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Human Subject Research - HSR
ACU/IACUC
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Monday, Nov 18th
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 Study
Location: Room 345-346
Speaker:
Amanda Matthews, AA, CIP (she/her/hers)
– The Children's Mercy Hospital | Children’s Mercy Research Institute
Speaker:
Carley Emerson, MS, CIP, CCRP (she/her/hers)
– The University of North Carolina at Chapel Hill
FDA Regulated Research
IRB Fundamentals
IRB Review
Tuesday, Nov 19th
10:30 AM – 11:45 AM
PT
D07 - Reviewing Incidents of Non-Compliance: Strategies for IRB Chairs and Members
Location: Ballroom 3
Speaker:
Megan Kasimatis Singleton, JD, MBE, CIP
– Office of Human Subjects Research Johns Hopkins University School of Medicine
Speaker:
Bruce G. Gordon, MD (he/him/his)
– University of Nebraska Medical Center
Speaker:
George Gasparis
– The PEER Consulting Group
QA/QI and Postapproval Monitoring
IRB Review
IRB Fundamentals
Tuesday, Nov 19th
10:30 AM – 11:45 AM
PT
D10 - Accessibility Basics: Making Word Documents Accessible
Location: Room 336
Speaker:
Sarah Muenster-Blakley, MA, CIP (she/her/hers)
– University of St. Thomas, Minnesota
Speaker:
Cecilia Brooke Cholka, PhD, CIP (she/her/hers)
– Weill Cornell Medicine
Speaker:
Willyanne DeCormier Plosky, DrPH (she/her/hers)
– Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
Advancing Equity and Justice
Education, Qualifications, and Training
IRB Review
IRB Fundamentals
Social, Behavioral, and Educational Research
Tuesday, Nov 19th
1:45 PM – 3:00 PM
PT
E03 - All Things Subpart C
Location: Signature Room
Speaker:
Bridget McKenney, PhD, CIP (she/her/hers)
– National Institute of Justice
Speaker:
Julia G. Gorey, JD (she/her/hers)
– OHRP
Speaker:
Nancy E. Kass, ScD (she/her/hers)
– The Johns Hopkins University
Populations Requiring Additional Protections
IRB Review
IRB Fundamentals
Social, Behavioral, and Educational Research
Tuesday, Nov 19th
5:00 PM – 6:00 PM
PT
N14 - Human Subjects Research Trivia!
Location: Ballroom 2
Speaker:
Nyssa Towsley, MS, CIP (they/she)
– University of Nevada, Las Vegas
Speaker:
John D. Horigan, MA, CIP (he/him/his)
– Independent Professional
Speaker:
Tonya Ferraro, MEd (she/her/hers)
– AAHRPP
Speaker:
Andrew Hedrick, MPA, CIP
– The Ohio State University
HRPP/IRB Management and Administration
IRB Review
Social, Behavioral, and Educational Research
IRB Fundamentals
Wednesday, Nov 20th
8:45 AM – 10:00 AM
PT
G14 - No Findings? No Problem: Why Non-Issue Audits Still Matter
Location: Room 333-334
Speaker:
Courtney Karmelita, D.Ed (she/her/hers)
– Penn State
Speaker:
Neala J. Lane, MS, CCRC (she/her/hers)
– Indiana University
Speaker:
Alyssa AK Speier, MS, CIP (she/her/hers)
– Harvard T.H. Chan School of Public Health
IRB Fundamentals
IACUC Fundamentals
QA/QI and Postapproval Monitoring
Wednesday, Nov 20th
10:30 AM – 11:45 AM
PT
H09 - Exempt Study Review: How to Find Flexibilities in the Current Regulations
Location: Ballroom 1
Speaker:
Ben Mooso, MS, CCRP (he/him/his)
– UC San Diego
Speaker:
Beverley W. Alberola, CIP (she/her/hers)
– University of California, Irvine, IRB
Speaker:
Jaime O. Hernandez, JD, MBE (he/him/his)
– Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
IRB Review
Social, Behavioral, and Educational Research
IRB Fundamentals
Wednesday, Nov 20th
10:30 AM – 11:45 AM
PT
H13 - Tick-Tock! How to Not Waste Your Time While Writing Minutes!
Location: Room 423-425
Speaker:
John D. Horigan, MA, CIP (he/him/his)
– Independent Professional
Speaker:
Crystal Kelly, MPH (she/her/hers)
– Office for Human Research Protections (OHRP)
Speaker:
Lauren Milner, PhD (she/her/hers)
– Office of the Chief Medical Officer, FDA
FDA Regulated Research
IRB Review
IRB Fundamentals
IACUC Fundamentals
IACUC Review