Who should review this material:
- Personnel building project
- Personnel managing the project
- Regulatory personnel on the study team
Obtaining informed consent electronically is an increasingly important capability for clinical research. The OHSU IRB has released guidance (Use of Electronic Consent - Quick Guide) that provides definitions and requirements for implementation of systems that support electronic consent.
OCTRI has worked closely with the 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). REDCap can be used for real time consenting for studies that are not FDA regulated (21 CFR Part 11). This toolkit not intended to be used for studies conducted under an 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. If you need an electronic consent for an FDA regulated study, contact OCTRI Research Navigator and request a consultation.
Consenting in REDCap requires using REDCap survey functionality. Study team personnel build survey(s) for their consent form(s) by copying and pasting the text of their consent document into a REDCap form, and then configure that form’s survey settings to meet the consent requirements for their study.
Depending on the study requirements for consent, advanced setup of REDCap in addition to the e-consent framework to collect legally valid signatures, may be required. In addition to our usual REDCap support services, build services are available from OCTRI when these advanced features are required.
Study teams should plan for extended development and testing time, and possibly additional support costs to ensure a successful implementation of electronic consent.
The following is a list of the key determinants for configuring the survey settings, as well as deciding if other features in REDCap will also be needed to implement consent:
Is there an IRB approved information sheet with or without HIPAA language (no signature required) or a consent form (with signature lines)?
Is a signature required?
Did the IRB waive the requirement for obtaining written consent and waive the signature requirement for HIPAA (e.g., with a waiver of authorization form)?
Minimal risk studies may be able to request a waiver of written consent and waiver of the signature requirement for HIPAA.
Is documentation of the study staff who obtained consent needed?