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Human Subject Research - HSR

ACU/IACUC

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Monday, Nov 18th
8:30 AM – 9:00 AM PT
PRIMR24 Co-Chairs Welcome and Executive Director Remarks
Location: Ballroom 1
Opening Remarks: Ivy Tillman, EdD, CIP, (she/her/hers) – PRIM&R
Emerging Research Challenges and Breaking Issues
Monday, Nov 18th
9:00 AM – 10:00 AM PT
PRIMR24 Opening Session: The Next Frontier: Space Exploration Research
Location: Ballroom 1
Moderator: Nichelle Cobb, PhD, CIP (she/her/hers) – AAHRPP
Keynote Speaker: Rachael Dempsey, MBA (she/her/hers) – Translational Research Institute for Space Health
Emerging Research Challenges and Breaking Issues
Monday, Nov 18th
10:30 AM – 11:45 AM PT
A02 - How Do You Actually Review a Protocol Involving Artificial Intelligence (AI)?
Location: Ballroom 1
Speaker: Ivana Simic, PhD – University of Florida
Speaker: Megan Kasimatis Singleton, JD, MBE, CIP – Office of Human Subjects Research Johns Hopkins University School of Medicine
Speaker: Benjamin C. Silverman, MD – Mass General Brigham
Speaker: Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I (she/her/hers) – Stanford University
Emerging Research Challenges and Breaking IssuesIRB ReviewResearch Involving Data and New Technologies
Monday, Nov 18th
10:30 AM – 11:45 AM PT
A11 - PLENARY: Global Perspectives on the Ethics, Principles, and Regulations Guiding Research Involving Nonhuman Animals
Location: Room 323-324
Panelist: Sally Thompson-Iritani, DVM, PhD, CPIA, CCFP, CHABP, CFE (she/her/hers) – University of Washington
Moderator: Janet D. Stemwedel, PhD (she/her/hers) – San Jose State University
Panelist: Margaret S. Landi, VMD, MS, DACLAM, MBioethics (she/her/hers) – Landi Animal Research and Bioethics
Emerging Research Challenges and Breaking IssuesAnimal Well-Being and the 3Rs
Monday, Nov 18th
12:30 PM – 1:30 PM PT
N02 - REACH, the Research Ethics Action Collaborative for HRPPs, for Justice
Location: Signature Room
Speaker: Ivy Tillman, EdD, CIP, (she/her/hers) – PRIM&R
Speaker: Martha F. Jones, MA, CIP – Mass General Brigham Incorporated
Speaker: Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center
Advancing Equity and JusticeEmerging Research Challenges and Breaking Issues
Monday, Nov 18th
1:45 PM – 3:00 PM PT
B02 - Cybersecurity and Research Integrity: Can We Be Trusted to Keep Research Information Safe?
Location: Ballroom 1
Speaker: Brian Decker, MBA, CISSP, PMP – Mayo Clinic
Speaker: Glenn Martin, MD CIP (he/him/his) – Icahn School of Medicine at Mount Sinai
Speaker: Tomislav Mustac – Mount Sinai Health System
Emerging Research Challenges and Breaking IssuesResearch Involving Data and New Technologies
Monday, Nov 18th
1:45 PM – 3:00 PM PT
B13 - An Examination of HHS ORI’s Changes to Research Misconduct Regulations
Location: Room 333-334
Speaker: Lauran Qualkenbush (she/her/hers) – Northwestern University
Speaker: Sheila Garrity, JD, MPH, MBA (she/her/hers) – Office of Assistant Secretary for Health
Emerging Research Challenges and Breaking Issues
Monday, Nov 18th
3:30 PM – 4:45 PM PT
C01 - PLENARY: Taking Stock of the Research Ethics Oversight Ecosystem: Healthy Developments, Overgrowth, and Audit Culture
Location: Ballroom 3
Moderator: Holly Fernandez Lynch, JD, MBe – Perelman School of Medicine, University of Pennsylvania
Panelist: Eric C. Mah, EdD, MHS – UC San Diego
Panelist: Holly A. Taylor, PhD, MPH (she/her/hers) – NIH
QA/QI and Postapproval MonitoringEmerging Research Challenges and Breaking Issues
Monday, Nov 18th
3:30 PM – 4:45 PM PT
C04 - What's That You're Wearing? Human Research Protections and Wearable Devices
Location: Ballroom 1
Speaker: Sara Meeder, CIP (she/her/hers) – Maimonides Medical Center
Speaker: Natalie M. Klein, PhD (she/her/hers) – DHHS Office for Human Research Protections
Research Involving Data and New TechnologiesEmerging Research Challenges and Breaking IssuesIRB ReviewSocial, Behavioral, and Educational Research
Monday, Nov 18th
3:30 PM – 4:45 PM PT
C09 - From Researcher to Sponsor Investigator: How to Work With Your Broader HRPP to Develop and Deploy Safe, Effective, and Ethical Artificial Intelligence (AI)
Location: Room 444
Speaker: Brenna Loufek, MS (she/her/hers) – Mayo Clinic - Center for Digital Health
Speaker: Mark Lifson, PhD (he/him/his) – Mayo Clinic
Speaker: Caroline K. Davis – Microsoft Research
HRPP/IRB Management and AdministrationEmerging Research Challenges and Breaking IssuesResearch Involving Data and New Technologies
Monday, Nov 18th
3:30 PM – 4:45 PM PT
C11 - PLENARY: The Historical Impact of Politics on Scientific Research With Nonhuman Animals
Location: Room 320-321
Moderator: Paula Clifford, MLA, CVT, RLATG – Americans for Medical Progress
Panelist: Naomi Charalambakis, PhD (she/her/hers) – Americans for Medical Progress
Panelist: Brandon Morton – National Association for Biomedical Research
Communication With the PublicEmerging Research Challenges and Breaking Issues
Monday, Nov 18th
3:30 PM – 4:45 PM PT
C15 - Exploring NAMs and Complement-ARIE: Insights for IACUCs
Location: Room 331
Speaker: Sally Thompson-Iritani, DVM, PhD, CPIA, CCFP, CHABP, CFE (she/her/hers) – University of Washington
Speaker: Christine Happel (she/her/hers) – National Center for Advancing Translational Sciences
Speaker: Lisa H. Levin, DVM (she/her/hers) – Coridea, LLC
Emerging Research Challenges and Breaking IssuesIACUC ReviewACU/IACUC Program Management and AdministrationAnimal Well-Being and the 3Rs
Monday, Nov 18th
3:30 PM – 4:45 PM PT
C16 - PLENARY: Bridging Preclinical to Clinical Research With Artificial Intelligence (AI) and Digital Biomarkers: Current Landscape, Vision, and the Collaborative Path Toward Improved Translation
Location: Room 333-334
Panelist: Brian R. Berridge, DVM, PhD, DACVP (he/him/his) – Digital In Vivo Alliance
Panelist: Carrie Annalice Northcott, PhD (she/her/hers) – Pfizer, Inc.
Moderator: Natalie Bratcher-Petersen, MS (she/her/hers) – TLR Ventures/ Digital In Vivo Alliance
Emerging Research Challenges and Breaking IssuesPharma/Biotech PerspectivesAnimal Well-Being and the 3RsResearch Involving Data and New Technologies
Tuesday, Nov 19th
10:30 AM – 11:45 AM PT
D01 - PLENARY: Responsibility Does Not End With Death: Establishing Systems for Ethical Decedent Research
Location: Signature Room
Moderator: Robert S. Salzar, PhD (he/him/his) – Center for Applied Biomechanics, Department of Mechanical and Aerospace Engineering, University of Virginia
Panelist: Carson Cancel, MA, CIP – OHARO, USAMRDC
Panelist: Sara Sochor, MS, CST, FSL, CAISS, CTBS – UVA Center for Applied Biomechanics
Panelist: Paul Micah Johnson, PhD – FBI
Legal Considerations in Research OversightEmerging Research Challenges and Breaking IssuesIRB Review
Tuesday, Nov 19th
10:30 AM – 11:45 AM PT
D09 - The Shifting Paradigm of Data Sharing: Navigating New Challenges Through a Participant-Centered Lens
Location: Room 423-425
Speaker: Stephanie A. Kraft, JD (she/her/hers) – Geisinger College of Health Sciences
Speaker: Ella Greene-Moton (she/her/hers) – Community Based Organization Partners - Community Ethics Review Board
Speaker: Meyad Bird, BA, CIP (she/her/hers) – UT Southwestern Medical Center
Research Involving Data and New TechnologiesIRB ReviewEmerging Research Challenges and Breaking Issues
Tuesday, Nov 19th
1:45 PM – 3:00 PM PT
E04 - Building Trust in Science: Enabling Frameworks for Returning Individual Research Results to Research Participants
Location: Room 423-425
Speaker: Adam C. Berger, PhD (he/him/his) – National Institutes of Health
Speaker: Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center
Emerging Research Challenges and Breaking IssuesHRPP/IRB Management and AdministrationIRB Review
Tuesday, Nov 19th
1:45 PM – 3:00 PM PT
E07 - Using Artificial Intelligence (AI) to Author Key Information (KI) Sections of Human Research Consent Documents
Location: Ballroom 2
Speaker: Judy Birk, JD (she/her/hers) – University of Michigan
Speaker: Autumn Toney – SciTech Strategies, Inc.
Informed ConsentEmerging Research Challenges and Breaking IssuesResearch Involving Data and New Technologies
Tuesday, Nov 19th
1:45 PM – 3:00 PM PT
E08 - PLENARY: Responsible Research Practices in Computing
Location: Room 331
Moderator: Jenn Wortman Vaughan (she/her/hers) – Microsoft Research
Panelist: Margaret Levi – Stanford University
Panelist: Andrew Strait – Ada Lovelace Institute
Panelist: Alicia Edelman Pelton (she/her/hers) – Microsoft
Research Involving Data and New TechnologiesEmerging Research Challenges and Breaking IssuesIRB Review
Tuesday, Nov 19th
1:45 PM – 3:00 PM PT
E09 - Robots in Disguise: When Your Participants are More Than Meets the Eye
Location: Room 343-344
Speaker: Myra Luna-Lucero, EdD (she/her/hers) – Teachers College, Columbia University
Speaker: Karen Stein, PhD (she/her/hers) – Abt Global
Speaker: Kristen D. Krause, PhD, MPH (she/her/hers) – Rutgers School of Public Health & CHIBPS
Research Involving Data and New TechnologiesEmerging Research Challenges and Breaking IssuesIRB ReviewSocial, Behavioral, and Educational Research
Tuesday, Nov 19th
3:30 PM – 4:45 PM PT
F01 - PLENARY: Risk Associated With Human Subjects Research: Whom Are We Obligated to Protect?
Location: Signature Room
Moderator: Susan Stayn, JD – University of California
Panelist: Susan Z. Kornetsky, MPH – Boston Children's Hospital
Panelist: Nora Hutchinson, MD,CM (she/her/hers) – Department of Medicine, University of California, San Francisco
Panelist: David Peloquin, JD (he/him/his) – Ropes & Gray
Emerging Research Challenges and Breaking IssuesIRB ReviewHRPP/IRB Management and Administration
Tuesday, Nov 19th
3:30 PM – 4:45 PM PT
F02 - PLENARY: Artificial Intelligence (AI) Days of Future's Past: Tomorrow's Research Yesterday
Location: Ballroom 1
Moderator: Heather H. Pierce, JD, MPH (she/her/hers) – Association of American Medical Colleges
Panelist: Brenda L. Curtis, PhD, MSPH (she/her/hers) – National Institutes of Health
Panelist: Mary L. Gray, PhD (she/her/hers) – Microsoft Research
Panelist: Tamiko Eto, CIP (she/her/hers) – The Mayo Clinic
Social, Behavioral, and Educational ResearchHRPP/IRB Management and AdministrationIRB ReviewResearch Involving Data and New TechnologiesEmerging Research Challenges and Breaking Issues
Tuesday, Nov 19th
3:30 PM – 4:45 PM PT
F04 - IRB Review of Research Involving Politicized Topics and Populations
Location: Ballroom 3
Speaker: Michael Centola, MHS, CIP (he/him/his) – University of Connecticut
Speaker: Karen Christianson (she/her/hers) – HRP Consulting Group
Speaker: Leandra Smollin, PhD (she/her/hers) – The Fenway Institute, Fenway Health
IRB ReviewEmerging Research Challenges and Breaking IssuesAdvancing Equity and JusticePopulations Requiring Additional ProtectionsSocial, Behavioral, and Educational Research
Wednesday, Nov 20th
7:30 AM – 8:30 AM PT
Opening General Session: More Cure, Less Side Effects: A Potential Role for Preclinical Studies
Location: Ballroom 1
Moderator: Jennie Lofgren, DVM, MS, DACLAM (she/her/hers) – Novartis Institutes for Biomedical Research
Panelist: Courtney Horvath, PhD, DABT (she/her/hers) – Novartis Biomedical Research
Panelist: Brian R. Berridge, DVM, PhD, DACVP (he/him/his) – Digital In Vivo Alliance
Emerging Research Challenges and Breaking IssuesIACUC ReviewIRB ReviewPharma/Biotech Perspectives
Wednesday, Nov 20th
8:45 AM – 10:00 AM PT
G01 - Are the Ways We Contemplate Risk Outdated?
Location: Ballroom 2
Speaker: Katherine D. Blizinsky, PhD (she/they) – National Institutes of Health
Speaker: Christine Suver, PhD, PMP – Sage Bionetworks
Speaker: Barbara Thomas – National Human Genome Research Institute, National Institutes of Health
Emerging Research Challenges and Breaking IssuesIRB ReviewHRPP/IRB Management and Administration
Wednesday, Nov 20th
8:45 AM – 10:00 AM PT
G06 - Managing Dual/Multiple Relationships: Grappling With Identity and Interpersonal Boundaries in Human Subjects Research
Location: Room 445-446
Speaker: Benjamin C. Silverman, MD – Mass General Brigham
Speaker: Amy Ben-Arieh, JD, MPH (she/her/hers) – The Fenway Institute
Emerging Research Challenges and Breaking IssuesHRPP/IRB Management and AdministrationAdvancing Equity and Justice
Wednesday, Nov 20th
8:45 AM – 10:00 AM PT
G10 - PLENARY: Replicability, Reproducibility, Rigor, and Red Herrings
Location: Room 320-321
Moderator: Lisa H. Levin, DVM (she/her/hers) – Coridea, LLC
Panelist: Stacy Pritt, MS, DVM, MBA, CPIA, CHRC, DACAW (she/her/hers) – Texas A&M University System
Panelist: Penny S. Reynolds, PhD (she/her/hers) – University of Florida College of Medicine
Emerging Research Challenges and Breaking IssuesAnimal Well-Being and the 3RsIACUC Review
Wednesday, Nov 20th
10:30 AM – 11:45 AM PT
H04 - Comparative Effectiveness Research (CER): When Important Research Does Not Fit the Regulatory Mold
Location: Room 431-432
Speaker: Joshua Fedewa, MS, CIP (he/him/his) – Advarra
Speaker: Charles Natanson, MD – National Institutes of Health
Speaker: Kelly FitzGerald, PhD, CIP (she/her/hers) – WCG
Speaker: Ivor A. Pritchard, PhD (he/him/his) – None
IRB ReviewEmerging Research Challenges and Breaking Issues
Wednesday, Nov 20th
10:30 AM – 11:45 AM PT
H05 - Pharma Perspectives on the Use of Social Media and Social Media Influencers in Clinical Research
Location: Room 335
Speaker: Missy Heidelberg, B.S., M.S. Bioethics (she/her/hers) – Takeda Pharmaceuticals
Speaker: Karla Childers, BA, MSJ, MBE (she/her/hers) – Johnson & Johnson
Speaker: David G. Forster, JD, MA, CIP (he/him/his) – WCG
Pharma/Biotech PerspectivesEmerging Research Challenges and Breaking Issues