Full Schedule
Conference recordings were available for 90 days after the conclusion of the conference (March 15, 2023). Recordings access is no longer available. PRIM&R members will have access to the PRIMR22 recordings one year after the meeting date (December 12, 2023). To purchase recordings, visit: https://www.pathlms.com/primr/courses/48273.
To access your transcript/certificate, click on the Evaluations tile below and evaluate the sessions you attended.
- Home
- Full Schedule
- Tuesday, December 6, 2022
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10:00 AM – 1:00 PM ET
Morning Workshops
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10:00 AM – 1:00 PM ET
Clarifying the Ethics and Oversight of Chimeric ResearchLocation: Livestreamed
Speaker: – Museum of Science, Boston
Speaker: – The Hastings Center
Resource Person: – Case Western Reserve University
Resource Person:
Resource Person: – The Hastings Center
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10:00 AM – 1:00 PM ET
Ethical Considerations for Conducting Research During Uncertain Times: A Focus on PharmaLocation: Livestreamed
Speaker: – Johnson & Johnson
Speaker: – Takeda Pharmaceuticals
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10:00 AM – 1:00 PM ET
Introduction to the IACUCLocation: On-Demand
Presenter: – New York University Grossman School of Medicine
Presenter: – UCLA
Presenter: – Cincinnati Children's Hospital Medical Center
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10:00 AM – 1:00 PM ET
Introduction to the IRB: Ethics and RegulationLocation: On-Demand
Presenter: – University of Kentucky
Presenter: – Columbia University
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10:00 AM – 1:00 PM ET
Quality Assurance/Quality Improvement (QA/QI) in Human Subjects ResearchLocation: Livestreamed
Speaker: – Harvard T.H. Chan School of Public Health
Speaker: – Indiana University
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1:00 PM – 2:30 PM ET
CIP Office Hours
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1:00 PM – 2:30 PM ET
CIP Office HoursLocation: Livestreamed
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1:00 PM – 2:30 PM ET
Mid-Day Break
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1:00 PM – 2:30 PM ET
Mid-Day Break
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2:30 PM – 5:30 PM ET
Afternoon Workshops
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2:30 PM – 5:30 PM ET
Applying the FDA Framework in Conducting IRB ReviewLocation: Livestreamed
Speaker: – FDA
Speaker: – University of Kentucky
Speaker: – University of Kentuckky
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2:30 PM – 5:30 PM ET
Lead From Anywhere: Strategies for Oversight ProfessionalsLocation: Livestreamed
Speaker: – Mass General Brigham
Speaker: – University of Colorado Denver | Anschutz Medical Campus
Resource Person: – WMU Homer Stryker MD School of Medicine
- Thursday, December 8, 2022
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10:00 AM – 1:00 PM ET
Morning Workshops
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10:00 AM – 1:00 PM ET
Crash Course in Ethical Frameworks and How to Use ThemLocation: Livestreamed
Speaker: – San Jose State University
Speaker: – San Jose State University
Speaker: – San Jose State University
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10:00 AM – 1:00 PM ET
Daily PAM Without the SPAM: Building an Ideal Postapproval Monitoring (PAM) Program Without Excess BurdenLocation: Livestreamed
Speaker: – Brigham and Women's Hospital
Speaker: – Brigham and Women's Hospital
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10:00 AM – 1:00 PM ET
Exploring Hot Topics in Social, Behavioral, and Educational Research (SBER)Location: Livestreamed
Speaker: – Northwestern University
Speaker: – Indiana University
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1:00 PM – 2:30 PM ET
CPIA Office Hours
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1:00 PM – 2:30 PM ET
CPIA Office HoursLocation: Livestreamed
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1:00 PM – 2:30 PM ET
Mid-Day Break
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1:00 PM – 2:30 PM ET
Mid-Day Break
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2:30 PM – 5:30 PM ET
Afternoon Workshops
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2:30 PM – 5:30 PM ET
Institutional Official (IO) Discussion: Navigating Ethical and Regulatory Challenges While Accelerating ResearchLocation: Livestreamed
Presenter: – Emory University
Presenter: – University of Cincinnati
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2:30 PM – 5:30 PM ET
The IRB and Diversity, Equity, Inclusion, and Justice (DEIJ): Lead? Follow? Or Get Out of the Way? Exploring the Role of the IRB in DEIJ EffortsLocation: Livestreamed
Speaker: – Mass General Brigham
Speaker: – Boston Children's Hospital
Speaker: – Boston Children's Hospital
Speaker: – Mayo Clinic
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2:30 PM – 5:30 PM ET
When Change Is Constant: Balancing Regulatory, Workload, Safety, and Workplace Changes During the Pandemic and BeyondLocation: Livestreamed
Speaker: – Georgia State University
Speaker: – University of Texas Southwestern Medical Center
- Monday, December 12, 2022
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9:00 AM – 9:15 AM ET
PRIMR22 Attendee Orientation
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9:00 AM – 9:15 AM ET
PRIMR22 Attendee OrientationLocation: On-Demand
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10:00 AM – 11:30 AM ET
General Session: The Evolution of Ethics and Compliance in IACUC and IRB Oversight
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10:00 AM – 11:30 AM ET
Welcome Remarks from PRIM&R's Executive Director, and PRIMR22 Opening General Session: The Evolution of Ethics and Compliance in IACUC and IRB OversightLocation: Livestreamed
Speaker: – Public Responsibility in Medicine & Research
Moderator: – Novartis Institutes for Biomedical Research
Panelist: – Boston University
Panelist: – University of Virginia
Emerging Challenges and Breaking IssuesShared Oversight ChallengesFlexibility and Innovation in Research Oversight ProcessesResearch Oversight Leaders and Institutional Officials
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11:30 AM – 11:45 AM ET
Break
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11:30 AM – 11:45 AM ET
Break
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11:45 AM – 12:45 PM ET
Concurrent Breakout Sessions Series A
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11:45 AM – 12:45 PM ET
A01 - Bringing the IRB to the People, and the People to the IRBLocation: Livestreamed
Resource Person: – Department of Health and Human Services, Office for Human Research Protections
Speaker: – Neiswanger Institute for Bioethics, Loyola University Chicago
Speaker: – Clinical Epidemiology Program, Ottawa Hospital Research Institute
Speaker: – Mayo Clinic
Advancing Equity and Justice in ResearchCommunication With the PublicFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and ProcessIRB Chairs
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11:45 AM – 12:45 PM ET
A02 - Ethical Considerations in Studies Involving Usual Care ArmsLocation: Livestreamed
Speaker: – Emory University School of Medicine, Division of Cardiology
Speaker: – Vanderbilt University Medical Center
Speaker: – University of Michigan
Resource Person: – OHRP
Emerging Challenges and Breaking Issues
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11:45 AM – 12:45 PM ET
A03 - Incorporating Investigator Education into Postapproval Compliance ActivitiesLocation: Livestreamed
Speaker: – University of Utah
Speaker: – University of Michigan
Speaker: – Johns Hopkins University School of Medicine
QA/QI and Postapproval MonitoringEducation, Qualifications, and TrainingFlexibility and Innovation in Research Oversight Processes
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11:45 AM – 12:45 PM ET
A04 - Categorical Conundrum: What Is the Tipping Point for Non-Exempt SBER Needing Convened ReviewLocation: Livestreamed
Speaker: – Seattle University
Speaker: – University of Wisconsin—Madison
Social, Behavioral, and Educational Research
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11:45 AM – 12:45 PM ET
A05 - A Case Study Exploring the Ethical Considerations for Pediatric Clinical TrialsLocation: Livestreamed
Speaker: – Pediatric Drug Development, Safety and Bioethics
Speaker: – Food and Drug Administration
Speaker: – Boston Children's Hospital
Speaker: – Food and Drug Administration
Populations Requiring Additional ProtectionsAdvancing Equity and Justice in Research
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11:45 AM – 12:45 PM ET
A06 - A Dialogue With NIH OLAWLocation: Livestreamed
Presenter: – National Institutes of Health
Presenter: – NIH, OLAW
Presenter: – NIH Office of Laboratory Animal Welfare
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11:45 AM – 12:45 PM ET
A07 - Experimental Design as a 3Rs ImperativeLocation: Livestreamed
Speaker: – AAALAC International
Speaker: – Novartis
Animal Well-Being and the 3RsIACUC Protocol Review
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11:45 AM – 12:45 PM ET
A08 - Flexibility and Innovation in Semiannual InspectionsLocation: Livestreamed
Speaker: – Nationwide Children's Hospital, Abigail Wexner Research Institute
Speaker: – Brigham and Women's Hospital
Speaker: – NIH/NIEHS
Resource Person: – Office of Laboratory Animal Welfare, NIH
Flexibility and Innovation in Research Oversight ProcessesACU Program Management
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11:45 AM – 12:45 PM ET
A09 - Formalizing Community Bridges for Research Ethics and TrustLocation: Livestreamed
Speaker: – Oregon National Primate Research Center
Speaker: – Northwest Association for Biomedical Research
Speaker: – University of Utah
Speaker: – Mass General Brigham
Advancing Equity and Justice in ResearchCommunication With the PublicEmerging Challenges and Breaking Issues
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11:45 AM – 12:45 PM ET
A10 - Leading With Respect, Communication, and Collaboration at All Levels of the Research EnterpriseLocation: Livestreamed
Speaker: – Johns Hopkins University
Speaker: – University of Missouri
Leadership Skills DevelopmentResearch Oversight Leaders and Institutional Officials
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11:45 AM – 12:45 PM ET
A11 - A Dialogue With the Department of Veterans Affairs (VA): A Federal Agency’s Challenges and Solutions in Working with External IRBs to Facilitate Implementation of the Cooperative Research ProvisionsLocation: On-Demand
Presenter: – Veterans Health Administration
Presenter: – Department of Veterans Affairs
Presenter: – Department of Veterans Affairs
Presenter: – Department of Veterans Affairs
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11:45 AM – 12:45 PM ET
A12 - Navigating Data and Specimen Sharing for Transnational ResearchLocation: On-Demand
Presenter:
Presenter: – International Society for Biological and Environmental Repositories
Presenter: – none
Transnational Research CollaborationsResearch Involving Data and Biospecimens
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11:45 AM – 12:45 PM ET
A13 - When Employees Are Research Participants: Ethical Considerations and Perspectives of Academia, Government, and Private IndustryLocation: On-Demand
Presenter: – National Institutes of Health
Presenter: – Eli Lilly and Company
Presenter: – Office of Human Subjects Research Johns Hopkins University School of Medicine
Emerging Challenges and Breaking IssuesPharma/Biotech PerspectivesPopulations Requiring Additional Protections
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11:45 AM – 12:45 PM ET
A14 - FDA and the Center for Biologics Evaluation and Research's (CBER) Regulation of Biological Products, Including Regenerative Medicine TherapiesLocation: On-Demand
Presenter: – WIRB-Copernicus Group
Presenter: – US Food and Drug Administration
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11:45 AM – 12:45 PM ET
A15 - Inspiring Innovation: The Seven Habits of Highly Effective and Flexible HRPPsLocation: On-Demand
Presenter: – University of Minnesota
Presenter: – University of Miami
Presenter: – Utah State University
Flexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
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11:45 AM – 12:45 PM ET
A16 - An Update From AAALAC InternationalLocation: On-Demand
Presenter: – AAALAC International
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11:45 AM – 12:45 PM ET
A17 - New and Evolving Considerations for Disaster PlanningLocation: On-Demand
Presenter: – Novartis Institutes for Biomedical Research Inc.
Presenter: – NIH, OLAW
Presenter: – Information Network Associates, Inc. (INA)
Presenter: – Oregon National Primate Research Center
Presenter: – USDA APHIS Animal Care
ACU Program ManagementIACUC Administration/Management and Process
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11:45 AM – 12:45 PM ET
A18 - How Ethical Review Occurs in IndustryLocation: On-Demand
Presenter: – Novartis International AG
Presenter: – Eli Lilly and Company
Pharma/Biotech Perspectives
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11:45 AM – 12:45 PM ET
A19 - Is Your Institution Ready to Handle Open Record and FOIA Requests?Location: On-Demand
Presenter: – University of Wisconsin-Madison
Presenter: – University of Colorado Denver | Anschutz Medical Campus
Shared Oversight ChallengesLegal Considerations in Research Oversight
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11:45 AM – 12:45 PM ET
A20 - Creating Expectations for Equity and Justice in Research ProtocolsLocation: On-Demand
Presenter: – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
Presenter: – Yale University
Presenter: – University of Texas Health Science Center at Houston
Advancing Equity and Justice in ResearchResearch Oversight Leaders and Institutional Officials
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12:45 PM – 1:15 PM ET
CIP Office Hours
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12:45 PM – 1:15 PM ET
CIP Office HoursLocation: Livestreamed
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12:45 PM – 1:15 PM ET
CPIA Office Hours
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12:45 PM – 1:15 PM ET
CPIA Office HoursLocation: Livestreamed
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12:45 PM – 1:30 PM ET
Mid-Day Break
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12:45 PM – 1:30 PM ET
Mid-Day Break
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12:45 PM – 1:30 PM ET
Sponsored Presentation from Cayuse: The Power of Configurable, Flexible, and Integrated Compliance Solutions
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12:45 PM – 1:30 PM ET
Sponsored Presentation from Cayuse: The Power of Configurable, Flexible, and Integrated Compliance SolutionsLocation: Livestreamed
Presenter: – Cayuse
Presenter: – Cayuse
Presenter: – Cayuse
Flexibility and Innovation in Research Oversight ProcessesShared Oversight Challenges
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1:30 PM – 2:30 PM ET
Concurrent Breakout Sessions Series B
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1:30 PM – 2:30 PM ET
B01 - May I Borrow a Tissue? Secondary Use of Biological SamplesLocation: Livestreamed
Speaker: – National Institutes of Health
Speaker: – Johns Hopkins University Berman Institute of Bioethics
Speaker: – Pearl IRB
Pharma/Biotech PerspectivesResearch Involving Data and Biospecimens
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1:30 PM – 2:30 PM ET
B02 - Recruiting, Training, and Retaining IRB ChairsLocation: Livestreamed
Speaker: – Utah Tech University
Speaker: – UHCMC Rainbow Babies and Children's Hospital
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1:30 PM – 2:30 PM ET
B03 - "Perfect" Study Submissions: Approaches to Improving IRB Submissions for a Better Review ProcessLocation: Livestreamed
Speaker: – Augusta University
Speaker: – Learn eCORE, LLC
Speaker: – Uniformed Services University of the Health Sciences
QA/QI and Postapproval MonitoringFlexibility and Innovation in Research Oversight ProcessesEducation, Qualifications, and Training
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1:30 PM – 2:30 PM ET
B04 - Beyond Subpart C: Understanding Prisoner Vulnerability, the Role of Prisoner Representatives, and Best Practices for Just and Comprehensive IRB ReviewLocation: Livestreamed
Speaker: – Nehemiah Community Development Corporation
Speaker: – University of Washington
Speaker: – William Paterson University
Resource Person: – OHRP
Populations Requiring Additional ProtectionsAdvancing Equity and Justice in Research
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1:30 PM – 2:30 PM ET
B05 - A Dialogue With USDA, APHIS, Animal CareLocation: Livestreamed
Presenter: – USDA APHIS Animal Care
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1:30 PM – 2:30 PM ET
B06 - Challenges and Strategies for Adequate Staffing in Animal Care and Use ProgramsLocation: Livestreamed
Speaker: – Princeton University
Speaker: – Medical University of South Carolina
ACU Program ManagementEmerging Challenges and Breaking IssuesLeadership Skills DevelopmentSmall Research Programs
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1:30 PM – 2:30 PM ET
B07 - The Need for Transparency as the Public and Legislators Weigh Legal Challenges to the Future of Research With AnimalsLocation: Livestreamed
Speaker: – University of Wisconsin-Madison
Speaker: – Novartis Pharma AG
Speaker: – Novartis Institutes for Biomedical Research
Pharma/Biotech Perspectives
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1:30 PM – 2:30 PM ET
B08 - Addressing Implicit, Unconscious, and Conscious Biases: Leadership, Investigators, and Ethics Boards Throughout the Lifecycle of Research InitiativesLocation: Livestreamed
Speaker: – Weill Cornell Medicine
Speaker: – Stanford University
Speaker: – CITI Program
Speaker: – Self
Advancing Equity and Justice in Research
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1:30 PM – 2:30 PM ET
B09 - Let's Get Digital: Challenges and Best Practices With Implementation of Remote Monitoring PracticesLocation: Livestreamed
Speaker: – University of Washington
Speaker: – Johns Hopkins University School of Medicine
Speaker: – West Virginia University
QA/QI and Postapproval MonitoringFlexibility and Innovation in Research Oversight Processes
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1:30 PM – 2:30 PM ET
B10 - What You Don't Know Can Hurt You: Using Metrics to Evaluate Research Administrative ActivitiesLocation: Livestreamed
Speaker: – University of Texas Southwestern Medical Center
Speaker: – University of Cincinnati
Research Oversight Leaders and Institutional Officials
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1:30 PM – 2:30 PM ET
B11 - An Update From AAHRPPLocation: On-Demand
Presenter: – AAHRPP
Presenter: – AAHRPP, Inc.
Presenter: – AAHRPP, Inc.
Presenter: – Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)
Presenter: – Association for the Accreditation of Human Research Protection Programs, Inc.
Presenter: – AAHRPP
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1:30 PM – 2:30 PM ET
B12 - International Data Privacy Regulations: An Overview of the Regulatory Landscape and Tools for Implementing a Review ProcessLocation: On-Demand
Presenter: – Harvard T.H. Chan School of Public Health
Presenter: – Northwell Health, The Feinstein Institutes for Medical Research
Presenter: – Advarra, Institutional Research Center of Excellence
Legal Considerations in Research OversightResearch Involving Data and Biospecimens
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1:30 PM – 2:30 PM ET
B13 - Apparently, Looks Do Matter: Visualizing IRB Data DifferentlyLocation: On-Demand
Presenter: – Icahn School of Medicine at Mount Sinai
Presenter: – Icahn School of Medicine at Mount Sinai
Presenter: – The Pennsylvania State University
Presenter: – WCG Clinical
HRPP/IRB Administration/Management and ProcessEducation, Qualifications, and Training
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1:30 PM – 2:30 PM ET
B14 - How to Evaluate Terms of Service and Privacy Policies of Mobile TechnologiesLocation: On-Demand
Presenter: – Advarra
Presenter: – Ropes & Gray
Research Conducted in the Digital WorldLegal Considerations in Research Oversight
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1:30 PM – 2:30 PM ET
B15 - Continuing Review as a QA/QI OpportunityLocation: On-Demand
Presenter: – The Pennsylvania State University
Presenter: – The Ohio State University
QA/QI and Postapproval MonitoringFlexibility and Innovation in Research Oversight Processes
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1:30 PM – 2:30 PM ET
B16 - Conducting Ethical Transnational Research in Times of ConflictLocation: On-Demand
Presenter: – University of Miami
Transnational Research Collaborations
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1:30 PM – 2:30 PM ET
B17 - Developing Safe Spaces, Including Online Environments, that Allow for Continuous Improvements of Animal Care and Use ProgramsLocation: On-Demand
Presenter: – UCLA
Presenter: – Florida A&M University
Advancing Equity and Justice in ResearchACU Program Management
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1:30 PM – 2:30 PM ET
B18 - Conducting and Reviewing 3Rs Literature Searches for Animal Use Protocol Location: On-Demand
Presenter: – USDA, AWIC
Presenter: – Health Sciences Library System, University of Pittsburgh
Animal Well-Being and the 3RsIACUC Protocol Review
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1:30 PM – 2:30 PM ET
B19 - Inconsistencies in Review and Regulatory Creep: Is it a Problem?Location: On-Demand
Presenter: – University of Miami
Presenter: – MaineHealth System
Presenter: – Massachusetts General Research Institute
Shared Oversight Challenges
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1:30 PM – 2:30 PM ET
B20 - Best Practices for Communicating QA/QI Findings to External GroupsLocation: On-Demand
Presenter: – Nathan Kline Institute for Psychiatric Research
Presenter: – Institute of Health System Science, Feinstein Institutes for Medical Research, Northwell Health
Presenter: – Saint Luke’s Health System, Missouri/Kansas
QA/QI and Postapproval Monitoring
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2:30 PM – 3:00 PM ET
Break
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2:30 PM – 3:00 PM ET
Break
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2:30 PM – 5:00 PM ET
Office Hours: Federal Agency/Accrediting Body/CIP and CPIA Office
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2:30 PM – 3:30 PM ET
FDA Office HoursLocation: Livestreamed
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2:30 PM – 4:00 PM ET
AAALAC International Office HoursLocation: Livestreamed
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2:30 PM – 5:00 PM ET
AAHRPP, Inc. Office HoursLocation: Livestreamed
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2:30 PM – 5:00 PM ET
Department of Navy Office HoursLocation: Livestreamed
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2:30 PM – 5:00 PM ET
NIH OLAW Office HoursLocation: Livestreamed
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3:00 PM – 4:00 PM ET
CIP Office HoursLocation: Livestreamed
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3:30 PM – 4:30 PM ET
OHRP Office HoursLocation: Livestreamed
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3:00 PM – 4:00 PM ET
Concurrent Networking Sessions
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3:00 PM – 4:00 PM ET
Build Your Network and Advance Your Career With PRIM&R MembershipLocation: On-Demand
Presenter: – PRIM&R
Presenter: – PRIM&R
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3:00 PM – 4:00 PM ET
Evaluating the Committee: Strategies for Conducting QA and QI of Our Ethics CommitteesLocation: Livestreamed
Speaker: – University of Oklahoma Health Sciences Center
Speaker: – University of Massachusetts Amherst
QA/QI and Postapproval Monitoring
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3:00 PM – 4:00 PM ET
Everything You Wanted to Know About the CPIA CredentialLocation: Livestreamed
Presenter: – Florida A&M University
Presenter: – Cedars-Sinai Medical Center
IACUC Administration/Management and Process
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3:00 PM – 4:00 PM ET
HRPP/IRB Management 101: Real-World Discussions Regarding How to Effectively Run a HRPP/IRB OfficeLocation: Livestreamed
Speaker: – Yale University
Speaker: – Northwestern University
Speaker: – Office of Human Subjects Research Johns Hopkins University School of Medicine
Leadership Skills DevelopmentHRPP/IRB Administration/Management and Process
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3:00 PM – 4:00 PM ET
A New Hope: IRB Jedi Unite—Exploring Regulations, Guidance, and Institutional PolicesLocation: Livestreamed
Speaker: – Boston Children's Hospital
Speaker: – The Ohio State University
Speaker: – OHRP
Speaker: – Harvard T.H. Chan School of Public Health
IRB BasicsFlexibility and Innovation in Research Oversight Processes
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3:00 PM – 4:00 PM ET
The Role of Institutional Leadership: A Case Study AnalysisLocation: Livestreamed
Speaker: – Northwell Health
Speaker: – University of Arizona
Research Oversight Leaders and Institutional Officials
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5:00 PM – 6:00 PM ET
Happy Hour Sponsored by Advarra: Trivia and Networking
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5:00 PM – 6:00 PM ET
Happy Hour Sponsored by Advarra: Trivia and Networking - Tuesday, December 13, 2022
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10:00 AM – 11:30 AM ET
Concurrent Plenary Sessions
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10:00 AM – 11:30 AM ET
PRIM&R Service Award Presentation, and Plenary I: When Research Context Changes—Politics, Legislation, the Culture Wars impact on Independent Ethics OversightLocation: Livestreamed
Moderator: – Johns Hopkins University
Panelist: – The Fenway Institute
Panelist: – University of Utah
Panelist: – The University of Texas at Austin
Advancing Equity and Justice in ResearchLegal Considerations in Research OversightEmerging Challenges and Breaking Issues
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10:00 AM – 11:30 AM ET
PRIM&R Service Award Presentation, and Plenary II: Caring for Our People, Caring for Our Animals—Supporting Compassion Fatigue ResiliencyLocation: Livestreamed
Moderator: – Washington National Primate Research Center, University of Washington
Panelist: – Georgetown University Medical School
Panelist: – The North American 3Rs Collaborative.
Panelist: – Oregon Health and Science University
Panelist: – Office of Laboratory Animal Welfare, NIH
ACU Program ManagementEmerging Challenges and Breaking Issues
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10:00 AM – 11:30 AM ET
PRIM&R Service Award Presentation, and Plenary III: Lost in TranslationLocation: Livestreamed
Moderator: – University of Minnesota
Panelist: – National Institute of Environmental Health Sciences, National Institutes of Health
Panelist: – Berlin Institute of Health, Charite
Panelist: – Yale University School of Medicine
Emerging Challenges and Breaking IssuesShared Oversight Challenges
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10:00 AM – 11:30 AM ET
PRIM&R Service Award Presentation, and Plenary IV: Balancing Reputational Harm and Academic FreedomLocation: Livestreamed
Moderator: – Macalester College
Panelist: – Vanderbilt University Medical Center
Panelist: – University of Arizona
Panelist: – Memorial Sloan Kettering Cancer Center
Research Oversight Leaders and Institutional OfficialsEmerging Challenges and Breaking Issues
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11:30 AM – 11:45 AM ET
Break
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11:30 AM – 11:45 AM ET
Break
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11:45 AM – 12:45 PM ET
Concurrent Breakout Sessions Series C
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11:45 AM – 12:45 PM ET
C01 - A Dialogue With OHRPLocation: Livestreamed
Speaker: – Office for Human Research Protections
Speaker: – Office for Human Research Protections (OHRP)
Speaker: – DHHS Office for Human Research Protections
Speaker: – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS
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11:45 AM – 12:45 PM ET
C02 - Building Your Toolbox: Strategies for Educating and Training Adult LearnersLocation: Livestreamed
Presenter: – AAHRPP
Presenter: – University of Nebraska Medical Center
Presenter: – PRIM&R
Education, Qualifications, and Training
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11:45 AM – 12:45 PM ET
C03 - Investigational Device Exemptions (IDE) and Bioresearch Monitoring (BIMO) Inspection for Medical Device Clinical InvestigationsLocation: Livestreamed
Speaker: – US Food and Drug Administration
Speaker: – US Food and Drug Administration
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11:45 AM – 12:45 PM ET
C04 - The Workplace Shift: New Realities, Future Uncertainty, and Meeting Staff Needs in a Post-Pandemic WorldLocation: Livestreamed
Speaker: – Children's Hospital of Philadelphia
Speaker: – Northwestern University
Leadership Skills DevelopmentHRPP/IRB Administration/Management and Process
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11:45 AM – 12:45 PM ET
C05 - The Use of Social Media in Research: The Good, the Bad, and the UglyLocation: Livestreamed
Speaker: – National Institutes of Health
Speaker: – Clemson University
Social, Behavioral, and Educational ResearchResearch Conducted in the Digital WorldEmerging Challenges and Breaking Issues
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11:45 AM – 12:45 PM ET
C06 - IACUC Oversight and Evaluation of an Effective Institutional Training ProgramLocation: Livestreamed
Speaker: – NIH Office of Animal Care and Use
Speaker: – University of Michigan
Resource Person: – NIH Office of Laboratory Animal Welfare
Education, Qualifications, and TrainingIACUC Administration/Management and Process
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11:45 AM – 12:45 PM ET
C07 - Effectively Identify, Track, and Report Departures: Meeting OLAW and USDA RequirementsLocation: Livestreamed
Speaker: – USDA, APHIS
Speaker: – NIH-OLAW
Speaker: – UC Berkeley
IACUC Administration/Management and Process
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11:45 AM – 12:45 PM ET
C08 - Keeping the Peace: Conflict Resolution Strategies for IACUC ChairsLocation: Livestreamed
Presenter: – WMU Homer Stryker MD School of Medicine
Presenter: – Colorado State University
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11:45 AM – 12:45 PM ET
C09 - Take Advantage of Your "Small Pond": Cultivating Community Between Researchers and Compliance CommitteesLocation: Livestreamed
Speaker: – John Carroll University
Speaker: – Whitworth University
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11:45 AM – 12:45 PM ET
C10 - Managing Your Research Program's Risk ToleranceLocation: Livestreamed
Speaker: – St. Jude Children's Research Hospital
Speaker: – Advarra, Inc.
Research Oversight Leaders and Institutional Officials
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11:45 AM – 12:45 PM ET
C11 - An Update From ORI: Misconduct in Clinical, Translational, and Animal Research: Protocol Violations, Research Misconduct, or Both?Location: On-Demand
Presenter: – Office of Research Integrity, Department of Health and Human Services
Presenter: – Office of Research Integrity, Office of the Assistant Secretary for Health (OASH), Department of Health and Human Services (HHS)
Presenter:
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11:45 AM – 12:45 PM ET
C12 - Enhancing Inclusion in a Time of DivisionLocation: On-Demand
Presenter: – The Fenway Institute
Presenter: – Fordham University
Presenter: – University of Pennsylvania, Abramson Cancer Center, Clinical Research Unit
Advancing Equity and Justice in ResearchEmerging Challenges and Breaking IssuesPopulations Requiring Additional Protections
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11:45 AM – 12:45 PM ET
C13 - Bridging the Gap: Gene Therapy Research From the Perspectives of IRBs and Patient AdvocatesLocation: On-Demand
Presenter: – Saint Louis University
Presenter: – Harvard Medical School
Presenter:
Emerging Challenges and Breaking IssuesResearch Involving Data and Biospecimens
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11:45 AM – 12:45 PM ET
C14 - IRB Guidance on Data-Sharing in the Social Sciences: Evidence of a ShiftLocation: On-Demand
Presenter: – Qualitative Data Repository www.qdr.org
Presenter: – Department of Government, Georgetown University
Presenter: – Clarkson University
Social, Behavioral, and Educational ResearchHRPP/IRB Administration/Management and ProcessResearch Involving Data and Biospecimens
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11:45 AM – 12:45 PM ET
C15 - Innovations in the Oversight of Research Data Location: On-Demand
Presenter: – University of Utah
Presenter: – Division of Research
The Permanente Medical Group at Kaiser Permanente
Presenter: – Johns Hopkins Medicine
Flexibility and Innovation in Research Oversight ProcessesResearch Involving Data and Biospecimens
-
11:45 AM – 12:45 PM ET
C16 - Effective Change Management Processes in an IACUC OfficeLocation: On-Demand
Presenter: – Northwell Health - Feinstein Institutes for Medical Research
Presenter: – KBR
Presenter: – UCLA
Education, Qualifications, and TrainingACU Program Management
-
11:45 AM – 12:45 PM ET
C17 - The Periodic Trends Assessment of Changes Over the Lifespan of Living Documents: Reflection on edits to Policies/Standard Operating Procedures (SOP)Location: On-Demand
Presenter: – UT Southwestern Medical Center
Presenter: – HRP Consulting Group
Flexibility and Innovation in Research Oversight Processes
-
11:45 AM – 12:45 PM ET
C18 - Collaborating to Advance the 3Rs in North America and Beyond: Highlighting the North American 3Rs Collaborative (NA3RsC) 3Rs Certificate Course, Refined Mouse Handling, and Environmental Health MonitoringLocation: On-Demand
Presenter: – The North American 3Rs Collaborative.
Presenter: – Charles River Laboratories
Presenter: – Eli Lilly and Company
Animal Well-Being and the 3Rs
-
11:45 AM – 12:45 PM ET
C19 - "One Health” and Veterinary Research With Human Health GoalsLocation: On-Demand
Presenter: – University of Washington
Presenter: – Washington State University; One Health Clinic Seattle
Presenter:
Presenter:
Emerging Challenges and Breaking IssuesShared Oversight Challenges
-
11:45 AM – 12:45 PM ET
C20 - What Is Safety?Location: On-Demand
Presenter: – University of Texas Health Science Center at Houston
Presenter: – Emory University
Emerging Challenges and Breaking IssuesResearch Oversight Leaders and Institutional Officials
-
12:45 PM – 1:15 PM ET
CIP Office Hours
-
12:45 PM – 1:15 PM ET
CIP Office HoursLocation: Livestreamed
-
12:45 PM – 1:15 PM ET
CPIA Office Hours
-
12:45 PM – 1:15 PM ET
CPIA Office HoursLocation: Livestreamed
-
12:45 PM – 1:30 PM ET
Mid-Day Break
-
12:45 PM – 1:30 PM ET
Mid-Day Break
-
12:45 PM – 1:30 PM ET
Sponsored Presentation from Advarra: The Secret to Single IRB (sIRB) Reliance Success
-
12:45 PM – 1:30 PM ET
Sponsored Presentation from Advarra: The Secret to Single IRB (sIRB) Reliance SuccessLocation: Livestreamed
Presenter: – Advarra
Presenter:
HRPP/IRB Administration/Management and ProcessFlexibility and Innovation in Research Oversight Processes
-
1:30 PM – 2:45 PM ET
Concurrent Plenary Sessions
-
1:30 PM – 2:45 PM ET
Plenary V: Progress in Defining and Evaluating HRPP/IRB Quality and EffectivenessLocation: Livestreamed
Moderator: – National Institutes of Health
Panelist: – Neiswanger Institute for Bioethics, Loyola University Chicago
Panelist: – Perelman School of Medicine, University of Pennsylvania
Panelist: – University of Utah
HRPP/IRB Administration/Management and ProcessFlexibility and Innovation in Research Oversight ProcessesIRB ChairsQA/QI and Postapproval MonitoringResearch Oversight Leaders and Institutional Officials
-
1:30 PM – 2:45 PM ET
Plenary VI: How to Balance Experimental Refinements With Scientific Justification Location: Livestreamed
Moderator: – Novartis Institutes for Biomedical Research, Inc.
Panelist: – Animal Welfare Institute & University of British Columbia, Animal Welfare Program
Panelist: – NIH Office of Laboratory Animal Welfare
IACUC Protocol ReviewAnimal Well-Being and the 3Rs
-
1:30 PM – 2:45 PM ET
Plenary VII: How Research Environments Influence the Ability of the People in Them to Behave EthicallyLocation: Livestreamed
Moderator: – San Jose State University
Panelist: – University of Central Florida
Panelist: – University of Massachusetts at Lowell
Panelist: – Bioethics Research Center
Washington University School of Medicine
Advancing Equity and Justice in ResearchShared Oversight Challenges
-
1:30 PM – 2:45 PM ET
Plenary VIII: Conducting Research: The Institutional Official (IO) as the ConductorLocation: Livestreamed
Moderator: – Indiana University
Panelist: – University of Colorado Anschutz Medical Campus
Panelist: – Baptist Health South Florida
Panelist: – Emory University
Research Oversight Leaders and Institutional Officials
-
2:30 PM – 5:00 PM ET
Office Hours: Federal Agency/Accrediting Body/CIP and CPIA Office
-
2:30 PM – 3:30 PM ET
FDA Office HoursLocation: Livestreamed
-
2:30 PM – 4:00 PM ET
AAALAC International Office HoursLocation: Livestreamed
-
2:30 PM – 4:00 PM ET
Department of Veterans Affairs Office HoursLocation: Livestreamed
-
2:30 PM – 5:00 PM ET
AAHRPP, Inc. Office HoursLocation: Livestreamed
-
2:30 PM – 5:00 PM ET
Department of Navy Office HoursLocation: Livestreamed
-
2:30 PM – 5:00 PM ET
NIH OLAW Office HoursLocation: Livestreamed
-
3:00 PM – 4:00 PM ET
CIP Office HoursLocation: Livestreamed
-
3:00 PM – 4:00 PM ET
CPIA Office HoursLocation: Livestreamed
-
3:30 PM – 4:30 PM ET
OHRP Office HoursLocation: Livestreamed
-
4:00 PM – 5:00 PM ET
Department of Energy Office HoursLocation: Livestreamed
-
2:45 PM – 3:00 PM ET
Break
-
2:45 PM – 3:00 PM ET
Break
-
3:00 PM – 4:00 PM ET
Concurrent Networking Sessions
-
3:00 PM – 4:00 PM ET
Hitting the Mark: Best Practices for IACUC AdministratorsLocation: Livestreamed
Speaker: – University of North Texas Health Science Center
Speaker: – Janssen
Speaker: – Georgia State University
IACUC Administration/Management and Process
-
3:00 PM – 4:00 PM ET
IACUC Chairs Networking Session: Let's Discuss IACUC Chair Challenges and Solutions!Location: Livestreamed
Speaker: – Zucker School of Medicine at Hofstra/Northwell
The Feinstein Institute for Medical Research / Northwell Health
Speaker: – Creighton University
Speaker: – WMU Homer Stryker MD School of Medicine
Resource Person: – NIH Office of Laboratory Animal Welfare
-
3:00 PM – 4:00 PM ET
Insights into Key Recommendations from the Secretary’s Advisory Committee on Human Research Protections (SACHRP)Location: Livestreamed
Speaker: – Ropes & Gray Law Firm
Speaker: – WCG
Speaker: – University of Washington School of Medicine
-
3:00 PM – 4:00 PM ET
PRIM&R’s Online Courses—EROC and AROCLocation: On-Demand
-
3:00 PM – 4:00 PM ET
PRIMR22 Poster Presentation Program: Outstanding Work in Human Subjects ProtectionsLocation: Livestreamed
Moderator: – WCG
Speaker: – University of South Florida School of Social Work
Speaker: – Kaiser Permanente Department of Research and Evaluation
Speaker: – Cedars-Sinai Medical Center
Speaker: – National Institute of Mental Health
Informed ConsentEducation, Qualifications, and TrainingFlexibility and Innovation in Research Oversight Processes
-
3:00 PM – 4:00 PM ET
SBER Network Discussion: Faculty Mentorship in Human Research ProtectionsLocation: Livestreamed
Speaker: – Weill Cornell Medicine
Speaker: – University of South Dakota
Speaker: – Rocky Mountain University of Health Professions
Speaker: – Michigan Technological University
Speaker: – The University of New Mexico
Speaker: – Virginia Tech
Speaker: – University of New Hampshire
Social, Behavioral, and Educational Research
-
3:00 PM – 4:00 PM ET
When You're the New Kid in Town: Taking Over as an HRPP/IRB LeaderLocation: Livestreamed
Speaker: – Nationwide Children's Hospital
Speaker: – Virginia Commonwealth University
Speaker: – UAMS Institutional Review Board
Leadership Skills DevelopmentHRPP/IRB Administration/Management and Process
- Wednesday, December 14, 2022
-
10:00 AM – 11:30 AM ET
General Session: Deciphering the Code, Interpreting, and Responding to Misinformation
-
10:00 AM – 11:30 AM ET
Welcome Remarks from the Chair of PRIM&R's Board of Directors, and General Session: Deciphering the Code, Interpreting, and Responding to MisinformationLocation: Livestreamed
Moderator: – San Jose State University
Panelist: – Science Writer and Editor
Panelist: – North Carolina State University
Panelist: – Georgetown University
Emerging Challenges and Breaking IssuesShared Oversight ChallengesCommunication With the PublicResearch Oversight Leaders and Institutional Officials
-
11:30 AM – 11:45 AM ET
Break
-
11:30 AM – 11:45 AM ET
Break
-
11:45 AM – 12:45 PM ET
Concurrent Breakout Sessions Series D
-
11:45 AM – 12:45 PM ET
D01 - A Dialogue With FDALocation: Livestreamed
Presenter: – Center for Devices and Radiological Health, FDA
Presenter: – Food and Drug Administration
Presenter: – FDA
Presenter: – FDA
Presenter: – Food and Drug Administration
-
11:45 AM – 12:45 PM ET
D02 - Equitable Inclusion and Local Community Context in Multi-Site ResearchLocation: Livestreamed
Speaker: – The Fenway Institute
Speaker: – NYU Langone Health
Advancing Equity and Justice in ResearchEmerging Challenges and Breaking IssuesHRPP/IRB Administration/Management and Process
-
11:45 AM – 12:45 PM ET
D03 - Communication in Minimal Risk Research Using Waiver of ConsentLocation: Livestreamed
Speaker: – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
Speaker: – Johns Hopkins University
Speaker: – University of Utah IRB
Emerging Challenges and Breaking IssuesInformed ConsentCommunication With the Public
-
11:45 AM – 12:45 PM ET
D04 - When Institutional Research and Corporate Worlds Collide: The Impact of Corporate Collaborations in Data ResearchLocation: Livestreamed
Presenter: – University of Utah
Presenter: – Microsoft Research
Presenter: – ACT, Inc.
Research Involving Data and BiospecimensEmerging Challenges and Breaking IssuesFlexibility and Innovation in Research Oversight ProcessesResearch Conducted in the Digital World
-
11:45 AM – 12:45 PM ET
D05 - CANCELLED: Developing and Sustaining Tribal IRB Infrastructure: Lessons Learned from the Collaborative Research Center for American Indian Health (CRCAIH) InitiativesLocation: Livestreamed
-
11:45 AM – 12:45 PM ET
D06 - Nonhuman Primate Sourcing Challenges: Implications for Animal WelfareLocation: Livestreamed
Speaker: – Novartis Institutes for Biomedical Research Inc.
Speaker: – Emory University
Speaker: – Labcorp Drug Development
Animal Well-Being and the 3RsACU Program ManagementEmerging Challenges and Breaking Issues
-
11:45 AM – 12:45 PM ET
D07 - Meeting the Challenges of IACUC Administration: Case Studies in Handling Complex Protocol Issues/Situations Location: Livestreamed
Presenter: – United States Department of Agriculture (USDA)
Presenter: – OLAW, NIH
Presenter: – Washington University in St. Louis
IACUC Administration/Management and ProcessIACUC Protocol Review
-
11:45 AM – 12:45 PM ET
D08 - Postapproval Monitoring (PAM) for Wildlife Studies and Field ResearchLocation: Livestreamed
Speaker: – USDA Forest Service
Speaker: – San Jose State University
Resource Person: – NIH, OLAW
QA/QI and Postapproval MonitoringOversight of Non-Typical Species and SituationsSmall Research Programs
-
11:45 AM – 12:45 PM ET
D09 - Some Things Are Not So Different: The Intersection of IRB, IACUC, IBC, and ESCROLocation: Livestreamed
Speaker: – University of California, Berkeley
Speaker: – UT Southwestern Medical Center
Speaker: – Nathan Kline Institute for Psychiatric Research
Shared Oversight ChallengesFlexibility and Innovation in Research Oversight Processes
-
11:45 AM – 12:45 PM ET
D10 - Supporting Workforce DiversityLocation: Livestreamed
Speaker: – Capella University
Speaker: – Wake County Government
Advancing Equity and Justice in ResearchResearch Oversight Leaders and Institutional Officials
-
11:45 AM – 12:45 PM ET
D11 - Conducting an Effective IRB Review of Artificial Intelligence (AI) Human Subjects Research (HSR) (The Non-Clinical Edition)Location: On-Demand
Presenter: – Division of Research
The Permanente Medical Group at Kaiser Permanente
Presenter: – IRC
Research Involving Data and BiospecimensResearch Conducted in the Digital World
-
11:45 AM – 12:45 PM ET
D12 - Small Research Program and Your First Clinical Trial: Now What?!Location: On-Demand
Presenter: – Avera Research Institute
Presenter: – University of Southern Maine
Small Research ProgramsSocial, Behavioral, and Educational Research
-
11:45 AM – 12:45 PM ET
D13 - IRB Process Improvements: Collaborative Methods With Institutional Clinical Research LiaisonsLocation: On-Demand
Presenter: – UC Davis Health
Presenter: – University of California, Davis/Clinical and Translational Science Center (CTSC)/Clinical Trials Office
Presenter: – UC Davis
Education, Qualifications, and TrainingFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
-
11:45 AM – 12:45 PM ET
D14 - When The @#&% Hits the Fan: When HRPP Noncompliance and Research Misconduct Occur TogetherLocation: On-Demand
Presenter: – University of Maryland, Baltimore
Presenter: – AAHRPP
Presenter: – Human Research Affairs, Mass General Brigham; Harvard Medical School
HRPP/IRB Administration/Management and ProcessLegal Considerations in Research Oversight
-
11:45 AM – 12:45 PM ET
D15 - In the Eyes of the Consenter: The Informed Consent Process From the Perspective of People Who Obtain ConsentLocation: On-Demand
Presenter: – Cincinnati Children's Hospital Medical Center
Presenter: – Cincinnati Children's Hospital Medical Center
Presenter: – Cincinnati Children's Hospital Medical Center
-
11:45 AM – 12:45 PM ET
D16 - Leading and Lagging Indicators of QualityLocation: On-Demand
Presenter: – University of Michigan
Presenter: – NIH Office of Animal Care and Use
Flexibility and Innovation in Research Oversight ProcessesACU Program ManagementIACUC Administration/Management and Process
-
11:45 AM – 12:45 PM ET
D17 - Fish and Wildlife Protocol Reviews: Research vs. ManagementLocation: On-Demand
Presenter: – National Parks Service, BRD, Wildlife Health Branch
Presenter: – USDA Forest Service
Presenter: – NIH, OLAW
Oversight of Non-Typical Species and SituationsACU Program ManagementFlexibility and Innovation in Research Oversight ProcessesIACUC Protocol Review
-
11:45 AM – 12:45 PM ET
D18 - Educating Researchers Involved in Collaborative ResearchLocation: On-Demand
Presenter: – NYU Langone Health
Presenter: – The Ohio State University
Presenter: – San Jose State University
Flexibility and Innovation in Research Oversight ProcessesEducation, Qualifications, and Training
-
11:45 AM – 12:45 PM ET
D19 - It's Not You, It's Us: Dealing With the Difficult IRB/IACUC/IBCLocation: On-Demand
Presenter: – Indiana University
Presenter: – The University of Texas at Austin
QA/QI and Postapproval MonitoringShared Oversight Challenges
-
12:45 PM – 1:15 PM ET
CIP Office Hours
-
12:45 PM – 1:15 PM ET
CIP Office HoursLocation: Livestreamed
-
12:45 PM – 1:15 PM ET
CPIA Office Hours
-
12:45 PM – 1:15 PM ET
CPIA Office HoursLocation: Livestreamed
-
12:45 PM – 1:30 PM ET
Mid-Day Break
-
12:45 PM – 1:30 PM ET
Mid-Day Break
-
12:45 PM – 1:30 PM ET
Sponsored Presentation from Huron: Improving Efficiency and Effectiveness for HRPPs and Beyond
-
12:45 PM – 1:30 PM ET
Sponsored Presentation from Huron: Improving Efficiency and Effectiveness for HRPPs and BeyondLocation: Livestreamed
Presenter: – Huron Consulting Group
Presenter: – Huron Consulting Group
-
1:30 PM – 2:30 PM ET
Concurrent Breakout Sessions Series E
-
1:30 PM – 2:30 PM ET
E01 - Innovations in Recruiting Research ParticipantsLocation: Livestreamed
Speaker: – Emory University School of Medicine, Division of Cardiology
Speaker: – Stanford University
Speaker: – Pharmaceutical Product Development (PPD)
Flexibility and Innovation in Research Oversight Processes
-
1:30 PM – 2:30 PM ET
E02 - Bottlenecks to Bridges: Defining and Implementing Your HRPP Vision and the Importance of HRPP LeadershipLocation: Livestreamed
Speaker: – University of California Los Angeles
Speaker: – University of Alabama at Birmingham
Speaker: – Advarra, Inc.
HRPP/IRB Administration/Management and ProcessLeadership Skills Development
-
1:30 PM – 2:30 PM ET
E03 - “Do Not Take if You Are Pregnant”: Demystifying the Inclusion of Pregnant Participants in ResearchLocation: Livestreamed
Speaker: – University of North Carolina at Chapel Hill
Speaker: – Florida State University
Populations Requiring Additional Protections
-
1:30 PM – 2:30 PM ET
E04 - Equity Beyond Selection: Applying Principles of Justice After RecruitmentLocation: Livestreamed
Presenter: – Rutgers University
Presenter: – PRIM&R
Social, Behavioral, and Educational ResearchAdvancing Equity and Justice in Research
-
1:30 PM – 2:30 PM ET
E05 - Training IRBs for the Review of Transnational ResearchLocation: Livestreamed
Speaker: – Walter Reed Army Institue for Research
Speaker: – Unity Health Toronto
Speaker: – Johns Hopkins Bloomberg School of Public Health
Transnational Research CollaborationsEducation, Qualifications, and Training
-
1:30 PM – 2:30 PM ET
E06 - Fostering Collaborative Relationships with IACUCs, Attending Veterinarians (AVs), and InvestigatorsLocation: Livestreamed
Speaker: – Federation of American Societies for Experimental Biology (FASEB)
Speaker:
Speaker: – Northwest Association for Biomedical Research
Speaker: – University of Pennsylvania
ACU Program ManagementCommunication With the PublicFlexibility and Innovation in Research Oversight ProcessesEducation, Qualifications, and Training
-
1:30 PM – 2:30 PM ET
E07 - Veterinary Mentoring for Wildlife Research and Field Procedures Location: Livestreamed
Speaker: – National Parks Service, BRD, Wildlife Health Branch
Speaker: – USDA Forest Service
Oversight of Non-Typical Species and SituationsACU Program ManagementEducation, Qualifications, and Training
-
1:30 PM – 2:30 PM ET
E08 - The Patients are Waiting! Balancing the Pressure of Getting New Therapies to Clinical TrialLocation: Livestreamed
Speaker: – Massachusetts General Hospital
Speaker: – AbbVie
Pharma/Biotech PerspectivesFlexibility and Innovation in Research Oversight Processes
-
1:30 PM – 2:30 PM ET
E09 - Doing More With Less: Managing Infrastructure and Staffing ResourcesLocation: Livestreamed
Speaker: – UT Southwestern Medical Center
Speaker: – University of Texas at Austin
Shared Oversight ChallengesEmerging Challenges and Breaking Issues
-
1:30 PM – 2:30 PM ET
E10 - What's Coming Down the Line that Institutional Leadership Needs to Know?Location: Livestreamed
Speaker: – Association of American Medical Colleges
Speaker: – University of Pittsburgh
Emerging Challenges and Breaking IssuesResearch Oversight Leaders and Institutional Officials
-
1:30 PM – 2:30 PM ET
E11 - An Update From DoDLocation: On-Demand
Presenter: – Army Human Research Protections Office (AHRPO)
Presenter: – Uniformed Services University of the Health Sciences
Presenter: – Department of Defense
Presenter: – Department of the Air Force
Presenter: – US Army Medical Research and Development Command
-
1:30 PM – 2:30 PM ET
E12 - The Regulation and Ethics of the Return of Research Results to Human SubjectsLocation: On-Demand
Presenter: – Montclair State University
Advancing Equity and Justice in ResearchResearch Involving Data and BiospecimensCommunication With the Public
-
1:30 PM – 2:30 PM ET
E13 - Rigor Rules! How IRBs Assess Sound Research DesignLocation: On-Demand
Presenter: – Program for the Protection of Human Subjects
Presenter: – New York State Psychiatric Institute/Columbia University Irving Medical Center
IRB BasicsFlexibility and Innovation in Research Oversight Processes
-
1:30 PM – 2:30 PM ET
E14 - The Protection of Non-Subjects From Research HarmLocation: On-Demand
Presenter: – Yale University
Presenter: – Wake Forest University School of Medicine
Presenter: – Columbia University
Legal Considerations in Research Oversight
-
1:30 PM – 2:30 PM ET
E15 - The IRB Role and Practical Tools for IRB Review of Research Proposals Involving Artificial Intelligence (AI)Location: On-Demand
Presenter: – Institute of Health System Science, Feinstein Institutes for Medical Research, Northwell Health
Presenter: – Good Clinical Practice Alliance
Research Conducted in the Digital WorldEmerging Challenges and Breaking IssuesFlexibility and Innovation in Research Oversight ProcessesResearch Involving Data and Biospecimens
-
1:30 PM – 2:30 PM ET
E16 - IACUC Basics for the Use of Wildlife and Non-Typical Species in Research and EducationLocation: On-Demand
Presenter: – Zachery Consulting, LLC
Presenter: – University of Arkansas at Little Rock, Biology
Presenter: – NIH, OLAW
Oversight of Non-Typical Species and SituationsIACUC Basics
-
1:30 PM – 2:30 PM ET
E17 - Keeping Them in the Fold: Creating Collaborative External RelationshipsLocation: On-Demand
Presenter: – Novartis Institutes for Biomedical Research Inc.
Presenter: – Novartis Pharma AG
Presenter: – Scientist.com
Pharma/Biotech PerspectivesACU Program Management
-
1:30 PM – 2:30 PM ET
E18 - Researcher RehabLocation: On-Demand
Presenter: – Medical University of South Carolina
Presenter: – The University of Texas at Austin
Education, Qualifications, and TrainingQA/QI and Postapproval MonitoringShared Oversight Challenges
-
1:30 PM – 2:30 PM ET
E19 - Incentives and Strategies to Encourage Robust Committee Member EngagementLocation: On-Demand
Presenter: – Novartis Institutes for Biomedical Research Inc.
Presenter: – University of Massachusetts Amherst
Presenter: – San Jose State University
Shared Oversight Challenges
-
1:30 PM – 2:30 PM ET
E20 - Investing in People: Facilitating Engagement and Professional DevelopmentLocation: On-Demand
Presenter: – University of Colorado Anschutz Medical Campus
Presenter: – Capella University
Leadership Skills DevelopmentResearch Oversight Leaders and Institutional Officials
-
2:30 PM – 3:00 PM ET
Break
-
2:30 PM – 3:00 PM ET
Break
-
2:30 PM – 5:00 PM ET
Office Hours: Federal Agency/Accrediting Body/CIP and CPIA Office
-
2:30 PM – 3:30 PM ET
FDA Office HoursLocation: Livestreamed
-
2:30 PM – 3:30 PM ET
OHRP Office HoursLocation: Livestreamed
-
2:30 PM – 5:00 PM ET
AAHRPP, Inc. Office HoursLocation: Livestreamed
-
2:30 PM – 5:00 PM ET
Department of Navy Office HoursLocation: Livestreamed
-
2:30 PM – 5:00 PM ET
NIH OLAW Office HoursLocation: Livestreamed
-
3:00 PM – 4:00 PM ET
CIP Office HoursLocation: Livestreamed
-
3:00 PM – 4:00 PM ET
CPIA Office HoursLocation: Livestreamed
-
4:00 PM – 5:00 PM ET
Department of Energy Office HoursLocation: Livestreamed
-
3:00 PM – 4:00 PM ET
Concurrent Networking Sessions
-
3:00 PM – 4:00 PM ET
"A Little Help Here?" Finding Support and Community for Compliance Committees at Small Research ProgramsLocation: Livestreamed
Speaker: – Seattle University
Speaker: – Trillium Health Partners
Speaker: – San Jose State University
-
3:00 PM – 4:00 PM ET
Everyone Is Doing it, But Are We Doing it Well? Evaluating Your Role as a Single IRB (sIRB) Location: Livestreamed
Speaker: – Johns Hopkins University school of Medicine
Speaker: – NYU Langone Health
Speaker: – Washington University in St. Louis
Flexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
-
3:00 PM – 4:00 PM ET
IRB Closet Clean-Out: Keep, Toss, TBD (to be determined)Location: Livestreamed
Speaker: – Weill Cornell Medicine
Speaker: – The Pennsylvania State University
Speaker: – Cameo Consulting Group, LLC
Flexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
-
3:00 PM – 4:00 PM ET
Leadership in Action: Real-life Scenarios and SolutionsLocation: Livestreamed
Speaker: – AAALAC International
Speaker: – Weill Cornell Medicine
Speaker: – University of California, San Francisco
Speaker: – Oregon Health & Science University
Leadership Skills Development
-
3:00 PM – 4:00 PM ET
PRIMR22 Poster Presentation Program: Outstanding Work in Animal Care and UseLocation: Livestreamed
Moderator: – Vanderbilt University Medical Center
Speaker: – Cedars-Sinai Medical Center
Speaker: – Mayo Clinic
IACUC Administration/Management and ProcessACU Program ManagementQA/QI and Postapproval Monitoring
-
3:00 PM – 4:00 PM ET
What's Your 4th R?Location: Livestreamed
Speaker: – Merck KGaA, Darmstadt, Germany
Speaker: – GSK
Speaker: – Oregon National Primate Research Center, Oregon Health & Science University
Animal Well-Being and the 3Rs
- Thursday, December 15, 2022
-
10:00 AM – 11:30 AM ET
Concurrent Plenary Sessions
-
10:00 AM – 11:30 AM ET
PRIM&R Service Award Presentation, and Plenary IX: Decentralized Clinical Trials (DCTs): Considerations of and for IRB reviewLocation: Livestreamed
Moderator: – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
Panelist: – Medable, Inc.
Panelist: – Advarra, Inc.
Panelist: – Office of Human Subjects Research Johns Hopkins University School of Medicine
Emerging Challenges and Breaking IssuesFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and ProcessPharma/Biotech Perspectives
-
10:00 AM – 11:30 AM ET
PRIM&R Service Award Presentation, and Plenary X: Exploring the Future of The Guide for the Care and Use of Laboratory AnimalsLocation: Livestreamed
Moderator: – University of Arkansas at Little Rock, Biology
Panelist: – University of Mississippi Medical Center
Panelist: – Intuitive
Panelist: – Strategic Initiatives on Animal Research; Director, Institute for Laboratory Animal Research (ILAR), Director, Roundtable on Science and Welfare of Laboratory Animal Use, Director, World Organisation on Animal Health (formerly called OIE)
-
10:00 AM – 11:30 AM ET
PRIM&R Service Award Presentation, and Plenary XI: Entrepreneurialism and Research Institutions: Considerations for Successful PartnershipsLocation: Livestreamed
Moderator: – Maimonides Medical Center
Panelist: – University of California, Berkeley
Panelist: – University of Texas Southwestern Medical Center At Dallas
Panelist: – University of Pennsylvania
Emerging Challenges and Breaking IssuesResearch Oversight Leaders and Institutional OfficialsLegal Considerations in Research OversightShared Oversight Challenges
-
10:00 AM – 11:30 AM ET
PRIM&R Service Award Presentation, and Plenary XII: Finding Value and Purpose: Why We Do What We DoLocation: Livestreamed
Moderator: – Northwell Health
Panelist: – University of Colorado Anschutz Medical Campus
Panelist: – University of Arizona
Panelist: – Indiana University School of Medicine
Research Oversight Leaders and Institutional Officials
-
11:30 AM – 11:45 AM ET
Break
-
11:30 AM – 11:45 AM ET
Break
-
11:45 AM – 12:45 PM ET
Concurrent Breakout Sessions Series F
-
11:45 AM – 12:45 PM ET
F01 - A Dialogue With NIHLocation: Livestreamed
-
11:45 AM – 12:45 PM ET
F02 - Developing a System of IRB Precedent: Value, Approaches, and ChallengesLocation: Livestreamed
Speaker: – Perelman School of Medicine, University of Pennsylvania
Speaker: – Dana-Farber Cancer Institute
Speaker: – Freeport Research Systems
IRB ChairsFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
-
11:45 AM – 12:45 PM ET
F03 - Compensation: How Much Inducement Is Due?Location: Livestreamed
Speaker: – School of Medicine, University of California, Riverside
Speaker: – Emory University School of Medicine, Division of Cardiology
Speaker: – Perelman School of Medicine, University of Pennsylvania
Resource Person: – Office for Human Research Protections
Pharma/Biotech PerspectivesPopulations Requiring Additional ProtectionsAdvancing Equity and Justice in Research
-
11:45 AM – 12:45 PM ET
F04 - Risky Business: The Basics of Evaluating Research RiskLocation: Livestreamed
Speaker: – National Institutes of Health
Speaker: – DHHS Office for Human Research Protections
Speaker: – Virginia Commonwealth University
-
11:45 AM – 12:45 PM ET
F05 - Big Data and Novel Technology: Considerations for Privacy and Participant RightsLocation: Livestreamed
Speaker: – Encoura
Speaker: – Children's Hospital of Philadelphia
Research Involving Data and BiospecimensEmerging Challenges and Breaking IssuesResearch Conducted in the Digital World
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11:45 AM – 12:45 PM ET
F06 - Communicating With and Educating the Public About IACUCs and Their Efforts to Ensure Animal Welfare in Research Settings Location: Livestreamed
Speaker: – Oregon National Primate Research Center, OHSU
Speaker: – Americans for Medical Progress
Speaker: – University of Washington
Speaker: – AALAS
Communication With the PublicEmerging Challenges and Breaking Issues
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11:45 AM – 12:45 PM ET
F07 - Flexibility and Innovation in Postapproval Monitoring (PAM): Many Parts, What Counts? Location: Livestreamed
Speaker: – University of Michigan
Speaker: – GSK
Speaker: – Brown University
Resource Person: – NIH, OLAW
Flexibility and Innovation in Research Oversight ProcessesACU Program ManagementQA/QI and Postapproval Monitoring
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11:45 AM – 12:45 PM ET
F08 - Flexibility and Innovation in Protocol Review: What's the Right Process for Your Institution?Location: Livestreamed
Speaker: – Northwell Health - Feinstein Institutes for Medical Research
Speaker: – UT Southwestern Medical Center
Speaker: – UC Berkeley
Resource Person: – OLAW/NIH
Flexibility and Innovation in Research Oversight ProcessesIACUC Protocol Review
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11:45 AM – 12:45 PM ET
F09 - The Lifespan of a Research Protocol: The Journey From Research Using Animals to Research Involving HumansLocation: Livestreamed
Speaker: – Advarra
Speaker: – Presbyterian Healthcare Services
Speaker: – University of Minnesota
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11:45 AM – 12:45 PM ET
F10 - To Share or Not to Share? Academic Freedom, Fundamental Research Exemptions, Open Data, and Foreign InfluenceLocation: Livestreamed
Speaker: – Association of American Medical Colleges
Speaker: – Harvard University
Research Oversight Leaders and Institutional OfficialsEmerging Challenges and Breaking IssuesLegal Considerations in Research Oversight
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11:45 AM – 12:45 PM ET
F11 - A Dialogue With the Department of Energy (DOE): Addressing Implicit Bias in Human Subject Research—A Roundtable Style Discussion With Members of the DOE Implicit Bias Task ForceLocation: On-Demand
Presenter: – U.S. Department of Energy
Presenter: – Department of Energy/National Nuclear Security Administration
Presenter: – PNNL & Central DOE
Presenter: – Department of Energy
Presenter: – Oak Ridge Associated Universities
Presenter: – United States Department of Energy
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11:45 AM – 12:45 PM ET
F12 - The Return of Genetic InformationLocation: On-Demand
Presenter: – WCG
Presenter:
Presenter:
Pharma/Biotech PerspectivesResearch Involving Data and Biospecimens
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11:45 AM – 12:45 PM ET
F13 - Creating a Quality HRPP Reliance ProgramLocation: On-Demand
Presenter: – Augusta University
Presenter: – The University of Texas MD Anderson Cancer Center
Presenter: – Johns Hopkins University School of Medicine
Small Research ProgramsHRPP/IRB Administration/Management and ProcessFlexibility and Innovation in Research Oversight Processes
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11:45 AM – 12:45 PM ET
F14 - Reviewing Exercise Science Research at Primarily SBER InstitutionsLocation: On-Demand
Presenter: – Montclair State University
Presenter: – Salem State University
Social, Behavioral, and Educational Research
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11:45 AM – 12:45 PM ET
F15 - Research with Minors: Balancing Autonomy and ProtectionLocation: On-Demand
Presenter: – University of South Florida
Social, Behavioral, and Educational ResearchPopulations Requiring Additional Protections
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11:45 AM – 12:45 PM ET
F16 - Zebrafish WelfareLocation: On-Demand
Presenter: – Charles River Laboratories - Senneville
Presenter: – University of Gothenburg
Animal Well-Being and the 3RsOversight of Non-Typical Species and Situations
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11:45 AM – 12:45 PM ET
F17 - Postapproval Monitoring (PAM) in the Context of Small Research ProgramsLocation: On-Demand
Resource Person: – NIH OLAW
Presenter: – Allen Institute
Presenter: – Lawrence Berkeley National Laboratory
Small Research ProgramsQA/QI and Postapproval Monitoring
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11:45 AM – 12:45 PM ET
F18 - Situational Vulnerability and Power Dynamics in the Research SphereLocation: On-Demand
Presenter: – Office for Human Research Protections (OHRP)
Presenter: – Allen Institute
Presenter: – UC Berkeley
Advancing Equity and Justice in ResearchShared Oversight Challenges
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11:45 AM – 12:45 PM ET
F19 - Planning a Quality Assessment for Your Oversight Committee? Let's Create an Intentional Lens to Justice and Equity for Student and Faculty ResearchersLocation: On-Demand
Presenter: – Rutgers University
Presenter: – Montclair State University
Presenter: – Self
Advancing Equity and Justice in ResearchShared Oversight Challenges
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12:45 PM – 1:15 PM ET
CIP Office Hours
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12:45 PM – 1:15 PM ET
CIP Office HoursLocation: Livestreamed
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12:45 PM – 1:15 PM ET
CPIA Office Hours
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12:45 PM – 1:15 PM ET
CPIA Office HoursLocation: Livestreamed
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12:45 PM – 1:30 PM ET
Mid-Day Break
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12:45 PM – 1:30 PM ET
Mid-Day Break
-
12:45 PM – 1:30 PM ET
Sponsored Presentation from Insight: Turbocharge Your IACUC Research Administration
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12:45 PM – 1:30 PM ET
Sponsored Presentation from Insight: Turbocharge Your IACUC Research Administration Location: Livestreamed
Presenter: – Massachusetts General Research Institute
Presenter: – Brigham and Women's Hospital
ACU Program ManagementIACUC Administration/Management and ProcessIACUC Protocol Review
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1:30 PM – 2:45 PM ET
Concurrent Plenary Sessions
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1:30 PM – 2:45 PM ET
Plenary XIII: What Can We Learn From Participant Experiences of Informed Consent Processes?Location: Livestreamed
Moderator: – Perelman School of Medicine, University of Pennsylvania
Panelist: – Saint Louis University
Panelist: – Seattle Children's Research Institute
Panelist: – Johns Hopkins University
Informed ConsentEmerging Challenges and Breaking IssuesFlexibility and Innovation in Research Oversight ProcessesIRB Basics
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1:30 PM – 2:45 PM ET
Plenary XIV: Welcome to Compliance Unit Standard Procedure (CUSP): An Opportunity to Address Administrative Burden at the Institutional Level and BeyondLocation: Livestreamed
Moderator: – Vanderbilt University Medical Center
Panelist: – University of Washington
Panelist: – Indiana University
Panelist: – Research IT Consulting
Panelist: – University of Washington
IACUC Administration/Management and ProcessIACUC Protocol ReviewACU Program ManagementFlexibility and Innovation in Research Oversight Processes
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1:30 PM – 2:45 PM ET
Plenary XV: Public Trust Is Key to the Future of Biomedical ResearchLocation: Livestreamed
Moderator: – Northwest Association for Biomedical Research
Panelist: – Yale University
Panelist: – Americans for Medical Progress
Panelist: – Oregon National Primate Research Center
Communication With the PublicShared Oversight Challenges
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1:30 PM – 2:45 PM ET
Plenary XVI: Institutional Official as JEDI MasterLocation: Livestreamed
Moderator: – Boston Children's Hospital
Panelist: – Massachusetts General Hospital
Panelist: – Rutgers University
Panelist: – National Center For Bioethics In Research And Health Care, Tuskegee University
Advancing Equity and Justice in ResearchResearch Oversight Leaders and Institutional Officials
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2:30 PM – 5:00 PM ET
Office Hours: Federal Agency/Accrediting Body/CIP and CPIA Office
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2:30 PM – 3:30 PM ET
FDA Office HoursLocation: Livestreamed
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2:30 PM – 3:30 PM ET
OHRP Office HoursLocation: Livestreamed
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2:30 PM – 5:00 PM ET
AAHRPP, Inc. Office HoursLocation: Livestreamed
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2:30 PM – 5:00 PM ET
Department of Navy Office HoursLocation: Livestreamed
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2:30 PM – 5:00 PM ET
NIH OLAW Office HoursLocation: Livestreamed
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3:00 PM – 4:00 PM ET
CPIA Office HoursLocation: Livestreamed
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2:45 PM – 3:00 PM ET
Break
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2:45 PM – 3:00 PM ET
Break
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3:00 PM – 4:00 PM ET
Concurrent Networking Sessions
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3:00 PM – 4:00 PM ET
BYO (Building Your Own) Circle of Influence and Professional Network to Empower Yourself and Others in the HRPP and IACUC WorldLocation: Livestreamed
Speaker: – Weill Cornell Medicine
Speaker: – SUNY Downstate Health Sciences University
Speaker: – Eli Lilly and Company
Leadership Skills Development
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3:00 PM – 4:00 PM ET
Institute for Laboratory Animal Research (ILAR) Wildlife Workshop: Highlights and ReviewLocation: Livestreamed
Speaker: – KBR
Speaker: – University of Massachusetts Lowell
Speaker: – University of Arkansas at Little Rock, Biology
Oversight of Non-Typical Species and Situations
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3:00 PM – 4:00 PM ET
IRB Chairs Forum: A Structured Networking EventLocation: Livestreamed
Speaker: – Beth Israel Deaconess Medical Center
Speaker: – University of Southern California
Speaker: – Great Bay Community College
Speaker: – Montclair State University
Speaker: – Human Research Affairs, Mass General Brigham; Harvard Medical School
Speaker: – University of Southern California
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3:00 PM – 4:00 PM ET
Mad Science on Trial: The Real Ethical Problems With Fictional ScientistsLocation: Livestreamed
Speaker: – University of Utah
Speaker: – University of Utah
Speaker: – OHRP
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3:00 PM – 4:00 PM ET
The Certified IRB Professional (CIP®) Credential PresentationLocation: Livestreamed
Speaker: – University of Southern Maine
Speaker: – Children's Wisconsin
HRPP/IRB Administration/Management and Process
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