A PRIM&R Workshop
The Assurance of Privacy and Confidentiality in Research: Is it Still Possible?
February 26, 2026 1:00 – 2:30 PM ET
Overview
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(21 CFR 50/56) can still be meaningfully upheld—or whether traditional assumptions about data protection are becoming outdated in an AI-driven, data-saturated environment.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.
What Will You Learn?
To describe the expanding scope of personal data available through commercial, public, and digital sources and how this growth impacts regulatory definitions of identifiable private information under the Common Rule and FDA regulations.
To analyze the limitations of deidentification in light of modern data-linkage techniques, and evaluate how these challenges affect regulatory pathways such as exempt research, limited IRB review, and minimal-risk determinations.
To re-examine institutional obligations to protect privacy and maintain confidentiality—including requirements for informed consent, data security, and IRB review—given current risks of reidentification, AI-driven analytics, and persistent data breaches.
Speakers
- Robert Ramonchuk
- Luke Gelinas
Accommodations
PRIM&R is committed to hosting inclusive, accessible events that enable all individuals to engage and participate fully. For inquiries about session accessibility or requests for specific accommodations, please contact Scott Rule at srule@primr.org or 617.303.1876. Requests for American Sign Language interpreters and/or CART providers should be made at least two weeks in advance of the event. Please note that PRIM&R will make every effort to secure services, but that these services are subject to availability.
CE Credit
Participants will receive a certificate of attendance that documents up to 1.5 continuing education credit hours for their attendance at this webinar. Certificates of attendance are useful for obtaining CE credits from professional associations. Each association's guidelines for accepting CE credit hours (in-person or virtual) may differ. Please consult the appropriate association representative for information on if, and how many, CE credits from this PRIM&R webinar may be used.
CIP® Credit:
Participants holding the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP recertification. Please refer to the CIP® recertification guidelines for additional information.
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