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Human Subject Research - HSR

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Monday, Nov 18th
1:45 PM – 3:00 PM PT
B06 - Evaluating the Impact of Current and Future Single IRB (sIRB) Requirements on Local IRBs
Location: Ballroom 2
Speaker: Ivana Simic, PhD – University of Florida
Speaker: Solymar Solís-Báez (she/her/hers) – Auxilio Mutuo Hospital
Speaker: Megan Kasimatis Singleton, JD, MBE, CIP – Office of Human Subjects Research Johns Hopkins University School of Medicine
Single IRBHRPP/IRB Management and Administration
Monday, Nov 18th
3:30 PM – 4:45 PM PT
C03 - Postapproval Monitoring (PAM) in a Single IRB (sIRB) World: FDA Edition
Location: Ballroom 2
Speaker: Joshua Fedewa, MS, CIP (he/him/his) – Advarra
Speaker: Adam J. McClintock, MBA, CIP – University of Alabama at Birmingham
Speaker: Nadia Johnson, MS, CIP – NYU Langone Health
Single IRBQA/QI and Postapproval MonitoringFDA Regulated Research
Tuesday, Nov 19th
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: Marcella Cooks, MS (she/her/hers) – Northwestern University
Speaker: Malica T. Dock (she/her/hers) – Rutgers University
Speaker: Ann Johnson, PhD, MPH (she/her/hers) – Stanford University
Single IRBFDA Regulated Research
Tuesday, Nov 19th
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: Nichelle Cobb, PhD, CIP (she/her/hers) – AAHRPP
Speaker: Megan Kasimatis Singleton, JD, MBE, CIP – Office of Human Subjects Research Johns Hopkins University School of Medicine
Single IRBResearch Involving Data and New TechnologiesIRB ReviewPharma/Biotech Perspectives
Wednesday, Nov 20th
8:45 AM – 10:00 AM PT
G08 - Let It Go! Strategies to Prevent Over-Regulation During Local Context Review
Location: Signature Room
Speaker: Rafael Santos, MBE, CIP (he/him/his) – The Pennsylvania State University
Speaker: Courtney Jarboe, DrPH, CIP (she/her/hers) – University of Minnesota
Speaker: Rachel A. Wenzl, MPH, CIP (she/her/hers) – Research Compliance Services, University of Nebraska - Lincoln
Single IRBIRB Review
Wednesday, Nov 20th
10:30 AM – 11:45 AM PT
H03 - Houston, We Have Problem: Exploring Noncompliance in a Single IRB (sIRB) Universe
Location: Ballroom 3
Speaker: Scott J. Lipkin, DPM, CIP – Baptist Health South Florida
Speaker: Hallie Kassan, MS,CIP (she/her/hers) – University of Texas, MD Anderson Cancer Center
Speaker: Raffaella Hart, MSHS, CIP (she/her/hers) – BRANY IRB
Single IRBQA/QI and Postapproval Monitoring