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OCTRI has worked closely with the OHSU's IRB to develop a REDCap-based electronic consent toolkit and methodology for research teams to use in research studies that are not FDA regulated (21 CFR Part 11). If you need an electronic consent for an FDA regulated study, contact OCTRI Research Navigator at octri@ohsu.edu and request a consultation.

The toolkit includes:

  • Guidance and instruction
  • Training video
  • e-Consent templates


Topics covered:


Disclaimer: In our guidance and instruction, we will refer to REDCap features and functionality that are common to all survey projects and are covered in detail in our Basics and Survey trainings. Functionality and features not specific to consenting will not be described in detail.


Special Considerations & Limitations

Start with a Template

Effective May 1st, 2021, project builders are required to use one of OCTRI's REDCap consent templates. There are fees for any help, including help at drop-in, for consent forms built from scratch. Using templates  is covered in the section: 3 - Building:  Decision Points & Instructions for Setting Up Consent in a Project.

When E-Consent is NOT Supported

IND, IDE and FDA
REDCap and the instructions we've included in the wiki should not be used for studies conducted under and IND (21 CFR part 312) or an IDE (21 CFR part 812) or where data is intended to be submitted to FDA in support of a 510K submission.

Multi-Site Studies (when oversight for the consent process is NOT ceded to OHSU)
Currently, we are not able to support e-consents for other institutions in OHSU's REDCap. This is because other institutions' legal and IRB teams would need to understand AND approve the methods that we use at OHSU for obtaining e-consent, agree to the level of oversight provided by the REDCap Team, and an additional assessment by our legal team be required for studies that are more than minimal risk.


1 - Getting Started: Understanding the Process & Setting Expectations 

It is essential to understand, at a high level, the activities and efforts involved, as well as the requirements for using REDCap for consenting, not just for the personnel building and managing the project, but also for the PI, the CO-PI and the regulatory personnel on the study team.

Who should review this material:

  • PI
  • Co-PI
  • Personnel building project
  • Personnel managing the project
  • Regulatory personnel on the study team


(blue star) Review Getting Started documentation → 


 

Getting Started: Key Points

Consenting in REDCap requires using survey functionality.


Plan for extended development and testing time, and possibly additional support costs.


Whether or not a signature is required on the consent form is a key regulatory determinant that informs how to set up your project.


2 - Planning: Regulatory Considerations & Preparing to Use REDCap

To determine the scope of work for setting up a REDCap project for consenting your participants, it's critical to understand: 1) the related regulatory issues that will need to be addressed by the study team, and 2) OCTRI's model of support for consent implementations, including requirements for the personnel building the project and when additional help from the REDCap Team will be needed. 

Who should review this material:

  • PI
  • Co-PI
  • Personnel building project
  • Personnel managing the project
  • Regulatory personnel on the study team


(blue star) Review Planning Documentation →

Planning: When to Contact REDCap Team

Additional help, for which there are charges, applies to implementing consents that involve:


  • Re-consenting
  • Consenting persons under 18
  • Accommodating an LAR or a translator/interpreter
  • Distributing the consent in multiple languages
  • Adding consent to a project in production

Charges depend on the consent requirements and the personnel’s REDCap experience.




3 - Building:  Decision Points & Instructions for Setting Up Consent in a Project

It's essential that the personnel building and managing the project understand both how to set up their REDCap project for consenting, and for using the project, real-time, for consenting their research participants. They  will need to consider the workflow that pertains to their study's consent process as they plan for 1) testing the project, 2) training the study team on using the project for consenting, and 3) documenting consent operations.  

Who should review this material:

  • Personnel building project
  • Personnel managing the project


(blue star) Review Building Documentation →


Project Building: Training

Watch Training video (from 08/2020 training)


Download Training Slide Deck




4 - Project Management: Documentation, User Permissions & Making Revisions 

To be effective at managing a project used for consenting research participants, it's important for the personnel who build and manage the project to understand: 1) what to address in documentation, 2) how to account for users permissions related to the consent survey, and 3) how to make revisions to the consent form.

Who should review this material:

  • Personnel building project
  • Personnel managing the project


(blue star) Review Project Management Documentation →