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2023 PRIM&R Annual Conference

[IN-PERSON] Half Day Workshop: Overseeing Decentralized Clinical Trials (DCTs): Navigating Ethical and Regulatory Challenges With Single IRBs

Sunday, December 3, 2023
8:30 AM – 11:45 AM ET
Location: Room 208 AB
CIP Accredited Human Subjects Research Pre-Reg Required Additional Fee Workshop Series
This Workshop is being offered in-person only; advanced registration is required.

DCTs use a variety of modalities to facilitate research in today’s digital world. The implementation of DCTs relies on the use of digital tools for recruitment, consent, monitoring (e.g., wearable devices), interventions, etc. across multiple sites. While DCTs and the use of digital tools make research more accessible to a much wider population, it also raises new ethical challenges. This three-hour session will discuss the various ethical considerations and challenges surrounding decentralized trials and single IRBs.

Learning Objectives:

  • Explain the concept and background of DCTs and differentiate them from traditional clinical trials
  • Identify the key ethical considerations for sponsors, investigators, and IRBs when overseeing DCTs, including the use of digital tools for recruitment, consent, and monitoring
  • Discuss ethical challenges in DCTs with single IRBs and the opportunities and challenges associated with conducting these trials
  • Note: A boxed lunch will be offered to those attending full day Workshops or a morning AND afternoon Workshop (those only attending one half day Workshop are not eligible for lunch on this day).