Rush has a new digital platform for collecting e-consent from participants. This REDCap platform is part 11 compliant and supported by Rush IS. As everyone is becoming familiar with the process, we are receiving the following questions related to the REDCap e-consenting process:
What are REDCap e-consents?
REDCap is a tool for building online surveys and databases. The REDCap e-consent platform is a piece of the software that is the electronic way of capturing consent forms and signatures from participants.
What is the difference between REDCap vs REDCap Beta?
REDCap-Beta was a production server with an updated version of the REDCap software that allowed us to pilot the e-consent framework. The framework allows users to collect and store consent documents electronically. We now have the updated software available at https://redcap.rush.edu. The updated software allows study teams to create their own e-consents.
How to use e-consents?
The consent process can happen either on-site or remotely. You can use the computer, mobile phone, or on a tablet for completing e-consents forms via telecommunication or Webex meetings with the participants. You can also use a computer or tablet to consent a subject in person.
Is IRB approval required before creating e-consents in REDCap?
Yes! IRB approval is required before usage of this e-consent platform. Please ensure you are familiar with the e-consent guidance (link to the RRP) available for appropriate operational usage of e consenting at Rush.
How do I create and set up an e-consent?
You can build your own project from scratch or use an e-consent template. The guidance document is available on the Rush Research Portal under Electronic Informed Consent with detailed steps for creating and setting up your e-consent form.
What are the required documents for an e-consent project?
REDCap e-consent project comprises the following data instruments:
IRB stamped, approved ICF
Consent Collection Form
Consent Process Documentation
If you have an IRB approved addendum or need to collect any questionnaire from the participants that can be included in the project as well. The e-consent template has all the three required documents, and you can always update these forms according to your project or create them outside the system if you choose. The IRB stamped, approved ICF is required to utilize this platform.
Who is responsible for submitting the consent collection form and process document?
The individual obtaining consent or study staff is responsible for completing these forms, once the participant submits the e-consent.
What is REDCap ICF upload?
If the patient is consented using a traditional method. The ICF document would need to be scanned and uploaded to REDCap (assuming the study requires a full coverage analysis) using the ICF upload link on the Rush Research Portal.
How will external collaborators gain access to REDCap?
Please perform the following steps to request an external/collaborator REDCap account: