Thank you for attending PRIMR25/SBER25!
Recordings and evaluations will be available to attendees until February 14, 2026. After this date, PRIM&R members will receive complimentary access to the recordings one year after the event, beginning November 6, 2026.
If you have any questions, please contact registration@primr.org.
For details on how to download your Certificate of Attendance, please visit our CE/CIP/CPIA webpage (linked below).
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Thursday, Nov 6th
11:30 AM - 12:30 PM ETB02 - When SBER Meets FDA: A Survival Guide to Support SBE IRBs and ResearchersLocation: Room 339-342
Speaker: – Indiana University
Speaker: – Advarra
Social, Behavioral, and Educational ResearchFoundations of Research Ethics and OversightRegulatory Frameworks and ComplianceIRB Operations and Management
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Thursday, Nov 6th
11:30 AM - 12:30 PM ETB03 - Trust me, I Know What I'm Doing: SBER Edition!Location: Room 314-317
Speaker: – AAHRPP
Speaker: – Independent Professional
Social, Behavioral, and Educational ResearchRegulatory Frameworks and ComplianceIRB Operations and Management
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Friday, Nov 7th
10:30 AM - 11:45 AM ETA01 - PLENARY: Navigating the IRB's Role Beyond Regulatory ComplianceLocation: Ballroom III-IV
Moderator: – North Star Review Board
Panelist: – Perelman School of Medicine, University of Pennsylvania
Panelist: – Loyola University Chicago Stritch School of Medicine
Foundations of Research Ethics and OversightIRB Operations and ManagementNavigating Ethical ChallengesRegulatory Frameworks and Compliance
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Friday, Nov 7th
10:30 AM - 11:45 AM ETA02 - Collaborative Project on Artificial Intelligence (AI) Regulatory and Ethical Review: Insights, Challenges, and Practical ToolsLocation: Ballroom II
Speaker: – Center for AI & Digital Policy (CAIDP)
Speaker: – Multi-Regional Clinical Trials Center
Speaker: – WCG
Speaker: – Multi-Regional Clinical Trials Center
Speaker:
Emerging Challenges and Innovations in ResearchRegulatory Frameworks and Compliance
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Friday, Nov 7th
10:30 AM - 11:45 AM ETA03 - The Ethics of Placebo Controls in Vaccine Clinical TrialsLocation: Room 345-346
Speaker: – The Johns Hopkins University
Speaker: – Johns Hopkins Bloomberg School of Public Health
Speaker:
Regulatory Frameworks and ComplianceEmerging Challenges and Innovations in ResearchNavigating Ethical Challenges
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Friday, Nov 7th
10:30 AM - 11:45 AM ETA04 - Local Context Review: Why It’s Essential and How to Do It WellLocation: Room 324-326
Speaker: – AAHRPP
Speaker: – Johns Hopkins University School of Medicine
IRB Operations and ManagementRegulatory Frameworks and Compliance
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Friday, Nov 7th
12:30 PM - 1:30 PM ETN07 - Round Table: Insights from Industry: Research Participant CompensationLocation: Room 339-342
Speaker: – WCG
Speaker: – Johnson & Johnson
Speaker: – Equipoise Consulting, LLC
Emerging Challenges and Innovations in ResearchRegulatory Frameworks and ComplianceNavigating Ethical Challenges
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Friday, Nov 7th
1:45 PM - 3:00 PM ETB01 - PLENARY: Ethical and Regulatory Considerations for Cutting-Edge Neurotechnology ResearchLocation: Ballroom III-IV
Panelist: – Mass General Brigham
Panelist: – Mass General Brigham
Panelist: – Johns Hopkins University
Emerging Challenges and Innovations in ResearchIRB Operations and ManagementRegulatory Frameworks and ComplianceNavigating Ethical Challenges
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Friday, Nov 7th
1:45 PM - 3:00 PM ETB02 - Navigating the New Frontier: IRB Challenges with Complex Innovative Trial DesignsLocation: Room 324-326
Speaker: – Klote Medical Research Advisors, LLC
Speaker: – WCG
Navigating Ethical ChallengesEmerging Challenges and Innovations in ResearchRegulatory Frameworks and Compliance
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Friday, Nov 7th
1:45 PM - 3:00 PM ETB03 - Navigating Ethical and Regulatory Complexities in Research with ChildrenLocation: Room 339-342
Speaker: – Research Foundation for Mental Health
Speaker: – University of South Florida
Speaker: – Teachers College, Columbia University
Foundations of Research Ethics and OversightRegulatory Frameworks and Compliance
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Friday, Nov 7th
1:45 PM - 3:00 PM ETB04 - Building a Positive Post-Approval Program—Even with Limited ResourcesLocation: Room 345-346
Speaker: – Medical University of South Carolina
Speaker: – KBR
Speaker: – Connecticut Children's
IRB Operations and ManagementRegulatory Frameworks and Compliance
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Friday, Nov 7th
3:30 PM - 4:45 PM ETC01 - PLENARY: Ethical Considerations for Discontinued Clinical Trials and ProgramsLocation: Ballroom II
Moderator: – Johnson & Johnson
Panelist: – Takeda Pharmaceuticals
Panelist: – Equipoise Consulting, LLC
Panelist: – Sanofi
Emerging Challenges and Innovations in ResearchNavigating Ethical ChallengesRegulatory Frameworks and Compliance
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Friday, Nov 7th
3:30 PM - 4:45 PM ETC02 - FDA Oversight Made Simple: Key Concepts and Application to ResearchLocation: Room 343-344
Speaker: – The University of North Carolina at Chapel Hill
Speaker: – The Children's Mercy Hospital | Children’s Mercy Research Institute
Speaker: – Sanford
Foundations of Research Ethics and OversightRegulatory Frameworks and ComplianceIRB Operations and Management
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Friday, Nov 7th
3:30 PM - 4:45 PM ETC03 - Spotlight on Post-Approval Monitoring & Single IRB: What’s Working Now?Location: Ballroom I
Speaker: – University of Iowa Human Subjects Office
Speaker: – Indiana University
Speaker: – Northwestern University
IRB Operations and ManagementRegulatory Frameworks and Compliance
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Friday, Nov 7th
3:30 PM - 4:45 PM ETC04 - Leveraging AI and Emerging Digital Technologies in Risk Management for Human Health ResearchLocation: Ballroom III-IV
Speaker: – Pontificia Universidad Javeriana
Speaker: – Hospital Universitario San Ignacio, Pontificia Universidad Javeriana
Speaker: – Center for AI & Digital Policy (CAIDP)
Emerging Challenges and Innovations in ResearchRegulatory Frameworks and ComplianceIRB Operations and Management
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Saturday, Nov 8th
10:30 AM - 11:45 AM ETD02 - Beyond Emerging Tech: Using Embedded Ethics to Support the Design and Conduct of Clinical TrialsLocation: Room 345-346
Speaker: – Johns Hopkins Berman Institute of Bioethics
Speaker: – University of Pennsylvania Perelman School of Medicine
Speaker: – Johns Hopkins Berman Institute of Bioethics
Speaker: – Johns Hopkins University
Emerging Challenges and Innovations in ResearchNavigating Ethical ChallengesRegulatory Frameworks and Compliance
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Saturday, Nov 8th
10:30 AM - 11:45 AM ETD03 - PLENARY: What Counts as a Direct Benefit of Research?Location: Ballroom II
Panelist: – Advarra
Panelist: – Mass General Brigham
Panelist: – Takeda Pharmaceuticals
Foundations of Research Ethics and OversightIRB Operations and ManagementNavigating Ethical ChallengesRegulatory Frameworks and Compliance
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Saturday, Nov 8th
10:30 AM - 11:45 AM ETD04 - Inclusive Informed Consent: Engaging People with Disabilities in Research ParticipationLocation: Ballroom I
Speaker: – Columbia University Irving Medical Center
Speaker: – Johns Hopkins University
Speaker: – University of Nebraska Medical Center
Foundations of Research Ethics and OversightIRB Operations and ManagementRegulatory Frameworks and Compliance
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Saturday, Nov 8th
12:30 PM - 1:30 PM ETN19 - Round Table Discussion: Should We Still Be Using Unconsented Biospecimens for Research in 2025?Location: Room 349-350
Speaker: – Advarra
Speaker: – Mass General Brigham
Speaker: – Mass General Brigham Incorporated
Contributor (Not Presenting): – Multi-Regional Clinical Trials Center
Emerging Challenges and Innovations in ResearchIRB Operations and ManagementRegulatory Frameworks and ComplianceNavigating Ethical Challenges
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Saturday, Nov 8th
12:30 PM - 1:30 PM ETN20 - Everything You Wanted to Know About SMART IRB Agreement Version 3.0Location: Room 318-320
Speaker: – SMART IRB, Harvard University
Speaker: – Harvard University
Speaker: – Multi-Regional Clinical Trials Center
Emerging Challenges and Innovations in ResearchRegulatory Frameworks and Compliance
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Saturday, Nov 8th
1:45 PM - 3:00 PM ETE02 - Research Plot Twists: Addressing and Expecting the UnexpectedLocation: Ballroom II
Speaker: – The Ohio State University
Speaker: – Independent Professional
Foundations of Research Ethics and OversightIRB Operations and ManagementRegulatory Frameworks and Compliance
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Saturday, Nov 8th
1:45 PM - 3:00 PM ETE03 - Truth, Lies, and Research: The Paradox of DeceptionLocation: Ballroom III-IV
Speaker: – Indiana University
Speaker: – Virginia Tech
Speaker: – Research Compliance, Integrity & Security, University of Nebraska - Lincoln
Foundations of Research Ethics and OversightRegulatory Frameworks and Compliance
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Saturday, Nov 8th
1:45 PM - 3:00 PM ETE04 - Preparing for sIRB Review: Perspectives from Institutional and Independent IRBsLocation: Ballroom I
Speaker: – Johns Hopkins University School of Medicine
Speaker: – WCG
Speaker: – North Star Review Board
IRB Operations and ManagementRegulatory Frameworks and Compliance
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Saturday, Nov 8th
3:30 PM - 4:45 PM ETF01 - PLENARY: Redefining Private Information and Privacy in the Digital EraLocation: Ballroom II
Moderator: – None
Panelist: – Arizona State
Panelist: – Purdue University
Panelist: – Ropes & Gray LLP
Emerging Challenges and Innovations in ResearchRegulatory Frameworks and Compliance
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Saturday, Nov 8th
3:30 PM - 4:45 PM ETF02 - Approaches to Ethical Oversight of Research Involving Recently DeceasedLocation: Room 345-346
Speaker: – Vanderbilt University Medical Center
Speaker: – NYU Langone Health
Speaker: – NYU Langone Health
Communication With the PublicFoundations of Research Ethics and OversightEmerging Challenges and Innovations in ResearchIRB Operations and ManagementNavigating Ethical ChallengesRegulatory Frameworks and Compliance
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Saturday, Nov 8th
3:30 PM - 4:45 PM ETF10 - The Evolving Regulatory Landscape for AI in Human Subjects ResearchLocation: Ballroom III-IV
Speaker: – Office for Human Research Protections
Speaker: – AI Strategy LLC
Emerging Challenges and Innovations in ResearchRegulatory Frameworks and Compliance
