With the commercial marketplace for large data sets, the increasing ease of re-identification, the frequency of data breaches, and the accelerating capabilities of artificial intelligence, the long-standing regulatory promises of privacy and confidentiality in human subjects research are under mounting pressure. This session will critically examine whether the commitments required under the Common Rule (45 CFR 46) and FDA human subject protections (21 CFR 50/56) can still be meaningfully upheld—or whether traditional assumptions about data protection are becoming outdated in an AI-driven, data-saturated environment.
Participants will explore current regulatory expectations for safeguarding identifiable private information and biospecimens, and consider emerging challenges that strain the regulatory framework’s adequacy.