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Human Subject Research - HSR

ACU/IACUC

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Pre-Reg Required

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Full PRIMR25 Schedule

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Full PRIMR25 Schedule

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Thu, Nov 6
Fri, Nov 7
Sat, Nov 8

Full PRIMR25 Schedule

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Friday, November 7, 2025
7:00 AM - 8:30 AM ET
PRIMR25 Morning Beverage Service

7:00 AM - 8:30 AM ET

PRIMR25 Morning Beverage Service

7:00 AM - 5:00 PM ET
Registration Open

7:00 AM - 5:00 PM ET

Registration Open

7:15 AM - 8:15 AM ET
Federal Agency, Accrediting Body, CIP/CPIA Council Office Hours

7:15 AM - 8:15 AM ET

Federal Agency, Accrediting Body, CIP/CPIA Council Office Hours

7:15 AM - 8:15 AM ET
First Time Attendee Morning Coffee

7:15 AM - 8:15 AM ET

N01 - First Time Attendee Morning Coffee

8:30 AM - 9:00 AM ET
Welcome Remarks from PRIM&R Executive Director and Planning Committee Co-Chairs

8:30 AM - 8:45 AM ET

Welcome Remarks from PRIM&R Executive Director and Planning Committee Co-Chairs

Session will be livestreamed in real time and captured for on-demand viewing.

Session is being held in person and will be recorded for on-demand viewing.

Opening Remarks: Ivy Tillman, EdD, CIP, (she/her/hers) – PRIM&R

8:45 AM - 10:00 AM ET
Opening Keynote Presentation: Vardit Ravitsky, PhD

8:45 AM - 10:00 AM ET

Opening Keynote Presentation: Vardit Ravitsky, PhD

Keynote Speaker: Vardit Ravitsky, PhD – The Hastings Center

10:00 AM - 10:30 AM ET
Beverage Break in the Exhibit Hall

10:00 AM - 10:30 AM ET

Beverage Break in the Exhibit Hall

10:30 AM - 11:45 AM ET
PRIMR25 Plenary/Breakout/Networking A Series

10:30 AM - 11:45 AM ET

A01 - PLENARY: Navigating the IRB's Role Beyond Regulatory Compliance

Panelist: Holly A. Taylor, PhD, MPH (she/her/hers) – NIH

Foundations of Research Ethics and OversightIRB Operations and ManagementNavigating Ethical ChallengesRegulatory Frameworks and Compliance

10:30 AM - 11:45 AM ET

A02 - The Evolving Regulatory Landscape for AI in Human Subjects Research

Speaker: Shu Hui Chen

Speaker: Julie Kaneshiro, MA – Office for Human Research Protections

Emerging Challenges and Innovations in ResearchRegulatory Frameworks and Compliance

10:30 AM - 11:45 AM ET

A03 - The Ethics of Placebo Controls in Vaccine Clinical Trials

Speaker: Nancy E. Kass, ScD (she/her/hers) – The Johns Hopkins University

Regulatory Frameworks and ComplianceEmerging Challenges and Innovations in ResearchNavigating Ethical Challenges

10:30 AM - 11:45 AM ET

A04 - Local Context Review: Why It’s Essential and How to Do It Well

IRB Operations and ManagementRegulatory Frameworks and Compliance

10:30 AM - 11:45 AM ET

A05 - PLENARY: Planning for the Unknown: Organizational Strategies to Protect Animal Care and Use Programs from Unexpected Dangers

Moderator: Gary L. Borkowski, DVM, MS, DACLAM, CAE (he/him/his) – AAALAC International

Panelist: Tiffany M. Borjeson, DVM, DACLAM, CPIA (she/her/hers) – MIT

Panelist: Paula Clifford, MLA, CVT, RLATG – Americans for Medical Progress

Panelist: CeCe Brotchie-Fine, MA, MS, DBe, CPIA (she/her/hers) – Novartis Pharmaceuticals

Emerging Research Challenges and Breaking IssuesAnimal Well-Being and the 3Rs

10:30 AM - 11:45 AM ET

A06 - Meeting the Challenges of IACUC Administration: Case Studies in Handling Complex Protocol Issues/Situations

Speaker: Meredith L. Moore, PhD (she/her/hers) – Washington University in St. Louis

ACU/IACUC Program Management and AdministrationIACUC ReviewIACUC Fundamentals

10:30 AM - 11:45 AM ET

A07 - Setting New Faculty Up for Success: Onboarding Faculty Who Conduct Animal Research

Speaker: Nick Van De Velde

Education, Qualifications, and TrainingACU/IACUC Program Management and AdministrationEnhancing Collaboration and Inclusion in IACUC/ACU Programs

10:30 AM - 11:45 AM ET

A08 - Proactive Strategies for Emerging Trends and Crisis Management

Speaker: Michelle C. Stickler, DEd, CIP (she/her/hers) – The University of Texas at Austin

Research Oversight Leaders and Institutional OfficialsShared Research Oversight ChallengesEmerging Research Challenges and Breaking Issues

10:30 AM - 11:45 AM ET

A09 - PLENARY: AI Policy for Institutional Leaders

Panelist: Minal M. Caron

Research Oversight Leaders and Institutional OfficialsShared Research Oversight ChallengesEmerging Challenges and Innovations in Research

10:30 AM - 11:45 AM ET

A10 - Demystifying Sponsored Programs: A Compliance-Focused Introduction to Grants & Contracts

Speaker: John Baumann, PhD (he/him/his) – Univ of CA San Diego

Speaker: Melissa McGee, J.D. (she/her/hers) – University of New Hampshire

Education, Qualifications, and TrainingShared Research Oversight Challenges

11:45 AM - 1:30 PM ET
Lunch Service - Kiosks Open in Exhibit Hall

11:45 AM - 1:30 PM ET

Lunch Service - Kiosks Open in Exhibit Hall

12:30 PM - 1:30 PM ET
Federal Agency, Accrediting Body, CIP/CPIA Council Office Hours

12:30 PM - 1:30 PM ET

Federal Agency, Accrediting Body, CIP/CPIA Council Office Hours

12:30 PM - 1:30 PM ET
Meet and Greet With the Supporters and Exhibitors

12:30 PM - 1:30 PM ET

Meet and Greet With the Supporters and Exhibitors

12:15 PM - 1:30 PM ET
PRIMR25 Networking Series

12:15 PM - 1:30 PM ET

N02 - Collaborative Project on Artificial Intelligence (AI) Regulatory and Ethical Review: Insights, Challenges, and Practical Tools

Emerging Challenges and Innovations in ResearchRegulatory Frameworks and Compliance

12:30 PM - 1:30 PM ET
PRIMR25 Networking Series

12:30 PM - 1:30 PM ET

N03 - Lunch with Leaders: Conversations for Institutional Officials

Speaker: Stacy Pritt, MS, DVM, MBA, CPIA, CHRC, DACAW (she/her/hers) – Texas A&M University System

Speaker: CeCe Brotchie-Fine, MA, MS, DBe, CPIA (she/her/hers) – Novartis Pharmaceuticals

Research Oversight Leaders and Institutional OfficialsEmerging Research Challenges and Breaking Issues

12:30 PM - 1:30 PM ET

N04 - Measuring Success: Evaluating the Effectiveness of IACUC Training Programs

Education, Qualifications, and TrainingQA/QI and Postapproval MonitoringACU/IACUC Program Management and Administration

12:30 PM - 1:30 PM ET

N05 - Future of Regulatory Oversight of Research in the US

Emerging Research Challenges and Breaking IssuesACU/IACUC Program Management and Administration

12:30 PM - 1:30 PM ET

N06 - Building a Positive Post-Approval Program—Even with Limited Resources

Speaker: Jessica Orak (she/her/hers) – Medical University of South Carolina

Speaker: Jen Ensley Gorshe

Speaker: Regan Pulaski

IRB Operations and ManagementRegulatory Frameworks and Compliance

12:30 PM - 1:30 PM ET

N07 - Round Table: Insights from Industry: Research Participant Compensation

Speaker: Kelly FitzGerald, PhD, CIP (she/her/hers) – WCG

Speaker: Karla Childers, BA, MSJ, MBE (she/her/hers) – Johnson & Johnson

Speaker: Lindsay McNair, MD, MPH, MSB (she/her/hers) – Equipoise Consulting, LLC

Emerging Challenges and Innovations in ResearchRegulatory Frameworks and ComplianceNavigating Ethical Challenges

12:30 PM - 1:30 PM ET

N09 - Create & Connect: A Mindful Networking Session

12:30 PM - 1:30 PM ET
View the PRIMR25 Poster Abstracts

12:30 PM - 1:30 PM ET

View the PRIMR25 Poster Abstracts

1:45 PM - 3:00 PM ET
PRIMR25 Plenary/Breakout/Networking B Series

1:45 PM - 3:00 PM ET

B01 - PLENARY: Ethical and Regulatory Considerations for Cutting-Edge Neurotechnology Research

Panelist: Benjamin C. Silverman, MD – Mass General Brigham

Panelist: Leigh Hochberg

Emerging Challenges and Innovations in ResearchIRB Operations and ManagementRegulatory Frameworks and ComplianceNavigating Ethical Challenges

1:45 PM - 3:00 PM ET

B02 - Navigating the New Frontier: IRB Challenges with Complex Innovative Trial Designs

Speaker: Molly Klote, MD – Klote Medical Research Advisors, LLC

Navigating Ethical ChallengesEmerging Challenges and Innovations in ResearchRegulatory Frameworks and Compliance

1:45 PM - 3:00 PM ET

B03 - Navigating Ethical and Regulatory Complexities in Research with Children

Speaker: Saraf Salim, MPH (she/her/hers) – Office for Human Research Protections (OHRP)

Foundations of Research Ethics and OversightRegulatory Frameworks and Compliance

1:45 PM - 3:00 PM ET

B04 - Creating a Joint Human Research Protection Program: Challenges and Prospects

Emerging Challenges and Innovations in ResearchIRB Operations and Management

1:45 PM - 3:00 PM ET

B05 - PLENARY: Future of Animal Bioethics for IACUCs, Research, and Society

Moderator: Jennie Lofgren, DVM, MS, DACLAM (she/her/hers) – Novartis Institutes for Biomedical Research

Panelist: Margaret S. Landi, VMD, MS, DACLAM, MBioethics (she/her/hers) – Landi Animal Research and Bioethics

Animal Well-Being and the 3RsEmerging Research Challenges and Breaking IssuesACU/IACUC Program Management and AdministrationNavigating Ethical Challenges

1:45 PM - 3:00 PM ET

B06 - Strengthening the IACUC: Recruiting, Training, and Supporting a Diverse Committee

Speaker: Richelle L. Scales, B.Sc., CPIA (she/her/hers) – UC Berkeley

Speaker: Rachel A. Murray, MS, CPIA, LATG – Cincinnati Children's Hospital Medical Center

Education, Qualifications, and TrainingEnhancing Collaboration and Inclusion in IACUC/ACU ProgramsIACUC Fundamentals

1:45 PM - 3:00 PM ET

B07 - Adverse Event and Noncompliance Investigations: How to Get the Relevant Information You Need Without Burning Bridges

Speaker: Laura Fontaine

Speaker: Esmeralda Meyer, CPIA – Emory University

Speaker: Christopher S. Keator, PhD (he/him/his) – WMU Homer Stryker MD School of Medicine

Enhancing Collaboration and Inclusion in IACUC/ACU ProgramsQA/QI and Postapproval MonitoringACU/IACUC Program Management and Administration

1:45 PM - 3:00 PM ET

B08 - Emergency Preparedness for Institutional Leadership: You need a plan!

Speaker: Amy Casey

Speaker: Cathryn Lucas

Emerging Research Challenges and Breaking IssuesResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges

1:45 PM - 3:00 PM ET

B09 - Institutional Models for Managing Conflicts of Interest in Research

Speaker: Michelle C. Stickler, DEd, CIP (she/her/hers) – The University of Texas at Austin

Shared Research Oversight ChallengesACU/IACUC Program Management and AdministrationIACUC FundamentalsIRB Operations and ManagementFoundations of Research Ethics and Oversight

1:45 PM - 3:00 PM ET

B10 - Cultivating a Strong Research Culture

Speaker: Joshua Mangin, PhD (he/him/his) – University of New England

Shared Research Oversight ChallengesACU/IACUC Program Management and AdministrationResearch Oversight Leaders and Institutional OfficialsEnhancing Collaboration and Inclusion in IACUC/ACU ProgramsIRB Operations and Management

3:00 PM - 3:30 PM ET
Beverage Break in the Exhibit Hall

3:00 PM - 3:30 PM ET

Beverage Break in the Exhibit Hall

3:30 PM - 4:45 PM ET
PRIMR25 Plenary/Breakout/Networking C Series

3:30 PM - 4:45 PM ET

C01 - PLENARY: Ethical Considerations for Discontinued Clinical Trials and Programs

Moderator: Karla Childers, BA, MSJ, MBE (she/her/hers) – Johnson & Johnson

Panelist: Missy Heidelberg, B.S., M.S. Bioethics (she/her/hers) – Takeda Pharmaceuticals

Panelist: Lindsay McNair, MD, MPH, MSB (she/her/hers) – Equipoise Consulting, LLC

Panelist: Crispin Woolston

Emerging Challenges and Innovations in ResearchNavigating Ethical ChallengesRegulatory Frameworks and Compliance

3:30 PM - 4:45 PM ET

C02 - FDA Oversight Made Simple: Key Concepts and Application to Research

Speaker: Carley Emerson, MS, CIP, CCRP (she/her/hers) – The University of North Carolina at Chapel Hill

Speaker: Amanda Matthews, AA, CIP (she/her/hers) – The Children's Mercy Hospital | Children’s Mercy Research Institute

Foundations of Research Ethics and OversightRegulatory Frameworks and ComplianceIRB Operations and Management

3:30 PM - 4:45 PM ET

C03 - Spotlight on Post-Approval Monitoring & Single IRB: What’s Working Now?

Speaker: Catherine Fruehling, MBA, CHRC (she/her/hers) – University of Iowa Human Subjects Office

Speaker: Neala J. Lane, MA, CCRC (she/her/hers) – Indiana University

Speaker: Marcella Cooks, MS (she/her/hers) – Northwestern University

IRB Operations and ManagementRegulatory Frameworks and Compliance

3:30 PM - 4:45 PM ET

C04 - Leveraging AI and Emerging Digital Technologies in Risk Management for Human Health Research

Speaker: Rafael Gonzalez

Emerging Challenges and Innovations in ResearchRegulatory Frameworks and ComplianceIRB Operations and Management

3:30 PM - 4:45 PM ET

C05 - Wildlife Animal Welfare 201: A Foundational Overview for Navigating the World of Oversight and Compliance With Free-Range Species

Oversight of Non-Typical Animals and SituationsIACUC Review

3:30 PM - 4:45 PM ET

C06 - AI-Driven Behavioral Monitoring in Preclinical Studies of Mice and Rats

Speaker: Chang-Ning Liu, PhD – Pfizer Inc.

Pharma/Biotech PerspectivesAnimal Well-Being and the 3RsQA/QI and Postapproval Monitoring

3:30 PM - 4:45 PM ET

C07 - Innovative and Alternative Strategies for Developing the AAALAC Program Description

Speaker: Leigh Ann Tulleson

Speaker: Deb Hickman

ACU/IACUC Program Management and AdministrationEnhancing Collaboration and Inclusion in IACUC/ACU Programs

3:30 PM - 4:45 PM ET

C08 - Living Through Lean Times: Managing on Constricted F&A

Speaker: Mark Barnes, JD, LLM – Ropes & Gray Law Firm

Speaker: Jane Strasser, PhD (she/her/hers) – University of Cincinnati

Research Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges

3:30 PM - 4:45 PM ET

C09 - Developing Leaders Within Research Compliance

Speaker: Sujatha Sridhar, MBBS, MCE – University of Texas Health Science Center at Houston

Speaker: Karen Christianson (she/her/hers) – HRP Consulting Group

Research Oversight Leaders and Institutional OfficialsShared Research Oversight ChallengesCareer Development

3:30 PM - 4:45 PM ET

C10 - Shared Risks, Local Responsibility: Empowering IRB and IACUC Professionals in Research Security

Speaker: Hila F. Berger, MPH, CIP, CHC (she/her/hers) – Rutgers University

Speaker: Amanda Humphrey

ACU/IACUC Program Management and AdministrationResearch Oversight Leaders and Institutional OfficialsIRB Operations and ManagementEmerging Challenges and Innovations in ResearchFoundations of Research Ethics and Oversight

4:45 PM - 6:00 PM ET
Meet and Greet With the Supporters and Exhibitors

4:45 PM - 6:00 PM ET

Meet and Greet With the Supporters and Exhibitors

4:45 PM - 6:00 PM ET
View the PRIMR25 Poster Abstracts

4:45 PM - 6:00 PM ET

View the PRIMR25 Poster Abstracts

4:45 PM - 6:00 PM ET
Welcome Reception in the Exhibit Hall

4:45 PM - 6:00 PM ET

Welcome Reception in the Exhibit Hall