The Clinical and Translational Science Institute (CTSI) in conjunction with the University of Utah Institutional Review Board and in partnership with the Utah Data Coordinating Center, have built and validated electronic informed consent processes and templates to be used for all REDCap based projects. This also includes 21 CFR Part 11 requirements for FDA regulated studies. These templates can be used as standalone REDCap projects for e-consent only where study data resides in other systems or for use with projects in REDCap. (Existing projects will likely need modifications and updates to match guidelines outlined below.)
eConsent and REDCap
What is eConsent? eConsent is an electronic format used to supplement or replace paper-based informed consent forms to provide information to a potential research participant. It can also be used to obtain documentation of informed consent. It is important to note that the consent process and investigator responsibilities remain the same regardless of the format used to obtain consent.
What is REDCap? REDCap is an easy to use, self-service application subsidized for University of Utah research needs by the Clinical Translational Science Institute (CTSI). All users must first register their projects / study in ProTrackS. Please visit the ProTrackS page to register the study and obtain a CTSI ID. The CTSI REDCap instance is available to support researchers across the University of Utah.
Prepare your IRB Application for eConsent in REDCap
Follow the outlined steps carefully. Each step includes the name of the IRB Application Page and question the step pertains to.
- Consent Process Page, Question 2: This question asks for a description of the location(s) where consent will be obtained. Provide a description of where consent may be obtained in person (e.g., clinic, office, ER, etc.). If applicable, provide a description of any remote aspects of consent (e.g., telephone or video conferencing).
- Consent Process Page, Question 3:
- Provide a clear description of the consent process, including a statement confirming the investigator is using REDCap FDA 21 CFR Part 11 compliant eConsent.
- Your answer should also describe whether there is a waiting period between the consent process and signing the consent.
- State how the participant will receive a copy of the eConsent. For example, you may send a hard copy or email a copy of the consent form before using the eConsent to document the consent procedure. Other projects may deliver the eConsent via email at the time of initial contact and will view the eConsent on a tablet or phone.
- Describe how you will provide a copy of the signed eConsent to the participant. REDCap offers a function to automatically send a copy of the signed eConsent to the participant via email once complete.
- Consent Process Page, Question 4 and 5: Clearly describe the measures taken to minimize coercion or undue influence and describe the provisions made to allow adequate time for questions and to exchange information.
- Consent Process Page, Question 8: Remember that if you are collecting a signature via eConsent, you will not request that documentation of informed consent be waived.
- Documents and Attachments: Remember that your consent document should have a signature block that reflects the signatures that need to be obtained even though using eConsent. Your REDCap project created from the econsent template will contain the appropriate fields in the project for consenting, these fields may not be the same as the signature block on your uploaded consent document to the IRB.
- Whether a PDF consent will be used, or the text of the consent will be entered in REDCap fields as components, the copy of the consent submitted to the IRB should have the watermark in the footer to enable the IRB approval stamp. Find the Blank Watermark Document on the Forms page of the IRB website.
Example eConsent REDCap Project
Leveraging eConsent within REDCap proves to be a versatile solution for a wide array of consent scenarios. REDCap's capabilities extend to projects necessitating Legal Authorized Representatives (LARs), interpreters, or witnesses. With its project functionalities, it accommodates consent processes across all age groups, while also serving as a repository for both informed consent documentation and attestation data gathering. Detailed guidelines on attestation can be found in our comprehensive training resources (linked below).
Illustrating this versatility, the following example project seamlessly integrates eConsent procedures for adults, pediatrics, and parental permissions. It seamlessly incorporates attestation data collection and supports the involvement of interpreters, when required. Inclusive eConsent projects encompass all essential surveys and data entry instruments required for your study. There is no need to separate eConsent from the rest of your study instruments if you wish to use REDCap for surveys AND data collection.
Training and Overview Materials
Please review the training materials outlined below. Regardless of your level of competency within REDCap, you must enroll in the REDCap 101 Canvas training to access the REDCap FDA 21 CFR Part 11 Compliance and non-FDA regulated general eConsent modules. We recommend everyone enroll in the canvas training through this provided link Canvas Enrollment.
| New to REDCap? | REDCap 101 Training Articles |
| Knowledge Based Articles for Validated Projects | Validated Projects KB |
| General Information For Using eConsent in a REDCap Project | e-Consent (initial setup) |
| Using the eConsent Template in a REDCap Project | eConsent REDCap Template Instructions |
Introduction to eConsent Templates in REDCap Video
eConsent in REDCap Presentation Training
Getting Started After Training
After familiarizing yourself with our training material, proceed with the following instructions to attain approval for your eConsent project and make it ready for utilization in REDCap.
- Utilize the steps provided above to finalize your IRB application and secure the necessary approval for implementing eConsent within the REDCap platform.
- Examine all training materials and hyperlinks present on this webpage to enhance your understanding and confidence in navigating REDCap.
- Request your new REDCap project using the eConsent template by following the steps in this article How to Register & Create New REDCap Project
- Follow the eConsent REDCap Template Instructions
- Request your project to be moved to production. A member of the BMIC team will review your project before approving for use. How to Move a Project to Production
Best Practices for eConsent in REDCap
When Facilitating eConsent without the Need for a Signature:
- In situations where a participant is unable to provide a physical signature due to a physical limitation, consider these recommended strategies to effectively address this concern:
- Utilize the provided attestation form in the eConsent template.
- Certain studies with minimal risks might not necessitate a traditional "wet" signature.
- Leverage the e-consent framework, removing the mandatory signature field.
When Consenting In-Person:
- For studies not subject to FDA regulation (21 CFR Part 11) that employ REDCap solely for in-person consent processes, it is permissible to incorporate up to five signatures within the consent document and integrate them into the established e-Consent framework.
- Important: The inclusion of coordinator signatures in the consent document, while reflecting its authenticity, does not eliminate the requirement to document informed consent separately using the attestation instrument as is, or modifying to capture documentation of informed consent only.
Guidelines Applicable to All eConsent Projects:
- Activate the Auto Archiver + eConsent Framework settings within the survey configuration for EACH eConsent instrument. Detailed instructions are provided here: e-Consent Framework
- Maintain a systematic approach to version control for your consent materials. Embed the approval date within the instrument's name (i.e. eConsent PPF V1, 01-01-2023), for eConsent documents to streamline version tracking. Further insights on version control are available in the comprehensive resource Validated Projects: Electronic Consent
- Avoid deleting expired eConsent instruments. Deleting the instrument will result in the loss of all data collected within that specific instrument. Instead, generate new instruments for newly approved consent instances, incorporating the fresh approval date into the instrument's nomenclature. Disable any ASI settings associated with expired consent instruments.
Get Started by Requesting a REDCap Project
FDA regulated studies require additional ProTrackS registration, additional fees for support and administrative management from the Biomedical Informatics Core (BMIC). These 21 CRF Part 11 services for FDA regulated studies must be requested from a general REDCap project request with ProTrackS. A BMIC team member will help with setting up and reviewing the needed items be completed for your FDA regulated study in order to maintain compliance with implementation. Service fees for a provisioning a validated REDCap project instance can be found on the BMIC Services and Fees page. (26.3 hours recharge for project oversight and implementation @ $95/hr. totaling $2500 as a one time fee for project setup.) (See UUSOP-13-A: For Industry Sponsored Fee Schedule)
Need to request a validated project? Follow this link How To Request a Validated Project
Non-FDA Regulated Studies - The new Electronic Consent template is accessible through the REDCap template list in the CTSI production instance for ALL eConsent projects to use. Instructions on how to use the template and how to setup eConsent in REDCap are in the paragraphs below