e-Consent Framework (initial setup)

Obtaining consent is a critical step in the clinical research process. The type and extent of a project's e-Consent is driven by the project's IRB and is the responsibility of the Principle Investigator to ensure all IRB criteria are met and enforced.

If you are working on FDA regulated study, please begin your consent process following: CFR Part 11 Validated Projects
For any NON-FDA regulated studies, best practices are provided below, however it may be the case that not all components mentioned are necessary for your specific study

This article reviews the below topics:

1 Initial Considerations
2 Don’t want to build your E-Consent from scratch? Use the template!
3 How to build your e-consent survey instrument
4 How to enable the e-consent framework
5 How to automatically send a copy of the consent form to participant

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 instrument and e-consent framework are 2 separate functions, working together! When these 2 functions are combined, REDCap provides a standardized method to obtain electronic consent.

For E-Consent to be valid the below must always be true:
1. Consent is always captured in ‘SURVEY MODE’ :
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.
  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.
  4. The file repository tool should be used for consent tracking/auditing purposes.

Don’t want to build your E-Consent from scratch? Use the template!

‘eConsent REDCap Template' is now available for use when requesting a new project be created:

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

NOTE: This article covers how to build your e-consent instrument. When gathering e-consent you must ensure you capture Documentation of Informed Consent within in separate instrument!

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

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.

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’

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’

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

	INSTRUCTIONS:	Click on image to expand
1	Enable surveys on the "Project Setup" page by pressing the Enable button.
2	Create e-consent instrument via Online Designer page
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)
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.
5	Include any discrete fields needed for you consent documentation needs, such as storing images, genetic results, future contact, etc.
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:

	INSTRUCTIONS:	click on image to expand

	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 to be valid!
2	After clicking ‘enable’ you are dropped into the ‘survey settings’:
3	Update Survey Title: 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.
4	Next, scroll to the bottom of the survey settings page to enable to e-consent framework: (This is mandatory to save the real time pdf to your projects file repository)
5	Turn on "Auto-Archiver + e-Consent Framework" Click "Auto-Archiver + e-Consent Framework" Ensure ‘allow edits’ is unchecked De-selection is CRITICAL! By default the system has this setting checked, you must de-select.
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
11	Click ‘Save Changes’
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!

	INSTRUCTIONS: click on image to expand

	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’
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!! Since the consent will host PHI/PII, you MUST encrypt the subject line Subject line encryption options: PHI, [encrypt], [secure] Check ‘Include PDF of completed survey as attachment’
6	Click ‘Save Changes’

How Participants Use 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.

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.

Assent and Parental Permission Surveys

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:

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:

Creation of new instruments
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 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.