F05 - [IN-PERSON/RECORDED] IRB Review of FDA‐regulated Research: From Comfort to Competence!

This session will be offered in-person and recorded for on-demand access by in-person PRIMR23 attendees registered for this day, and PRIMR23/SBER23 Virtual Meeting registrants.

As technologies advance, it can be challenging to confidently identify when human research involves products regulated by the Food and Drug Administration (FDA) and is a clinical investigation for which FDA’s human subject regulations apply. Increasingly, research involves software applications, artificial intelligence, treatment algorithms, dietary supplements, cosmetics, essential oils and other “test articles”, and originates from varied disciplines and/or researchers who may not realize the full regulatory context of a project. This session will cover how the frequent and familiar--FDA-regulated research--and comfort with the routine might hinder recognition of the occasional twists and new or unique products that may be subject to FDA regulation.