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Human Subject Research - HSR

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PRIMR24 Full Schedule

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Wednesday, November 20, 2024
7:00 AM – 7:45 AM PT
PRIMR24 Morning Beverage Service

7:00 AM – 12:00 PM PT
Registration Open

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

8:45 AM – 10:00 AM PT
PRIMR24 Plenary/Breakout/Networking G Series

8:45 AM – 10:00 AM PT

G01 - Are the Ways We Contemplate Risk Outdated?

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.

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
Break in the Exhibit Hall

10:30 AM – 11:45 AM PT
PRIMR24 Plenary/Breakout/Networking H Series

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