2 After clicking ‘enable’ you are dropped into the ‘survey settings’ page to..a) : Image Added 3 Update Survey Title: This is what b) Enable the Survey title, reflects will appear at the top of the participants survey page. Instrument name, reflects what projects users will see when working in REDcap Note, the survey title (red) and the instrument name (blue) can be different. Image RemovedImage Removed Image Added 4 Next, scroll to the bottom of the survey settings page to enable to e-consent framework , follow steps below : Scroll to very bottom of your survey settings page, locate 'e-Consent Framework' section (This is mandatory to save the real time pdf to your projects file repository) 5 Turn on "Auto-Archiver + e-Consent Framework" The ' Click "Auto-Archiver + e-Consent Framework ' survey option adds two things to the typical survey-taking process.  Before a participant completes the survey, an extra certification page is added to end of the survey which displays an in-line PDF copy of their survey responses where the participant must certify all information in the document is correct. Once certified, the survey will then be marked as complete. Upon completion of the survey, the framework automatically saves a PDF version of the consent in the file repository Click "Auto-Archiver + e-Consent Framework" Ensure ‘allow edits’ is unchecked (shown in black below) Provide required inputs: Version number, (you may give it a number or alpha-numeric designation to represent the current version of the consent) select name fields (first & last) select signature field Image Removed " Ensure ‘allow edits’ is unchecked De-selection is CRITICAL! By default the system has this setting checked, you must de-select. Image Added 6 Provide e-Consent Version number 7 Select first name field 8 Select last name field 9 Select signature field 10 You can select the optional fields like date of birth or the e-consent type. e-Consent 'type' is a free-form text field that can be used to signify the type of e-Consent that this survey represents (e.g., Pediatric versus Adult). 'Type' is often used to distinguish between multiple e-Consent forms within a project. The Optional fields will be inserted at the bottom of the page on the PDF Version  Image RemovedTo ensure the participant receives Image Added 11 Click ‘Save Changes’ Image Added 12 If you wish to automatically send the participant a copy of their completed consent document:Image Removed consent survey, see ‘automatic process’ below!

How to automatically send a copy of the consent form to participant

NOTE: the below process only works if you first Designating & Enable a survey participant email field AND the email field is captured in the project before the consent survey instrument is completed!

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title Click here to view instructions
INSTRUCTIONS: click on image to expand 1 Ensure you first, Designating & Enable a survey participant email field 2 Navigate the your e-consent instruments ‘survey settings’ Image Added 3 Scroll to the bottom of the survey settings page 4 Select 'Send confirmation email?’ setting to ‘YES’ 5 Ensure the ‘from’ sender is selected as desired Ensure you’ve: Designating & Enabled a survey participant email field utilizes a study members/team email so users can contact you. Do NOT leave ‘redcap’ as the from sender, if you do, when a participant responds to contact the study team, the study team will not be notified!! Input subject, line and Encrypt the subject line to meet University Policy!! Image Added Since the consent will host PHI/PII, you MUST encrypt the subject line Subject line encryption options: PHI, [encrypt], [secure] Image Removed Input desired text within the email body Select to ‘Include Image Added Check ‘Include PDF of completed survey as attachment’Finishby clicking "Save Changes" button, found at the bottom of the survey settings page

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How Participants Use e-Consent

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title Click here to review participant process of e-consent
The participant will open the survey and read through the consent form. When they get to the bottom, they will have the opportunity to fill in their information and sign their name if they agree to participate. Image RemovedImage Added Participant will select "Next Page" and a read only copy of the consent will be generated that they can review, download, and/or print. At the bottom of the page they will need to select "I certify that all the information in the document above is correct, and I understand that signing this form electronically is the equivalent of signing a physical document." Once this is selected they will be able to submit the survey. Image RemovedImage Added

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Assent and Parental Permission Surveys

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title Click here to view more info on Assent & PPF
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 name, parent's signature, and date signed. 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. Image Removed   If your study will included Assent/PPF, we highly suggest initiating your project creation using our template:   Image Added

Consent Modification Process

Design changes after the Production phase are discouraged but sometimes necessary. If a new version of the consent is needed, it is critical to modify the project in such a way as to not lose existing data nor compromise the audit trail of the REDCap e-Consent.

There are two ways to implement new versions of e-consent:

1. Creation of new instruments

2. Branching Logic

View process: Modify E-Consent: (version control)

Additional Considerations Related to e-Consent

• Obtaining an eConsent that doesn't require a signature 

  1. Sometimes a study subject is unable to complete the signature due to physical handicap. Here are some suggestions which could be implemented to address this issue:

     1. Use attestation form as provided above

  2. Some low risk studies may not need a "wet" signature.

     In this case you should

     , in that case you should still include your consent verbiage and IRB stamp of approval within a consent survey instrument.

     1. We suggest you still utilize e-consent framework, but however the selection of the signature field is not required

These Knowledge Articles have been developed by the University of Utah’s REDCap Analysts using data garnered from the REDCap Consortium Library and other REDCap Affiliate members’ online resources and documents.