Increasingly, social, behavioral, and educational research (SBER) incorporates techniques and devices that are more traditionally found in biomedical research, creating challenges for IRBs in determining whether a study falls under US Food and Drug Administration (FDA) oversight. The FDA’s authority includes drugs, biologics, and medical devices. FDA oversight may also extend to mobile medical applications and other innovations, which can create challenging regulatory questions as to whether a study falls under FDA jurisdiction.
During this 90-minute webinar, speakers will pair key regulatory concepts with illustrative scenarios to provide a broad overview of essential FDA issues for IRBs reviewing relevant SBER. Speakers will:
- Define several fundamental regulatory concepts present in the FDA regulations—including drug, Investigational New Drug (IND), Investigational Device Exemption (IDE), significant risk (SR), non-significant risk (NSR), dietary supplement, medical device, and mobile medical app—and explore application of these definitions to SBER
- Discuss factors to consider when determining whether an SBER protocol involves FDA-regulated drugs or devices and is therefore subject to FDA oversight
- Examine a diverse set of SBER cases in areas such as mobile apps, exploratory devices, food and dietary supplements, and transcranial magnetic stimulation
- Explore other relevant IRB issues, including the application of different levels of review that can be applied to FDA-regulated SBER and considerations for informed consent
(Presented on September 20, 2018)
What will I learn?
After attending this webinar, you will be able to:
- Define some key FDA regulatory concepts and recognize their potential application to SBER
- Determine whether an SBER protocol involves FDA-regulated drugs or devices
- Apply appropriate IRB review levels to studies with FDA-regulated drugs or devices
Who should attend?
This webinar will review basic FDA definitions and terminology. IRB professionals and members as well as researchers who review and conduct SBER 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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Access to purchased content will be available for 90 days after the date of purchase. After 90 days, access to the content will be removed, but users will retain access to any certificates of attendance earned. Content purchased prior to January 1, 2021 will remain available indefinitely. After access has expired, users can purchase an additional 90 days of access.
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Please note that this content is a part of multiple bundles. Click here to see the FDA-Regulated Research Bundle. Click here to see the SBER Bundle.