Use of eConsent in Human Subjects Research

Megan Doerr, MS, LGC, principal scientist at Sage Bionetworks delivered a lunch-and-learn webcast for OHRP in January 2020. Ms Doerr described various forms of e-consent, the importance of accessibility and readability, the use of apps for research purposes, and shared case studies to explore ways of approaching e-consent to satisfy regulatory requirements and ethical standards. Sage Bionetworks posted this video for public distribution.

• Review the FDA/OHRP 2016 Guidance on Use of Electronic Informed Consent: Questions and Answers at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/use-electronic-informed-consent-questions-and-answers/
• Review OHRP featured video "Simplifying Informed Consent" at https://www.hhs.gov/ohrp/education-and-outreach/online-education/videos/index.html