PRIMR24 Full Schedule

7:00 AM – 8:30 AM PT

PRIMR24 Morning Beverage Service

Location: LV3 Pine Lobby

7:00 AM – 5:00 PM PT

Registration Open

Location: Flex Hall B

8:30 AM – 4:15 PM PT

WS1 - Ethical and Regulatory Oversight of National and Transnational Social Science Research

Location: Room 320-321

Workshop Speaker: – Florida State University

8:30 AM – 4:15 PM PT

WS2 - Navigating Stormy IACUC Waters: Tackling Complex Protocols and Difficult Conversations

Location: Room 322

Workshop Speaker: – University of Washington

Workshop Speaker: – San Jose State University

8:30 AM – 11:45 AM PT

WS3 - Are We and They Doing It Right? Building an Effective Monitoring Program for Ongoing Oversight of Regulatory Compliance

Location: Room 323-324

Workshop Speaker: – formerly of Indiana University

Workshop Speaker: – The University of Texas at Austin

8:30 AM – 11:45 AM PT

WS4 - Immersive Technologies and Human Subjects Protections

Location: Room 333-334

Workshop Speaker: – Santa Clara University

Workshop Speaker: – XRSI - X Reality Safety Intelligence

8:30 AM – 11:45 AM PT

WS5 - Leadership Development: Pathways to Career Growth for Senior Research Oversight Personnel

Location: Room 331

Workshop Speaker: – University of Florida

Workshop Speaker: – Weill Cornell Medicine

10:00 AM – 10:30 AM PT

PRIMR24 Workshop Morning Beverage Service

Location: LV3 Pine Lobby

11:45 AM – 1:00 PM PT

Lunch

Location: Flex Hall A

1:00 PM – 4:15 PM PT

WS6 - When Noncompliance and Research Misconduct Worlds Collide: Navigating Cross-Committee Compliance Issues

Location: Room 323-324

Workshop Speaker: – University of Maryland, Baltimore

Workshop Speaker: – Penn State

Workshop Speaker: – Mass General Brigham

1:00 PM – 4:15 PM PT

WS7 - Building a Quality Assurance (QA) Program for Compliance

Location: Room 333-334

Workshop Speaker: – Yale University

Workshop Speaker: – Ann & Robert H. Lurie Children’s Hospital of Chicago

Workshop Speaker: – Tufts University SBER IRB

1:00 PM – 4:15 PM PT

WS8 - The Role of the Institutional Official in Facilitating Ethical and Compliant Research

Location: Room 331

Workshop Speaker: – Emory University

Workshop Speaker: – University of Cincinnati

3:00 PM – 3:30 PM PT

PRIMR24 Workshop Afternoon Beverage Service

Location: LV3 Pine Lobby

4:15 PM – 5:30 PM PT

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

Location: Flex Hall BC

4:15 PM – 5:30 PM PT

Meet and Greet With the Supporters and Exhibitors

Location: Flex Hall BC

4:15 PM – 5:30 PM PT

View the PRIMR24 Poster Abstracts

Location: Flex Hall BC

4:15 PM – 5:30 PM PT

Workshops Networking Reception

Location: Flex Hall BC

7:00 AM – 8:30 AM PT

PRIMR24 Morning Beverage Service

Location: Flex Hall BC

7:00 AM – 5:00 PM PT

Registration Open

Location: Flex Hall B

7:00 AM – 8:15 AM PT

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

Location: Flex Hall BC

7:15 AM – 8:15 AM PT

N01 - IACUC Morning Coffee

Location: Flex Hall BC

ACU/IACUC Program Management and AdministrationIACUC Review

8:30 AM – 9:00 AM PT

PRIMR24 Co-Chairs Welcome and Executive Director Remarks

Location: Ballroom 1

Opening Remarks: – PRIM&R

Emerging Research Challenges and Breaking Issues

9:00 AM – 10:00 AM PT

PRIMR24 Opening Session: The Next Frontier: Space Exploration Research

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

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

Location: Ballroom 1

Moderator: – AAHRPP

Keynote Speaker: – Translational Research Institute for Space Health

Emerging Research Challenges and Breaking Issues

10:00 AM – 10:30 AM PT

Beverage Break in the Exhibit Hall

Location: Flex Hall BC

10:30 AM – 11:45 AM PT

A01 - PLENARY: Reimagining Informed Consent Processes to Support Informed, Values-Concordant Decisions

Location: Ballroom 3

Moderator: – Seattle Children's Research Institute

Panelist: – Geisinger College of Health Sciences

Panelist: – Advarra

Panelist: – NIH

Informed Consent

10:30 AM – 11:45 AM PT

A02 - How Do You Actually Review a Protocol Involving Artificial Intelligence (AI)?

Location: Ballroom 1

Speaker: – University of Florida

Speaker: – Office of Human Subjects Research Johns Hopkins University School of Medicine

Speaker: – Mass General Brigham

Speaker: – Stanford University

Emerging Research Challenges and Breaking IssuesIRB ReviewResearch Involving Data and New Technologies

10:30 AM – 11:45 AM PT

A03 - Why “It Depends”: General Considerations for IRBs and HRPPs When Reviewing Research Using FDA-Regulated Products

Location: Room 431-432

Speaker: – Office of the Chief Medical Officer, FDA

Speaker: – Office of Scientific Investigations/CDER/FDA

Speaker: – US Food and Drug Administration

Speaker: – USFDA

FDA Regulated ResearchIRB ReviewPharma/Biotech Perspectives

10:30 AM – 11:45 AM PT

A04 - Advancing Gender Inclusivity in Research: Overcoming Political and Regulatory Challenges in Participant Materials

Location: Room 423-425

Speaker: – North Star Review Board

Speaker: – University of Nevada, Las Vegas

Speaker: – SUNY Downstate Health Sciences University

Advancing Equity and JusticeEducation, Qualifications, and Training

10:30 AM – 11:45 AM PT

A05 - The Ethical Conduct of Cell and Gene Therapy Research: Novel Challenges for Industry and the IRB

Location: Room 444

Speaker: – Takeda Pharmaceuticals

Speaker: – Boston Children's Hospital

Speaker: – Advarra

Pharma/Biotech PerspectivesResearch Involving Data and New Technologies

10:30 AM – 11:45 AM PT

A06 - Great “Private” Expectations: What Is Publicly Available Private Information?

Location: Room 345-346

Speaker: – UC San Diego

Speaker: – Research Compliance Services, University of Nebraska - Lincoln

Speaker: – Human Research Protection Office, University of Massachusetts Amherst

Social, Behavioral, and Educational ResearchResearch Involving Data and New TechnologiesIRB Review

10:30 AM – 11:45 AM PT

A07 - A Dialogue With the Office of Research Integrity (ORI)

Location: Room 336

Speaker: – Office of Assistant Secretary for Health

A Dialogue with the Feds

10:30 AM – 11:45 AM PT

A08 - What is the Role of Regret and Apology in Protecting the Human Participants of Clinical Trials?

Location: Room 335

Speaker: – PIRE-Southwest

Speaker: – PRIM&R

Speaker: – Northwest Indian College

HRPP/IRB Management and AdministrationPharma/Biotech PerspectivesIRB Review

10:30 AM – 11:45 AM PT

A09 - Shift Your Focus: Transforming an HRPP Into a Collegial and Efficient Partner of the Research Community

Location: Room 343-344

Speaker: – Icahn School of Medicine at Mount Sinai

Speaker: – Columbia University in the City of New York

Speaker: – Weill Cornell Medicine

Speaker: – NYU Langone Health

HRPP/IRB Management and Administration

10:30 AM – 11:45 AM PT

A10 - Decentralized Clinical Trials (DCTs) and the Community Dimension: Advantages and Challenges

Location: Room 443

Speaker: – Johns Hopkins University School of Medicine

Speaker: – University of Utah

Speaker: – Epstein Becker & Green PC

Populations Requiring Additional ProtectionsAdvancing Equity and Justice

10:30 AM – 11:45 AM PT

A11 - PLENARY: Global Perspectives on the Ethics, Principles, and Regulations Guiding Research Involving Nonhuman Animals

Location: Room 323-324

Panelist: – University of Washington

Moderator: – San Jose State University

Panelist: – Landi Animal Research and Bioethics

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

10:30 AM – 11:45 AM PT

A12 - Welfare Considerations for Cephalopods

Location: Room 320-321

Speaker: – The Ohio State University

Speaker: – San Francisco State University

Oversight of Non-Typical Animals and SituationsAnimal Well-Being and the 3Rs

10:30 AM – 11:45 AM PT

A13 - IACUC SOS! Evaluating Difficult Protocols By Optimizing Your Review Toolkit

Location: Room 333-334

Speaker: – UCLA

Speaker: – Cincinnati Children's Hospital Medical Center

Speaker: – Michigan State University

IACUC ReviewACU/IACUC Program Management and Administration

10:30 AM – 11:45 AM PT

A14 - AAALAC International Update

Location: Room 322

Speaker: – AAALAC International

A Dialogue with the Feds

10:30 AM – 11:45 AM PT

A15 - Openness about Animal Research: Why and How to Share What We Do

Location: Room 332

Speaker: – AstraZeneca

Speaker: – Americans for Medical Progress

Speaker: – University of Washington

Communication With the Public

10:30 AM – 11:45 AM PT

A16 - PLENARY: PI Responsibility & Accountability Versus Effectiveness of Institutional Compliance and Ethics Review: What Will Really Make a Difference in How We Conduct Research?

Location: Ballroom 2

Moderator: – Mass General Brigham Incorporated

Panelist: – Fred Hutchinson Cancer Center

Panelist: – Labcorp

Panelist: – University of Nebraska Medical Center

Shared Research Oversight ChallengesResearch Oversight Leaders and Institutional OfficialsIRB ReviewIACUC Review

10:30 AM – 11:45 AM PT

A17 - Consciously Uncoupling? When Institutions and Investigators Separate (amicably, or sometimes not so much)

Location: Room 445-446

Speaker: – Northwestern University

Speaker: – Virginia Tech

Speaker: – New York University Grossman School of Medicine

Shared Research Oversight ChallengesHRPP/IRB Management and AdministrationACU/IACUC Program Management and AdministrationResearch Oversight Leaders and Institutional Officials

10:30 AM – 11:45 AM PT

A18 - The Cost to Having a Revolving Door: PI Onboarding & Exit Planning

Location: Room 347-348

Speaker: – Nationwide Children's Hospital

Speaker: – Florida A&M University

Education, Qualifications, and TrainingHRPP/IRB Management and AdministrationACU/IACUC Program Management and AdministrationShared Research Oversight ChallengesResearch Oversight Leaders and Institutional Officials

10:30 AM – 11:45 AM PT

A19 - New Regulations and Federal Policy Updates: Get Up to Speed!

Location: Signature Room

Speaker: – Advarra

Shared Research Oversight ChallengesResearch Oversight Leaders and Institutional Officials

10:30 AM – 11:45 AM PT

A20 - How Institutional Leaders Can Promote COI Program Effectiveness

Location: Room 331

Panelist: – Texas A&M University System

Speaker: – Johns Hopkins University

Speaker: – Memorial Sloan Kettering Cancer Center

Education, Qualifications, and TrainingShared Research Oversight ChallengesLegal Considerations in Research Oversight

11:45 AM – 1:30 PM PT

Lunch

Location: Flex Hall ABC

12:30 PM – 12:55 PM PT

Industry Expert Theater: PRIMR24 Poster Presentation—IRB Pre-Review Tools Reduce Expedited Initial Application Turn-Around Times

Location: Flex Hall BC

Moderator: – Seattle Children's Research Institute

Author: – University of Washington

12:30 PM – 12:55 PM PT

Room 320-321: PRIMR24 Poster Presentation—Using Research Electronic Data Capture (REDCap) to Modernize an Inspection Program

Location: Room 320-321

Poster Session Moderator: – North Carolina Central University

Author: – Cedars-Sinai Medical Center

12:30 PM – 1:30 PM PT

N02 - REACH, the Research Ethics Action Collaborative for HRPPs, for Justice

Location: Signature Room

Speaker: – PRIM&R

Speaker: – Mass General Brigham Incorporated

Speaker: – Multi-Regional Clinical Trials Center

Advancing Equity and JusticeEmerging Research Challenges and Breaking Issues

12:30 PM – 1:30 PM PT

N03 - Rodents and Birds and Cephalopods…Oh My!: Shared Procedures for All Species in CUSP

Location: Room 322

Speaker: – University of Washington

Speaker: – Vanderbilt University Medical Center

Speaker: – University of Houston

Speaker: – University of California, San Francisco

Speaker: – University of Washington

Oversight of Non-Typical Animals and Situations

12:30 PM – 1:30 PM PT

N04 - How It Works: A Peek Inside the IACUC in Industry

Location: Room 331

Speaker: – Novartis

Speaker: – Labcorp

ACU/IACUC Program Management and Administration

12:30 PM – 1:30 PM PT

N05 - Everything You Wanted to Know About the CIP Credential

Location: Room 332

Speaker: – Kelley O'Donoghue Consulting

HRPP/IRB Management and Administration

12:30 PM – 1:30 PM PT

N06 - Planning for Ethical and Regulatory Changes in Human and Non-human Animal Research Programs

Location: Room 333-334

Speaker: – The University of Texas at Austin

Speaker: – Novartis

Shared Research Oversight ChallengesResearch Oversight Leaders and Institutional Officials

12:30 PM – 1:30 PM PT

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

Location: Flex Hall BC

12:30 PM – 1:30 PM PT

Meet and Greet With the Supporters and Exhibitors

Location: Flex Hall BC

12:30 PM – 1:30 PM PT

View the PRIMR24 Poster Abstracts

Location: Flex Hall BC

12:45 PM – 1:30 PM PT

Sponsored Session by WCG: Mastering the FDA's Impending sIRB Mandate: Essential Insights & Institutional Success Stories

Location: Room 323-324

Speaker: – WCG

Speaker: – University of Cincinnati College of Medicine

Speaker: – Baptist Health South Florida

Speaker: – University of Florida

Sponsored By

1:00 PM – 1:25 PM PT

Room 320-321: PRIMR24 Poster Presentation—Quiz Time a tool to help analysts increase their knowledge of human research protections, regulations, and policies, as well as, foster engagement within a Human Research Protections Program (HRPP)

Location: Room 320-321

Poster Session Moderator: – Indiana University

Author: – Vanderbilt University Medical Center Human Research Protections Program

1:00 PM – 1:25 PM PT

Industry Expert Theater: PRIMR24 Poster Presentation—The ENVISION study: Creating a values-oriented platform for informed consent

Location: Flex Hall BC

Poster Session Moderator: – Rutgers University

Speaker: – Seattle Children's Research Institute

1:45 PM – 3:00 PM PT

B01 - PLENARY: Ethical Considerations With Healthy Research Participants: Current Perspectives From the Field

Location: Signature Room

Moderator: – Perelman School of Medicine, University of Pennsylvania

Panelist: – University of North Carolina at Chapel Hill

Panelist: – 1Day Sooner

Panelist: – Metcut Reasearch

IRB ReviewAdvancing Equity and Justice

1:45 PM – 3:00 PM PT

B02 - Cybersecurity and Research Integrity: Can We Be Trusted to Keep Research Information Safe?

Location: Ballroom 1

Speaker: – Mayo Clinic

Speaker: – Icahn School of Medicine at Mount Sinai

Speaker: – Mount Sinai Health System

Emerging Research Challenges and Breaking IssuesResearch Involving Data and New Technologies

1:45 PM – 3:00 PM PT

B03 - Assessing Capacity to Consent for Research Participation: When and How Do You Actually Do It?

Location: Ballroom 3

Speaker: – Mass General Brigham

Speaker: – Multi-Regional Clinical Trials Center

Populations Requiring Additional ProtectionsInformed ConsentAdvancing Equity and JusticeIRB ReviewSocial, Behavioral, and Educational Research

1:45 PM – 3:00 PM PT

B04 - Ethical Implications and Practical Application of Broad Consent

Location: Room 343-344

Speaker: – Huron

Speaker: – University of Texas, MD Anderson Cancer Center

Speaker: – Indiana University Center for Bioethics

Pharma/Biotech PerspectivesInformed ConsentResearch Involving Data and New TechnologiesIRB Review

1:45 PM – 3:00 PM PT

B05 - A Dialogue with the Department of Energy (DOE)

Location: Room 322

Speaker: – United States Department of Energy

Speaker: – Department of Energy/National Nuclear Security Administration

A Dialogue with the Feds

1:45 PM – 3:00 PM PT

B06 - Evaluating the Impact of Current and Future Single IRB (sIRB) Requirements on Local IRBs

Location: Ballroom 2

Speaker: – University of Florida

Speaker: – Auxilio Mutuo Hospital

Speaker: – Office of Human Subjects Research Johns Hopkins University School of Medicine

Single IRBHRPP/IRB Management and Administration

1:45 PM – 3:00 PM PT

B07 - A Crisis Is a Crisis: Lessons Learned From Human-Based and Animal-Based Controversies and What We Can Learn From Our Colleagues Across the Hall

Location: Room 331

Speaker: – University of Michigan

Speaker: – Emory University

Communication With the PublicACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationShared Research Oversight ChallengesResearch Oversight Leaders and Institutional Officials

1:45 PM – 3:00 PM PT

B08 - Empowering the Participant Voice: Using Research Participant Experience Data to Address Research Disparities and Enhance Quality

Location: Room 332

Speaker: – The Rockefeller University

Speaker: – University of California, Santa Cruz

QA/QI and Postapproval MonitoringAdvancing Equity and Justice

1:45 PM – 3:00 PM PT

B09 - When SBER Meets the Definition of a Clinical Trial, Then What?

Location: Room 347-348

Speaker: – Florida State University

Speaker: – Weill Cornell Medicine

Social, Behavioral, and Educational ResearchIRB Review

1:45 PM – 3:00 PM PT

B10 - Advancing Justice, Equity, and Trustworthiness Through Community Engaged Research (CEnR): What HRPPs/IRBs Need to Know

Location: Room 345-346

Speaker: – Loyola University Chicago Stritch School of Medicine

Speaker: – Medical College of Wisconsin

Speaker: – Johns Hopkins, Major Extremity Trauma Research Consortium, DSMB; Univ of Maryland, Baltimore IRB; National Institutes of Health IRB;

Advancing Equity and JusticeIRB ReviewSocial, Behavioral, and Educational Research

1:45 PM – 3:00 PM PT

B11 - Reserved for Late Breaking

1:45 PM – 3:00 PM PT

B12 - The First 48 Hours: What to Do Right Away When Things Go Wrong

Location: Room 323-324

Speaker: – Texas A&M University

Speaker: – Emory National Primate Research Center, Emory University

Communication With the Public

1:45 PM – 3:00 PM PT

B13 - An Examination of HHS ORI’s Changes to Research Misconduct Regulations

Location: Room 333-334

Speaker: – Northwestern University

Speaker: – Office of Assistant Secretary for Health

Emerging Research Challenges and Breaking Issues

1:45 PM – 3:00 PM PT

B14 - Reproducibility and the IACUC

Location: Room 320-321

Speaker: – University of Florida College of Medicine

Speaker: – The National Centre for the Replacement, Refinement and Reduction of Animals in Research

IACUC ReviewAnimal Well-Being and the 3RsIACUC Fundamentals

1:45 PM – 3:00 PM PT

B15 - Building a Professional Network in the Animal Care and Use Community

Location: Room 336

Speaker: – UC Berkeley

Speaker: – University of California, Merced

ACU/IACUC Program Management and AdministrationEducation, Qualifications, and Training

1:45 PM – 3:00 PM PT

B16 - A Conversation with DoD: Knowledge of the US Military Research Context

Location: Room 443

Speaker: – Army Human Research Protections Office (AHRPO)

Speaker: – Department of the Navy

Speaker: – Department of the Air Force, Component Office of Human Research Protection

Speaker: – United States Army Medical Research and Development Command

1:45 PM – 3:00 PM PT

B17 - Effectively Managing the Use of Controlled Substances in Research

Location: Room 445-446

Speaker: – Virginia Commonwealth University

Speaker: – University of Michigan

Education, Qualifications, and TrainingHRPP/IRB Management and AdministrationACU/IACUC Program Management and AdministrationShared Research Oversight ChallengesResearch Oversight Leaders and Institutional OfficialsLegal Considerations in Research OversightPharma/Biotech Perspectives

1:45 PM – 3:00 PM PT

B18 - Cross Training and Successful Transfer of Knowledge

Location: Room 431-432

Speaker: – Lawrence Berkeley National Laboratory

Speaker: – The University of Toledo

Speaker: – Hackensack Meridian Health

Shared Research Oversight ChallengesEducation, Qualifications, and TrainingACU/IACUC Program Management and AdministrationHRPP/IRB Management and Administration

1:45 PM – 3:00 PM PT

B19 - PLENARY: Institutional Approaches to Research Security Programs

Location: Room 423-425

Moderator: – Attain Partners

Panelist: – The University of Texas at Austin

Panelist: – University of Texas Health Science Center at Houston

Panelist: – Cayuse

ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges

1:45 PM – 3:00 PM PT

B20 - Leaders of International Research: Navigating Research Regulations and Promoting Ethical Practices

Location: Room 444

Speaker: – formerly of Indiana University

Speaker: – Harvard T.H. Chan School of Public Health

Speaker: – Stanford University

Research Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges

3:00 PM – 3:30 PM PT

Break in the Exhibit Hall

Location: Flex Hall BC

3:30 PM – 4:45 PM PT

C01 - PLENARY: Taking Stock of the Research Ethics Oversight Ecosystem: Healthy Developments, Overgrowth, and Audit Culture

Location: Ballroom 3

Moderator: – Perelman School of Medicine, University of Pennsylvania

Panelist: – UC San Diego

Panelist: – NIH

QA/QI and Postapproval MonitoringEmerging Research Challenges and Breaking Issues

3:30 PM – 4:45 PM PT

C02 - A Dialogue with SACHRP

Location: Room 323-324

Speaker: – Stanford University

Speaker: – OHRP

Speaker: – WCG

A Dialogue with the Feds

3:30 PM – 4:45 PM PT

C03 - Postapproval Monitoring (PAM) in a Single IRB (sIRB) World: FDA Edition

Location: Ballroom 2

Speaker: – Advarra

Speaker: – University of Alabama at Birmingham

Speaker: – NYU Langone Health

Single IRBQA/QI and Postapproval MonitoringFDA Regulated Research

3:30 PM – 4:45 PM PT

C04 - What's That You're Wearing? Human Research Protections and Wearable Devices

Location: Ballroom 1

Speaker: – Maimonides Medical Center

Speaker: – DHHS Office for Human Research Protections

Research Involving Data and New TechnologiesEmerging Research Challenges and Breaking IssuesIRB ReviewSocial, Behavioral, and Educational Research

3:30 PM – 4:45 PM PT

C05 - IRBs Greatest Challenges for Youth-Centered Research

Location: Room 343-344

Speaker: – Fordham University

Speaker: – Teachers College, Columbia University

Speaker: – NYC Department of Health and Mental Hygiene

Populations Requiring Additional ProtectionsIRB ReviewSocial, Behavioral, and Educational Research

3:30 PM – 4:45 PM PT

C06 - Medical Devices: A Beginner's Guide to Understanding the Basics of FDA Regulation and How to Apply it to a Study

Location: Room 345-346

Speaker: – The Children's Mercy Hospital | Children’s Mercy Research Institute

Speaker: – The University of North Carolina at Chapel Hill

FDA Regulated ResearchIRB FundamentalsIRB Review

3:30 PM – 4:45 PM PT

C07 - This Coffee Is HOT! Burning Topics in the SBER Space (Needle)

Location: Room 443

Speaker: – Tufts University

Speaker: – Western Washington University

Social, Behavioral, and Educational ResearchHRPP/IRB Management and AdministrationIRB Review

3:30 PM – 4:45 PM PT

C08 - Help! I Don't Understand: Making the Consent Process and Form Meaningful Through Health Literacy and Adult Learning Theory

Location: Room 347-348

Speaker: – Nationwide Children's Hospital

Speaker: – Virtua Health

Speaker: – Rutgers, The State University of New Jersey

Informed ConsentAdvancing Equity and JusticeSocial, Behavioral, and Educational Research

3:30 PM – 4:45 PM PT

C09 - From Researcher to Sponsor Investigator: How to Work With Your Broader HRPP to Develop and Deploy Safe, Effective, and Ethical Artificial Intelligence (AI)

Location: Room 444

Speaker: – Mayo Clinic - Center for Digital Health

Speaker: – Mayo Clinic

Speaker: – Microsoft Research

HRPP/IRB Management and AdministrationEmerging Research Challenges and Breaking IssuesResearch Involving Data and New Technologies

3:30 PM – 4:45 PM PT

C10 - Updates to the Declaration of Helsinki

Location: Room 336

Speaker: – National Institutes of Health

Speaker: – Office for Human Research Protections

Speaker: – American Medical Association

Speaker: – FDA

Pharma/Biotech Perspectives

3:30 PM – 4:45 PM PT

C11 - PLENARY: The Historical Impact of Politics on Scientific Research With Nonhuman Animals

Location: Room 320-321

Moderator: – Americans for Medical Progress

Panelist: – Americans for Medical Progress

Panelist: – National Association for Biomedical Research

Communication With the PublicEmerging Research Challenges and Breaking Issues

3:30 PM – 4:45 PM PT

C12 - Driving Postapproval Monitoring (PAM) Program Priorities by Harnessing Existing Data

Location: Room 445-446

Speaker: – Rutgers University

Speaker: – Allen Institute

Speaker: – University of Florida

QA/QI and Postapproval MonitoringACU/IACUC Program Management and Administration

3:30 PM – 4:45 PM PT

C13 - A Dialogue With USDA, APHIS, Animal Care

Location: Room 431-432

Speaker: – USDA, APHIS, Animal Care

A Dialogue with the Feds

3:30 PM – 4:45 PM PT

C14 - What Needs to Change in Nonhuman Primate (NHP) Housing and Why

Location: Room 322

Speaker: – Labcorp

Speaker: – MAV Consulting

Pharma/Biotech PerspectivesAnimal Well-Being and the 3Rs

3:30 PM – 4:45 PM PT

C15 - Exploring NAMs and Complement-ARIE: Insights for IACUCs

Location: Room 331

Speaker: – University of Washington

Speaker: – National Center for Advancing Translational Sciences

Speaker: – Coridea, LLC

Emerging Research Challenges and Breaking IssuesIACUC ReviewACU/IACUC Program Management and AdministrationAnimal Well-Being and the 3Rs

3:30 PM – 4:45 PM PT

C16 - PLENARY: Bridging Preclinical to Clinical Research With Artificial Intelligence (AI) and Digital Biomarkers: Current Landscape, Vision, and the Collaborative Path Toward Improved Translation

Location: Room 333-334

Panelist: – Digital In Vivo Alliance

Panelist: – Pfizer, Inc.

Moderator: – TLR Ventures/ Digital In Vivo Alliance

Emerging Research Challenges and Breaking IssuesPharma/Biotech PerspectivesAnimal Well-Being and the 3RsResearch Involving Data and New Technologies

3:30 PM – 4:45 PM PT

C17 - Nurturing True Inclusion: Moving Beyond Tokenism to Actual Inclusion

Location: Room 423-425

Speaker: – Rutgers University

Speaker: – KBR

Advancing Equity and JusticeEducation, Qualifications, and TrainingShared Research Oversight Challenges

3:30 PM – 4:45 PM PT

C18 - Committee Meeting Navigation for Those in the Room

Location: Room 332

Speaker: – Colorado State University

Speaker: – Nemours Children's Health

Speaker: – WCG

IRB ReviewIACUC ReviewShared Research Oversight Challenges

3:30 PM – 4:45 PM PT

C19 - What You Don't Know Can Hurt You: Using Metrics to Evaluate Research Administrative Activities

Location: Signature Room

Speaker: – Texas A&M University System

Speaker: – University of Cincinnati

ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges

3:30 PM – 4:45 PM PT

C20 - PLENARY: Research Integrity Management in the New Public Arena

Location: Room 335

Moderator: – University of Southern Maine

Panelist: – Office of Assistant Secretary for Health

Panelist: – Clemson University

Panelist: – Penn State

ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges

4:45 PM – 6:00 PM PT

Meet and Greet With the Supporters and Exhibitors

Location: Flex Hall BC

4:45 PM – 6:00 PM PT

View the PRIMR24 Poster Abstracts

Location: Flex Hall BC

4:45 PM – 6:00 PM PT

Welcome Reception & 50th Anniversary in the Exhibit Hall

Location: Flex Hall BC

7:00 AM – 8:30 AM PT

PRIMR24 Morning Beverage Service

Location: Flex Hall BC

7:00 AM – 5:00 PM PT

Registration Open

Location: Flex Hall B

7:00 AM – 8:15 AM PT

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

Location: Flex Hall BC

7:15 AM – 8:15 AM PT

N07 - SBER Network Discussion Session

Location: Room 320-321

Speaker: – Weill Cornell Medicine

Speaker: – Brown University

Social, Behavioral, and Educational Research

7:15 AM – 8:15 AM PT

N08 - IRB Chairs Community‐Building Networking Forum

Location: Room 322

Speaker: – University of Southern California

Speaker: – Utah Tech University

IRB Review

7:15 AM – 8:15 AM PT

N09 - Horror Stories from the IACUC Office’

Location: Room 333-334

Speaker: – Labcorp

Speaker: – Michigan State University

IACUC Review

7:30 AM – 8:15 AM PT

Sponsored Presentation from Advarra: FDA sIRB Mandate – Deja Vu All Over Again?

Location: Flex Hall BC

Speaker: – Advarra, Inc.

Speaker: – Advarra

Sponsored By

8:00 AM – 8:30 AM PT

Special Music by Ivor Pritchard & Lauren Hartsmith.

Location: Ballroom 1

Presenter: – None

Presenter: – Hartsmith Consulting, LLC

ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges

8:30 AM – 9:00 AM PT

PRIMR24 Opening Board Remarks & Award Presentation

Location: Ballroom 1

Opening Remarks: – University of Colorado Denver | Anschutz Medical Campus

Award Recipient: – University of Nebraska Medical Center

ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges

9:00 AM – 10:00 AM PT

General Session: 50 Years of PRIM&R: Pioneers, the Present, and the Path Forward

Location: Ballroom 1

Presenter: – None

Presenter: – Hartsmith Consulting, LLC

Opening Remarks: – University of Colorado Denver | Anschutz Medical Campus

Award Recipient: – University of Nebraska Medical Center

Moderator: – PRIM&R

Panelist: – PRIM&R

Panelist: – N/A

Panelist: – Boston Children's Hospital

Panelist: – University of Kentucky

Panelist: – AAHRPP

ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges

10:00 AM – 10:30 AM PT

Beverage Break in the Exhibit Hall

Location: Flex Hall BC

10:30 AM – 11:45 AM PT

D01 - PLENARY: Responsibility Does Not End With Death: Establishing Systems for Ethical Decedent Research

Location: Signature Room

Moderator: – Center for Applied Biomechanics, Department of Mechanical and Aerospace Engineering, University of Virginia

Panelist: – OHARO, USAMRDC

Panelist: – UVA Center for Applied Biomechanics

Panelist: – FBI

Legal Considerations in Research OversightEmerging Research Challenges and Breaking IssuesIRB Review

10:30 AM – 11:45 AM PT

D02 - When the Feds Come to Town: What to Expect from a Federal Site Visit or Inspection

Location: Room 347-348

Speaker: – DHHS, Office for Human Research Protections (OHRP)

Speaker: – FDA/CDER/OC/Office of Compliance

FDA Regulated ResearchHRPP/IRB Management and Administration, Compliance

10:30 AM – 11:45 AM PT

D03 - An Update from AAHRPP, Inc.

Location: Room 332

Speaker: – AAHRPP, Inc.

Speaker: – Association for the Accreditation of Human Research Protection Programs, Inc.

A Dialogue with the Feds

10:30 AM – 11:45 AM PT

D04 - Relationship Building to Respect Tribal Sovereignty and Improve Research Safety

Location: Ballroom 2

Speaker: – Minnesota State University, Mankato

Speaker: – Mayo Clinic

Populations Requiring Additional ProtectionsAdvancing Equity and JusticeIRB ReviewSocial, Behavioral, and Educational Research

10:30 AM – 11:45 AM PT

D05 - Are You Leaving Money on the Table? Ensuring IRB Fees Are Accounted for in a Single IRB (sIRB) World

Location: Room 335

Speaker: – Northwestern University

Speaker: – Rutgers University

Speaker: – Stanford University

Single IRBFDA Regulated Research

10:30 AM – 11:45 AM PT

D06 - The Limits of Permissible Research Without Consent

Location: Ballroom 1

Speaker: – Advarra

Speaker: – Department of Medicine, University of California, San Francisco

Speaker: – Stanford University

Informed ConsentIRB Review

10:30 AM – 11:45 AM PT

D07 - Reviewing Incidents of Non-Compliance: Strategies for IRB Chairs and Members

Location: Ballroom 3

Speaker: – Office of Human Subjects Research Johns Hopkins University School of Medicine

Speaker: – University of Nebraska Medical Center

Speaker: – The PEER Consulting Group

QA/QI and Postapproval MonitoringIRB ReviewIRB Fundamentals

10:30 AM – 11:45 AM PT

D08 - The Island of Misfit Rules: How Not-So Day-to-Day Issues Can Ruin Your Day

Location: Room 345-346

Speaker: – Independent Professional

Speaker: – The Ohio State University

Social, Behavioral, and Educational ResearchHRPP/IRB Management and Administration

10:30 AM – 11:45 AM PT

D09 - The Shifting Paradigm of Data Sharing: Navigating New Challenges Through a Participant-Centered Lens

Location: Room 423-425

Speaker: – Geisinger College of Health Sciences

Speaker: – Community Based Organization Partners - Community Ethics Review Board

Speaker: – UT Southwestern Medical Center

Research Involving Data and New TechnologiesIRB ReviewEmerging Research Challenges and Breaking Issues

10:30 AM – 11:45 AM PT

D10 - Accessibility Basics: Making Word Documents Accessible

Location: Room 336

Speaker: – University of St. Thomas, Minnesota

Speaker: – Weill Cornell Medicine

Speaker: – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

Advancing Equity and JusticeEducation, Qualifications, and TrainingIRB ReviewIRB FundamentalsSocial, Behavioral, and Educational Research

10:30 AM – 11:45 AM PT

D11 - Improving Efficiency and Effectiveness at the Intersection of IACUC and IBC Administration

Location: Room 431-432

Speaker: – Northwell Health - Feinstein Institutes for Medical Research

Speaker: – Arizona State University

Speaker: – Princeton University

IACUC ReviewACU/IACUC Program Management and Administration

10:30 AM – 11:45 AM PT

D12 - Dealing With Conflict and Difficult Discussions: The Role of the IACUC Chair

Location: Room 444

Speaker: – WMU Homer Stryker MD School of Medicine

Speaker: – Colorado State University

IACUC Review

10:30 AM – 11:45 AM PT

D13 - Wildlife Animal Welfare 101: A Foundational Overview for Navigating the World of Oversight and Compliance With Free-Range Species

Location: Room 320-321

Speaker: – American Society of Mammalogists

Oversight of Non-Typical Animals and SituationsIACUC Fundamentals

10:30 AM – 11:45 AM PT

D14 - Looking Inside the Cabinets: IACUC Facility Inspections from Start to Finish

Location: Room 443

Speaker: – University of Washington

Speaker: – Sanofi

ACU/IACUC Program Management and AdministrationEducation, Qualifications, and TrainingIACUC Fundamentals

10:30 AM – 11:45 AM PT

D15 - Impactful Animal Welfare Refinements When Options Are Limited and the Need Is Great

Location: Room 445-446

Speaker: – Emory University

Speaker: – Department of Veterans Affairs

Animal Well-Being and the 3RsACU/IACUC Program Management and AdministrationIACUC Review

10:30 AM – 11:45 AM PT

D16 - Reserved for Late Breaking

10:30 AM – 11:45 AM PT

D17 - Reserved for Late-Breaking

10:30 AM – 11:45 AM PT

D18 - Hiring , Diversity and Soft Skills: How Do We "Walk the Talk" and Get What We Need/Want From New Hires?

Location: Room 323-324

Speaker: – University of Nevada, Las Vegas

Speaker: – University of Southern California

Speaker: – The Pennsylvania State University

Education, Qualifications, and TrainingACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationAdvancing Equity and Justice

10:30 AM – 11:45 AM PT

D19 - Do Institutional Officials (IOs) Understand Ethics?

Location: Room 333-334

Speaker: – Emory University

Speaker: – Attain Partners

Speaker: – Loyola University Chicago Stritch School of Medicine

ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges

10:30 AM – 11:45 AM PT

D20 - Retaining Good Research Ethics and Oversight Staff

Location: Room 331

Speaker: – University of Arizona

Speaker: – University of Washington

Speaker: – Texas A&M University System

ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges

11:45 AM – 1:30 PM PT

Lunch

Location: Flex Hall ABC

12:30 PM – 12:55 PM PT

Room 322: PRIMR24 Poster Presentation—Community Engagement Practices of Institutional Review Boards

Location: Room 322

Poster Session Moderator: – Rutgers University

Author: – Drexel University

12:30 PM – 12:55 PM PT

Room 320-321: PRIMR24 Poster Presentation—Shedding Light on the Gray Area: Process Improvement in Exempt-Level Reviews

Location: Room 320-321

Poster Session Moderator: – Teachers College, Columbia University & University of New England

Author: – Virginia Tech

12:30 PM – 1:30 PM PT

N10 - An Update from the Consortium to Advance Effective Research Ethics Oversight (AEREO): Progress in Defining and Measuring HRPP and IRB Quality and Effectiveness

Location: Signature Room

Speaker: – Perelman School of Medicine, University of Pennsylvania

Speaker: – University of Texas Medical Branch

Speaker: – NIH

HRPP/IRB Management and AdministrationIRB Review

12:30 PM – 1:30 PM PT

N11 - Wildlife Animal Welfare 101: Networking Follow-Up Session

Location: Flex Hall BC

Speaker: – American Society of Mammalogists

Oversight of Non-Typical Animals and SituationsIACUC Fundamentals

12:30 PM – 1:30 PM PT

N12 - Everything You Wanted to Know About the CPIA Credential

Location: Room 323-324

ACU/IACUC Program Management and Administration

12:30 PM – 1:30 PM PT

N13 - Thriving in the Small Program Oasis: Navigating Challenges and Cultivating Success for the Single-Person Office

Location: Room 333-334

Speaker: – Brown University

Speaker: – Kennesaw State University

Education, Qualifications, and TrainingHRPP/IRB Management and Administration

12:30 PM – 1:30 PM PT

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

12:30 PM – 1:30 PM PT

View the PRIMR24 Poster Abstracts

Location: Flex Hall BC

12:45 PM – 1:30 PM PT

Sponsored Presentation from Huron: Leveraging Technology to Maintain Compliance and Efficiently Manage Your Research Compliance Programs

Location: Flex Hall BC

Speaker: – Huron

Speaker: – Huron Consulting Group

Sponsored By

1:00 PM – 1:25 PM PT

Room 320-321: PRIMR24 Poster Presentation—ARRIVE Study Plan: including rigour assessment before the conduct of each experiment to maximise output

Location: Room 320-321

Poster Session Moderator: – North Carolina Central University

Author: – NC3Rs

1:00 PM – 1:25 PM PT

Room 322: PRIMR24 Poster Presentation—Characterization of Users of an Online Human Research Protections Training Program for Community Research Partners

Location: Room 322

Moderator: – Seattle Children's Research Institute

Author: – Loyola University Chicago Stritch School of Medicine

1:45 PM – 3:00 PM PT

E01 - PLENARY: Fast Forward: Update on Inclusion of Sexual and Gender Minorities in Clinical Research

Location: Ballroom 1

Moderator: – National Institutes of Health (NIH)

Panelist: – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

Panelist: – Genentech

Panelist: – The Fenway Institute

Advancing Equity and Justice

1:45 PM – 3:00 PM PT

E02 - A Dialogue with the FDA

Location: Room 444

Speaker: – Food and Drug Administration

Speaker: – US Food and Drug Administration

Speaker: – CDER/FDA/OC/OSI/DCCE

Speaker: – USFDA

A Dialogue with the Feds

1:45 PM – 3:00 PM PT

E03 - All Things Subpart C

Location: Signature Room

Speaker: – National Institute of Justice

Speaker: – OHRP

Speaker: – The Johns Hopkins University

Populations Requiring Additional ProtectionsIRB ReviewIRB FundamentalsSocial, Behavioral, and Educational Research

1:45 PM – 3:00 PM PT

E04 - Building Trust in Science: Enabling Frameworks for Returning Individual Research Results to Research Participants

Location: Room 423-425

Speaker: – National Institutes of Health

Speaker: – Multi-Regional Clinical Trials Center

Emerging Research Challenges and Breaking IssuesHRPP/IRB Management and AdministrationIRB Review

1:45 PM – 3:00 PM PT

E05 - A Dialogue with the Department of Veteran Affairs (VA)

Location: Room 336

Speaker: – Veterans Health Administration, U.S. Department of Veterans Affairs

Speaker: – Department of Veterans Affairs

A Dialogue with the Feds

1:45 PM – 3:00 PM PT

E06 - Couch to QA/QI: Creating a QA/QI Program

Location: Room 345-346

Speaker: – Tufts University SBER IRB

Speaker: – Indiana University

QA/QI and Postapproval Monitoring

1:45 PM – 3:00 PM PT

E07 - Using Artificial Intelligence (AI) to Author Key Information (KI) Sections of Human Research Consent Documents

Location: Ballroom 2

Speaker: – University of Michigan

Speaker: – SciTech Strategies, Inc.

Informed ConsentEmerging Research Challenges and Breaking IssuesResearch Involving Data and New Technologies

1:45 PM – 3:00 PM PT

E08 - PLENARY: Responsible Research Practices in Computing

Location: Room 331

Moderator: – Microsoft Research

Panelist: – Stanford University

Panelist: – Ada Lovelace Institute

Panelist: – Microsoft

Research Involving Data and New TechnologiesEmerging Research Challenges and Breaking IssuesIRB Review

1:45 PM – 3:00 PM PT

E09 - Robots in Disguise: When Your Participants are More Than Meets the Eye

Location: Room 343-344

Speaker: – Teachers College, Columbia University

Speaker: – Abt Global

Speaker: – Rutgers School of Public Health & CHIBPS

Research Involving Data and New TechnologiesEmerging Research Challenges and Breaking IssuesIRB ReviewSocial, Behavioral, and Educational Research

1:45 PM – 3:00 PM PT

E10 - The Essentials of Onboarding and Training IRB Administrators

Location: Room 443

Speaker: – Indiana University

Speaker: – Vanderbilt University Medical Center

Education, Qualifications, and TrainingHRPP/IRB Management and Administration

1:45 PM – 3:00 PM PT

E11 - PLENARY: Striving for Consistency: Institutional Efforts to Sync the Letter and Spirit of Regulations in Nonhuman Animal Research

Location: Room 333-334

Moderator: – University of Pennsylvania

Panelist: – San Jose State University

Panelist: – National Association for Biomedical Research

Panelist: – University of Florida College of Medicine

IACUC ReviewACU/IACUC Program Management and Administration

1:45 PM – 3:00 PM PT

E12 - How to Manage a Noncompliance or Adverse Event

Location: Ballroom 3

Speaker: – UCLA

Speaker: – University of Colorado Denver | Anschutz Medical Campus

Speaker: – Neuralink Corp

ACU/IACUC Program Management and AdministrationIACUC Fundamentals

1:45 PM – 3:00 PM PT

E13 - From Alpacas to Zebrafish: How to Select and Evaluate Environmental Enrichment

Location: Room 320-321

Speaker: – University of Michigan

Speaker: – NC3Rs

Education, Qualifications, and TrainingACU/IACUC Program Management and AdministrationIACUC ReviewOversight of Non-Typical Animals and Situations

1:45 PM – 3:00 PM PT

E14 - Specialized IACUC Applications for Studies in the Field

Location: Room 332

Speaker: – American Society of Mammalogists

Oversight of Non-Typical Animals and SituationsIACUC Review

1:45 PM – 3:00 PM PT

E15 - Improved Communications About Nonhuman Animal Studies: Starting on the Inside

Location: Room 335

Speaker: – University of Michigan

Speaker: – Harvard Medical School

Communication With the Public

1:45 PM – 3:00 PM PT

E16 - Done Wrong, Gotta Pay: Research Non-compliance and Research Misconduct and Possible Sponsor Pay-Back

Location: Room 431-432

Speaker: – formerly of Indiana University

Education, Qualifications, and TrainingHRPP/IRB Management and AdministrationACU/IACUC Program Management and AdministrationShared Research Oversight ChallengesResearch Oversight Leaders and Institutional OfficialsLegal Considerations in Research Oversight

1:45 PM – 3:00 PM PT

E17 - Roundtable Listening Session with the PRIM&R’s Executive Director & Leadership Team

Location: Room 323-324

Speaker: – PRIM&R

ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges

1:45 PM – 3:00 PM PT

E18 - What Institutional Leadership Needs to Know...From You!

Location: Room 347-348

Speaker: – University of Arizona

Speaker: – UC San Diego

ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationShared Research Oversight ChallengesResearch Oversight Leaders and Institutional Officials

1:45 PM – 3:00 PM PT

E19 - Balancing Risk and Reward in Research Programs

Location: Room 445-446

Speaker: – Advarra, Inc.

Speaker: – The PEER Consulting Group

ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight ChallengesLegal Considerations in Research Oversight

1:45 PM – 3:00 PM PT

E20 - Institutional Officials (IOs): Navigating the Complex Roles of IOs and the Model Best for Your Organization

Location: Room 322

Speaker: – Emory University

Speaker: – Attain Partners

Research Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges

3:00 PM – 3:30 PM PT

Break in the Exhibit Hall

Location: Flex Hall BC

3:30 PM – 4:45 PM PT

F01 - PLENARY: Risk Associated With Human Subjects Research: Whom Are We Obligated to Protect?

Location: Signature Room

Moderator: – University of California

Panelist: – Boston Children's Hospital

Panelist: – Department of Medicine, University of California, San Francisco

Panelist: – Ropes & Gray

Emerging Research Challenges and Breaking IssuesIRB ReviewHRPP/IRB Management and Administration

3:30 PM – 4:45 PM PT

F02 - PLENARY: Artificial Intelligence (AI) Days of Future's Past: Tomorrow's Research Yesterday

Location: Ballroom 1

Moderator: – Association of American Medical Colleges

Panelist: – National Institutes of Health

Panelist: – Microsoft Research

Panelist: – The Mayo Clinic

Social, Behavioral, and Educational ResearchHRPP/IRB Management and AdministrationIRB ReviewResearch Involving Data and New TechnologiesEmerging Research Challenges and Breaking Issues

3:30 PM – 4:45 PM PT

F03 - Key Information in Informed Consent: Ethical Principles, Policy, and Practice

Location: Ballroom 2

Speaker: – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS

Speaker: – UC San Diego

Speaker: – University of California, Office of the President

Speaker: – Food and Drug Administration

FDA Regulated ResearchInformed Consent

3:30 PM – 4:45 PM PT

F04 - IRB Review of Research Involving Politicized Topics and Populations

Location: Ballroom 3

Speaker: – University of Connecticut

Speaker: – HRP Consulting Group

Speaker: – The Fenway Institute, Fenway Health

IRB ReviewEmerging Research Challenges and Breaking IssuesAdvancing Equity and JusticePopulations Requiring Additional ProtectionsSocial, Behavioral, and Educational Research

3:30 PM – 4:45 PM PT

F05 - A Dialogue with the NIH

Location: Room 332

Speaker: – National Institutes of Health

A Dialogue with the Feds

3:30 PM – 4:45 PM PT

F06 - Human Subjects Research Determinations: Before and After the Fact

Location: Room 423-425

Speaker: – The Ohio State University Office of Responsible Research Practices

Speaker: – None

Education, Qualifications, and TrainingQA/QI and Postapproval MonitoringSocial, Behavioral, and Educational Research

3:30 PM – 4:45 PM PT

F07 - Adults with Developmental Disabilities and Research: Ethical, Legal, and Social Implications (ELSI) Solutions to Inclusion as Co-Researchers and Research Participants

Location: Room 443

Speaker: – Loyola University Chicago Stritch School of Medicine

Speaker: – Mass General Brigham

Speaker: – School of Nursing, University of Wisconsin - Madison

Speaker: – University of Washington

Advancing Equity and JusticePopulations Requiring Additional Protections

3:30 PM – 4:45 PM PT

F08 - Navigating Ethical and Institutional Considerations for Data and Biospecimen Sharing in the Era of Single (sIRB)

Location: Room 345-346

Speaker: – AAHRPP

Speaker: – Office of Human Subjects Research Johns Hopkins University School of Medicine

Single IRBResearch Involving Data and New TechnologiesIRB ReviewPharma/Biotech Perspectives

3:30 PM – 4:45 PM PT

F09 - I Don't Remember This Being in the Training Manual: An Exploration of Challenging IRB Situations

Location: Room 343-344

Speaker: – James Madison University

Speaker: – Old Dominion University

IRB ReviewHRPP/IRB Management and AdministrationSocial, Behavioral, and Educational Research

3:30 PM – 4:45 PM PT

F10 - Designing an HRPP/IRB Website that Builds Trust

Location: Room 347-348

Speaker: – University of Utah

Speaker: – Kaiser Permanente

Speaker: – NIH

Speaker: – Perelman School of Medicine, University of Pennsylvania

HRPP/IRB Management and Administration

3:30 PM – 4:45 PM PT

F11 - PLENARY: New and Evolving Considerations for Disaster Planning

Location: Room 323-324

Moderator: – UCLA

Panelist: – USDA APHIS AC

Panelist: – Novartis

Panelist: – Rosemary Broome DVM

ACU/IACUC Program Management and Administration

3:30 PM – 4:45 PM PT

F12 - Unlocking the Potential of IACUC Members: A Comprehensive Guide to Training

Location: Room 431-432

Speaker: – UC Berkeley

Speaker: – Texas A&M University System

Education, Qualifications, and TrainingACU/IACUC Program Management and AdministrationIACUC Fundamentals

3:30 PM – 4:45 PM PT

F13 - Challenges and Opportunities in IACUC Administration at Underrepresented Minority (URM)-Serving Institutions

Location: Room 320-321

Speaker: – North Carolina Agricultural &Technical State University

Speaker: – North Carolina Central University

Advancing Equity and JusticeACU/IACUC Program Management and Administration

3:30 PM – 4:45 PM PT

F14 - What happened to ILAR and what is BAHSCR?

Location: Room 322

Speaker: – University of Washington

Speaker: – Pathology/DLAR University of Pittsburgh

Speaker: – National Academies of Sciences, Engineering and Medicine, Board on Animal Health Sciences, Conservation, and Research

A Dialogue with the Feds

3:30 PM – 4:45 PM PT

F15 - Avoiding the Slippery Slope: Complimenting Semi-annual Reviews With a Program of Ongoing QA/QI Review

Location: Room 331

Speaker: – formerly of Indiana University

Speaker: – Indiana University

Speaker: – Northwell Health - Feinstein Institutes for Medical Research

QA/QI and Postapproval MonitoringACU/IACUC Program Management and Administration

3:30 PM – 4:45 PM PT

F16 - Plenary: Conducting Research "With" and "Not On" Indigenous Populations

Location: Room 336

Moderator: – University of Washington

Panelist: – University of Washington School of Medicine

Panelist: – Alaska Area IRB

Advancing Equity and JusticeEducation, Qualifications, and TrainingLegal Considerations in Research OversightShared Research Oversight Challenges

3:30 PM – 4:45 PM PT

F17 - Trust Me, I Know What I'm Doing

Location: Room 445-446

Speaker: – Independent Professional

Speaker: – AAHRPP

Speaker: – Allen Institute

Shared Research Oversight ChallengesResearch Oversight Leaders and Institutional OfficialsIRB ReviewIACUC ReviewACU/IACUC Program Management and AdministrationHRPP/IRB Management and Administration

3:30 PM – 4:45 PM PT

F18 - Shake It Up: An Interactive Discussion of Lessons Learned from IRB/IACUC Leaders

Location: Room 444

Speaker: – Nationwide Children's Hospital

Speaker: – Northeastern University

Speaker: – Hackensack Meridian Health

Shared Research Oversight ChallengesResearch Oversight Leaders and Institutional OfficialsIRB ReviewIACUC Review

3:30 PM – 4:45 PM PT

F19 - Proposed Changes to the Public Health Policy (PHS) on Research Misconduct: Impact on the Researcher Community

Location: Room 333-334

Speaker: – Office of Assistant Secretary for Health

Speaker: – University of Cincinnati

ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight ChallengesLegal Considerations in Research Oversight

3:30 PM – 4:45 PM PT

F20 - Developing an Emergency Preparedness Plan for an Effective Research System

Location: Room 335

Speaker: – Mass General Brigham Incorporated

Speaker: – Icahn School of Medicine at Mount Sinai

ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight ChallengesLegal Considerations in Research Oversight

4:45 PM – 6:00 PM PT

Emerging Professionals Networking Reception

Location: Terrace Suite

4:45 PM – 6:00 PM PT

Meet and Greet With the Supporters and Exhibitors

Location: Flex Hall BC

4:45 PM – 6:00 PM PT

View the PRIMR24 Poster Abstracts

Location: Flex Hall BC

5:00 PM – 6:00 PM PT

N14 - Human Subjects Research Trivia!

Location: Ballroom 2

Speaker: – University of Nevada, Las Vegas

Speaker: – Independent Professional

Speaker: – AAHRPP

Speaker: – The Ohio State University

HRPP/IRB Management and AdministrationIRB ReviewSocial, Behavioral, and Educational ResearchIRB Fundamentals

5:00 PM – 6:00 PM PT

N15 - IACUC Game night

Location: Flex Hall BC

ACU/IACUC Program Management and Administration

7:00 AM – 7:45 AM PT

PRIMR24 Morning Beverage Service

Location: Flex Hall BC

7:00 AM – 12:00 PM PT

Registration Open

Location: Flex Hall B

7:00 AM – 8:15 AM PT

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

7:30 AM – 8:30 AM PT

Opening General Session: More Cure, Less Side Effects: A Potential Role for Preclinical Studies

Location: Ballroom 1

Moderator: – Novartis Institutes for Biomedical Research

Panelist: – Novartis Biomedical Research

Panelist: – Digital In Vivo Alliance

Emerging Research Challenges and Breaking IssuesIACUC ReviewIRB ReviewPharma/Biotech Perspectives

8:45 AM – 10:00 AM PT

G01 - Are the Ways We Contemplate Risk Outdated?

Location: Ballroom 2

Speaker: – National Institutes of Health

Speaker: – Sage Bionetworks

Speaker: – National Human Genome Research Institute, National Institutes of Health

Emerging Research Challenges and Breaking IssuesIRB ReviewHRPP/IRB Management and Administration

8:45 AM – 10:00 AM PT

G02 - Change the Game By Working Together: Tips for Increasing HRPP/IRB and Researcher Collaboration

Location: Ballroom 1

Speaker: – The Pennsylvania State University

Speaker: – Institute of Health System Science, Feinstein Institutes for Medical Research, Northwell Health

IRB ReviewHRPP/IRB Management and AdministrationSocial, Behavioral, and Educational Research

8:45 AM – 10:00 AM PT

G03 - A Dialogue with OHRP

Location: Room 431-432

Speaker: – Office for Human Research Protections

Speaker: – DHHS Office for Human Research Protections

Speaker: – DHHS, Office for Human Research Protections (OHRP)

Speaker: – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS

Speaker: – Department of Health and Human Services

A Dialogue with the Feds

8:45 AM – 10:00 AM PT

G04 - Expectations for the Use of Electronic Systems to Conduct Clinical Trial Activities and Considerations for IRBs: Perspectives From Regulators and Institutional Review Boards

Location: Room 343-344

Speaker: – Clemson University

Speaker: – CDER/FDA/OC/OSI/DCCE

Speaker: – FDA/CDER/OC/OSI/DCCE

FDA Regulated ResearchHRPP/IRB Management and AdministrationPharma/Biotech PerspectivesQA/QI and Postapproval Monitoring

8:45 AM – 10:00 AM PT

G05 - Reserved for Late-Breaking

8:45 AM – 10:00 AM PT

G06 - Managing Dual/Multiple Relationships: Grappling With Identity and Interpersonal Boundaries in Human Subjects Research

Location: Room 445-446

Speaker: – Mass General Brigham

Speaker: – The Fenway Institute

Emerging Research Challenges and Breaking IssuesHRPP/IRB Management and AdministrationAdvancing Equity and Justice

8:45 AM – 10:00 AM PT

G07 - Exploring the Enigma of the Expedited (Category 7)

Location: Ballroom 3

Speaker: – Indiana University

Speaker: – University of California San Francisco

Social, Behavioral, and Educational ResearchIRB Review

8:45 AM – 10:00 AM PT

G08 - Let It Go! Strategies to Prevent Over-Regulation During Local Context Review

Location: Signature Room

Speaker: – The Pennsylvania State University

Speaker: – University of Minnesota

Speaker: – Research Compliance Services, University of Nebraska - Lincoln

Single IRBIRB Review

8:45 AM – 10:00 AM PT

G09 - IBC and IRB Collaboration: Working Together for Safety and Oversight

Location: Room 331

Speaker: – Advarra

Speaker: – University of Washington

Speaker: – Seattle Children's Research Institute

Shared Research Oversight ChallengesHRPP/IRB Management and Administration

8:45 AM – 10:00 AM PT

G10 - PLENARY: Replicability, Reproducibility, Rigor, and Red Herrings

Location: Room 320-321

Moderator: – Coridea, LLC

Panelist: – Texas A&M University System

Panelist: – University of Florida College of Medicine

Emerging Research Challenges and Breaking IssuesAnimal Well-Being and the 3RsIACUC Review

8:45 AM – 10:00 AM PT

G11 - Agricultural Animals in Research

Location: Room 323-324

Speaker: – Oklahoma State University

Speaker: – Veterans Health Administration, Office of Research Oversight, The Research Safety and Animal Welfare Team

Oversight of Non-Typical Animals and SituationsIACUC ReviewIACUC Fundamentals

8:45 AM – 10:00 AM PT

G12 - Better Together-Effective Collaboration During IACUC Protocol Review

Location: Room 347-348

Speaker: – Arizona State University

Speaker: – Novartis Biomedical Research, Inc.

Speaker: – Texas A&M University System

IACUC ReviewACU/IACUC Program Management and Administration

8:45 AM – 10:00 AM PT

G13 - PLENARY: Ethical Review of Human and Animal Subjects Research Proposals

Location: Room 423-425

Moderator: – Novartis Institutes for Biomedical Research

Panelist: – Landi Animal Research and Bioethics

Panelist: – The Johns Hopkins University

Panelist: – University of North Carolina at Chapel Hill

Shared Research Oversight ChallengesResearch Oversight Leaders and Institutional OfficialsIRB ReviewIACUC Review

8:45 AM – 10:00 AM PT

G14 - No Findings? No Problem: Why Non-Issue Audits Still Matter

Location: Room 333-334

Speaker: – Penn State

Speaker: – Indiana University

Speaker: – Harvard T.H. Chan School of Public Health

IRB FundamentalsIACUC FundamentalsQA/QI and Postapproval Monitoring

8:45 AM – 10:00 AM PT

G15 - Building Bridges: Towards an International Framework for Specimen Sharing (Part II)

Location: Room 335

Speaker: – BIopreservation & Biobanking

Speaker: – Takeda

Speaker: – Center for Integrative Medical Sciences, RIKEN

Speaker: – ARC-Net and Department of Engineering for Innovative Medicine, University of Verona, Italy

Pharma/Biotech PerspectivesResearch Involving Data and New TechnologiesIRB Review

10:00 AM – 10:30 AM PT

Beverage Break in the Exhibit Hall

Location: Flex Hall BC

10:30 AM – 11:45 AM PT

H01 - PLENARY: Regulatory and IRB Challenges in Reviewing Decentralized Clinical Trials (DCTs)

Location: Room 323-324

Moderator: – Department of Veterans Affairs

Panelist: – DHHS Office for Human Research Protections

Panelist: – Decentralized Trials and Research Alliance

Panelist: – NCATS/NIH

FDA Regulated ResearchHRPP/IRB Management and AdministrationIRB Review

10:30 AM – 11:45 AM PT

H02 - Group Harm: A Toolkit for Researchers, IRBs, and Data Access Committees

Location: Ballroom 2

Speaker: – Maimonides Medical Center

Speaker: – Johns Hopkins Bloomberg School of Public Health

Speaker: – University of Washington School of Medicine

Populations Requiring Additional ProtectionsIRB ReviewSocial, Behavioral, and Educational Research

10:30 AM – 11:45 AM PT

H03 - Houston, We Have Problem: Exploring Noncompliance in a Single IRB (sIRB) Universe

Location: Ballroom 3

Speaker: – Baptist Health South Florida

Speaker: – University of Texas, MD Anderson Cancer Center

Speaker: – BRANY IRB

Single IRBQA/QI and Postapproval Monitoring

10:30 AM – 11:45 AM PT

H04 - Comparative Effectiveness Research (CER): When Important Research Does Not Fit the Regulatory Mold

Location: Room 431-432

Speaker: – Advarra

Speaker: – National Institutes of Health

Speaker: – WCG

Speaker: – None

IRB ReviewEmerging Research Challenges and Breaking Issues

10:30 AM – 11:45 AM PT

H05 - Pharma Perspectives on the Use of Social Media and Social Media Influencers in Clinical Research

Location: Room 335

Speaker: – Takeda Pharmaceuticals

Speaker: – Johnson & Johnson

Speaker: – WCG

Pharma/Biotech PerspectivesEmerging Research Challenges and Breaking Issues

10:30 AM – 11:45 AM PT

H06 - What Are You Going To Do With My Specimens and Data? When Research Specimens and Data are Used for Commercial Profit

Location: Signature Room

Speaker: – Huron Consulting Group

Speaker: – BIopreservation & Biobanking

Speaker: – Takeda

Speaker: – ARC-Net and Department of Engineering for Innovative Medicine, University of Verona, Italy

Research Involving Data and New TechnologiesLegal Considerations in Research OversightIRB ReviewPharma/Biotech Perspectives

10:30 AM – 11:45 AM PT

H07 - PLENARY: Protecting Third Parties in Research: Whose Job Is it Anyway?

Location: Room 347-348

Moderator: – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

Speaker: – Virginia Tech

Speaker: – Sabai - www.sabaiglobal.com

Shared Research Oversight Challenges

10:30 AM – 11:45 AM PT

H08 - A Dialogue With the Environmental Protection Agency (EPA)

Location: Room 331

Speaker: – U.S. EPA

Speaker: – Oak Ridge Associated Universities

Speaker: – US EPA

A Dialogue with the Feds

10:30 AM – 11:45 AM PT

H09 - Exempt Study Review: How to Find Flexibilities in the Current Regulations

Location: Ballroom 1

Speaker: – UC San Diego

Speaker: – University of California, Irvine, IRB

Speaker: – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)

IRB ReviewSocial, Behavioral, and Educational ResearchIRB Fundamentals

10:30 AM – 11:45 AM PT

H10 - Making the 3Rs More Than a Checkbox: Institutional 3Rs Programs

Location: Room 333-334

Speaker: – University of Washington

Speaker: – Eli Lilly and Company

Speaker:

Animal Well-Being and the 3RsIACUC ReviewACU/IACUC Program Management and Administration

10:30 AM – 11:45 AM PT

H11 - Oversight of Animal Care and Veterinary Staff Qualifications and Training

Location: Room 320-321

Speaker: – University of Pennsylvania

Speaker: – University of Washington

Speaker: – Oregon National Primate Research Center, Oregon Health & Science University

Education, Qualifications, and TrainingIACUC Fundamentals

10:30 AM – 11:45 AM PT

H12 - Adverse Events and Animal Welfare in Biotech and Academia Alike: Creating Efficiency, an Open Program, and Automated Functions of Reporting

Location: Room 345-346

Speaker: – UC Berkeley

Speaker: – Novartis Biomedical Research, Inc.

Pharma/Biotech PerspectivesQA/QI and Postapproval MonitoringIACUC ReviewACU/IACUC Program Management and Administration

10:30 AM – 11:45 AM PT

H13 - Tick-Tock! How to Not Waste Your Time While Writing Minutes!

Location: Room 423-425

Speaker: – Independent Professional

Speaker: – Office for Human Research Protections (OHRP)

Speaker: – Office of the Chief Medical Officer, FDA

FDA Regulated ResearchIRB ReviewIRB FundamentalsIACUC FundamentalsIACUC Review

10:30 AM – 11:45 AM PT

H14 - Don't Reinvent the Wheel! How to Ask the Right Questions and Leverage Existing Resources to Address Critical Compliance Needs

Location: Room 445-446

Speaker: – University of Nevada, Las Vegas

Speaker: – Western Washington University

Speaker: – KBR

Education, Qualifications, and TrainingShared Research Oversight ChallengesHRPP/IRB Management and AdministrationACU/IACUC Program Management and AdministrationQA/QI and Postapproval Monitoring

10:30 AM – 11:45 AM PT

H15 - Considering Yourself: Self‐Care for Compliance Professionals

Location: Room 343-344

Speaker: – University of Texas at Arlington

Speaker: – Lawrence Berkeley National Laboratory

Education, Qualifications, and TrainingShared Research Oversight ChallengesHRPP/IRB Management and AdministrationACU/IACUC Program Management and Administration

12:00 PM – 5:00 PM PT

Bridging the Gap: Showcasing the University of Washington (UW) Animal Research Facilities and Program