Consent may be obtained electronically using DocuSign or REDCap. You may obtain HIPAA authorization electronically using DocuSign or REDCap for all studies, irrespective of risk level. In the event your participant population cannot access DocuSign or another secure and encrypted online platform (e.g., REDCap), you may consider having participants take photographs of their signed consents using their cell phones and emailing them to the study team. Make sure you document the consent process so that anyone examining your approach will be able to see how consent was obtained in good faith.
21 CFR Part 11 Compliance
- DocuSign – You may request a Part 11 Compliant version of DocuSign by going to the DocuSign wiki page and clicking on request additional roles. If the link is not accessible, please reach out to Jon Crumpler email@example.com requesting a DocuSign Part 11 compliant account and his team will create a ticket on your behalf.