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E-Consents


Initial Considerations


It is strongly recommended that you have a discussion with your local Institutional Review Board (IRB) if you wish to do e-Consent in REDCap.  


Obtaining written 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.

Practically speaking, eConsent means using an electronic method to obtain and document  informed consent .  It can be very simple (e-version of a paper document or it can include podcasts, videos & avatars)
REDCap offers a digital method to acquire and store participant consent through an e-Consent Framework and PDF Auto-Archiver. REDCap implements consent forms through an online survey.


Participants can 'sign' their consent by typing in their name or by utilizing REDCap's 'Signature' field type on the survey. Please note that the signature process is NOT implemented by REDCap automatically; a survey must be constructed using one of these two methods in order to capture a signature.


How the e-Consent Framework Works
The REDCap e-Consent Framework provides standardized tools to obtain consent and store consent documentation with a certification screen and a storage function which automatically generates a 'hard-copy' PDF of the signed form.
The 'Auto-Archiver + e-Consent Framework' survey option adds two things to the typical survey-taking process.

  1. Before a participant completes the survey, an extra certification page is added to the end of the survey that displays an in-line 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 considered complete until they fulfill the certification step.
  2. Upon completion of the survey, a static copy of their responses in the form of a consent-specific PDF will be stored in the project's File Repository.
    • The consent-specific PDF will have the values of the e-Consent Framework Options inserted at the bottom of each page in the PDF.
    • These values (i.e., name, date of birth, etc.) are added to the PDF as extra documentation of the identity of the person who is consenting.




Setting Up e-Consent

There is a template in the REDCap template library if you would like to use it, or you can build your on instruments.

  1. Enable surveys on the "Project Setup" page by pressing the Enable button. The line will turn green when this is complete
  2. Set up a survey instrument in Online Designer with the consent language you want as well as key fields like name field, signature, and a date field. Optional fields may be included, such as 'date of birth' depending upon the IRB requirements
  3. Click Online Designer                                                                                                                                 
    1. Click Choose Action > Rename to change the instrument name from My First Instrument to an appropriate name such as:  e-Consent.  Steps shown below:
    2. Rename and press SAVE
    3. Click on pencil to build (or Modify) the e-Consent form
    4. Click on ADD Field
    5. Select Field Type = Descriptive Text
    6. Add other fields as desired
    7. Return to main page list of instruments
  4. Enable the consent instrument as a survey by clicking the Enable button.  (eConsents are identified at the survey instrument level, not the project level)
  5. This brings you to the survey settings page. Scroll to bottom and turn on "Auto-Archiver + e-Consent Framework".
    1. The 'Auto-Archiver + e-Consent Framework' survey option adds two things to the typical survey-taking process.  The Auto Archiver saves automatically saves a PDF version of the consent in the file repository
      1. Before a participant completes the survey, an extra certification page is added to end of the survey that displays an in-line PDF copy of their survey responses in which they will be asked to confirm that all information in the document is correct. Once they confirm all is correct, the survey will then be marked as complete. The survey will not be considered complete until they fulfill the certification step.
      2. Upon completion of the survey, a static copy of their responses in the form of a consent-specific PDF will be stored in the project's File Repository.
    2. On the e-Consent Frame work, use the drop down arrows to auto fill the participant's name from the already collected fields.  
    3. e-Consent Version of a form is an option whereby you may give it a number or alpha-numeric designation to represent the current version of the consent.
    4. NOTE regarding Version Control: If the form is modified AFTER data collection begins, then it is recommended that a new version be applied. For example, the first version might simply be '1', and after collecting the consent of a few participants, a question is modified or added, which represents a new version of the form, so you might increment the version to '2'  or V1.2 (and so forth).
    5. You can select the optional fields like date of birth or the e-consent type.
      1. *The e-Consent 'type' is another 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.
      2. The Optional fields will be inserted at the bottom of the page on the PDF Version 
  6. Participants can 'sign' their consent by typing in their name or by utilizing REDCap's 'Signature' field type on the survey.
  7. Finish  by clicking the "Save Changes" button at the bottom of the screen.




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. They 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.


Additional Considerations Related to e-Consent

  1. 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. Include a witness or a second witness signature of the consent and potentially include an audio or video file of the participant's consent depending on the IRB's requirement for the level of risk of the study.
      2. Some low risk studies may not need a "wet" signature and can utilize initials, a PIN or other identifier. The e-consent framework will utilize the "wet" signature option where the participant draws a signature but it's not required to turn on the e-consent framework to auto archive the consent and create a PDF record of the consent document.
  2. eConsents in a multiple arm study. Example: You have a 5-Arm study. For the e-consent forms, 2 forms will be used by both Arm 4 & 5. Two other forms will be use by all arms of the study (RC-2680)
    1. The e-consent framework settings can only be set for 1 arm.
    2. In order to allow you to use the same eConsent for the other arm of the study, you'll have to copy the 2 consent documents and rename with a _v2 suffix for example and assign the originals to arm 4 and the _v2 to arm 5. Then the e-consent settings will be set for each, specific to their arm
  3. Downloading signed copies of consents after they have been completed 
    1. In order to access and download the consent ensure you have full data set export rights under User Permissions, then follow these steps:
      1. From the Left Menu, select Filer Repository
      2. Select PDF Survey Archive:
  4. eConsents and 21 CRF Part 11 Compliance 
    1. The University of Utah's REDCap instance is not currently CFR part 11 compliant. We are aggressively working toward completing the compliance requirements of a protected environment and verification. We hope to achieve this in the next 4-6 months.
    2. If you are interest in running your project on a REDCap Part 11 compliant environment, and would like to be added to our list of interested groups, please email https://utahccts.atlassian.net/servicedesk/customer/portal/3/group/16/create/41



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. 
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