Browse by HSR Content
Thank you for attending PRIMR24! You have 90 days to access the session recordings and evaluations, which will be unavailable after February 28, 2025. PRIM&R members will have free access to the recordings starting November 17, 2025, one year after the conference. Contact registration@primr.org with questions.
To download your Certificate of Attendance, log in to your conference profile, click on the evaluation tile, and complete the required evaluations.
- Home
- Browse by HSR Content
- Sunday, November 17, 2024
-
8:30 AM – 4:15 PM PT
Full Day Workshops
-
8:30 AM – 4:15 PM PT
WS1 - Ethical and Regulatory Oversight of National and Transnational Social Science ResearchLocation: Room 320-321
Workshop Speaker: – Florida State University
Workshop Speaker: – Florida State University
-
8:30 AM – 11:45 AM PT
AM Half-Day Workshops
-
8:30 AM – 11:45 AM PT
WS4 - Immersive Technologies and Human Subjects ProtectionsLocation: Room 333-334
Workshop Speaker: – Santa Clara University
Workshop Speaker: – XRSI - X Reality Safety Intelligence
-
1:00 PM – 4:15 PM PT
PM Half-Day Workshops
-
1:00 PM – 4:15 PM PT
WS7 - Building a Quality Assurance (QA) Program for ComplianceLocation: Room 333-334
Workshop Speaker: – Yale University
Workshop Speaker: – Ann & Robert H. Lurie Children’s Hospital of Chicago
Workshop Speaker: – Tufts University SBER IRB
- Monday, November 18, 2024
-
10:30 AM – 11:45 AM PT
PRIMR24 Plenary/Breakout/Networking A Series
-
10:30 AM – 11:45 AM PT
A01 - 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
-
10:30 AM – 11:45 AM PT
A02 - How Do You Actually Review a Protocol Involving Artificial Intelligence (AI)?Location: Ballroom 1
Speaker: – University of Florida
Speaker: – Office of Human Subjects Research Johns Hopkins University School of Medicine
Speaker: – Mass General Brigham
Speaker: – Stanford University
Emerging Research Challenges and Breaking IssuesIRB ReviewResearch Involving Data and New Technologies
-
10:30 AM – 11:45 AM PT
A03 - Why “It Depends”: General Considerations for IRBs and HRPPs When Reviewing Research Using FDA-Regulated 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
-
10:30 AM – 11:45 AM PT
A04 - 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
-
10:30 AM – 11:45 AM PT
A05 - 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
-
10:30 AM – 11:45 AM PT
A06 - Great “Private” Expectations: What Is Publicly Available Private Information?Location: Room 345-346
Speaker: – UC San Diego
Speaker: – Research Compliance Services, University of Nebraska - Lincoln
Speaker: – Human Research Protection Office, University of Massachusetts Amherst
Social, Behavioral, and Educational ResearchResearch Involving Data and New TechnologiesIRB Review
-
10:30 AM – 11:45 AM PT
A07 - A Dialogue With the Office of Research Integrity (ORI)Location: Room 336
Speaker: – Office of Assistant Secretary for Health
-
10:30 AM – 11:45 AM PT
A08 - What is the Role of Regret and Apology in Protecting the Human Participants of Clinical Trials?Location: Room 335
Speaker: – PIRE-Southwest
Speaker: – PRIM&R
Speaker: – Northwest Indian College
HRPP/IRB Management and AdministrationPharma/Biotech PerspectivesIRB Review
-
10:30 AM – 11:45 AM PT
A09 - Shift Your Focus: Transforming an HRPP Into a Collegial and Efficient Partner of the Research 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
-
10:30 AM – 11:45 AM PT
A10 - 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
-
12:30 PM – 12:55 PM PT
PRIMR24 Poster Presentation—IRB Pre-Review Tools Reduce Expedited Initial Application Turn-Around Times
-
12:30 PM – 12:55 PM PT
Industry Expert Theater: PRIMR24 Poster Presentation—IRB Pre-Review Tools Reduce Expedited Initial Application Turn-Around TimesLocation: Flex Hall BC
Moderator: – Seattle Children's Research Institute
Author: – University of Washington
-
12:30 PM – 1:30 PM PT
PRIMR24 Networking Series
-
12:30 PM – 1:30 PM PT
N02 - REACH, the Research Ethics Action Collaborative for HRPPs, for JusticeLocation: Signature Room
Speaker: – PRIM&R
Speaker: – Mass General Brigham Incorporated
Speaker: – Multi-Regional Clinical Trials Center
Advancing Equity and JusticeEmerging Research Challenges and Breaking Issues
-
12:30 PM – 1:30 PM PT
N05 - Everything You Wanted to Know About the CIP CredentialLocation: Room 332
Speaker: – Kelley O'Donoghue Consulting
HRPP/IRB Management and Administration
-
12:45 PM – 1:30 PM PT
Mastering the FDA’s Impending sIRB Mandate: Essential Insights & Institutional Success Stories
-
12:45 PM – 1:30 PM PT
Sponsored Session by WCG: Mastering the FDA's Impending sIRB Mandate: Essential Insights & Institutional Success StoriesLocation: Room 323-324
Speaker: – WCG
Speaker: – WCG
Speaker: – University of Cincinnati College of Medicine
Speaker: – Baptist Health South Florida
Speaker: – University of Florida
-
1:00 PM – 1:25 PM PT
PRIMR24 Poster Presentation—The ENVISION study: Creating a values-oriented platform for informed consent
-
1:00 PM – 1:25 PM PT
Industry Expert Theater: PRIMR24 Poster Presentation—The ENVISION study: Creating a values-oriented platform for informed consentLocation: Flex Hall BC
Poster Session Moderator: – Rutgers University
Speaker: – Seattle Children's Research Institute
-
1:45 PM – 3:00 PM PT
PRIMR24 Plenary/Breakout/Networking B Series
-
1:45 PM – 3:00 PM PT
B01 - 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
-
1:45 PM – 3:00 PM PT
B02 - Cybersecurity and Research Integrity: Can We Be Trusted to Keep Research Information Safe?Location: Ballroom 1
Speaker: – Mayo Clinic
Speaker: – Icahn School of Medicine at Mount Sinai
Speaker: – Mount Sinai Health System
Emerging Research Challenges and Breaking IssuesResearch Involving Data and New Technologies
-
1:45 PM – 3:00 PM PT
B03 - Assessing Capacity to Consent for Research Participation: When and How Do You Actually Do It?Location: Ballroom 3
Speaker: – Mass General Brigham
Speaker: – Multi-Regional Clinical Trials Center
Populations Requiring Additional ProtectionsInformed ConsentAdvancing Equity and JusticeIRB ReviewSocial, Behavioral, and Educational Research
-
1:45 PM – 3:00 PM PT
B04 - Ethical Implications and Practical Application of Broad 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
-
1:45 PM – 3:00 PM PT
B05 - A Dialogue with the Department of Energy (DOE)Location: Room 322
Speaker: – United States Department of Energy
Speaker: – Department of Energy/National Nuclear Security Administration
-
1:45 PM – 3:00 PM PT
B06 - 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
-
1:45 PM – 3:00 PM PT
B08 - 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
-
1:45 PM – 3:00 PM PT
B09 - When SBER Meets the Definition of a Clinical Trial, Then What?Location: Room 347-348
Speaker: – Florida State University
Speaker: – Weill Cornell Medicine
Social, Behavioral, and Educational ResearchIRB Review
-
1:45 PM – 3:00 PM PT
B10 - Advancing Justice, Equity, and Trustworthiness Through Community Engaged Research (CEnR): What HRPPs/IRBs Need to 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
-
3:30 PM – 4:45 PM PT
PRIMR24 Plenary/Breakout/Networking C Series
-
3:30 PM – 4:45 PM PT
C01 - 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
-
3:30 PM – 4:45 PM PT
C02 - A Dialogue with SACHRPLocation: Room 323-324
Speaker: – Stanford University
Speaker: – OHRP
Speaker: – WCG
-
3:30 PM – 4:45 PM PT
C03 - 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
-
3:30 PM – 4:45 PM PT
C04 - 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
-
3:30 PM – 4:45 PM PT
C05 - 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
-
3:30 PM – 4:45 PM PT
C06 - Medical Devices: A Beginner's Guide to Understanding the Basics of FDA Regulation and How to Apply it to a 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
-
3:30 PM – 4:45 PM PT
C07 - This Coffee Is HOT! Burning Topics in the SBER Space (Needle)Location: Room 443
Speaker: – Tufts University
Speaker: – Western Washington University
Social, Behavioral, and Educational ResearchHRPP/IRB Management and AdministrationIRB Review
-
3:30 PM – 4:45 PM PT
C08 - Help! I Don't Understand: Making the Consent Process and Form Meaningful Through Health Literacy and Adult Learning 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
-
3:30 PM – 4:45 PM PT
C09 - From Researcher to Sponsor Investigator: How to Work With Your Broader HRPP to Develop and Deploy Safe, Effective, and Ethical Artificial Intelligence (AI)Location: Room 444
Speaker: – Mayo Clinic - Center for Digital Health
Speaker: – Mayo Clinic
Speaker: – Microsoft Research
HRPP/IRB Management and AdministrationEmerging Research Challenges and Breaking IssuesResearch Involving Data and New Technologies
-
3:30 PM – 4:45 PM PT
C10 - Updates to the Declaration of HelsinkiLocation: Room 336
Speaker: – National Institutes of Health
Speaker: – Office for Human Research Protections
Speaker: – American Medical Association
Speaker: – FDA
Pharma/Biotech Perspectives
- Tuesday, November 19, 2024
-
7:15 AM – 8:15 AM PT
PRIMR24 Networking Series
-
7:15 AM – 8:15 AM PT
N07 - SBER Network Discussion SessionLocation: Room 320-321
Speaker: – Weill Cornell Medicine
Speaker: – Brown University
Social, Behavioral, and Educational Research
-
7:15 AM – 8:15 AM PT
N08 - IRB Chairs Community‐Building Networking ForumLocation: Room 322
Speaker: – University of Southern California
Speaker: – Utah Tech University
-
7:30 AM – 8:15 AM PT
Sponsored Presentation from Advarra: FDA sIRB Mandate – Deja Vu All Over Again?
-
7:30 AM – 8:15 AM PT
Sponsored Presentation from Advarra: FDA sIRB Mandate – Deja Vu All Over Again?Location: Flex Hall BC
Speaker: – Advarra, Inc.
Speaker: – Advarra
-
10:30 AM – 11:45 AM PT
PRIMR24 Plenary/Breakout/Networking D Series
-
10:30 AM – 11:45 AM PT
D01 - 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
-
10:30 AM – 11:45 AM PT
D02 - 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
-
10:30 AM – 11:45 AM PT
D03 - An Update from AAHRPP, Inc.Location: Room 332
Speaker: – AAHRPP, Inc.
Speaker: – Association for the Accreditation of Human Research Protection Programs, Inc.
-
10:30 AM – 11:45 AM PT
D04 - 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
-
10:30 AM – 11:45 AM PT
D05 - Are You Leaving Money on the Table? Ensuring IRB Fees Are Accounted for in a Single IRB (sIRB) World Location: Room 335
Speaker: – Northwestern University
Speaker: – Rutgers University
Speaker: – Stanford University
Single IRBFDA Regulated Research
-
10:30 AM – 11:45 AM PT
D06 - The Limits of Permissible Research Without ConsentLocation: Ballroom 1
Speaker: – Advarra
Speaker: – Department of Medicine, University of California, San Francisco
Speaker: – Stanford University
Informed ConsentIRB Review
-
10:30 AM – 11:45 AM PT
D07 - Reviewing Incidents of Non-Compliance: Strategies for IRB Chairs and 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
-
10:30 AM – 11:45 AM PT
D08 - 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
-
10:30 AM – 11:45 AM PT
D09 - 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
-
10:30 AM – 11:45 AM PT
D10 - 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
-
12:30 PM – 12:55 PM PT
PRIMR24 Poster Presentation—Community Engagement Practices of Institutional Review Boards
-
12:30 PM – 12:55 PM PT
Room 322: PRIMR24 Poster Presentation—Community Engagement Practices of Institutional Review BoardsLocation: Room 322
Poster Session Moderator: – Rutgers University
Author: – Drexel University
Author: – Drexel University
-
12:30 PM – 12:55 PM PT
PRIMR24 Poster Presentation—Shedding Light on the Gray Area: Process Improvement in Exempt-Level Reviews
-
12:30 PM – 12:55 PM PT
Room 320-321: PRIMR24 Poster Presentation—Shedding Light on the Gray Area: Process Improvement in Exempt-Level ReviewsLocation: Room 320-321
Poster Session Moderator: – Teachers College, Columbia University & University of New England
Author: – Virginia Tech
Author: – Virginia Tech
-
12:30 PM – 1:30 PM PT
PRIMR24 Networking Series
-
12:30 PM – 1:30 PM PT
N10 - An Update from the Consortium to Advance Effective Research Ethics Oversight (AEREO): Progress in Defining and Measuring HRPP and IRB Quality and EffectivenessLocation: Signature Room
Speaker: – Perelman School of Medicine, University of Pennsylvania
Speaker: – University of Texas Medical Branch
Speaker: – NIH
HRPP/IRB Management and AdministrationIRB Review
-
12:45 PM – 1:30 PM PT
Leveraging Technology to Maintain Compliance and Efficiently Manage Your Research Compliance Programs
-
12:45 PM – 1:30 PM PT
Sponsored Presentation from Huron: Leveraging Technology to Maintain Compliance and Efficiently Manage Your Research Compliance ProgramsLocation: Flex Hall BC
Speaker: – Huron
Speaker: – Huron Consulting Group
Speaker: – Huron Consulting Group
-
1:00 PM – 1:25 PM PT
PRIMR24 Poster Presentation—Characterization of Users of an Online Human Research Protections Training Program for Community Research Partners
-
1:00 PM – 1:25 PM PT
Room 322: PRIMR24 Poster Presentation—Characterization of Users of an Online Human Research Protections Training Program for Community Research PartnersLocation: Room 322
Moderator: – Seattle Children's Research Institute
Author: – Loyola University Chicago Stritch School of Medicine
-
1:45 PM – 3:00 PM PT
PRIMR24 Plenary/Breakout/Networking E Series
-
1:45 PM – 3:00 PM PT
E01 - 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
-
1:45 PM – 3:00 PM PT
E02 - 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
-
1:45 PM – 3:00 PM PT
E03 - 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
-
1:45 PM – 3:00 PM PT
E04 - 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
-
1:45 PM – 3:00 PM PT
E05 - A Dialogue with the Department of Veteran Affairs (VA)Location: Room 336
Speaker: – Veterans Health Administration, U.S. Department of Veterans Affairs
Speaker: – Department of Veterans Affairs
-
1:45 PM – 3:00 PM PT
E06 - 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
-
1:45 PM – 3:00 PM PT
E07 - 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
-
1:45 PM – 3:00 PM PT
E08 - 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
-
1:45 PM – 3:00 PM PT
E09 - 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
-
1:45 PM – 3:00 PM PT
E10 - 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
-
3:30 PM – 4:45 PM PT
PRIMR24 Plenary/Breakout/Networking F Series
-
3:30 PM – 4:45 PM PT
F01 - PLENARY: Risk Associated With Human Subjects Research: Whom Are We Obligated to Protect?Location: Signature Room
Moderator: – University of California
Panelist: – Boston Children's Hospital
Panelist: – Department of Medicine, University of California, San Francisco
Panelist: – Ropes & Gray
Emerging Research Challenges and Breaking IssuesIRB ReviewHRPP/IRB Management and Administration
-
3:30 PM – 4:45 PM PT
F02 - PLENARY: Artificial Intelligence (AI) Days of Future's Past: Tomorrow's Research 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
-
3:30 PM – 4:45 PM PT
F03 - 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
-
3:30 PM – 4:45 PM PT
F04 - 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
-
3:30 PM – 4:45 PM PT
F05 - A Dialogue with the NIHLocation: Room 332
Speaker: – National Institutes of Health
-
3:30 PM – 4:45 PM PT
F06 - 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
-
3:30 PM – 4:45 PM PT
F07 - Adults with Developmental Disabilities and Research: Ethical, Legal, and Social Implications (ELSI) Solutions to Inclusion as Co-Researchers and Research 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
-
3:30 PM – 4:45 PM PT
F08 - Navigating Ethical and Institutional Considerations for Data and Biospecimen Sharing in the Era of Single (sIRB)Location: Room 345-346
Speaker: – AAHRPP
Speaker: – Office of Human Subjects Research Johns Hopkins University School of Medicine
Single IRBResearch Involving Data and New TechnologiesIRB ReviewPharma/Biotech Perspectives
-
3:30 PM – 4:45 PM PT
F09 - I Don't Remember This Being in the Training Manual: An Exploration of Challenging IRB 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
-
3:30 PM – 4:45 PM PT
F10 - 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
-
3:30 PM – 4:45 PM PT
F16 - 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
-
5:00 PM – 6:00 PM PT
PRIMR24 Networking Series
-
5:00 PM – 6:00 PM PT
N14 - Human Subjects Research Trivia!Location: Ballroom 2
Speaker: – University of Nevada, Las Vegas
Speaker: – Independent Professional
Speaker: – AAHRPP
Speaker: – The Ohio State University
HRPP/IRB Management and AdministrationIRB ReviewSocial, Behavioral, and Educational ResearchIRB Fundamentals
- Wednesday, November 20, 2024
-
8:45 AM – 10:00 AM PT
PRIMR24 Plenary/Breakout/Networking G Series
-
8:45 AM – 10:00 AM PT
G01 - Are the Ways We Contemplate Risk Outdated?Location: Ballroom 2
Speaker: – National Institutes of Health
Speaker: – Sage Bionetworks
Speaker: – National Human Genome Research Institute, National Institutes of Health
Emerging Research Challenges and Breaking IssuesIRB ReviewHRPP/IRB Management and Administration
-
8:45 AM – 10:00 AM PT
G02 - Change the Game By Working Together: Tips for Increasing HRPP/IRB and Researcher 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
-
8:45 AM – 10:00 AM PT
G03 - 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
-
8:45 AM – 10:00 AM PT
G04 - Expectations for the Use of Electronic Systems to Conduct Clinical Trial Activities and Considerations for IRBs: Perspectives From Regulators and Institutional Review 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
-
8:45 AM – 10:00 AM PT
G06 - 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
-
8:45 AM – 10:00 AM PT
G07 - Exploring the Enigma of the Expedited (Category 7)Location: Ballroom 3
Speaker: – Indiana University
Speaker: – University of California San Francisco
Social, Behavioral, and Educational ResearchIRB Review
-
8:45 AM – 10:00 AM PT
G08 - Let It Go! Strategies to Prevent Over-Regulation During Local Context ReviewLocation: Signature Room
Speaker: – The Pennsylvania State University
Speaker: – University of Minnesota
Speaker: – Research Compliance Services, University of Nebraska - Lincoln
-
8:45 AM – 10:00 AM PT
G09 - 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
-
8:45 AM – 10:00 AM PT
G15 - Building Bridges: Towards an International Framework for Specimen Sharing (Part II)Location: Room 335
Speaker: – BIopreservation & Biobanking
Speaker: – Takeda
Speaker: – Center for Integrative Medical Sciences, RIKEN
Speaker: – ARC-Net and Department of Engineering for Innovative Medicine, University of Verona, Italy
Pharma/Biotech PerspectivesResearch Involving Data and New TechnologiesIRB Review
-
10:30 AM – 11:45 AM PT
PRIMR24 Plenary/Breakout/Networking H Series
-
10:30 AM – 11:45 AM PT
H01 - PLENARY: Regulatory and IRB Challenges in Reviewing Decentralized Clinical Trials (DCTs)Location: Room 323-324
Moderator: – Department of Veterans Affairs
Panelist: – DHHS Office for Human Research Protections
Panelist: – Decentralized Trials and Research Alliance
Panelist: – NCATS/NIH
FDA Regulated ResearchHRPP/IRB Management and AdministrationIRB Review
-
10:30 AM – 11:45 AM PT
H02 - Group Harm: A Toolkit for Researchers, IRBs, and Data Access 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
-
10:30 AM – 11:45 AM PT
H03 - 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
-
10:30 AM – 11:45 AM PT
H04 - 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
-
10:30 AM – 11:45 AM PT
H05 - 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
-
10:30 AM – 11:45 AM PT
H06 - What Are You Going To Do With My Specimens and Data? When Research Specimens and Data are Used for Commercial 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
-
10:30 AM – 11:45 AM PT
H07 - PLENARY: Protecting Third Parties in Research: Whose Job Is it Anyway?Location: Room 347-348
Moderator: – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
Speaker: – Virginia Tech
Speaker: – Sabai - www.sabaiglobal.com
Shared Research Oversight Challenges
-
10:30 AM – 11:45 AM PT
H08 - A Dialogue With the Environmental Protection Agency (EPA)Location: Room 331
Speaker: – U.S. EPA
Speaker: – Oak Ridge Associated Universities
Speaker: – US EPA
-
10:30 AM – 11:45 AM PT
H09 - 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
