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Monday, Nov 18th
10:30 AM – 11:45 AM PTA02 - How Do You Actually Review a Protocol Involving Artificial Intelligence (AI)?Location: Ballroom 1
Speaker: – University of Florida
Speaker: – Office of Human Subjects Research Johns Hopkins University School of Medicine
Speaker: – Mass General Brigham
Speaker: – Stanford University
Emerging Research Challenges and Breaking IssuesIRB ReviewResearch Involving Data and New Technologies
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA03 - Why “It Depends”: General Considerations for IRBs and HRPPs When Reviewing Research Using FDA-Regulated ProductsLocation: Room 431-432
Speaker: – Office of the Chief Medical Officer, FDA
Speaker: – Office of Scientific Investigations/CDER/FDA
Speaker: – US Food and Drug Administration
Speaker: – USFDA
FDA Regulated ResearchIRB ReviewPharma/Biotech Perspectives
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA06 - Great “Private” Expectations: What Is Publicly Available Private Information?Location: Room 345-346
Speaker: – UC San Diego
Speaker: – Research Compliance Services, University of Nebraska - Lincoln
Speaker: – Human Research Protection Office, University of Massachusetts Amherst
Social, Behavioral, and Educational ResearchResearch Involving Data and New TechnologiesIRB Review
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA08 - What is the Role of Regret and Apology in Protecting the Human Participants of Clinical Trials?Location: Room 335
Speaker: – PIRE-Southwest
Speaker: – PRIM&R
Speaker: – Northwest Indian College
HRPP/IRB Management and AdministrationPharma/Biotech PerspectivesIRB Review
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Monday, Nov 18th
10:30 AM – 11:45 AM PTA16 - PLENARY: PI Responsibility & Accountability Versus Effectiveness of Institutional Compliance and Ethics Review: What Will Really Make a Difference in How We Conduct Research?Location: Ballroom 2
Moderator: – Mass General Brigham Incorporated
Panelist: – Fred Hutchinson Cancer Center
Panelist: – Labcorp
Panelist: – University of Nebraska Medical Center
Shared Research Oversight ChallengesResearch Oversight Leaders and Institutional OfficialsIRB ReviewIACUC Review
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB01 - PLENARY: Ethical Considerations With Healthy Research Participants: Current Perspectives From the FieldLocation: Signature Room
Moderator: – Perelman School of Medicine, University of Pennsylvania
Panelist: – University of North Carolina at Chapel Hill
Panelist: – 1Day Sooner
Panelist: – Metcut Reasearch
IRB ReviewAdvancing Equity and Justice
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB03 - Assessing Capacity to Consent for Research Participation: When and How Do You Actually Do It?Location: Ballroom 3
Speaker: – Mass General Brigham
Speaker: – Multi-Regional Clinical Trials Center
Populations Requiring Additional ProtectionsInformed ConsentAdvancing Equity and JusticeIRB ReviewSocial, Behavioral, and Educational Research
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB04 - Ethical Implications and Practical Application of Broad ConsentLocation: Room 343-344
Speaker: – Huron
Speaker: – University of Texas, MD Anderson Cancer Center
Speaker: – Indiana University Center for Bioethics
Pharma/Biotech PerspectivesInformed ConsentResearch Involving Data and New TechnologiesIRB Review
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB09 - When SBER Meets the Definition of a Clinical Trial, Then What?Location: Room 347-348
Speaker: – Florida State University
Speaker: – Weill Cornell Medicine
Social, Behavioral, and Educational ResearchIRB Review
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Monday, Nov 18th
1:45 PM – 3:00 PM PTB10 - Advancing Justice, Equity, and Trustworthiness Through Community Engaged Research (CEnR): What HRPPs/IRBs Need to KnowLocation: Room 345-346
Speaker: – Loyola University Chicago Stritch School of Medicine
Speaker: – Medical College of Wisconsin
Speaker: – Johns Hopkins, Major Extremity Trauma Research Consortium, DSMB;
Univ of Maryland, Baltimore IRB;
National Institutes of Health IRB;
Advancing Equity and JusticeIRB ReviewSocial, Behavioral, and Educational Research
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC04 - What's That You're Wearing? Human Research Protections and Wearable DevicesLocation: Ballroom 1
Speaker: – Maimonides Medical Center
Speaker: – DHHS Office for Human Research Protections
Research Involving Data and New TechnologiesEmerging Research Challenges and Breaking IssuesIRB ReviewSocial, Behavioral, and Educational Research
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC05 - IRBs Greatest Challenges for Youth-Centered ResearchLocation: Room 343-344
Speaker: – Fordham University
Speaker: – Teachers College, Columbia University
Speaker: – NYC Department of Health and Mental Hygiene
Populations Requiring Additional ProtectionsIRB ReviewSocial, Behavioral, and Educational Research
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC06 - Medical Devices: A Beginner's Guide to Understanding the Basics of FDA Regulation and How to Apply it to a StudyLocation: Room 345-346
Speaker: – The Children's Mercy Hospital | Children’s Mercy Research Institute
Speaker: – The University of North Carolina at Chapel Hill
FDA Regulated ResearchIRB FundamentalsIRB Review
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC07 - This Coffee Is HOT! Burning Topics in the SBER Space (Needle)Location: Room 443
Speaker: – Tufts University
Speaker: – Western Washington University
Social, Behavioral, and Educational ResearchHRPP/IRB Management and AdministrationIRB Review
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Monday, Nov 18th
3:30 PM – 4:45 PM PTC18 - Committee Meeting Navigation for Those in the RoomLocation: Room 332
Speaker: – Colorado State University
Speaker: – Nemours Children's Health
Speaker: – WCG
IRB ReviewIACUC ReviewShared Research Oversight Challenges
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Tuesday, Nov 19th
7:15 AM – 8:15 AM PTN08 - IRB Chairs Community‐Building Networking ForumLocation: Room 322
Speaker: – University of Southern California
Speaker: – Utah Tech University
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD01 - PLENARY: Responsibility Does Not End With Death: Establishing Systems for Ethical Decedent ResearchLocation: Signature Room
Moderator: – Center for Applied Biomechanics, Department of Mechanical and Aerospace Engineering, University of Virginia
Panelist: – OHARO, USAMRDC
Panelist: – UVA Center for Applied Biomechanics
Panelist: – FBI
Legal Considerations in Research OversightEmerging Research Challenges and Breaking IssuesIRB Review
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD04 - Relationship Building to Respect Tribal Sovereignty and Improve Research SafetyLocation: Ballroom 2
Speaker: – Minnesota State University, Mankato
Speaker: – Mayo Clinic
Speaker: – Mayo Clinic
Populations Requiring Additional ProtectionsAdvancing Equity and JusticeIRB ReviewSocial, Behavioral, and Educational Research
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD06 - The Limits of Permissible Research Without ConsentLocation: Ballroom 1
Speaker: – Advarra
Speaker: – Department of Medicine, University of California, San Francisco
Speaker: – Stanford University
Informed ConsentIRB Review
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD07 - Reviewing Incidents of Non-Compliance: Strategies for IRB Chairs and MembersLocation: Ballroom 3
Speaker: – Office of Human Subjects Research Johns Hopkins University School of Medicine
Speaker: – University of Nebraska Medical Center
Speaker: – The PEER Consulting Group
QA/QI and Postapproval MonitoringIRB ReviewIRB Fundamentals
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD09 - The Shifting Paradigm of Data Sharing: Navigating New Challenges Through a Participant-Centered LensLocation: Room 423-425
Speaker: – Geisinger College of Health Sciences
Speaker: – Community Based Organization Partners - Community Ethics Review Board
Speaker: – UT Southwestern Medical Center
Research Involving Data and New TechnologiesIRB ReviewEmerging Research Challenges and Breaking Issues
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Tuesday, Nov 19th
10:30 AM – 11:45 AM PTD10 - Accessibility Basics: Making Word Documents AccessibleLocation: Room 336
Speaker: – University of St. Thomas, Minnesota
Speaker: – Weill Cornell Medicine
Speaker: – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
Advancing Equity and JusticeEducation, Qualifications, and TrainingIRB ReviewIRB FundamentalsSocial, Behavioral, and Educational Research
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Tuesday, Nov 19th
12:30 PM – 1:30 PM PTN10 - 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
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Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE03 - All Things Subpart CLocation: Signature Room
Speaker: – National Institute of Justice
Speaker: – OHRP
Speaker: – The Johns Hopkins University
Populations Requiring Additional ProtectionsIRB ReviewIRB FundamentalsSocial, Behavioral, and Educational Research
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Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE04 - Building Trust in Science: Enabling Frameworks for Returning Individual Research Results to Research ParticipantsLocation: Room 423-425
Speaker: – National Institutes of Health
Speaker: – Multi-Regional Clinical Trials Center
Emerging Research Challenges and Breaking IssuesHRPP/IRB Management and AdministrationIRB Review
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Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE08 - PLENARY: Responsible Research Practices in ComputingLocation: Room 331
Moderator: – Microsoft Research
Panelist: – Stanford University
Panelist: – Ada Lovelace Institute
Panelist: – Microsoft
Research Involving Data and New TechnologiesEmerging Research Challenges and Breaking IssuesIRB Review
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Tuesday, Nov 19th
1:45 PM – 3:00 PM PTE09 - Robots in Disguise: When Your Participants are More Than Meets the EyeLocation: Room 343-344
Speaker: – Teachers College, Columbia University
Speaker: – Abt Global
Speaker: – Rutgers School of Public Health & CHIBPS
Research Involving Data and New TechnologiesEmerging Research Challenges and Breaking IssuesIRB ReviewSocial, Behavioral, and Educational Research
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Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF01 - PLENARY: Risk Associated With Human Subjects Research: Whom Are We Obligated to Protect?Location: Signature Room
Moderator: – University of California
Panelist: – Boston Children's Hospital
Panelist: – Department of Medicine, University of California, San Francisco
Panelist: – Ropes & Gray
Emerging Research Challenges and Breaking IssuesIRB ReviewHRPP/IRB Management and Administration
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Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF02 - PLENARY: Artificial Intelligence (AI) Days of Future's Past: Tomorrow's Research YesterdayLocation: Ballroom 1
Moderator: – Association of American Medical Colleges
Panelist: – National Institutes of Health
Panelist: – Microsoft Research
Panelist: – The Mayo Clinic
Social, Behavioral, and Educational ResearchHRPP/IRB Management and AdministrationIRB ReviewResearch Involving Data and New TechnologiesEmerging Research Challenges and Breaking Issues
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Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF04 - IRB Review of Research Involving Politicized Topics and PopulationsLocation: Ballroom 3
Speaker: – University of Connecticut
Speaker: – HRP Consulting Group
Speaker: – The Fenway Institute, Fenway Health
IRB ReviewEmerging Research Challenges and Breaking IssuesAdvancing Equity and JusticePopulations Requiring Additional ProtectionsSocial, Behavioral, and Educational Research
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Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF08 - Navigating Ethical and Institutional Considerations for Data and Biospecimen Sharing in the Era of Single (sIRB)Location: Room 345-346
Speaker: – AAHRPP
Speaker: – Office of Human Subjects Research Johns Hopkins University School of Medicine
Single IRBResearch Involving Data and New TechnologiesIRB ReviewPharma/Biotech Perspectives
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Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF09 - I Don't Remember This Being in the Training Manual: An Exploration of Challenging IRB SituationsLocation: Room 343-344
Speaker: – James Madison University
Speaker: – James Madison University
Speaker: – Old Dominion University
IRB ReviewHRPP/IRB Management and AdministrationSocial, Behavioral, and Educational Research
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Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF17 - Trust Me, I Know What I'm DoingLocation: Room 445-446
Speaker: – Independent Professional
Speaker: – AAHRPP
Speaker: – Allen Institute
Shared Research Oversight ChallengesResearch Oversight Leaders and Institutional OfficialsIRB ReviewIACUC ReviewACU/IACUC Program Management and AdministrationHRPP/IRB Management and Administration
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Tuesday, Nov 19th
3:30 PM – 4:45 PM PTF18 - Shake It Up: An Interactive Discussion of Lessons Learned from IRB/IACUC LeadersLocation: Room 444
Speaker: – Nationwide Children's Hospital
Speaker: – Northeastern University
Speaker: – Hackensack Meridian Health
Shared Research Oversight ChallengesResearch Oversight Leaders and Institutional OfficialsIRB ReviewIACUC Review
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Tuesday, Nov 19th
5:00 PM – 6:00 PM PTN14 - 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
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Wednesday, Nov 20th
7:30 AM – 8:30 AM PTOpening General Session: More Cure, Less Side Effects: A Potential Role for Preclinical StudiesLocation: Ballroom 1
Moderator: – Novartis Institutes for Biomedical Research
Panelist: – Novartis Biomedical Research
Panelist: – Digital In Vivo Alliance
Emerging Research Challenges and Breaking IssuesIACUC ReviewIRB ReviewPharma/Biotech Perspectives
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Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG01 - Are the Ways We Contemplate Risk Outdated?Location: Ballroom 2
Speaker: – National Institutes of Health
Speaker: – Sage Bionetworks
Speaker: – National Human Genome Research Institute, National Institutes of Health
Emerging Research Challenges and Breaking IssuesIRB ReviewHRPP/IRB Management and Administration
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Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG02 - Change the Game By Working Together: Tips for Increasing HRPP/IRB and Researcher CollaborationLocation: Ballroom 1
Speaker: – The Pennsylvania State University
Speaker: – Institute of Health System Science, Feinstein Institutes for Medical Research, Northwell Health
IRB ReviewHRPP/IRB Management and AdministrationSocial, Behavioral, and Educational Research
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Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG07 - Exploring the Enigma of the Expedited (Category 7)Location: Ballroom 3
Speaker: – Indiana University
Speaker: – University of California San Francisco
Social, Behavioral, and Educational ResearchIRB Review
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Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG08 - Let It Go! Strategies to Prevent Over-Regulation During Local Context ReviewLocation: Signature Room
Speaker: – The Pennsylvania State University
Speaker: – University of Minnesota
Speaker: – Research Compliance Services, University of Nebraska - Lincoln
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Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG15 - Building Bridges: Towards an International Framework for Specimen Sharing (Part II)Location: Room 335
Speaker: – BIopreservation & Biobanking
Speaker: – Takeda
Speaker: – Center for Integrative Medical Sciences, RIKEN
Speaker: – ARC-Net and Department of Engineering for Innovative Medicine, University of Verona, Italy
Pharma/Biotech PerspectivesResearch Involving Data and New TechnologiesIRB Review
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Wednesday, Nov 20th
8:45 AM – 10:00 AM PTG13 - PLENARY: Ethical Review of Human and Animal Subjects Research ProposalsLocation: Room 423-425
Moderator: – Novartis Institutes for Biomedical Research
Panelist: – Landi Animal Research and Bioethics
Panelist: – The Johns Hopkins University
Panelist: – University of North Carolina at Chapel Hill
Shared Research Oversight ChallengesResearch Oversight Leaders and Institutional OfficialsIRB ReviewIACUC Review
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Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH01 - PLENARY: Regulatory and IRB Challenges in Reviewing Decentralized Clinical Trials (DCTs)Location: Room 323-324
Moderator: – Department of Veterans Affairs
Panelist: – DHHS Office for Human Research Protections
Panelist: – Decentralized Trials and Research Alliance
Panelist: – NCATS/NIH
FDA Regulated ResearchHRPP/IRB Management and AdministrationIRB Review
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Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH02 - Group Harm: A Toolkit for Researchers, IRBs, and Data Access CommitteesLocation: Ballroom 2
Speaker: – Maimonides Medical Center
Speaker: – Johns Hopkins Bloomberg School of Public Health
Speaker: – University of Washington School of Medicine
Populations Requiring Additional ProtectionsIRB ReviewSocial, Behavioral, and Educational Research
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Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH04 - Comparative Effectiveness Research (CER): When Important Research Does Not Fit the Regulatory MoldLocation: Room 431-432
Speaker: – Advarra
Speaker: – National Institutes of Health
Speaker: – WCG
Speaker: – None
IRB ReviewEmerging Research Challenges and Breaking Issues
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Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH06 - What Are You Going To Do With My Specimens and Data? When Research Specimens and Data are Used for Commercial ProfitLocation: Signature Room
Speaker: – Huron Consulting Group
Speaker: – BIopreservation & Biobanking
Speaker: – Takeda
Speaker: – ARC-Net and Department of Engineering for Innovative Medicine, University of Verona, Italy
Research Involving Data and New TechnologiesLegal Considerations in Research OversightIRB ReviewPharma/Biotech Perspectives
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Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH09 - Exempt Study Review: How to Find Flexibilities in the Current RegulationsLocation: Ballroom 1
Speaker: – UC San Diego
Speaker: – University of California, Irvine, IRB
Speaker: – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
IRB ReviewSocial, Behavioral, and Educational ResearchIRB Fundamentals
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Wednesday, Nov 20th
10:30 AM – 11:45 AM PTH13 - Tick-Tock! How to Not Waste Your Time While Writing Minutes!Location: Room 423-425
Speaker: – Independent Professional
Speaker: – Office for Human Research Protections (OHRP)
Speaker: – Office of the Chief Medical Officer, FDA
FDA Regulated ResearchIRB ReviewIRB FundamentalsIACUC FundamentalsIACUC Review
