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:
- Review regulatory requirements and challenges with respect to eIC
- Summarize the recently published joint guidance, Use of Electronic Informed Consent: Questions and Answers: Guidance for Institutional Review Boards, Investigators, and Sponsors and discuss its background and practical application
- Define and illustrate eIC
- Identify potential benefits of eIC and types of studies for which it may be best suited
- Suggest steps that investigators and IRBs can take to promote effective eIC
- Recommend directions for future research and guidance on eIC
(Presented on March 7, 2017)
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.
Webinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP recertification. Learn More »
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HRP Consulting Group provides expert advice to institutions seeking to develop or improve all aspects of their human research protection program. For more information, please visit www.thehrpconsultinggroup.com.
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