Page Comparison

This article reviews the below topics:

Initial Considerations

REDCap implements consent forms through an online survey

instrument, however it’s the surveys instrument’s "Auto-Archiver + e-Consent Framework", survey setting, that allows the real-time copy to be auto-saved within the project.

It’s important to understand that the survey instrumentand e-consent framework are 2 separate functions, working together! When these 2 functions are combined, REDCap provides a standardized method to obtain electronic consent.

1. For E-Consent to be valid the below must always be true:

   1. Consent is always captured in ‘SURVEY MODE’ :

      Image Added

   2. Signature fields are stand alone, and never embedded!

      1. Embedding signature fields will result in an invalid consent as the file that is then saved to your file repository will not host the participants signature!

   3. The e-consent framework is correctly enabled. When the e-consent is correctly enabled it ensures:

      1. A verification measure is added to e-consent survey, so the participant can review and verify their provided information is correct before submitting.

         Image Added

      2. Upon e-consent survey completion, the system automatically stores an exact, real-time, ‘hard-copy' PDF of the participants consent documentation within the project’s ‘file repository’ tool.

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

         Image Added

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

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 5 Include any discrete fields needed for you consent documentation needs, such as storing images, genetic results, 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:

Image Added 11 Click ‘Save Changes’ Image Added 12 If you wish to automatically send the participant a copy of their completed 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!

Expand
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 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 Added Check ‘Include PDF of completed survey as attachment’ 6 Click ‘Save Changes’

How Participants Use e-Consent

Image 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 Added

Assent and Parental Permission Surveys

Expand
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. 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. 1. Use attestation form as provided above

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

• 1. , 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, 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.