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  • Monday, Dec 4th
    1:00 PM – 2:00 PM ET
    A04 - [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 Proposals
    Location: Room 145 AB
    Speaker: Monica H. Kane, MPH (she/her/hers) – Northwestern University IRB Office
    Speaker: John Roberts, CIP – Drexel University
    Resource Person: Michael Stidham, DPT – DHHS Office for Human Research Protections
    Single IRBHRPP/IRB Administration/Management and Process
  • Monday, Dec 4th
    2:15 PM – 3:15 PM ET
    B05 - [IN-PERSON/RECORDED] Local Considerations: Navigating the Regulations, Recommendations, and Review
    Location: Room 147 AB
    Resource Person: Amanda P. Sly, MS, CIP (she/her/hers) – OHRP
    Speaker: Lubabah Helwani, CIP (she/her/hers) – University of California, Los Angeles
    Single IRBFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
  • Monday, Dec 4th
    3:45 PM – 4:45 PM ET
    C01 - [IN-PERSON/RECORDED] Single IRB (sIRB) Coordination Models: Innovative Approaches from Four Clinical and Translational Science Award (CTSA) Programs
    Location: Ballroom AB
    Speaker: Amy Trullinger, CCRP (she/her/hers) – Indiana University School of Medicine, Indiana CTSI
    Speaker: Emily Serdoz, MPA (she/her/hers) – Vanderbilt University Medical Center
    Speaker: Annie Risenmay, BA, CIP, MPA (she/her/hers) – University of Utah IRB
    Single IRBFlexibility and Innovation in Research Oversight ProcessesHRPP/IRB Administration/Management and Process
  • Tuesday, Dec 5th
    1:00 PM – 2:00 PM ET
    D03 - [IN-PERSON/RECORDED] A Tale of Two Institutions: Examining the Impact of the FDA Single (sIRB) Mandate
    Location: Ballroom AB
    Speaker: Joshua Fedewa, MS, CIP (he/him/his) – University of Michigan
    Speaker: Adam J. McClintock, MBA CIP – University of Alabama at Birmingham
    Single IRBEmerging Research Challenges and Breaking IssuesFDA Regulated ResearchHRPP/IRB Administration/Management and Process
  • Tuesday, Dec 5th
    4:00 PM – 5:00 PM ET
    E11 - [IN-PERSON ONLY] Maintaining a Robust HRPP in a Single IRB World
    Location: Room 149 AB
    Speaker: Scott J. Lipkin, DPM, CIP – Baptist Health South Florida
    Single IRBHRPP/IRB Administration/Management and ProcessSmall Research Programs
  • Wednesday, Dec 6th
    1:45 PM – 2:45 PM ET
    H05 - [IN-PERSON/RECORDED] Postapproval Monitoring (PAM) for Studies Overseen by a Single External IRB of Record: Challenges forLocal Monitoring Programs
    Location: Ballroom C
    Speaker: Frederick W. Luthardt, Jr., D.Be., MA (he/him/his) – Johns Hopkins University School of Medicine
    Speaker: Jessica Rowe, MA, MS, CCRP, CIP (she/her/hers) – Yale Cancer Center, Clinical Trials Office
    QA/QI and Postapproval MonitoringSingle IRB