Browse by HSR Content
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Sunday, Dec 3rd
8:30 AM – 11:45 AM ET[IN-PERSON] Half Day Workshop: Mastering FDA Regulations: Strategies for Review and Oversight of Complex Research ScenariosLocation: Room 204 AB
Workshop Speaker: – University of Kentuckky
Workshop Speaker: – Advarra
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Sunday, Dec 3rd
8:30 AM – 11:45 AM ET[IN-PERSON] Half Day Workshop: Overseeing Decentralized Clinical Trials (DCTs): Navigating Ethical and Regulatory Challenges With Single IRBsLocation: Room 208 AB
Workshop Speaker: – DHHS, Office for Human Research Protections (OHRP)
Workshop Speaker: – Columbia University in the City of New York
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Sunday, Dec 3rd
8:30 AM – 4:15 PM ET[IN-PERSON] Full Day Workshop: Introduction to the IRB: Ethics and RegulationLocation: Room 209 BC
Workshop Speaker: – Washington University in St. Louis
Workshop Speaker: – Hartsmith Consulting, LLC
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Sunday, Dec 3rd
10:15 AM – 11:15 AM ETA03 - [IN-PERSON ONLY] Privacy on Display: What Kind of Private Information Is Open to the Public and How Does That Make Sense?Location: Room 152A
Speaker: – Northern Arizona University
Speaker: – OHRPP, University of California, Los Angeles
Speaker: – Research Compliance Services, University of Nebraska - Lincoln
Resource Person: – Office for Human Research Protections, U.S.DHHS
Informed ConsentResearch Conducted in the Digital WorldSBERLegal Considerations in Research Oversight
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Sunday, Dec 3rd
10:15 AM – 11:15 AM ETA04 - [IN-PERSON ONLY] VO2 What? Reviewing Exercise Science Research at Primarily SBER InstitutionsLocation: Room 159 AB
Speaker: – University of Northern Iowa
SBEREducation, Qualifications, and TrainingFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
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Sunday, Dec 3rd
10:15 AM – 11:15 AM ETA05 - [IN-PERSON ONLY] Leave the Cold Cuts at Home: Hot Topics in SBER Networking SessionLocation: Room 158 AB
Speaker: – The Ohio State University
Speaker: – Western Washington University
Resource Person: – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
Education, Qualifications, and TrainingLeadership Skills DevelopmentSBERHRPP/IRB Administration/Management and Process
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Sunday, Dec 3rd
10:15 AM – 11:15 AM ETA01 - [IN-PERSON/RECORDED]: When Politics Collide With ResearchLocation: Room 152B
Speaker: – University of Utah
Speaker: – The University of Texas at Austin
Speaker: – Utah State University
Advancing Equity and Justice in ResearchHRPP/IRB Administration/Management and ProcessLegal Considerations in Research OversightSBEREmerging Research Challenges and Breaking IssuesResearch Oversight Leaders and Institutional Officials
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Sunday, Dec 3rd
10:15 AM – 11:15 AM ETA02 - [IN-PERSON/RECORDED] In a Land Far, Far Away: Lessons Learned From International Field ResearchLocation: Room 154 AB
Speaker: – The University of New Mexico
Speaker: – University of New Hampshire
SBERTransnational Research CollaborationsHRPP/IRB Administration/Management and Process
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Sunday, Dec 3rd
11:30 AM – 12:30 PM ETB03 - [IN-PERSON ONLY] Compensation and SBERLocation: Room 152A
Speaker: – University of New Hampshire
Speaker: – Clemson University
Resource Person: – DHHS Office for Human Research Protections
HRPP/IRB Administration/Management and ProcessPopulations Requiring Additional ProtectionsSBER
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Sunday, Dec 3rd
11:30 AM – 12:30 PM ETB04 - [IN-PERSON ONLY] Considering Yourself: Self‐Care for HRPP/IRB Professionals and MembersLocation: Room 158 AB
Speaker: – University of Texas At Arlington
Speaker: – Lawrence Berkeley National Laboratory
Speaker: – Westat
Education, Qualifications, and TrainingLeadership Skills DevelopmentSBERHRPP/IRB Administration/Management and Process
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Sunday, Dec 3rd
11:30 AM – 12:30 PM ETB01 - [IN-PERSON/RECORDED] What Is Greater than Minimal Risk When Studying Populations Engaged in Risk‐Taking Behaviors?Location: Room 154 AB
Speaker: – University of Arizona
Speaker: – The University of Arizona
HRPP/IRB Administration/Management and ProcessSBERPopulations Requiring Additional ProtectionsFlexibility and Innovation in Research Oversight Processes
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Sunday, Dec 3rd
11:30 AM – 12:30 PM ETB02 - [IN-PERSON/RECORDED] Rethinking the Application of Exempt Category 1Location: Room 152B
Speaker: – University of California San Francisco
Speaker: – Indiana University
Resource Person: – Office for Human Research Protections (OHRP)
HRPP/IRB Administration/Management and ProcessSBERFlexibility and Innovation in Research Oversight Processes
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Sunday, Dec 3rd
11:30 AM – 12:30 PM ETB06 - [ON-DEMAND] Virtual Reality (VR) Bites: Practical Considerations for Researchers and IRBs for Research in the VR SpacePresenter: – Tufts University SBER IRB
Presenter: – University of New Hampshire
Emerging Research Challenges and Breaking IssuesResearch Conducted in the Digital WorldSBER
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Sunday, Dec 3rd
12:40 PM – 1:35 PM ET[IN-PERSON/LIVESTREAMED] Town Hall: Is it Time to Revisit the Belmont Report?Location: Room 146 ABC
Panelist: – Prevail Therapeutics
Panelist: – University of California, Los Angeles
Communication With the PublicEmerging Research Challenges and Breaking IssuesSBER
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Sunday, Dec 3rd
1:00 PM – 4:15 PM ET[IN-PERSON] Half Day Workshop: Models of Tribal Research Governance and Ethical Oversight Location: Room 206
Workshop Speaker: – Avera Research Institute
Workshop Speaker: – Cherokee Nation
Workshop Speaker: – Alaska Area IRB
Workshop Speaker: – Child Trends
Workshop Speaker: – Alaska Area IRB
Workshop Speaker: – PIRE-Southwest
Workshop Speaker:
Workshop Speaker: – NIH
Workshop Speaker: – University of North Dakota / Department of Indigenous Health
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Sunday, Dec 3rd
1:45 PM – 3:00 PM ET[IN-PERSON/LIVESTREAMED] Plenary Session: In Community‐‐Research, Partnerships, and the IRBLocation: Room 145 AB
Moderator: – UC Berkeley
Panelist: – University of Nevada, Reno
Panelist: – School of Public Health, UC Berkeley
Panelist: – MASS Design Group
Advancing Equity and Justice in ResearchCommunication With the PublicHRPP/IRB Administration/Management and ProcessSBERFlexibility and Innovation in Research Oversight Processes
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Sunday, Dec 3rd
1:45 PM – 3:00 PM ET[IN-PERSON/LIVESTREAMED] Plenary Session: Navigating Tomorrow‐‐Ethical Implications in the Age of Emerging TechnologiesLocation: Room 146 ABC
Moderator: – University of Rhode Island
Panelist: – University of Pennsylvania
Panelist: – Arizona State
Panelist: – Harvard T.H. Chan School of Public Health
Emerging Research Challenges and Breaking IssuesResearch Conducted in the Digital WorldSBERSmall Research Programs
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Sunday, Dec 3rd
3:30 PM – 4:30 PM ETC03 - [IN-PERSON ONLY] Plenary Session Follow‐Up: Continuing Discussion on "In Community‐‐Research, Partnerships, andthe IRB"Location: Room 159 AB
Moderator: – UC Berkeley
Speaker: – School of Public Health, UC Berkeley
Speaker: – MASS Design Group
Speaker: – University of Nevada, Reno
Advancing Equity and Justice in ResearchCommunication With the PublicHRPP/IRB Administration/Management and ProcessSBERFlexibility and Innovation in Research Oversight Processes
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Sunday, Dec 3rd
3:30 PM – 4:30 PM ETC04 - [IN-PERSON ONLY] Plenary Session Follow‐Up: Navigating Tomorrow‐‐Ethical Implications in the Age of EmergingTechnologiesLocation: Room 152A
Moderator: – University of Rhode Island
Speaker: – University of Pennsylvania
Speaker: – Arizona State
Speaker: – Harvard T.H. Chan School of Public Health
Emerging Research Challenges and Breaking IssuesResearch Conducted in the Digital WorldSBER
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Sunday, Dec 3rd
3:30 PM – 4:30 PM ETC05 - [IN-PERSON ONLY] Avoiding “Research Tourism”: Considerations for IRB Review of Research with Unhoused ParticipantsLocation: Room 158 AB
Speaker: – Worcester Polytechnic Institute -WPI
Speaker: – University of Colorado, Denver | Anschutz Medical Campus
Advancing Equity and Justice in ResearchEducation, Qualifications, and TrainingHRPP/IRB Administration/Management and ProcessPopulations Requiring Additional ProtectionsSBER
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Sunday, Dec 3rd
3:30 PM – 4:30 PM ETC01 - [IN-PERSON/RECORDED] Assessment of Suicidality in SBER: Ethical Considerations vs. Regulatory Requirements IRBs MustNavigate When Protecting Participants in ResearchLocation: Room 154 AB
Speaker: – University of California San Francisco
Speaker: – The Ohio State University
Education, Qualifications, and TrainingPopulations Requiring Additional ProtectionsSBERHRPP/IRB Administration/Management and Process
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Sunday, Dec 3rd
3:30 PM – 4:30 PM ETC02 - [IN-PERSON/RECORDED] Evaluating the Use of Third Party Sites in Online ResearchLocation: Room 152B
Speaker: – Indiana University
Speaker: – US DHHS
SBEREmerging Research Challenges and Breaking IssuesInformed ConsentLegal Considerations in Research OversightResearch Conducted in the Digital World
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Sunday, Dec 3rd
3:30 PM – 4:30 PM ETC06 - [ON-DEMAND] Major League Research With Minor League Players: Studies With Children Outside the Classroom SettingPresenter: – The Ohio State University
Presenter: – University of South Florida
Informed ConsentPopulations Requiring Additional ProtectionsSBERHRPP/IRB Administration/Management and Process
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Monday, Dec 4th
10:30 AM – 11:45 AM ET[IN-PERSON/LIVESTREAMED] Plenary Session: Beyond Evaluating Risk: Now We Must Navigate Sociopolitical Events in ResearchLocation: Hall E
Moderator: – Emory University School of Medicine, Division of Cardiology
Panelist: – Mayo Clinic
Panelist: – Association of American Medical Colleges
Panelist: – Johns Hopkins University
Emerging Research Challenges and Breaking IssuesPopulations Requiring Additional ProtectionsAdvancing Equity and Justice in Research
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Monday, Dec 4th
1:00 PM – 2:00 PM ETA24 - [CANCELED] A Dialogue With the Department of Education: The New World of Education ResearchLocation: Room 204AB
Speaker: – US Department of Education
A Dialogue With the FedsSBER
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Monday, Dec 4th
1:00 PM – 2:00 PM ETA06 - [IN-PERSON ONLY] Research with Minors: Balancing Autonomy and ProtectionLocation: Room 201
Speaker: – University of South Florida
Resource Person: – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
Speaker: – WCG
SBERPopulations Requiring Additional Protections
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Monday, Dec 4th
1:00 PM – 2:00 PM ETA07 - [IN-PERSON ONLY] Confessions of a Seasoned IRB Professional: What I Thought I Knew, What I Think I Know, and What I’m Afraid I’ve Been Wrong AboutLocation: Room 202 AB
Speaker: – The Pennsylvania State University
Speaker: – University of Texas, MD Anderson Cancer Center
IRB BasicsFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
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Monday, Dec 4th
1:00 PM – 2:00 PM ETA08 - [IN-PERSON ONLY] One Million or More Considerations for Regulatory Management of a Large Scale Multi‐Site Research ProgramLocation: Room 149 AB
Speaker: – Sage Bionetworks
Resource Person: – OHRP
Speaker: – NYU Langone Health
Speaker: – Indiana University School of Medicine, Indiana CTSI
Flexibility and Innovation in Research Oversight Processes
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Monday, Dec 4th
1:00 PM – 2:00 PM ETA09 - [IN-PERSON ONLY] Designing and Implementing Quality Control (QC) for your Research Compliance ProgramLocation: Room 150 AB
Speaker: – Yale University
Speaker:
Speaker: – OHRP
Small Research ProgramsFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and ProcessQA/QI and Postapproval Monitoring
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Monday, Dec 4th
1:00 PM – 2:00 PM ETA10 - [IN-PERSON ONLY] Ethical Considerations in the Management of Research Data Using Tokens SessionLocation: Room 209 BC
Speaker: – WCG
Speaker: – Department of Veterans Affairs
Research Involving Data and BiospecimensEmerging Research Challenges and Breaking Issues
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Monday, Dec 4th
1:00 PM – 2:00 PM ETA11 - [IN-PERSON ONLY] Working Hard AND Smart: How to Improve Integrity, Effectiveness, and Efficiency with a Collaborative HRPPLocation: Room 151 AB
Speaker: – AAHRPP
Speaker: – Sage Bionetworks
Speaker: – Indiana University
Flexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
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Monday, Dec 4th
1:00 PM – 2:00 PM ETA12 - [IN-PERSON ONLY] Let's Not Be So HHS‐CentricLocation: Room 152A
Speaker: – Department of Veterans Affairs
Speaker: – United States Environmental Protection Agency
Speaker: – United States Department of Energy
HRPP/IRB Administration/Management and ProcessA Dialogue With the Feds
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Monday, Dec 4th
1:00 PM – 2:00 PM ETA01 - [IN-PERSON/RECORDED] Power Dynamics: Gearing Up to Do Research‐‐Conducting Research With People, Not on ThemLocation: Ballroom C
Speaker: – Florida Gulf Coast University
Speaker: – Florida Gulf Coast University
Speaker: – Rutgers University
Co-Author: – Life Chiropractic College West
Advancing Equity and Justice in ResearchCommunication With the PublicHRPP/IRB Administration/Management and ProcessPopulations Requiring Additional ProtectionsSBER
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Monday, Dec 4th
1:00 PM – 2:00 PM ETA02 - [IN-PERSON/RECORDED] A Dialogue With SACHRPLocation: Room 144 AB
Speaker: – OHRP
Speaker: – WIRB-Copernicus Group
Speaker: – UC San Diego
Speaker: – WCG
Speaker: – Yale University
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Monday, Dec 4th
1:00 PM – 2:00 PM ETA03 - [IN-PERSON/RECORDED] The Use of Artificial Intelligence (AI) for Informed Consent Form DevelopmentLocation: Ballroom AB
Speaker: – Weill Cornell Medicine
Resource Person: – The Office for Human Research Protections (OHRP), DHHS
Speaker: – National University of Singapore
Informed ConsentEmerging Research Challenges and Breaking Issues
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Monday, Dec 4th
1:00 PM – 2:00 PM ETA04 - [IN-PERSON/RECORDED] Do You Really Want to Be the Single IRB (sIRB)? Navigating Institutional Risk Assessments When Requested to Serve as the sIRB for Federal ProposalsLocation: Room 145 AB
Speaker: – Northwestern University IRB Office
Speaker: – Drexel University
Resource Person: – DHHS Office for Human Research Protections
Single IRBHRPP/IRB Administration/Management and Process
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Monday, Dec 4th
1:00 PM – 2:00 PM ETA05 - [IN-PERSON/RECORDED] Finding the Path Forward: Research that Faces a Difficult Route to ApprovalLocation: Room 147 AB
Speaker: – Columbia University
Speaker: – Office for Human Research Protections
Speaker: – DEVCOM Army Research Laboratory
Legal Considerations in Research OversightEmerging Research Challenges and Breaking IssuesFlexibility and Innovation in Research Oversight Processes
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Monday, Dec 4th
1:00 PM – 2:00 PM ETA25 - [IN-PERSON/RECORDED] Developing and Sustaining Tribal IRB Infrastructure: Lessons Learned from the Collaborative Research Center for American Indian Health (CRCAIH) InitiativesLocation: Room 206
Speaker: – Avera Research Institute
Speaker: – University of North Dakota / Department of Indigenous Health
Small Research ProgramsPopulations Requiring Additional Protections
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Monday, Dec 4th
2:15 PM – 3:15 PM ETB06 - [IN-PERSON ONLY] IRB Closet Clean‐Out: Keep, Toss, TBD (to be determined)Location: Room 140 AB
Speaker: – Weill Cornell Medicine
Speaker: – Northwestern University
Speaker: – University of Utah
HRPP/IRB Administration/Management and ProcessSBERFlexibility and Innovation in Research Oversight Processes
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Monday, Dec 4th
2:15 PM – 3:15 PM ETB07 - [IN-PERSON ONLY] Supporting Informed Decision Making: How to Foster the Development of Understandable Research-Related Information Location: Room 201
Speaker: – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
Resource Person: – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
Speaker: – Center for Information and Study on Clinical Research Participation
Communication With the PublicEducation, Qualifications, and TrainingInformed Consent
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Monday, Dec 4th
2:15 PM – 3:15 PM ETB08 - [IN-PERSON ONLY] Artificial Intelligence (AI) Is Not the Boogey Man: Simplifying the Concept of "Data" in the Context of AI to Enable Knowledge and Know‐How in ReviewLocation: Room 202 AB
Moderator: – Beth Israel Deaconess Medical Center
Speaker: – The Mayo Clinic
Speaker: – Prudential Financial
Speaker: – North star Review Board
Research Conducted in the Digital WorldCommunication With the PublicFlexibility and Innovation in Research Oversight Processes
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Monday, Dec 4th
2:15 PM – 3:15 PM ETB09 - [IN-PERSON ONLY] Determining the Undefined: Research Development and Generalizable KnowledgeLocation: Room 151 AB
Speaker: – The Ohio State University
Speaker: – The Office for Human Research Protections (OHRP), DHHS
Speaker: – National Institutes of Health
IRB BasicsFlexibility and Innovation in Research Oversight ProcessesSBER
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Monday, Dec 4th
2:15 PM – 3:15 PM ETB10 - [IN-PERSON ONLY] Protocol Deviations, Protocol Violations, Protocol Variances, Protocol Exceptions, and Noncompliance: What Really Needs to be Reported to an IRBLocation: Room 150 AB
Speaker: – Harvard T.H. Chan School of Public Health
Speaker: – WCG
Speaker: – Office for Human Research Protections (OHRP)
QA/QI and Postapproval Monitoring
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Monday, Dec 4th
2:15 PM – 3:15 PM ETB11 - [IN-PERSON ONLY] How to Cultivate a Vibrant HRPP TeamLocation: Room 149 AB
Speaker: – PRIM&R
Speaker: – University of Alabama at Birmingham
Speaker: – Baystate Health
Leadership Skills Development
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Monday, Dec 4th
2:15 PM – 3:15 PM ETB12 - [IN-PERSON ONLY] A Dialogue With the Environmental Protection Agency (EPA) Location: Room 203AB
Speaker: – United States Environmental Protection Agency
Speaker:
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Monday, Dec 4th
2:15 PM – 3:15 PM ETB01 - [IN-PERSON/RECORDED] A Dialogue With OHRPLocation: Ballroom AB
Speaker: – DHHS Office for Human Research Protections
Speaker: – Office for Human Research Protections
Speaker: – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS
Speaker: – Office for Human Research Protections, U.S.DHHS
Speaker: – DHHS, Office for Human Research Protections (OHRP)
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Monday, Dec 4th
2:15 PM – 3:15 PM ETB02 - [IN-PERSON/RECORDED] Grappling With “Classic” Research Ethics Cases: An Exercise in Humility and Course CorrectionLocation: Room 143 AB
Speaker: – NIH
Speaker: – Indian Health Service
Advancing Equity and Justice in ResearchCommunication With the Public
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Monday, Dec 4th
2:15 PM – 3:15 PM ETB03 - [IN-PERSON/RECORDED] Progress in Defining and Evaluating HRPP/IRB Quality and EffectivenessLocation: Ballroom C
Speaker: – Perelman School of Medicine, University of Pennsylvania
Speaker: – Neiswanger Institute for Bioethics, Loyola University Chicago
Speaker: – National Institutes of Health
Speaker: – University of Utah
HRPP/IRB Administration/Management and ProcessFlexibility and Innovation in Research Oversight ProcessesQA/QI and Postapproval Monitoring
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Monday, Dec 4th
2:15 PM – 3:15 PM ETB04 - [IN-PERSON/RECORDED] “Do Not Take if You Are Pregnant”: Demystifying the Inclusion of Pregnant Participants in ResearchLocation: Room 144 AB
Speaker: – Rice University
Speaker: – Mayo Clinic
Populations Requiring Additional Protections
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Monday, Dec 4th
2:15 PM – 3:15 PM ETB05 - [IN-PERSON/RECORDED] Local Considerations: Navigating the Regulations, Recommendations, and ReviewLocation: Room 147 AB
Speaker: – AAHRPP
Resource Person: – OHRP
Speaker: – University of California, Los Angeles
Single IRBFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
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Monday, Dec 4th
2:15 PM – 3:15 PM ETB13 - [IN-PERSON ONLY] IACUC Strategies in the Private SectorLocation: West Overlook
Speaker: – Novartis
Speaker: – Labcorp
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Monday, Dec 4th
3:45 PM – 4:45 PM ETC06 - [IN-PERSON ONLY] Beyond ResearchLocation: Room 140 AB
Speaker: – University of New England
Speaker: – Northern Arizona University
HRPP/IRB Administration/Management and ProcessSBER
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Monday, Dec 4th
3:45 PM – 4:45 PM ETC07 - [IN-PERSON ONLY] A Dialogue With the Department of Energy (DOE)Location: Room 159 AB
Speaker: – Department of Energy/National Nuclear Security Administration
Speaker: – United States Department of Energy
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Monday, Dec 4th
3:45 PM – 4:45 PM ETC08 - [IN-PERSON ONLY] Incentive Structures in Research: When the Conflict Is Inside the BuildingLocation: Room 149 AB
Speaker: – University of Utah
Speaker: – Maimonides Medical Center
Speaker: – North star Review Board
Legal Considerations in Research OversightEmerging Research Challenges and Breaking IssuesResearch Oversight Leaders and Institutional Officials
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Monday, Dec 4th
3:45 PM – 4:45 PM ETC09 - [IN-PERSON ONLY] Strengthening Research Ethics Committees (RECs) in Francophone African CountriesLocation: Room 203AB
Speaker:
Speaker: – Kinshasa School of Public Health, Center for Bioethics
Transnational Research CollaborationsHRPP/IRB Administration/Management and ProcessIRB Chairs
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Monday, Dec 4th
3:45 PM – 4:45 PM ETC10 - [IN-PERSON ONLY] Are We the Same or Are We Different? Addressing Challenges Faced by HRPPs Across All OrganizationsLocation: Room 202 AB
Speaker: – WellSpan Health
Speaker: – Advarra
Speaker: – Yale Cancer Center, Clinical Trials Office
HRPP/IRB Administration/Management and ProcessSmall Research Programs
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Monday, Dec 4th
3:45 PM – 4:45 PM ETC11 - [IN-PERSON ONLY] An Adult Lacks Capacity to Consent to Research... Now What Do I Do?Location: Room 150 AB
Speaker: – National Institutes of Health
Speaker: – National Institutes of Health
Informed ConsentPopulations Requiring Additional Protections
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Monday, Dec 4th
3:45 PM – 4:45 PM ETC12 - [IN-PERSON ONLY] IRB Review of Technology Used for Virtual and Virtual/Remote Clinical TrialsLocation: Room 201
Speaker: – Multi-Regional Clinical Trials Center
Speaker: – Advarra
Research Conducted in the Digital WorldEmerging Research Challenges and Breaking Issues
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Monday, Dec 4th
3:45 PM – 4:45 PM ETC01 - [IN-PERSON/RECORDED] Single IRB (sIRB) Coordination Models: Innovative Approaches from Four Clinical and Translational Science Award (CTSA) ProgramsLocation: Ballroom AB
Speaker: – Indiana University School of Medicine, Indiana CTSI
Speaker: – Vanderbilt University Medical Center
Speaker: – University of Utah IRB
Single IRBFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
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Monday, Dec 4th
3:45 PM – 4:45 PM ETC02 - [IN-PERSON/RECORDED] Decolonizing Science for Justice: Closing the Research LoopLocation: Room 147 AB
Speaker: – Virginia Commonwealth University
Speaker: – Boston Children's Hospital
Advancing Equity and Justice in ResearchCommunication With the PublicSBER
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Monday, Dec 4th
3:45 PM – 4:45 PM ETC03 - [IN-PERSON/RECORDED] Ethical, Legal, and Regulatory Challenges of Conducting Research on Psychedelic SubstancesLocation: Ballroom C
Speaker: – Epstein Becker & Green PC
Speaker: – Perelman School of Medicine, University of Pennsylvania
Speaker: – Mass General Brigham
Speaker: – Massachusetts General Hospital
Emerging Research Challenges and Breaking Issues
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Monday, Dec 4th
3:45 PM – 4:45 PM ETC04 - [IN-PERSON/RECORDED] Exception From Informed Consent (EFIC): Overview and Common PitfallsLocation: Room 145 AB
Speaker: – Yale University
Speaker: – Office of Clinical Policy / US Food and Drug Administration
Speaker: – Food and Drug Administration
FDA Regulated ResearchInformed Consent
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Monday, Dec 4th
3:45 PM – 4:45 PM ETC05 - [IN-PERSON/RECORDED] An Insider's Guide to Utilizing Outside Experts: What We Didn't Know, What We Now Know, and Where We Go From HereLocation: Room 143 AB
Speaker: – Harvard T.H. Chan School of Public Health
Education, Qualifications, and TrainingHRPP/IRB Administration/Management and ProcessFlexibility and Innovation in Research Oversight Processes
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Tuesday, Dec 5th
10:15 AM – 11:30 AM ET[IN-PERSON/LIVESTREAMED] Plenary Session: Informed Consent Perspectives from Those in the RoomLocation: Hall E
Moderator: – Saint Louis University
Panelist: – Cincinnati Children's Hospital Medical Center
Panelist: – Wisconsin Alzheimer's Disease Research Center
Panelist: – Seattle Children's Research Institute
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Tuesday, Dec 5th
1:00 PM – 2:00 PM ETD06 - Reserved for Late-BreakingSBERPopulations Requiring Additional ProtectionsHRPP/IRB Administration/Management and Process
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Tuesday, Dec 5th
1:00 PM – 2:00 PM ETD07 - [IN-PERSON ONLY] Adding Another P to the HRPP: The Voice of the Participant in HRPPsLocation: Room 150 AB
Speaker: – National Institutes of Health
Speaker: – UC San Diego
Speaker: – National Institutes of Health
Flexibility and Innovation in Research Oversight Processes
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Tuesday, Dec 5th
1:00 PM – 2:00 PM ETD08 - [IN-PERSON ONLY] IRB Chairs Community‐Building Networking ForumLocation: Room 209 BC
Speaker: – Saint Louis University
Speaker: – Beth Israel Deaconess Medical Center
Speaker: – University of Southern California
Speaker: – Mass General Brigham
Speaker: – Great Bay Community College
Speaker: – Kaiser Permanente
Speaker: – Walter Reed Army Institute for Research
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Tuesday, Dec 5th
1:00 PM – 2:00 PM ETD09 - [IN-PERSON ONLY] A Dialogue With the Department of Defense (DOD)Location: Room 152A
Speaker: – Department of Defense
Speaker: – US Army Medical Research and Development Command
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Tuesday, Dec 5th
1:00 PM – 2:00 PM ETD10 - [IN-PERSON ONLY] Research or Not? Applying the Common Rule "Carve‐Outs"Location: Room 202 AB
Speaker: – Centers for Disease Control and Prevention
Speaker: – Department of Homeland Security
Speaker: – DHHS Office for Human Research Protections
IRB BasicsFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
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Tuesday, Dec 5th
1:00 PM – 2:00 PM ETD11 - [IN-PERSON ONLY] Translating Ethical Principles for the Responsible Use of Emerging Science and Technology Across a Global Pharmaceutical CompanyLocation: Room 149 AB
Speaker: – Takeda Pharmaceuticals
Speaker: – Equipoise Consulting, LLC
Speaker: – Columbia University
Speaker: – Johnson & Johnson
Pharma/Biotech PerspectivesEmerging Research Challenges and Breaking IssuesResearch Conducted in the Digital World
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Tuesday, Dec 5th
1:00 PM – 2:00 PM ETD12 - [IN-PERSON ONLY] Leading Up: Strategies for Impacting the Oversight of Your HRPPLocation: Room 151 AB
Speaker: – Office of Human Subjects Research Johns Hopkins University School of Medicine
Speaker: – PRIM&R
HRPP/IRB Administration/Management and ProcessLeadership Skills Development
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Tuesday, Dec 5th
1:00 PM – 2:00 PM ETD01 - [IN-PERSON/RECORDED] Finding Our True North: Informed Consent as the Moral Compass in the SBER SeasLocation: Room 145 AB
Speaker: – The Ohio State University
Speaker: – Boston Children's Hospital
Resource Person: – Office for Human Research Protections (OHRP)
Education, Qualifications, and TrainingInformed ConsentSBERHRPP/IRB Administration/Management and Process
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Tuesday, Dec 5th
1:00 PM – 2:00 PM ETD02 - [IN-PERSON/RECORDED] Ethical and FDA Regulatory Considerations for Returning Individual Genetic Testing ResultsLocation: Ballroom C
Speaker: – Boston Children's Hospital
Speaker: – US Food and Drug Administration (FDA)
Speaker: – National Institutes of Health
FDA Regulated ResearchEmerging Research Challenges and Breaking IssuesShared Research Oversight Challenges
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Tuesday, Dec 5th
1:00 PM – 2:00 PM ETD03 - [IN-PERSON/RECORDED] A Tale of Two Institutions: Examining the Impact of the FDA Single (sIRB) MandateLocation: Ballroom AB
Speaker: – University of Michigan
Speaker: – Pearl IRB
Speaker: – University of Alabama at Birmingham
Single IRBEmerging Research Challenges and Breaking IssuesFDA Regulated ResearchHRPP/IRB Administration/Management and Process
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Tuesday, Dec 5th
1:00 PM – 2:00 PM ETD04 - [IN-PERSON/RECORDED] Change the Game By Working Together: Tips for Increasing HRPP/IRB and Researcher CollaborationLocation: Hall E
Speaker: – Institute of Health System Science, Feinstein Institutes for Medical Research, Northwell Health
Speaker: – The Pennsylvania State University
Speaker: – Mayo Clinic
Education, Qualifications, and TrainingFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
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Tuesday, Dec 5th
1:00 PM – 2:00 PM ETD05 - [IN-PERSON/RECORDED] Accessibility by Design: Operationalizing Full Commitment to the Americans With Disabilities Act in Clinical Research PracticeLocation: Room 152B
Speaker: – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
Speaker: – Johns Hopkins Disability Health Research Center
Speaker: – Eli Lilly & Company
Advancing Equity and Justice in ResearchEmerging Research Challenges and Breaking IssuesPopulations Requiring Additional ProtectionsLegal Considerations in Research Oversight
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Tuesday, Dec 5th
1:00 PM – 2:00 PM ETD13 - [ON-DEMAND] Developing Educational and Quality Assessment Materials for IRB Protocol SubmissionsPresenter: – Teachers College, Columbia University
Presenter: – Teachers College, Columbia University
Education, Qualifications, and TrainingIRB Basics
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Tuesday, Dec 5th
2:30 PM – 3:45 PM ET[IN-PERSON/LIVESTREAMED] Plenary Session: It's About Time: Inclusion of Sexual and Gender Minorities in Clinical ResearchLocation: Hall E
Moderator: – National Institutes of Health (NIH)
Panelist: – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
Panelist: – The Fenway Institute
Panelist: – Genentech
Populations Requiring Additional ProtectionsAdvancing Equity and Justice in ResearchHRPP/IRB Administration/Management and ProcessPharma/Biotech Perspectives
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Tuesday, Dec 5th
4:00 PM – 5:00 PM ETE06 - [IN-PERSON ONLY] Considering Yourself: Self‐Care for HRPP/IRB Professionals and MembersLocation: Room 151 AB
Speaker: – University of Texas At Arlington
Speaker: – Westat
Education, Qualifications, and TrainingLeadership Skills DevelopmentSBERHRPP/IRB Administration/Management and Process
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Tuesday, Dec 5th
4:00 PM – 5:00 PM ETE07 - [IN-PERSON ONLY] Whose Job Is it Anyway? The Role of the IRB in Increasing Protections of Vulnerable PopulationsLocation: Room 202 AB
Speaker: – Stanford University
Speaker: – Heritage University
Speaker: – University of Southern California
Resource Person: – The Office for Human Research Protections (OHRP), DHHS
Populations Requiring Additional ProtectionsAdvancing Equity and Justice in ResearchHRPP/IRB Administration/Management and ProcessSBER
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Tuesday, Dec 5th
4:00 PM – 5:00 PM ETE08 - [IN-PERSON ONLY] CARE: A Model for the Integration of Cultural Humility into Human Subjects ResearchLocation: Room 140 AB
Speaker: – Case Western Reserve University School of Medicine
Speaker: – Rutgers University
Advancing Equity and Justice in ResearchPopulations Requiring Additional ProtectionsSBERTransnational Research Collaborations
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Tuesday, Dec 5th
4:00 PM – 5:00 PM ETE09 - [IN-PERSON ONLY] Zen and the Art of IRB Meeting MinutesLocation: Room 150 AB
Speaker: – FDA
Speaker: – The Ohio State University
Speaker: – OHRP
IRB BasicsFDA Regulated ResearchHRPP/IRB Administration/Management and Process
-
Tuesday, Dec 5th
4:00 PM – 5:00 PM ETE11 - [IN-PERSON ONLY] Maintaining a Robust HRPP in a Single IRB WorldLocation: Room 149 AB
Speaker: – AAHRPP
Speaker: – Baptist Health South Florida
Single IRBHRPP/IRB Administration/Management and ProcessSmall Research Programs
-
Tuesday, Dec 5th
4:00 PM – 5:00 PM ETE12 - [IN-PERSON ONLY] Leading With Respect, Communication, and Collaboration at All Levels of the Research EnterpriseLocation: Room 152A
Speaker: – Johns Hopkins University
Speaker: – University of Missouri
Leadership Skills Development
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Tuesday, Dec 5th
4:00 PM – 5:00 PM ETE01 - [IN-PERSON/RECORDED] A Dialogue With FDALocation: Ballroom C
Speaker: – US Food and Drug Administration
Speaker: – US Food and Drug Administration
Speaker: – FDA
Speaker: – US Food and Drug Administration
Speaker: – USFDA
A Dialogue With the FedsFDA Regulated Research
-
Tuesday, Dec 5th
4:00 PM – 5:00 PM ETE02 - [IN-PERSON/RECORDED] Digital Marketing Strategies for Research Participant Recruitment: Ethical Considerations, Efficacy Assessment, and Regulatory ComplianceLocation: Room 146 ABC
Speaker: – National Institutes of Health
Speaker: – Clemson University
Resource Person: – DHHS, Office for Human Research Protections (OHRP)
Research Conducted in the Digital WorldEmerging Research Challenges and Breaking IssuesSBERHRPP/IRB Administration/Management and Process
-
Tuesday, Dec 5th
4:00 PM – 5:00 PM ETE03 - [IN-PERSON/RECORDED] Key Information Sections Four years In: Where Are We and Where Should We Be Going?Location: Ballroom AB
Speaker: – Advarra
Speaker: – DHHS Office for Human Research Protections
Speaker: – Department of Medicine, University of California, San Francisco
Informed ConsentIRB Basics
-
Tuesday, Dec 5th
4:00 PM – 5:00 PM ETE04 - [IN-PERSON/RECORDED] Leveraging Logic Tools for Not Human Subjects Research and Exemption DeterminationsLocation: Room 145 AB
Speaker: – University of Michigan
Speaker: – University of Florida
Speaker: – University of Utah
Flexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
-
Tuesday, Dec 5th
4:00 PM – 5:00 PM ETE05 - [IN-PERSON/RECORDED] Communicating With the Public: What Does the Public Have to Say?Location: Room 152B
Speaker: – Young Survival Coalition
Speaker: – Center for Information and Study on Clinical Research Participation
Speaker: – Loyola Marymount University
Communication With the Public
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Wednesday, Dec 6th
8:30 AM – 9:45 AM ET[IN-PERSON/LIVESTREAMED] Plenary Session: Ethical Considerations for Using Generative Artificial Intelligence (AI) in Human Subjects Research‐‐Implications for IRB RegulationLocation: Hall E
Moderator: – National Institutes of Health
Panelist: – Beth Israel Deaconess Medical Center
Panelist: – Johns Hopkins University
Panelist: – Masschusetts Institute of Technology (MIT)
Emerging Research Challenges and Breaking IssuesInformed ConsentResearch Conducted in the Digital World
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Wednesday, Dec 6th
8:30 AM – 9:45 AM ET[IN-PERSON/LIVESTREAMED] Plenary Session: From Compliance to Embracing the Belmont Report Tenets as the Framework for the Operations of the HRPPLocation: Ballroom AB
Moderator: – University of Southern California
Panelist: – National Institutes of Health
Panelist: – AAHRPP, Inc.
Panelist: – Office for Human Research Protections, U.S.DHHS
Panelist: – Baystate Health
HRPP/IRB Administration/Management and ProcessFlexibility and Innovation in Research Oversight Processes
-
Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF02 - [IN-PERSON ONLY] FDA Remote Regulatory Assessments (RRAs): Another Tool for Regulatory OversightLocation: Room 158 AB
Speaker: – FDA
Speaker: – Food and Drug Administration
-
Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF07 - [IN-PERSON ONLY] SBER Network Discussion SessionLocation: Room 204AB
Speaker: – The University of New Mexico
Speaker: – Weill Cornell Medicine
-
Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF08 - [IN-PERSON ONLY] Human Subjects Research TriviaLocation: Room 150 AB
Speaker: – National Institutes of Health
Speaker: – University of Nevada, Las Vegas
IRB BasicsHRPP/IRB Administration/Management and Process
-
Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF09 - [IN-PERSON ONLY] Are We Doing Enough? Creating a Sense of Belonging and Opportunities for HRPP Professionals Location: Room 152A
Speaker: – Arizona State University
Speaker: – Dana Farber Cancer Insititute
Speaker: – Harvard Catalyst | The Harvard Clinical and Translational Science Center and SMART IRB
Speaker: – The Valley Hospital
Advancing Equity and Justice in ResearchLeadership Skills Development
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Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF10 - [IN-PERSON ONLY] HRPP/IRB Management 101: Real‐World Discussions Regarding How to Effectively Run a HRPP/IRB OfficeLocation: Room 202 AB
Speaker: – Office of Human Subjects Research Johns Hopkins University School of Medicine
Speaker: – Northwestern University
Speaker: – Yale University
Leadership Skills DevelopmentHRPP/IRB Administration/Management and Process
-
Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF11 - [IN-PERSON ONLY] Navigating Data and Specimen Sharing for Transnational ResearchLocation: Room 140 AB
Speaker: – Ropes & Gray Law Firm
Speaker: – ARC-Net and Department of Engineering for Innovative Medicine, University of Verona, Italy
Speaker: – none
Transnational Research CollaborationsResearch Involving Data and Biospecimens
-
Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF12 - [IN-PERSON ONLY] Maintaining Compliance at Any Size: How to Get the Most Bang for Your Buck!Location: Room 201
Speaker: – Harvard T.H. Chan School of Public Health
Speaker: – Penn State
Speaker: – Indiana University
QA/QI and Postapproval MonitoringFlexibility and Innovation in Research Oversight Processes
-
Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF14 - [IN-PERSON/RECORDED] The Ethical Conduct of Cell and Gene Therapy Research: Novel Challenges for Industry and the IRB Location: Room 152B
Speaker: – Takeda Pharmaceuticals
Speaker: – Columbia University
Speaker: – Boston Children's Hospital
Pharma/Biotech PerspectivesAdvancing Equity and Justice in ResearchEmerging Research Challenges and Breaking IssuesResearch Involving Data and Biospecimens
-
Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF15 - [IN-PERSON ONLY] Show Me the Money: Models for Billing for HRPP/IRB Review FeesLocation: Room 149 AB
Speaker: – The Pennsylvania State University
Speaker: – Yale University
Speaker: – Yale University
HRPP/IRB Administration/Management and Process
-
Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF01 - [IN-PERSON/RECORDED] A Dialogue With the NIHLocation: Room 146 ABC
Speaker: – National Institutes of Health
-
Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF03 - [IN-PERSON/RECORDED] Utilizing a System of IRB Precedent: Moving Toward Consistency and TransparencyLocation: Ballroom AB
Speaker: – Multi-Regional Clinical Trials Center
Speaker: – Medical College of Wisconsin
Speaker: – Dana-Farber Cancer Institute
Speaker: – Dana-Farber Cancer Institute
Flexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and ProcessQA/QI and Postapproval Monitoring
-
Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF04 - [IN-PERSON/RECORDED] Supported Decision‐Making: From the Law to the BedsideLocation: Room 144 AB
Speaker: – Mass General Brigham
Speaker: – University of Utah
Legal Considerations in Research OversightAdvancing Equity and Justice in ResearchInformed ConsentPopulations Requiring Additional Protections
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Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF05 - [IN-PERSON/RECORDED] IRB Review of FDA‐regulated Research: From Comfort to Competence!Location: Ballroom C
Speaker: – Mayo Clinic
Speaker: – University of Illinois Urbana-Champaign
QA/QI and Postapproval MonitoringFDA Regulated ResearchHRPP/IRB Administration/Management and Process
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Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF06 - [IN-PERSON/RECORDED] What Are We Doing When We’re Doing What We’re Doing? Revisiting the Tenets of Biomedical Ethics and Embracing the “Ethics” in our “Applied Ethics” FieldLocation: Room 143 AB
Speaker: – Advarra
Speaker: – University of North Carolina at Chapel Hill
Speaker: – The Office for Human Research Protections (OHRP), DHHS
-
Wednesday, Dec 6th
10:15 AM – 11:15 AM ETF13 - [IN-PERSON/RECORDED] Bringing the IRB to the People, and the People to the IRBLocation: Room 145 AB
Speaker: – Institution Insights
Speaker: – Neiswanger Institute for Bioethics, Loyola University Chicago
Speaker: – University of Utah
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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Wednesday, Dec 6th
11:30 AM – 12:30 PM ETG07 - [IN-PERSON/RECORDED] “Let Me Tell You About This Awesome Clinical Trial!” Exploring the Role of Social Media Influencers in Clinical Trial RecruitmentLocation: Room 143 AB
Speaker: – Health Union, LLC
Speaker: – National Institute of Mental Health, Intramural Research Program
Communication With the PublicEmerging Research Challenges and Breaking IssuesResearch Conducted in the Digital World
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Wednesday, Dec 6th
11:30 AM – 12:30 PM ETG08 - [IN-PERSON ONLY] A Dialogue With AAHRPP, Inc.Location: Room 209 BC
Speaker: – AAHRPP, Inc.
Speaker: – The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)
Speaker: – Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)
Speaker: – Association for the Accreditation of Human Research Protection Programs, Inc.
Speaker: – AAHRPP, Inc.
Speaker: – AAHRPP
Speaker: – AAHRPP
-
Wednesday, Dec 6th
11:30 AM – 12:30 PM ETG09 - [IN-PERSON ONLY] IRB Chairs Hot Topics Networking ForumLocation: Room 149 AB
Speaker: – Mass General Brigham
Speaker: – Saint Louis University
-
Wednesday, Dec 6th
11:30 AM – 12:30 PM ETG10 - [IN-PERSON ONLY] Innovative Strategies to Improve Readability of Informed Consent FormsLocation: Room 202 AB
Speaker: – Office for Human Research Protections (OHRP)
Speaker: – Purdue University
Speaker: – Research Compliance Services, University of Nebraska - Lincoln
Speaker: – National Institutes of Health, Intramural Research Program
-
Wednesday, Dec 6th
11:30 AM – 12:30 PM ETG11 - [IN-PERSON ONLY] Bots as Study Participants: and Online Human Subjects ResearchLocation: Room 151 AB
Speaker: – Fordham University
Speaker: – Teachers College, Columbia University
Research Conducted in the Digital WorldEmerging Research Challenges and Breaking IssuesSBER
-
Wednesday, Dec 6th
11:30 AM – 12:30 PM ETG12 - [IN-PERSON ONLY] Recent Updates from FDA Guidances on Informed Consent and IRB Review for Expanded Access Use of Investigational DrugsLocation: Room 150 AB
Speaker: – Boston Children's Hospital
Speaker: – CDER/FDA
FDA Regulated ResearchInformed Consent
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Wednesday, Dec 6th
11:30 AM – 12:30 PM ETG13 - [IN-PERSON/RECORDED] Adding "A" to our Diversity Alphabet: Accessibility is Key to Diversity, Equity, and Inclusion (DEI)Location: Room 152B
Speaker: – Pace University
Speaker: – Weill Cornell Medicine
Speaker: – Weill Cornell Medicine
Populations Requiring Additional ProtectionsAdvancing Equity and Justice in ResearchEducation, Qualifications, and TrainingHRPP/IRB Administration/Management and Process
-
Wednesday, Dec 6th
11:30 AM – 12:30 PM ETG14 - [IN-PERSON ONLY] Building Bridges: Towards An International Framework for Specimen SharingLocation: Room 204AB
Speaker: – Ropes & Gray Law Firm
Speaker: – BIopreservation & Biobanking
Speaker: – Takeda
Speaker: – ARC-Net and Department of Engineering for Innovative Medicine, University of Verona, Italy
Research Involving Data and BiospecimensTransnational Research Collaborations
-
Wednesday, Dec 6th
11:30 AM – 12:30 PM ETG15 - [IN-PERSON ONLY] Everything You Wanted to Know about the CIP CredentialLocation: Room 201
Speaker: – University of Rochester
HRPP/IRB Administration/Management and Process
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Wednesday, Dec 6th
11:30 AM – 12:30 PM ETG01 - [IN-PERSON/RECORDED] Look Who's Doing Research Now! What Does it Mean for Walgreens, Walmart, Etc., to Be Conducting Human Subjects Research?Location: Room 145 AB
Speaker: – Walgreens
Speaker: – University of Utah
Pharma/Biotech PerspectivesEmerging Research Challenges and Breaking Issues
-
Wednesday, Dec 6th
11:30 AM – 12:30 PM ETG02 - [IN-PERSON/RECORDED] The Ethics of Data Sharing in SBERLocation: Ballroom C
Speaker: – Qualitative Data Repository
Speaker: – NC State University
Emerging Research Challenges and Breaking IssuesFlexibility and Innovation in Research Oversight ProcessesSBERResearch Involving Data and BiospecimensHRPP/IRB Administration/Management and Process
-
Wednesday, Dec 6th
11:30 AM – 12:30 PM ETG03 - [IN-PERSON/RECORDED] Improving IRB Quality: Learning from Participants, Investigators, and Outside ExpertsLocation: Ballroom AB
Speaker: – Perelman School of Medicine, University of Pennsylvania
Speaker: – National Institutes of Health
Speaker: – Harvard T.H. Chan School of Public Health
QA/QI and Postapproval MonitoringFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
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Wednesday, Dec 6th
11:30 AM – 12:30 PM ETG04 - [IN-PERSON/RECORDED] QA/QI for Non‐Clinical or Minimal Risk ResearchLocation: Room 147 AB
Speaker: – Office of Research Integrity, University of Kentucky
Speaker: – University of Michigan
QA/QI and Postapproval MonitoringFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and ProcessSmall Research Programs
-
Wednesday, Dec 6th
11:30 AM – 12:30 PM ETG05 - [IN-PERSON/RECORDED] The Metrics System: Launching a Formal IRB Metrics ProgramLocation: Room 146 ABC
Speaker: – UAMS Institutional Review Board
Speaker: – University of Massachusetts Amherst
HRPP/IRB Administration/Management and Process
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Wednesday, Dec 6th
12:40 PM – 1:35 PM ET[IN-PERSON/LIVESTREAMED] Town Hall: Is it Time to Revisit the Belmont Report?Location: Hall E
Panelist: – Perelman School of Medicine, University of Pennsylvania
Panelist: – PRIM&R
Resource Person: – Office for Human Research Protections, U.S.DHHS
Communication With the PublicEmerging Research Challenges and Breaking Issues
-
Wednesday, Dec 6th
1:45 PM – 2:45 PM ETH07 - [IN-PERSON ONLY] A Dialogue With the Department of Veteran Affairs (VA)Location: Room 158 AB
Speaker: – Veterans Health Administration
Speaker: – Department of Veterans Affairs
Speaker: – Veterans Health Administration
-
Wednesday, Dec 6th
1:45 PM – 2:45 PM ETH08 - [IN-PERSON ONLY] When You're the New Kid in Town: Taking Over as an HRPP/IRB LeaderLocation: Room 204AB
Speaker: – Rutgers University
Speaker: – Virginia Commonwealth University
Speaker: – UAMS Institutional Review Board
Leadership Skills DevelopmentHRPP/IRB Administration/Management and Process
-
Wednesday, Dec 6th
1:45 PM – 2:45 PM ETH09 - [IN-PERSON ONLY] Human Subjects Protections in the US Intelligence Community (IC)Location: Room 152A
Speaker: – National Intelligence University
Speaker: – FEDERAL BUREAU OF INVESTIGATION
Speaker: – DoD
Communication With the PublicEmerging Research Challenges and Breaking IssuesPopulations Requiring Additional ProtectionsLegal Considerations in Research Oversight
-
Wednesday, Dec 6th
1:45 PM – 2:45 PM ETH10 - [IN-PERSON ONLY] Training IRBs for the Review of Transnational ResearchLocation: Room 209 BC
Speaker: – Unity Health Toronto
Speaker: – WCG
Speaker: – Harvard T.H. Chan School of Public Health
Transnational Research Collaborations
-
Wednesday, Dec 6th
1:45 PM – 2:45 PM ETH11 - [IN-PERSON ONLY] When Secondary Data Use Involves an FDA Regulated Device StudyLocation: Room 202 AB
Speaker: – National Institutes of Health
Speaker: – United States Food and Drug Administration
Speaker: – Digital Health Center of Excellence, FDA
Research Involving Data and BiospecimensFDA Regulated Research
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Wednesday, Dec 6th
1:45 PM – 2:45 PM ETH12 - [IN-PERSON ONLY] Methods for Improving Diversity, Equity, Inclusion, and Justice (DEIJ) in Research Administration and OversightLocation: Room 151 AB
Speaker: – University of California, Davis
Speaker: – Boston Children's Hospital
Speaker: – Indiana University
Speaker: – Teachers College, Columbia University
Advancing Equity and Justice in ResearchHRPP/IRB Administration/Management and Process
-
Wednesday, Dec 6th
1:45 PM – 2:45 PM ETH13 - [CANCELED] Essentials of Ethical Research with Human Subjects at Risk for Suicide: Overview of eLearning Course and Suicide Risk MitigationLocation: Room 150 AB
Speaker: – Suicide Care, Prevention, and Research Initiative, Uniformed Services University
Speaker: – Suicide Care, Prevention, and Research Initiative, Uniformed Services University
Populations Requiring Additional ProtectionsEducation, Qualifications, and TrainingSBER
-
Wednesday, Dec 6th
1:45 PM – 2:45 PM ETH14 - [IN-PERSON ONLY] Incorporating Human Research Protections Training in the Preparation of Research ProfessionalsLocation: Room 140 AB
Speaker: – Rutgers, The State University of New Jersey
Education, Qualifications, and TrainingHRPP/IRB Administration/Management and ProcessIRB Basics
-
Wednesday, Dec 6th
1:45 PM – 2:45 PM ETH15 - [IN-PERSON ONLY] Oversight Committee Interaction in Clinical Research Beyond the IRBLocation: Room 148
Speaker: – Advarra
Speaker: – Yale University
Flexibility and Innovation in Research Oversight ProcessesFDA Regulated Research
-
Wednesday, Dec 6th
1:45 PM – 2:45 PM ETH01 - [IN-PERSON/RECORDED] Insights into IRB Student‐Led Protocol SubmissionsLocation: Room 146 ABC
Speaker: – Teachers College, Columbia University
Speaker: – Fordham University
Speaker: – Teachers College Columbia University
Education, Qualifications, and TrainingSBERHRPP/IRB Administration/Management and ProcessQA/QI and Postapproval Monitoring
-
Wednesday, Dec 6th
1:45 PM – 2:45 PM ETH02 - [IN-PERSON/RECORDED] OHRP, FDA, and the General Accountability Office (GAO) Report on IRB Oversight and Effectiveness: A Conversation With the PRIM&R CommunityLocation: Ballroom AB
Speaker: – DHHS Office for Human Research Protections
Speaker: – North star Review Board
Speaker: – FDA
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Wednesday, Dec 6th
1:45 PM – 2:45 PM ETH03 - [IN-PERSON/RECORDED] The Speech Act of Informed ConsentLocation: Room 145 AB
Speaker: – Seattle Children's Research Institute
Speaker: – Office for Human Research Protections, U.S.DHHS
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Wednesday, Dec 6th
1:45 PM – 2:45 PM ETH04 - [IN-PERSON/RECORDED] Eliminating Financial Barriers to Clinical Study Participation: The Need for Industry and Academic Partnership for a Sustainable SolutionLocation: Room 144 AB
Speaker: – Yale University
Speaker: – Equipoise Consulting, LLC
Speaker: – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
Pharma/Biotech PerspectivesAdvancing Equity and Justice in Research
-
Wednesday, Dec 6th
1:45 PM – 2:45 PM ETH05 - [IN-PERSON/RECORDED] Postapproval Monitoring (PAM) for Studies Overseen by a Single External IRB of Record: Challenges forLocal Monitoring ProgramsLocation: Ballroom C
Speaker: – Johns Hopkins University School of Medicine
Speaker: – Yale Cancer Center, Clinical Trials Office
QA/QI and Postapproval MonitoringSingle IRB
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Wednesday, Dec 6th
1:45 PM – 2:45 PM ETH06 - [IN-PERSON/RECORDED] Engaging Our Community in the Mission of IRBsLocation: Room 143 AB
Speaker: – MSOE
Speaker: – Medical College of Wisconsin
Speaker: – Yale University
Communication With the PublicFlexibility and Innovation in Research Oversight Processes
