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Evaluation

2025 PRIM&R Annual Conference

Emerging Challenges and Innovations in Research

Navigating Ethical Challenges

Regulatory Frameworks and Compliance

D02 - Beyond Emerging Tech: Using Embedded Ethics to Support the Design and Conduct of Clinical Trials

Saturday, November 8, 2025
10:30 AM - 11:45 AM ET
Location: Room 345-346
Human Subject Research - HSR Deep Dive Series Call for Session Proposal - CSP
CLICK HERE to view captioning for this session! 

Embedded ethics traditionally refers to integrating ethics experts into the development of emerging medical technologies to help anticipate and address ethical and societal concerns. Increasingly, this model is being applied to clinical research, where it can support the ethical design and conduct of trials. This session will explore the role of "ethics and regulatory cores" within three federally funded national research networks. Speakers will share their experiences providing project-specific ethics consultation and discuss how this work contributes to broader efforts to advance ethical and regulatory best practices across the research enterprise.

Learning Objectives:

  • Describe how ethics and regulatory cores can function in clinical trial networks
  • Identify the potential contributions of structured, systematic ethics and regulatory consultation teams for the design and conduct of clinical trials
  • Assess the advantages of providing ethics consultations at various stages of the research lifecycle, including trial development, pre-implementation, and active conduct