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Synthetic Data and the IRB

In this webinar we talk about synthetic data and why there is widespread confusion about what it is and how it should be treated in research oversight. Synthetic data is often casually labeled as “fake data.” That label is misleading, and in regulatory contexts, it is dangerous. While synthetic data is frequently promoted as a solution to privacy challenges, it can also introduce new compliance, ethical, and scientific risks. Research compliance professionals are increasingly unsure how to treat it.Is it non–human subjects research? Is it exempt? What are the actual risks?And what happens if we get that determination wrong? This presentation explains why synthetic data should not automatically be treated as fake, harmless, or exempt from oversight. The goal is to help IRB members and research administrators make informed, risk-based decisions using existing federal rules and guidance.