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Thursday, Nov 6th
10:15 AM - 11:15 AM ET
A01 - Bot or Not? Fraud, Data Integrity, and the Role of the IRB in the Online Survey Sphere
Speaker: Julie F. Simpson, PhD (she/her/hers) – University of New Hampshire
Speaker: Jessie Hemmons, M.S., J.D. Candidate – Technology and Translational Research Unit, National Institute on Drug Abuse
Social, Behavioral, and Educational ResearchEmerging Challenges and Innovations in Research
Thursday, Nov 6th
11:30 AM - 12:30 PM ET
B01 - Through the Looking Glass: How Research Participants and IRBs See Ethics in HIV and SUD Studies
Speaker: Celia B. Fisher, PhD (she/her/hers) – Fordham University
Speaker: Brenda L. Curtis, PhD, MSPH (she/her/hers) – National Institutes of Health
Social, Behavioral, and Educational ResearchEmerging Challenges and Innovations in Research
Thursday, Nov 6th
1:45 PM - 3:00 PM ET
PLENARY: Navigating the Risks and Opportunities of Emerging Technologies in Social and Behavioral Research
Moderator: Benjamin C. Silverman, MD – Mass General Brigham
Panelist: Bennett Allen, PhD (he/him/his) – NYU Grossman School of Medicine
Panelist: Brenda L. Curtis, PhD, MSPH (she/her/hers) – National Institutes of Health
Panelist: Makella S. Coudray, PhD, MPH, CPH (she/her/hers) – University of Central Florida
Social, Behavioral, and Educational ResearchEmerging Challenges and Innovations in ResearchIRB Operations and Management
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
A09 - PLENARY: AI Policy for Institutional Leaders
Panelist: Minal M. Caron, J.D. (he/him/his) – Ropes & Gray LLP
Panelist: Judy Birk, JD (she/her/hers) – University of Michigan
Panelist: Mariette Marsh, MPA, CIP, CHPC, CHRC (she/her/hers) – University of Arizona
Research Oversight Leaders and Institutional OfficialsShared Research Oversight ChallengesEmerging Challenges and Innovations in Research
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
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
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
Friday, Nov 7th
3:30 PM - 4:45 PM ET
C10 - Shared Risks, Local Responsibility: Empowering IRB and IACUC Professionals in Research Security
Speaker: Hila F. Berger, MPH, CIP, CHC (she/her/hers) – Rutgers University
Speaker: Amanda R. Humphrey, CRA, MBA – Northeastern University
ACU/IACUC Program Management and AdministrationResearch Oversight Leaders and Institutional OfficialsIRB Operations and ManagementEmerging Challenges and Innovations in ResearchFoundations of Research Ethics and Oversight
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
12:30 PM - 1:30 PM ET
N18 - Science Under Siege: Defending Scientific Integrity in a Politicized World
Speaker: Tiffany Chenneville, PhD (she/her/hers) – University of South Florida
Speaker: Willyanne DeCormier Plosky, DrPH (she/her/hers) – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
Speaker: Cheri M. Pettey, MA, CIP (she/they) – Advarra, Inc.
Foundations of Research Ethics and OversightEmerging Challenges and Innovations in ResearchCommunication With the PublicShared Research Oversight Challenges
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
E01 - PLENARY: Making the Ethical Oversight of Clinical Trials Fit for Purpose
Moderator: P. Pearl O'Rourke, MD (she/her/hers) – Harvard Medical School
Panelist: Stephanie Morain, PhD, MPH – Johns Hopkins Berman Institute of Bioethics
Panelist: Ruth R. Faden, PhD, MPH (she/her/hers) – Johns Hopkins Berman Institute of Bioethics
Panelist: Todd W. Rice, MD – Vanderbilt University Medical Center
Research Oversight Leaders and Institutional OfficialsNavigating Ethical ChallengesEmerging Challenges and Innovations in Research
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
F04 - Redrawing the Line: Informed Consent and Therapeutic Misconception in Decentralized and Patient-Centered Research
Speaker: Robert H. Romanchuk, CIP, BSHS – Univo IRB
Speaker: Don E. Workman, PhD (he/him/his) – Department of Veterans Affairs
Speaker: Robert (Skip) M. Nelson, MD, PhD (he/him/his) – Johnson & Johnson
Foundations of Research Ethics and OversightEmerging Challenges and Innovations in Research
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