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2023 PRIM&R Annual Conference

Pharma/Biotech Perspectives

Advancing Equity and Justice in Research

Emerging Research Challenges and Breaking Issues

Research Involving Data and Biospecimens

F14 - [IN-PERSON/RECORDED] The Ethical Conduct of Cell and Gene Therapy Research: Novel Challenges for Industry and the IRB

Wednesday, December 6, 2023
10:15 AM – 11:15 AM ET
Location: Room 152B
Human Subjects Research Call for Session Proposal Deep Dive Series Live Session Recorded CIP Accredited
This session will be offered in-person and recorded for on-demand access by in-person PRIMR23 attendees registered for this day, and PRIMR23/SBER23 Virtual Meeting registrants.

Cell and gene therapy presents complex challenges in trial design and implementation to ensure equitable recruitment, effective informed consent, and participant safety. The scientific and clinical novelty of each intervention, cost of treatment development, the irreversibility of the therapeutic intervention, and the required commitment by industry to long-term engagement with participants each create new standards for ethical conduct and its oversight that are distinct from other interventional trials. Fulfilling the goals of equitable and diverse enrollment introduces additional responsibilities. In this panel session, experts from industry and bioethics will describe the novel ethical demands of gene therapy trials in adults and in children and discuss model approaches.

Learning Objectives:

  • Identify the distinct elements of cell and gene therapy trials requiring special ethical considerations
  • Discuss the challenges of informed consent in cell and gene therapy in adults and in children
  • Review the challenges of equitable participant recruitment and engagement in cell and gene therapy in medically underserved communities and low resource countries