Informed Consent
CCTS's informed consent support includes human subject participant training for ethically obtaining consent, IRB guidance for eConsent protocols and modules for implementing eConsent in REDCap.
Informed Consent Action Options Heading link
Informed Consent in Action Heading link
“Informed Consent in Action” is a 60-minute training DVD designed to demonstrate best practices for recruiting participants and obtaining informed consent in community-based research. Five experienced community research partners share lessons learned. Vignettes show what community-based research looks like, and group discussions highlight key points and raise issues for further discussion.
The Facilitator Guide summarizes each segment of the DVD and provides discussion questions and key summary points for each vignette. Additional discussion questions are also provided for use in conjunction with study protocol-specific training.
Training Video Heading link
Consent Self-Audit Checklists Heading link
Writing a consent document can be a challenging process, involving an understanding of the research project to be undertaken and familiarity with the various federal, state, and local requirements for the content of consent. In addition, this information must be presented in a way that will facilitate understanding of the research project for the people who are being asked to participate.
This series of checklists covers the regulatory requirements for consent documents, the requirements for documenting consent, and situations when a waiver or alteration of consent may be applied. In addition, guidance is provided for writing consent documents for a variety of situations.
This series includes checklists and guidance for:
- Consent Checklist: Instructions and Guidance
- Consent Checklist: Regulatory Requirements Common Rule
- Consent Checklist: FDA Requirements
- Consent Checklist: UIC and Other Requirements
- Consent Checklist: Documentation Requirements
- Consent Checklist: Waivers and Alterations
- Consent Checklist: General Writing Tips
eConsent in Human Subject Research Heading link
Researchers who want to utilize eConsent will need to prospectively report this to the UIC Office for the Protection of Research Subjects during the review process, whether the project requires IRB approval (expedited review, convened review) or acknowledgment of a claim of exemption.
eConsent Using REDCap Heading link
Overview
eConsent can be obtained electronically using REDCap by creating your IRB approved consent document as a REDCap survey form. By setting up eConsent in REDCap, research participants can review, agree, sign and download the consented PDF form remotely or in clinics using internet accessible devices.
Setting Up REDCap eConsent
You will need full access user rights in our REDCap system. If you do not have a REDCap account established yet, please refer to the REDCap account setup page.
eConsent will need to be implemented by each project manager. As such, a basic understanding of the REDCap tool is necessary. Get REDCap training.
Once you understand the basic functionality…
Learn how to implement the eConsent module
Creating the eConsent Form
Consent forms in REDCap are created the same as other regular data entry forms- no external modules or special installations required. REDCap available in any web browser (however, we recommend the most recent version of Chrome or Firefox) without an additional installation. Some additional eConsent settings in the eConsent framework are open for all under “Survey Settings” in each REDCap project.