In recent years, there has been increased interest in and greater use of electronic methods of informed consent (eIC) in research. In December 2016, the Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP) published joint guidance on the use of eIC for IRBs, investigators, and sponsors. As the prevalence of eIC increases, IRBs and investigators need to anticipate and address its specific challenges, and be prepared to take advantage of its potential benefits.
Presented by a health science policy analyst at FDA and a bioethicist at the University of Iowa who conducts empirical research on eIC, this intermediate-level webinar will:
Speakers will be joined by additional panelists from FDA and the University of Iowa during an interactive question and answer session at the conclusion of the webinar.
What will I learn?
After attending this webinar, attendees will be able to:
- Understand what eIC is
- Grasp the regulatory requirements and context for using eIC in FDA-regulated clinical investigations
- Better anticipate the challenges and benefits associated with eIC
- Recognize how investigators and IRBs can help in promoting ethical and effective eIC
Who should attend?
IRB professionals, members, investigators, and compliance staff who currently utilize or will utilize electronic methods of informed consent in the future will benefit from this webinar.