PRIMR24 Virtual Meeting
Thank you for attending PRIMR24! The 90-day access period for recordings and evaluations has now expired (cut-off was March 15, 2025). Recordings can be purchased via a link in the left hand navigation; members receive access to the recordings for free after one year (starting on November 17, 2025). Contact registration@primr.org with questions.
For information on how to download your Certificate of Attendance, please see our CE/CIP/CPIA webpage for more information (located below) .
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- PRIMR24 Virtual Meeting
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Monday, Nov 18th
8:30 AM – 9:00 AM PTPRIMR24 Co-Chairs Welcome and Executive Director Remarks Location: Ballroom 1
Opening Remarks: – PRIM&R
Emerging Research Challenges and Breaking Issues
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Monday, Nov 18th
9:00 AM – 10:00 AM PTPRIMR24 Opening Session: The Next Frontier: Space Exploration ResearchLocation: Ballroom 1
Moderator: – AAHRPP
Keynote Speaker: – Translational Research Institute for Space Health
Emerging Research Challenges and Breaking Issues
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA01 - PLENARY: Reimagining Informed Consent Processes to Support Informed, Values-Concordant DecisionsLocation: Ballroom 3
Moderator: – Seattle Children's Research Institute
Panelist: – Geisinger College of Health Sciences
Panelist: – Advarra
Panelist: – NIH
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA02 - 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
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA03 - Why “It Depends”: General Considerations for IRBs and HRPPs When Reviewing Research Using FDA-Regulated ProductsLocation: 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
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA04 - Advancing Gender Inclusivity in Research: Overcoming Political and Regulatory Challenges in Participant MaterialsLocation: 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
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA05 - The Ethical Conduct of Cell and Gene Therapy Research: Novel Challenges for Industry and the IRBLocation: Room 444
Speaker: – Takeda Pharmaceuticals
Speaker: – Boston Children's Hospital
Speaker: – Advarra
Pharma/Biotech PerspectivesResearch Involving Data and New Technologies
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA06 - 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
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA07 - A Dialogue With the Office of Research Integrity (ORI)Location: Room 336
Speaker: – Office of Assistant Secretary for Health
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA08 - 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
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA09 - Shift Your Focus: Transforming an HRPP Into a Collegial and Efficient Partner of the Research CommunityLocation: 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
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA10 - Decentralized Clinical Trials (DCTs) and the Community Dimension: Advantages and ChallengesLocation: 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
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA11 - PLENARY: Global Perspectives on the Ethics, Principles, and Regulations Guiding Research Involving Nonhuman AnimalsLocation: 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
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA12 - Welfare Considerations for CephalopodsLocation: 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
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA13 - IACUC SOS! Evaluating Difficult Protocols By Optimizing Your Review ToolkitLocation: Room 333-334
Speaker: – UCLA
Speaker: – Cincinnati Children's Hospital Medical Center
Speaker: – Michigan State University
IACUC ReviewACU/IACUC Program Management and Administration
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA14 - AAALAC International UpdateLocation: Room 322
Speaker: – AAALAC International
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA15 - Openness about Animal Research: Why and How to Share What We DoLocation: Room 332
Speaker: – AstraZeneca
Speaker: – Americans for Medical Progress
Speaker: – University of Washington
Communication With the Public
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA19 - New Regulations and Federal Policy Updates: Get Up to Speed!Location: Signature Room
Shared Research Oversight ChallengesResearch Oversight Leaders and Institutional Officials
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA20 - How Institutional Leaders Can Promote COI Program EffectivenessLocation: 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
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA16 - 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
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA17 - 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
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA18 - The Cost to Having a Revolving Door: PI Onboarding & Exit PlanningLocation: 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
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB01 - PLENARY: Ethical Considerations With Healthy Research Participants: Current Perspectives From the FieldLocation: 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
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB02 - 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
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB03 - 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
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB04 - Ethical Implications and Practical Application of Broad ConsentLocation: 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
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB05 - 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
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB06 - Evaluating the Impact of Current and Future Single IRB (sIRB) Requirements on Local IRBsLocation: 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
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB08 - Empowering the Participant Voice: Using Research Participant Experience Data to Address Research Disparities and Enhance QualityLocation: Room 332
Speaker: – The Rockefeller University
Speaker: – University of California, Santa Cruz
QA/QI and Postapproval MonitoringAdvancing Equity and Justice
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB09 - 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
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB10 - Advancing Justice, Equity, and Trustworthiness Through Community Engaged Research (CEnR): What HRPPs/IRBs Need to KnowLocation: 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
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB12 - The First 48 Hours: What to Do Right Away When Things Go WrongLocation: Room 323-324
Speaker: – Texas A&M University
Speaker: – Emory National Primate Research Center, Emory University
Communication With the Public
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB14 - Reproducibility and the IACUCLocation: 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
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB15 - Building a Professional Network in the Animal Care and Use CommunityLocation: Room 336
Speaker: – UC Berkeley
Speaker: – University of California, Merced
ACU/IACUC Program Management and AdministrationEducation, Qualifications, and Training
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB13 - An Examination of HHS ORI’s Changes to Research Misconduct RegulationsLocation: Room 333-334
Speaker: – Northwestern University
Speaker: – Office of Assistant Secretary for Health
Emerging Research Challenges and Breaking Issues
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB19 - PLENARY: Institutional Approaches to Research Security ProgramsLocation: 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
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB20 - Leaders of International Research: Navigating Research Regulations and Promoting Ethical PracticesLocation: 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
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB11 - Reserved for Late Breaking
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB07 - A Crisis Is a Crisis: Lessons Learned From Human-Based and Animal-Based Controversies and What We Can Learn From Our Colleagues Across the HallLocation: Room 331
Speaker: – University of Michigan
Speaker: – Emory University
Speaker: – Emory University
Communication With the PublicACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationShared Research Oversight ChallengesResearch Oversight Leaders and Institutional Officials
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB16 - A Conversation with DoD: Knowledge of the US Military Research ContextLocation: 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
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB17 - Effectively Managing the Use of Controlled Substances in ResearchLocation: Room 445-446
Speaker: – Virginia Commonwealth University
Speaker: – University of Michigan
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
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB18 - Cross Training and Successful Transfer of KnowledgeLocation: Room 431-432
Speaker: – Lawrence Berkeley National Laboratory
Speaker: – The University of Toledo
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
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC01 - PLENARY: Taking Stock of the Research Ethics Oversight Ecosystem: Healthy Developments, Overgrowth, and Audit CultureLocation: 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
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC02 - A Dialogue with SACHRPLocation: Room 323-324
Speaker: – Stanford University
Speaker: – OHRP
Speaker: – WCG
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC03 - Postapproval Monitoring (PAM) in a Single IRB (sIRB) World: FDA EditionLocation: Ballroom 2
Speaker: – Advarra
Speaker: – University of Alabama at Birmingham
Speaker: – NYU Langone Health
Single IRBQA/QI and Postapproval MonitoringFDA Regulated Research
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC04 - What's That You're Wearing? Human Research Protections and Wearable DevicesLocation: 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
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC05 - IRBs Greatest Challenges for Youth-Centered ResearchLocation: 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
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC06 - Medical Devices: A Beginner's Guide to Understanding the Basics of FDA Regulation and How to Apply it to a StudyLocation: 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
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC07 - 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
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC08 - Help! I Don't Understand: Making the Consent Process and Form Meaningful Through Health Literacy and Adult Learning TheoryLocation: 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
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC09 - 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
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC10 - Updates to the Declaration of HelsinkiLocation: Room 336
Speaker: – National Institutes of Health
Speaker: – Office for Human Research Protections
Speaker: – American Medical Association
Speaker: – FDA
Pharma/Biotech Perspectives
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC11 - PLENARY: The Historical Impact of Politics on Scientific Research With Nonhuman AnimalsLocation: 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
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC12 - Driving Postapproval Monitoring (PAM) Program Priorities by Harnessing Existing DataLocation: Room 445-446
Speaker: – Rutgers University
Speaker: – Allen Institute
Speaker: – University of Florida
QA/QI and Postapproval MonitoringACU/IACUC Program Management and Administration
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC13 - A Dialogue With USDA, APHIS, Animal CareLocation: Room 431-432
Speaker: – USDA, APHIS, Animal Care
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC14 - What Needs to Change in Nonhuman Primate (NHP) Housing and WhyLocation: Room 322
Speaker: – Labcorp
Speaker: – MAV Consulting
Pharma/Biotech PerspectivesAnimal Well-Being and the 3Rs
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC15 - Exploring NAMs and Complement-ARIE: Insights for IACUCsLocation: 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
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC19 - What You Don't Know Can Hurt You: Using Metrics to Evaluate Research Administrative ActivitiesLocation: 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
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC20 - PLENARY: Research Integrity Management in the New Public ArenaLocation: 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
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC16 - PLENARY: Bridging Preclinical to Clinical Research With Artificial Intelligence (AI) and Digital Biomarkers: Current Landscape, Vision, and the Collaborative Path Toward Improved TranslationLocation: 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
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC17 - 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
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC18 - Committee Meeting Navigation for Those in the RoomLocation: Room 332
Speaker: – Colorado State University
Speaker: – Nemours Children's Health
Speaker: – WCG
IRB ReviewIACUC ReviewShared Research Oversight Challenges
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Tuesday, Nov 19th
8:00 AM – 8:30 AM PTSpecial 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
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Tuesday, Nov 19th
8:30 AM – 9:00 AM PTPRIMR24 Opening Board Remarks & Award PresentationLocation: 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
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Tuesday, Nov 19th
9:00 AM – 10:00 AM PTGeneral Session: 50 Years of PRIM&R: Pioneers, the Present, and the Path ForwardLocation: 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
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD01 - PLENARY: Responsibility Does Not End With Death: Establishing Systems for Ethical Decedent ResearchLocation: 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
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD02 - When the Feds Come to Town: What to Expect from a Federal Site Visit or InspectionLocation: 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
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD03 - An Update from AAHRPP, Inc.Location: Room 332
Speaker: – AAHRPP, Inc.
Speaker: – Association for the Accreditation of Human Research Protection Programs, Inc.
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD04 - Relationship Building to Respect Tribal Sovereignty and Improve Research SafetyLocation: Ballroom 2
Speaker: – Minnesota State University, Mankato
Speaker: – Mayo Clinic
Speaker: – Mayo Clinic
Populations Requiring Additional ProtectionsAdvancing Equity and JusticeIRB ReviewSocial, Behavioral, and Educational Research
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD05 - 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
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD06 - The Limits of Permissible Research Without ConsentLocation: Ballroom 1
Speaker: – Advarra
Speaker: – Department of Medicine, University of California, San Francisco
Speaker: – Stanford University
Informed ConsentIRB Review
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD07 - Reviewing Incidents of Non-Compliance: Strategies for IRB Chairs and MembersLocation: 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
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD08 - The Island of Misfit Rules: How Not-So Day-to-Day Issues Can Ruin Your DayLocation: Room 345-346
Speaker: – Independent Professional
Speaker: – The Ohio State University
Social, Behavioral, and Educational ResearchHRPP/IRB Management and Administration
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD09 - The Shifting Paradigm of Data Sharing: Navigating New Challenges Through a Participant-Centered LensLocation: 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
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD10 - Accessibility Basics: Making Word Documents AccessibleLocation: 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
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD11 - Improving Efficiency and Effectiveness at the Intersection of IACUC and IBC AdministrationLocation: 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
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD12 - Dealing With Conflict and Difficult Discussions: The Role of the IACUC ChairLocation: Room 444
Speaker: – WMU Homer Stryker MD School of Medicine
Speaker: – Colorado State University
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD13 - Wildlife Animal Welfare 101: A Foundational Overview for Navigating the World of Oversight and Compliance With Free-Range SpeciesLocation: Room 320-321
Speaker: – American Society of Mammalogists
Oversight of Non-Typical Animals and SituationsIACUC Fundamentals
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD14 - Looking Inside the Cabinets: IACUC Facility Inspections from Start to FinishLocation: Room 443
Speaker: – University of Washington
Speaker: – Sanofi
ACU/IACUC Program Management and AdministrationEducation, Qualifications, and TrainingIACUC Fundamentals
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD15 - Impactful Animal Welfare Refinements When Options Are Limited and the Need Is GreatLocation: Room 445-446
Speaker: – Emory University
Speaker: – Department of Veterans Affairs
Animal Well-Being and the 3RsACU/IACUC Program Management and AdministrationIACUC Review
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD19 - 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
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD20 - Retaining Good Research Ethics and Oversight StaffLocation: 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
-
Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD16 - Reserved for Late Breaking
-
Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD17 - Reserved for Late-Breaking
-
Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD18 - 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
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Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE01 - PLENARY: Fast Forward: Update on Inclusion of Sexual and Gender Minorities in Clinical ResearchLocation: 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
-
Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE02 - A Dialogue with the FDALocation: Room 444
Speaker: – Food and Drug Administration
Speaker: – US Food and Drug Administration
Speaker: – CDER/FDA/OC/OSI/DCCE
Speaker: – USFDA
-
Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE03 - All Things Subpart CLocation: Signature Room
Speaker: – National Institute of Justice
Speaker: – OHRP
Speaker: – The Johns Hopkins University
Populations Requiring Additional ProtectionsIRB ReviewIRB FundamentalsSocial, Behavioral, and Educational Research
-
Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE04 - Building Trust in Science: Enabling Frameworks for Returning Individual Research Results to Research ParticipantsLocation: 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
-
Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE05 - 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
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Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE06 - Couch to QA/QI: Creating a QA/QI ProgramLocation: Room 345-346
Speaker: – Tufts University SBER IRB
Speaker: – Indiana University
QA/QI and Postapproval Monitoring
-
Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE07 - Using Artificial Intelligence (AI) to Author Key Information (KI) Sections of Human Research Consent DocumentsLocation: Ballroom 2
Speaker: – University of Michigan
Speaker: – SciTech Strategies, Inc.
Informed ConsentEmerging Research Challenges and Breaking IssuesResearch Involving Data and New Technologies
-
Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE08 - PLENARY: Responsible Research Practices in ComputingLocation: 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
-
Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE09 - Robots in Disguise: When Your Participants are More Than Meets the EyeLocation: 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
-
Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE10 - The Essentials of Onboarding and Training IRB AdministratorsLocation: Room 443
Speaker: – Indiana University
Speaker: – Vanderbilt University Medical Center
Education, Qualifications, and TrainingHRPP/IRB Management and Administration
-
Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE11 - PLENARY: Striving for Consistency: Institutional Efforts to Sync the Letter and Spirit of Regulations in Nonhuman Animal ResearchLocation: 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
-
Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE12 - How to Manage a Noncompliance or Adverse EventLocation: Ballroom 3
Speaker: – UCLA
Speaker: – University of Colorado Denver | Anschutz Medical Campus
Speaker: – Neuralink Corp
ACU/IACUC Program Management and AdministrationIACUC Fundamentals
-
Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE13 - From Alpacas to Zebrafish: How to Select and Evaluate Environmental EnrichmentLocation: 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
-
Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE14 - Specialized IACUC Applications for Studies in the FieldLocation: Room 332
Speaker: – American Society of Mammalogists
Oversight of Non-Typical Animals and SituationsIACUC Review
-
Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE15 - Improved Communications About Nonhuman Animal Studies: Starting on the InsideLocation: Room 335
Speaker: – University of Michigan
Speaker: – Harvard Medical School
Communication With the Public
-
Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE19 - Balancing Risk and Reward in Research ProgramsLocation: 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
-
Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE20 - Institutional Officials (IOs): Navigating the Complex Roles of IOs and the Model Best for Your OrganizationLocation: Room 322
Speaker: – Emory University
Speaker: – Attain Partners
Research Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges
-
Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE16 - Done Wrong, Gotta Pay: Research Non-compliance and Research Misconduct and Possible Sponsor Pay-BackLocation: 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
-
Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE17 - Roundtable Listening Session with the PRIM&R’s Executive Director & Leadership TeamLocation: Room 323-324
Speaker: – PRIM&R
Speaker: – PRIM&R
Speaker: – PRIM&R
Speaker: – PRIM&R
Speaker: – PRIM&R
Speaker: – PRIM&R
Speaker: – PRIM&R
ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges
-
Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE18 - 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
-
Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF01 - 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
-
Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF02 - PLENARY: Artificial Intelligence (AI) Days of Future's Past: Tomorrow's Research YesterdayLocation: 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
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Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF03 - Key Information in Informed Consent: Ethical Principles, Policy, and PracticeLocation: 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
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Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF04 - IRB Review of Research Involving Politicized Topics and PopulationsLocation: 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
-
Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF05 - A Dialogue with the NIHLocation: Room 332
Speaker: – National Institutes of Health
-
Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF06 - Human Subjects Research Determinations: Before and After the FactLocation: 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
-
Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF07 - Adults with Developmental Disabilities and Research: Ethical, Legal, and Social Implications (ELSI) Solutions to Inclusion as Co-Researchers and Research ParticipantsLocation: 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
-
Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF08 - 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
-
Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF09 - I Don't Remember This Being in the Training Manual: An Exploration of Challenging IRB SituationsLocation: Room 343-344
Speaker: – James Madison University
Speaker: – James Madison University
Speaker: – Old Dominion University
IRB ReviewHRPP/IRB Management and AdministrationSocial, Behavioral, and Educational Research
-
Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF10 - Designing an HRPP/IRB Website that Builds TrustLocation: 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
-
Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF16 - Plenary: Conducting Research "With" and "Not On" Indigenous PopulationsLocation: 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
-
Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF11 - PLENARY: New and Evolving Considerations for Disaster PlanningLocation: Room 323-324
Moderator: – UCLA
Panelist: – USDA APHIS AC
Panelist: – Novartis
Panelist: – Rosemary Broome DVM
ACU/IACUC Program Management and Administration
-
Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF12 - Unlocking the Potential of IACUC Members: A Comprehensive Guide to TrainingLocation: Room 431-432
Speaker: – UC Berkeley
Speaker: – Texas A&M University System
Education, Qualifications, and TrainingACU/IACUC Program Management and AdministrationIACUC Fundamentals
-
Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF13 - Challenges and Opportunities in IACUC Administration at Underrepresented Minority (URM)-Serving InstitutionsLocation: Room 320-321
Speaker: – North Carolina Agricultural &Technical State University
Speaker: – North Carolina Central University
Advancing Equity and JusticeACU/IACUC Program Management and Administration
-
Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF14 - 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
-
Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF15 - Avoiding the Slippery Slope: Complimenting Semi-annual Reviews With a Program of Ongoing QA/QI ReviewLocation: 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
-
Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF19 - Proposed Changes to the Public Health Policy (PHS) on Research Misconduct: Impact on the Researcher CommunityLocation: 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
-
Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF20 - Developing an Emergency Preparedness Plan for an Effective Research SystemLocation: 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
-
Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF17 - Trust Me, I Know What I'm DoingLocation: 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
-
Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF18 - Shake It Up: An Interactive Discussion of Lessons Learned from IRB/IACUC LeadersLocation: 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
-
Wednesday, Nov 20th
7:30 AM – 8:30 AM PTOpening General Session: More Cure, Less Side Effects: A Potential Role for Preclinical StudiesLocation: 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
-
Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG01 - 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
-
Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG02 - Change the Game By Working Together: Tips for Increasing HRPP/IRB and Researcher CollaborationLocation: 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
-
Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG03 - A Dialogue with OHRPLocation: 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
-
Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG04 - Expectations for the Use of Electronic Systems to Conduct Clinical Trial Activities and Considerations for IRBs: Perspectives From Regulators and Institutional Review BoardsLocation: 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
-
Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG06 - Managing Dual/Multiple Relationships: Grappling With Identity and Interpersonal Boundaries in Human Subjects ResearchLocation: Room 445-446
Speaker: – Mass General Brigham
Speaker: – The Fenway Institute
Emerging Research Challenges and Breaking IssuesHRPP/IRB Management and AdministrationAdvancing Equity and Justice
-
Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG07 - 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
-
Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG08 - Let It Go! Strategies to Prevent Over-Regulation During Local Context ReviewLocation: Signature Room
Speaker: – The Pennsylvania State University
Speaker: – University of Minnesota
Speaker: – Research Compliance Services, University of Nebraska - Lincoln
-
Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG09 - IBC and IRB Collaboration: Working Together for Safety and OversightLocation: Room 331
Speaker: – Advarra
Speaker: – University of Washington
Speaker: – Seattle Children's Research Institute
Shared Research Oversight ChallengesHRPP/IRB Management and Administration
-
Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG15 - 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
-
Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG10 - PLENARY: Replicability, Reproducibility, Rigor, and Red HerringsLocation: 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
-
Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG11 - Agricultural Animals in ResearchLocation: 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
-
Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG12 - Better Together-Effective Collaboration During IACUC Protocol ReviewLocation: 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
-
Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG05 - Reserved for Late-Breaking -
Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG13 - PLENARY: Ethical Review of Human and Animal Subjects Research ProposalsLocation: 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
-
Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG14 - No Findings? No Problem: Why Non-Issue Audits Still MatterLocation: 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
-
Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH01 - 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
-
Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH02 - Group Harm: A Toolkit for Researchers, IRBs, and Data Access CommitteesLocation: 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
-
Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH03 - Houston, We Have Problem: Exploring Noncompliance in a Single IRB (sIRB) UniverseLocation: Ballroom 3
Speaker: – Baptist Health South Florida
Speaker: – University of Texas, MD Anderson Cancer Center
Speaker: – BRANY IRB
Single IRBQA/QI and Postapproval Monitoring
-
Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH04 - Comparative Effectiveness Research (CER): When Important Research Does Not Fit the Regulatory MoldLocation: Room 431-432
Speaker: – Advarra
Speaker: – National Institutes of Health
Speaker: – WCG
Speaker: – None
IRB ReviewEmerging Research Challenges and Breaking Issues
-
Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH05 - Pharma Perspectives on the Use of Social Media and Social Media Influencers in Clinical ResearchLocation: Room 335
Speaker: – Takeda Pharmaceuticals
Speaker: – Johnson & Johnson
Speaker: – WCG
Pharma/Biotech PerspectivesEmerging Research Challenges and Breaking Issues
-
Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH06 - What Are You Going To Do With My Specimens and Data? When Research Specimens and Data are Used for Commercial ProfitLocation: 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
-
Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH07 - 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
-
Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH08 - A Dialogue With the Environmental Protection Agency (EPA)Location: Room 331
Speaker: – U.S. EPA
Speaker: – Oak Ridge Associated Universities
Speaker: – US EPA
-
Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH09 - Exempt Study Review: How to Find Flexibilities in the Current RegulationsLocation: 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
-
Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH10 - Making the 3Rs More Than a Checkbox: Institutional 3Rs ProgramsLocation: 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
-
Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH11 - Oversight of Animal Care and Veterinary Staff Qualifications and TrainingLocation: 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
-
Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH12 - Adverse Events and Animal Welfare in Biotech and Academia Alike: Creating Efficiency, an Open Program, and Automated Functions of ReportingLocation: Room 345-346
Speaker: – UC Berkeley
Speaker: – Novartis Biomedical Research, Inc.
Pharma/Biotech PerspectivesQA/QI and Postapproval MonitoringIACUC ReviewACU/IACUC Program Management and Administration
-
Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH13 - 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
-
Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH14 - Don't Reinvent the Wheel! How to Ask the Right Questions and Leverage Existing Resources to Address Critical Compliance NeedsLocation: 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
-
Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH15 - Considering Yourself: Self‐Care for Compliance ProfessionalsLocation: 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
