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Human Subject Research - HSR

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Thursday, Nov 6th
11:30 AM - 12:30 PM ET
B02 - When SBER Meets FDA: A Survival Guide to Support SBE IRBs and Researchers
Speaker: Kanti Crain, MA, MBA, CIP – Indiana University
Speaker: Erin M. Odor, MA, CIP (she/her/hers) – Advarra
Social, Behavioral, and Educational ResearchFoundations of Research Ethics and OversightRegulatory Frameworks and ComplianceIRB Operations and Management
Thursday, Nov 6th
11:30 AM - 12:30 PM ET
B03 - Trust me, I Know What I'm Doing: SBER Edition!
Speaker: Tonya Ferraro, MEd (she/her/hers) – AAHRPP
Speaker: John D. Horigan, MA, CIP (he/him/his) – Independent Professional
Social, Behavioral, and Educational ResearchRegulatory Frameworks and ComplianceIRB Operations and Management
Friday, Nov 7th
10:30 AM - 11:45 AM ET
A01 - PLENARY: Navigating the IRB's Role Beyond Regulatory Compliance
Moderator: Stephen J. Rosenfeld, MD, MBA (he/him/his) – North Star Review Board
Panelist: Holly A. Taylor, PhD, MPH (she/her/hers) – NIH
Panelist: Holly Fernandez Lynch, JD, MBe (she/her/hers) – Perelman School of Medicine, University of Pennsylvania
Panelist: Emily E. Anderson, PhD, MPH (she/her/hers) – Loyola University Chicago Stritch School of Medicine
Foundations of Research Ethics and OversightIRB Operations and ManagementNavigating Ethical ChallengesRegulatory Frameworks and Compliance
Friday, Nov 7th
10:30 AM - 11:45 AM ET
A02 - Collaborative Project on Artificial Intelligence (AI) Regulatory and Ethical Review: Insights, Challenges, and Practical Tools
Speaker: Tamiko Eto, CIP (she/her/hers) – Center for AI & Digital Policy (CAIDP)
Speaker: Trevor Baker – Multi-Regional Clinical Trials Center
Speaker: Donna Snyder, MD, MBE (she/her/hers) – WCG
Speaker: Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center
Speaker: David Clifford
Emerging Challenges and Innovations in ResearchRegulatory Frameworks and Compliance
Friday, Nov 7th
10:30 AM - 11:45 AM ET
A03 - The Ethics of Placebo Controls in Vaccine Clinical Trials
Speaker: Nancy E. Kass, ScD (she/her/hers) – The Johns Hopkins University
Speaker: Daniel Salmon, PhD, MPH – Johns Hopkins Bloomberg School of Public Health
Speaker: Christine Grady
Regulatory Frameworks and ComplianceEmerging Challenges and Innovations in ResearchNavigating Ethical Challenges
Friday, Nov 7th
10:30 AM - 11:45 AM ET
A04 - Local Context Review: Why It’s Essential and How to Do It Well
Speaker: Nichelle Cobb, PhD, CIP (she/her/hers) – AAHRPP
Speaker: Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine
IRB Operations and ManagementRegulatory Frameworks and Compliance
Friday, Nov 7th
12:30 PM - 1:30 PM ET
N07 - Round Table: Insights from Industry: Research Participant Compensation
Speaker: Kelly FitzGerald, PhD, CIP (she/her/hers) – WCG
Speaker: Karla Childers, BA, MSJ, MBE (she/her/hers) – Johnson & Johnson
Speaker: Lindsay McNair, MD, MPH, MSB (she/her/hers) – Equipoise Consulting, LLC
Emerging Challenges and Innovations in ResearchRegulatory Frameworks and ComplianceNavigating Ethical Challenges
Friday, Nov 7th
1:45 PM - 3:00 PM ET
B01 - PLENARY: Ethical and Regulatory Considerations for Cutting-Edge Neurotechnology Research
Panelist: Benjamin C. Silverman, MD – Mass General Brigham
Panelist: Leigh R. Hochberg, MD, PhD – Mass General Brigham
Panelist: Debra JH Mathews, PhD, MA (she/her/hers) – Johns Hopkins University
Emerging Challenges and Innovations in ResearchIRB Operations and ManagementRegulatory Frameworks and ComplianceNavigating Ethical Challenges
Friday, Nov 7th
1:45 PM - 3:00 PM ET
B02 - Navigating the New Frontier: IRB Challenges with Complex Innovative Trial Designs
Speaker: Molly Klote, MD – Klote Medical Research Advisors, LLC
Speaker: Kelly FitzGerald, PhD, CIP (she/her/hers) – WCG
Navigating Ethical ChallengesEmerging Challenges and Innovations in ResearchRegulatory Frameworks and Compliance
Friday, Nov 7th
1:45 PM - 3:00 PM ET
B03 - Navigating Ethical and Regulatory Complexities in Research with Children
Speaker: Saraf Salim, MPH (she/her/hers) – Research Foundation for Mental Health
Speaker: Tiffany Chenneville, PhD (she/her/hers) – University of South Florida
Speaker: Myra Luna-Lucero, EdD (she/her/hers) – Teachers College, Columbia University
Foundations of Research Ethics and OversightRegulatory Frameworks and Compliance
Friday, Nov 7th
1:45 PM - 3:00 PM ET
B04 - Building a Positive Post-Approval Program—Even with Limited Resources
Speaker: Jessica Orak, BA (she/her/hers) – Medical University of South Carolina
Speaker: Jennifer Ensley Gorshe, CIP, CHRC (she/her/hers) – KBR
Speaker: Regan Pulaski, BS, CCRP – Connecticut Children's
IRB Operations and ManagementRegulatory Frameworks and Compliance
Friday, Nov 7th
3:30 PM - 4:45 PM ET
C01 - PLENARY: Ethical Considerations for Discontinued Clinical Trials and Programs
Moderator: Karla Childers, BA, MSJ, MBE (she/her/hers) – Johnson & Johnson
Panelist: Missy Heidelberg, B.S., M.S. Bioethics (she/her/hers) – Takeda Pharmaceuticals
Panelist: Lindsay McNair, MD, MPH, MSB (she/her/hers) – Equipoise Consulting, LLC
Panelist: Crispin Woolston, PhD (he/him/his) – Sanofi
Emerging Challenges and Innovations in ResearchNavigating Ethical ChallengesRegulatory Frameworks and Compliance
Friday, Nov 7th
3:30 PM - 4:45 PM ET
C02 - FDA Oversight Made Simple: Key Concepts and Application to Research
Speaker: Carley Emerson, MS, CIP, CCRP (she/her/hers) – The University of North Carolina at Chapel Hill
Speaker: Amanda Matthews, AA, CIP (she/her/hers) – The Children's Mercy Hospital | Children’s Mercy Research Institute
Speaker: Angela Robinson, MEd, LATg, CIP (she/her/hers) – Sanford
Foundations of Research Ethics and OversightRegulatory Frameworks and ComplianceIRB Operations and Management
Friday, Nov 7th
3:30 PM - 4:45 PM ET
C03 - Spotlight on Post-Approval Monitoring & Single IRB: What’s Working Now?
Speaker: Catherine Branham, MBA, CHRC (she/her/hers) – University of Iowa Human Subjects Office
Speaker: Neala J. Lane, MA, CCRC (she/her/hers) – Indiana University
Speaker: Marcella Cooks, MS (she/her/hers) – Northwestern University
IRB Operations and ManagementRegulatory Frameworks and Compliance
Friday, Nov 7th
3:30 PM - 4:45 PM ET
C04 - Leveraging AI and Emerging Digital Technologies in Risk Management for Human Health Research
Speaker: Rafael Gonzalez – Pontificia Universidad Javeriana
Speaker: Margarita Manrique-Andrade (she/her/hers) – Hospital Universitario San Ignacio, Pontificia Universidad Javeriana
Speaker: Tamiko Eto, CIP (she/her/hers) – Center for AI & Digital Policy (CAIDP)
Emerging Challenges and Innovations in ResearchRegulatory Frameworks and ComplianceIRB Operations and Management
Saturday, Nov 8th
10:30 AM - 11:45 AM ET
D02 - Beyond Emerging Tech: Using Embedded Ethics to Support the Design and Conduct of Clinical Trials
Speaker: Joseph Ali, JD – Johns Hopkins Berman Institute of Bioethics
Speaker: Emily Largent, JD, PhD, RN – University of Pennsylvania Perelman School of Medicine
Speaker: Stephanie Morain, PhD, MPH – Johns Hopkins Berman Institute of Bioethics
Speaker: Jeremy Sugarman, MD, MPH, MA – Johns Hopkins University
Emerging Challenges and Innovations in ResearchNavigating Ethical ChallengesRegulatory Frameworks and Compliance
Saturday, Nov 8th
10:30 AM - 11:45 AM ET
D03 - PLENARY: What Counts as a Direct Benefit of Research?
Panelist: Luke Gelinas, PhD (he/him/his) – Advarra
Panelist: Benjamin C. Silverman, MD – Mass General Brigham
Panelist: Missy Heidelberg, B.S., M.S. Bioethics (she/her/hers) – Takeda Pharmaceuticals
Foundations of Research Ethics and OversightIRB Operations and ManagementNavigating Ethical ChallengesRegulatory Frameworks and Compliance
Saturday, Nov 8th
10:30 AM - 11:45 AM ET
D04 - Inclusive Informed Consent: Engaging People with Disabilities in Research Participation
Speaker: Maya Sabatello, LLB, PhD (she/her/hers) – Columbia University Irving Medical Center
Speaker: Franz Castro, MD, MSc, MPH – Johns Hopkins University
Speaker: Nancy A. Olson, JD – University of Nebraska Medical Center
Speaker: Natalie M. Klein, PhD – HHS Office for Human Research Protections
Foundations of Research Ethics and OversightIRB Operations and ManagementRegulatory Frameworks and Compliance
Saturday, Nov 8th
12:30 PM - 1:30 PM ET
N19 - Round Table Discussion: Should We Still Be Using Unconsented Biospecimens for Research in 2025?
Speaker: Luke Gelinas, PhD (he/him/his) – Advarra
Speaker: Benjamin C. Silverman, MD – Mass General Brigham
Speaker: Martha F. Jones, MA, CIP – Mass General Brigham Incorporated
Contributor (Not Presenting): Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center
Emerging Challenges and Innovations in ResearchIRB Operations and ManagementRegulatory Frameworks and ComplianceNavigating Ethical Challenges
Saturday, Nov 8th
12:30 PM - 1:30 PM ET
N20 - Everything You Wanted to Know About SMART IRB Agreement Version 3.0
Speaker: Jeremy Lavigne, MA, CIP – SMART IRB, Harvard University
Speaker: Polly Goodman, BS, CIP (she/her/hers) – Harvard University
Speaker: Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center
Emerging Challenges and Innovations in ResearchRegulatory Frameworks and Compliance
Saturday, Nov 8th
1:45 PM - 3:00 PM ET
E02 - Research Plot Twists: Addressing and Expecting the Unexpected
Speaker: Cheri M. Pettey, MA, CIP (she/they) – Advarra, Inc.
Speaker: Andrew Hedrick, MPA, CIP – The Ohio State University
Foundations of Research Ethics and OversightIRB Operations and ManagementRegulatory Frameworks and Compliance
Saturday, Nov 8th
1:45 PM - 3:00 PM ET
E03 - Truth, Lies, and Research: The Paradox of Deception
Speaker: Casey Mumaw, CIP (he/him/his) – Indiana University
Speaker: Iris L. Jenkins, PhD (she/her/hers) – Virginia Tech
Speaker: Rachel A. Wenzl, PhD, MPH, CIP (she/her/hers) – Research Compliance, Integrity & Security, University of Nebraska - Lincoln
Foundations of Research Ethics and OversightRegulatory Frameworks and Compliance
Saturday, Nov 8th
1:45 PM - 3:00 PM ET
E04 - Preparing for sIRB Review: Perspectives from Institutional and Independent IRBs
Speaker: Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine
Speaker: David A. Borasky, Jr., MPH, CIP (he/him/his) – WCG
Speaker: Stephen J. Rosenfeld, MD, MBA (he/him/his) – North Star Review Board
IRB Operations and ManagementRegulatory Frameworks and Compliance
Saturday, Nov 8th
3:30 PM - 4:45 PM ET
F01 - PLENARY: Redefining Private Information and Privacy in the Digital Era
Moderator: Ivor A. Pritchard, PhD (he/him/his) – None
Panelist: Nicholas Proferes, PhD (he/him/his) – Arizona State
Panelist: Randolph D. Hubach, PhD, MPH – Purdue University
Panelist: Colleen Roberts, J.D. (she/her/hers) – Ropes & Gray LLP
Emerging Challenges and Innovations in ResearchRegulatory Frameworks and Compliance
Saturday, Nov 8th
3:30 PM - 4:45 PM ET
F02 - Approaches to Ethical Oversight of Research Involving Recently Deceased
Speaker: Molly Shiflet, MPH, CIP – Vanderbilt University Medical Center
Speaker: Helen Panageas, CIP – NYU Langone Health
Speaker: Joan Margiotta, J.D. – NYU Langone Health
Communication With the PublicFoundations of Research Ethics and OversightEmerging Challenges and Innovations in ResearchIRB Operations and ManagementNavigating Ethical ChallengesRegulatory Frameworks and Compliance
Saturday, Nov 8th
3:30 PM - 4:45 PM ET
F10 - The Evolving Regulatory Landscape for AI in Human Subjects Research
Speaker: Shu Hui Chen (she/her/hers) – National Institutes of Health
Speaker: Julie Kaneshiro, MA (she/her/hers) – Office for Human Research Protections
Emerging Challenges and Innovations in ResearchRegulatory Frameworks and Compliance