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Wednesday, June 18
 

10:30am EDT

#316: Research in Participants with Progressive Cognitive Impairment: Best Practices for Ensuring Continuing Informed Consent
Wednesday June 18, 2025 10:30am - 11:30am EDT
150AB
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-622-L04-P; CME 1.00; RN 1.00

The session will describe informed consent in research participants with cognitive decline, discussing behavioral cues and consent/assent requirements for ethical practices when participants lose the ability to provide informed consent during a study

Learning Objectives

Recognize the ethical and operational challenges of engaging participants with cognitive impairment; Describe ethical options for retaining participants with cognitive impairment in clinical trials; Review best practices for informed consent/ caregiver consent/participant assent when the ability to give consent is lost during the course of a trial

Chair

Karla Childers, MS

Speaker

Sharing Clinical/Investigator Perspective
Thos Cochrane, MD, MBA

Sharing an IRB Perspective
Linda Reuter, MS


Speakers
avatar for Karla Childers

Karla Childers

Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States
Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →
avatar for Thos Cochrane

Thos Cochrane

Director, Fellowships in Bioethics, Harvard Medical School, United States
Thos Cochrane is a medical ethicist, neuromuscular neurologist, and specialist in drug development for rare diseases. He currently directs the Fellowships in Bioethics at Harvard Medical School (HMS). He has completed two fellowships in medical ethics and was the first Director of... Read More →
avatar for Linda Reuter

Linda Reuter

Senior Director, BRANY IRB, United States
Over a 34-year career, Linda has held multiple IRB administrative positions and for several years ran a consulting business providing training and assistance for several institutional IRB programs across the country. Currently serving as Sr. IRB Director at BRANY, Linda supervises... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum
  • Level Advanced
  • Keyword Bioethics
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Feature Topics Bioethics
  • Tags Forum

1:45pm EDT

#337: AI, Virtual Control Groups, and Organoids: How New Technologies are Being Developed to Align With Ethical Principles in Animal Research
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
207A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-637-L04-P; CME 1.00; RN 1.00

This session will review the 3Rs (replacement, refinement, reduction) of animal use in non-clinical drug development research, and how new technologies including AI, Victorian Clinical Genetics Services (VCGs) and organoids are introducing innovative ways to meet these ethical principles.

Learning Objectives

Discuss the “3Rs” (replacement, refinement, reduction) of ethical animal use in non-clinical drug development research; Recognize how new technologies including AI, VCGs and organoids are being explored to follow these ethical principles as part of the overall drug development program.

Chair

Lindsay McNair, MD, MPH, MS

Speaker

How New Technologies are Being Developed to Align With Ethical Principles in Animal Research
Julie Frearson, PhD

Panelist
Szczepan Baran


Speakers
SB

Szczepan Baran

Tech4Pets, Chief Barks and Purrs Officer, United States
avatar for Julie Frearson

Julie Frearson

Senior Vice President, Chief Scientific Officer, Charles River Laboratories, United States
avatar for Lindsay McNair

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States
Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session
 
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143ABC
144ABC
145AB
146ABC
146BC
147AB
150AB
151A
151B
152AB
201
202A
204ABC
206
207A
207B
209ABC
Ballroom
Ballroom Foyer 3rd Floor
EH
Exhibit Hall / Zone A
Exhibit Hall / Zone B
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Exhibit Hall Lunch
Innovation Theater 1
Innovation Theater 2
Innovation Theater 3
L Street Bridge
Nationals Park
Planet Word
Room 145-147 Lobby
Salon B
Salon C
TBD
Virtual
West Salon
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD-Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: ProfDevelopment
  • 13: Spotlight
  • 14: DIAmond
  • 15: Content-Hubs
  • 16: Community-Rounds
  • 17: Posters
  • 18: InnovationTheaters
  • 19: Networking Opportunities
  • 20: Short-Courses
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Keyword
  • Advanced Analytics
  • Artificial Intelligence (AI)
  • Bioethics
  • Biomarkers
  • Cell and Gene Therapy
  • Clinical Trial Design
  • Diagnostics
  • Digital Technology
  • Global Perspectives
  • Non-CE
  • Patient Experience
  • Payers
  • Pediatrics
  • Rare Disease
  • Real-World Data (RWD) / Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Convergence and Harmonization
  • Regulatory Reliance
  • Student Programming