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Human Subject Research - HSR

ACU/IACUC

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Monday, Nov 18th
10:30 AM – 11:45 AM PT
A19 - New Regulations and Federal Policy Updates: Get Up to Speed!
Location: Signature Room
Speaker: James Riddle, MCSE, CIP, CPIA, CRQM – Advarra
Shared Research Oversight ChallengesResearch Oversight Leaders and Institutional Officials
Monday, Nov 18th
10:30 AM – 11:45 AM PT
A16 - 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: Martha F. Jones, MA, CIP – Mass General Brigham Incorporated
Panelist: Gordon Roble, DVM, MBA, DACLAM (he/him/his) – Fred Hutchinson Cancer Center
Panelist: Brad Ahrens, DVM, PhD – Labcorp
Panelist: Bruce G. Gordon, MD (he/him/his) – University of Nebraska Medical Center
Shared Research Oversight ChallengesResearch Oversight Leaders and Institutional OfficialsIRB ReviewIACUC Review
Monday, Nov 18th
10:30 AM – 11:45 AM PT
A17 - Consciously Uncoupling? When Institutions and Investigators Separate (amicably, or sometimes not so much)
Location: Room 445-446
Speaker: Crista Brawley, Ph. D., CCRP (she/her/hers) – Northwestern University
Speaker: Iris L. Jenkins, PhD (she/her/hers) – Virginia Tech
Speaker: Natalie L. Mays, BA, LATG, CPIA – New York University Grossman School of Medicine
Shared Research Oversight ChallengesHRPP/IRB Management and AdministrationACU/IACUC Program Management and AdministrationResearch Oversight Leaders and Institutional Officials
Monday, Nov 18th
10:30 AM – 11:45 AM PT
A18 - The Cost to Having a Revolving Door: PI Onboarding & Exit Planning
Location: Room 347-348
Speaker: Margie Brackeen (she/her/hers) – Nationwide Children's Hospital
Speaker: Tanise L. Jackson, DVM, DACLAM, CPIA (she/her/hers) – Florida A&M University
Education, Qualifications, and TrainingHRPP/IRB Management and AdministrationACU/IACUC Program Management and AdministrationShared Research Oversight ChallengesResearch Oversight Leaders and Institutional Officials
Monday, Nov 18th
12:30 PM – 1:30 PM PT
N06 - Planning for Ethical and Regulatory Changes in Human and Non-human Animal Research Programs
Location: Room 333-334
Speaker: Michelle C. Stickler, DEd, CIP (she/her/hers) – The University of Texas at Austin
Speaker: CeCe Brotchie-Fine, DBe, CPIA (she/her/hers) – Novartis
Shared Research Oversight ChallengesResearch Oversight Leaders and Institutional Officials
Monday, Nov 18th
1:45 PM – 3:00 PM PT
B19 - PLENARY: Institutional Approaches to Research Security Programs
Location: Room 423-425
Moderator: Susan W. Sedwick, PhD, CRA, CSM (she/her/hers) – Attain Partners
Panelist: Michelle C. Stickler, DEd, CIP (she/her/hers) – The University of Texas at Austin
Panelist: Sujatha Sridhar, MBBS, MCE – University of Texas Health Science Center at Houston
Panelist: Matt McLellan – Cayuse
ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges
Monday, Nov 18th
1:45 PM – 3:00 PM PT
B20 - Leaders of International Research: Navigating Research Regulations and Promoting Ethical Practices
Location: Room 444
Speaker: John R. Baumann, PhD (he/him/his) – formerly of Indiana University
Speaker: Delia Wolf Christiani, MD, JD, MSCI (she/her/hers) – Harvard T.H. Chan School of Public Health
Speaker: Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I (she/her/hers) – Stanford University
Research Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges
Monday, Nov 18th
1:45 PM – 3:00 PM PT
B07 - A Crisis Is a Crisis: Lessons Learned From Human-Based and Animal-Based Controversies and What We Can Learn From Our Colleagues Across the Hall
Location: Room 331
Speaker: Amy Puffenberger, M.A.M. (she/her/hers) – University of Michigan
Speaker: Deepika Bhatia, CHRC, CHPC, CCEP,CCRP (she/her/hers) – Emory University
Speaker: Maria G. Davila, MD MA CCRC CIP (she/her/hers) – Emory University
Communication With the PublicACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationShared Research Oversight ChallengesResearch Oversight Leaders and Institutional Officials
Monday, Nov 18th
1:45 PM – 3:00 PM PT
B17 - Effectively Managing the Use of Controlled Substances in Research
Location: Room 445-446
Speaker: Amy Kuei-Lan Chuang, MS,, RQAP-GLP, CPIA (she/her/hers) – Virginia Commonwealth University
Speaker: Kelli Christman, MHA (she/her/hers) – University of Michigan
Speaker: Joshua L. West, B.S. (he/him/his) – University of Michigan
Education, Qualifications, and TrainingHRPP/IRB Management and AdministrationACU/IACUC Program Management and AdministrationShared Research Oversight ChallengesResearch Oversight Leaders and Institutional OfficialsLegal Considerations in Research OversightPharma/Biotech Perspectives
Monday, Nov 18th
3:30 PM – 4:45 PM PT
C19 - What You Don't Know Can Hurt You: Using Metrics to Evaluate Research Administrative Activities
Location: Signature Room
Speaker: Stacy Pritt, MS, DVM, MBA, CPIA, CHRC, DACAW (she/her/hers) – Texas A&M University System
Speaker: Jane Strasser, PhD (she/her/hers) – University of Cincinnati
ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges
Monday, Nov 18th
3:30 PM – 4:45 PM PT
C20 - PLENARY: Research Integrity Management in the New Public Arena
Location: Room 335
Moderator: Ross A. Hickey, JD, CIP, CPIA – University of Southern Maine
Panelist: Sheila Garrity, JD, MPH, MBA (she/her/hers) – Office of Assistant Secretary for Health
Panelist: Robin S. Tyndall, MS (she/her/hers) – Clemson University
Panelist: Courtney Karmelita, D.Ed (she/her/hers) – Penn State
ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges
Tuesday, Nov 19th
8:00 AM – 8:30 AM PT
Special Music by Ivor Pritchard & Lauren Hartsmith.
Location: Ballroom 1
Presenter: Ivor A. Pritchard, PhD (he/him/his) – None
Presenter: Lauren Hartsmith, JD, CIP (she/her/hers) – Hartsmith Consulting, LLC
ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges
Tuesday, Nov 19th
8:30 AM – 9:00 AM PT
PRIMR24 Opening Board Remarks & Award Presentation
Location: Ballroom 1
Opening Remarks: Jori K. Leszczynski, DVM, DACLAM (she/her/hers) – University of Colorado Denver | Anschutz Medical Campus
Award Recipient: Nancy A. Olson, JD – University of Nebraska Medical Center
ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges
Tuesday, Nov 19th
9:00 AM – 10:00 AM PT
General Session: 50 Years of PRIM&R: Pioneers, the Present, and the Path Forward
Location: Ballroom 1
Presenter: Ivor A. Pritchard, PhD (he/him/his) – None
Presenter: Lauren Hartsmith, JD, CIP (she/her/hers) – Hartsmith Consulting, LLC
Opening Remarks: Jori K. Leszczynski, DVM, DACLAM (she/her/hers) – University of Colorado Denver | Anschutz Medical Campus
Award Recipient: Nancy A. Olson, JD – University of Nebraska Medical Center
Moderator: Ivy Tillman, EdD, CIP, (she/her/hers) – PRIM&R
Panelist: Joan Rachlin, JD, MPH (she/her/hers) – PRIM&R
Panelist: Elisa A. Hurley, PhD (she/her/hers) – N/A
Panelist: Susan Z. Kornetsky, MPH – Boston Children's Hospital
Panelist: Noé Tirado-Muñiz, DMV, DVM, MS, CPIA (he/him/his) – University of Kentucky
Panelist: Tonya Ferraro, MEd (she/her/hers) – AAHRPP
ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges
Tuesday, Nov 19th
10:30 AM – 11:45 AM PT
D19 - Do Institutional Officials (IOs) Understand Ethics?
Location: Room 333-334
Speaker: Robert E. Nobles, II, DrPH, MPH (he/him/his) – Emory University
Speaker: Susan W. Sedwick, PhD, CRA, CSM (she/her/hers) – Attain Partners
Speaker: Emily E. Anderson, PhD, MPH (she/her/hers) – Loyola University Chicago Stritch School of Medicine
ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges
Tuesday, Nov 19th
10:30 AM – 11:45 AM PT
D20 - Retaining Good Research Ethics and Oversight Staff
Location: Room 331
Speaker: Mariette Marsh, MPA, CIP, CHPC, CHRC (she/her/hers) – University of Arizona
Speaker: Jason M. Malone, MPA, CIP (he/him/his) – University of Washington
Speaker: Stacy Pritt, MS, DVM, MBA, CPIA, CHRC, DACAW (she/her/hers) – Texas A&M University System
ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges
Tuesday, Nov 19th
1:45 PM – 3:00 PM PT
E19 - Balancing Risk and Reward in Research Programs
Location: Room 445-446
Speaker: Julie Ozier, MHL, CHRC, CIP – Advarra, Inc.
Speaker: George Gasparis – The PEER Consulting Group
ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight ChallengesLegal Considerations in Research Oversight
Tuesday, Nov 19th
1:45 PM – 3:00 PM PT
E20 - Institutional Officials (IOs): Navigating the Complex Roles of IOs and the Model Best for Your Organization
Location: Room 322
Speaker: Robert E. Nobles, II, DrPH, MPH (he/him/his) – Emory University
Speaker: Susan W. Sedwick, PhD, CRA, CSM (she/her/hers) – Attain Partners
Research Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges
Tuesday, Nov 19th
1:45 PM – 3:00 PM PT
E16 - Done Wrong, Gotta Pay: Research Non-compliance and Research Misconduct and Possible Sponsor Pay-Back
Location: Room 431-432
Speaker: John R. Baumann, PhD (he/him/his) – formerly of Indiana University
Education, Qualifications, and TrainingHRPP/IRB Management and AdministrationACU/IACUC Program Management and AdministrationShared Research Oversight ChallengesResearch Oversight Leaders and Institutional OfficialsLegal Considerations in Research Oversight
Tuesday, Nov 19th
1:45 PM – 3:00 PM PT
E17 - Roundtable Listening Session with the PRIM&R’s Executive Director & Leadership Team
Location: Room 323-324
Speaker: Ivy Tillman, EdD, CIP, (she/her/hers) – PRIM&R
Speaker: Catherine Batsford (she/her/hers) – PRIM&R
Speaker: Shana Sonbolian (she/her/hers) – PRIM&R
Speaker: Maeve Luthin, JD (she/her/hers) – PRIM&R
Speaker: Ann Waterbury, MBA – PRIM&R
Speaker: Ianthe N. Bryant-Gawthrop, MS, CRA, CIP (she/her/hers) – PRIM&R
Speaker: Beverly Andrade, MBA (she/her/hers) – PRIM&R
ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight Challenges
Tuesday, Nov 19th
1:45 PM – 3:00 PM PT
E18 - What Institutional Leadership Needs to Know...From You!
Location: Room 347-348
Speaker: Mariette Marsh, MPA, CIP, CHPC, CHRC (she/her/hers) – University of Arizona
Speaker: Eric C. Mah, EdD, MHS – UC San Diego
ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationShared Research Oversight ChallengesResearch Oversight Leaders and Institutional Officials
Tuesday, Nov 19th
3:30 PM – 4:45 PM PT
F19 - Proposed Changes to the Public Health Policy (PHS) on Research Misconduct: Impact on the Researcher Community
Location: Room 333-334
Speaker: Sheila Garrity, JD, MPH, MBA (she/her/hers) – Office of Assistant Secretary for Health
Speaker: Jane Strasser, PhD (she/her/hers) – University of Cincinnati
ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight ChallengesLegal Considerations in Research Oversight
Tuesday, Nov 19th
3:30 PM – 4:45 PM PT
F20 - Developing an Emergency Preparedness Plan for an Effective Research System
Location: Room 335
Speaker: Martha F. Jones, MA, CIP – Mass General Brigham Incorporated
Speaker: Glenn Martin, MD CIP (he/him/his) – Icahn School of Medicine at Mount Sinai
ACU/IACUC Program Management and AdministrationHRPP/IRB Management and AdministrationResearch Oversight Leaders and Institutional OfficialsShared Research Oversight ChallengesLegal Considerations in Research Oversight
Tuesday, Nov 19th
3:30 PM – 4:45 PM PT
F17 - Trust Me, I Know What I'm Doing
Location: Room 445-446
Speaker: John D. Horigan, MA, CIP (he/him/his) – Independent Professional
Speaker: Tonya Ferraro, MEd (she/her/hers) – AAHRPP
Speaker: Shannon Ramsey (she/her/hers) – Allen Institute
Shared Research Oversight ChallengesResearch Oversight Leaders and Institutional OfficialsIRB ReviewIACUC ReviewACU/IACUC Program Management and AdministrationHRPP/IRB Management and Administration
Tuesday, Nov 19th
3:30 PM – 4:45 PM PT
F18 - Shake It Up: An Interactive Discussion of Lessons Learned from IRB/IACUC Leaders
Location: Room 444
Speaker: Margie Brackeen (she/her/hers) – Nationwide Children's Hospital
Speaker: Anita Balgopal, PhD (she/her/hers) – Northeastern University
Speaker: Avery E. Freed, CIP (she/her/hers) – Hackensack Meridian Health
Shared Research Oversight ChallengesResearch Oversight Leaders and Institutional OfficialsIRB ReviewIACUC Review
Wednesday, Nov 20th
8:45 AM – 10:00 AM PT
G13 - PLENARY: Ethical Review of Human and Animal Subjects Research Proposals
Location: Room 423-425
Moderator: Jennie Lofgren, DVM, MS, DACLAM (she/her/hers) – Novartis Institutes for Biomedical Research
Panelist: Margaret S. Landi, VMD, MS, DACLAM, MBioethics (she/her/hers) – Landi Animal Research and Bioethics
Panelist: Nancy E. Kass, ScD (she/her/hers) – The Johns Hopkins University
Panelist: Rebecca Walker, PhD (she/her/hers) – University of North Carolina at Chapel Hill
Shared Research Oversight ChallengesResearch Oversight Leaders and Institutional OfficialsIRB ReviewIACUC Review