Beyond the Trial: Ethical Oversight in Gene Therapy Long-Term Follow-Up

Join WCG’s expert panel for a dynamic discussion on the evolving roles of Institutional Review Boards (IRBs) and Institutional Biosafety Committees (IBCs) in gene therapy studies. Drawing from real-world experience, our expert panel will explore how collaborative oversight can safeguard participants, ensure an ethical trial, and address challenges in long-term follow-up, especially in the face of unexpected study discontinuations. Discover how IRBs and IBCs play distinct yet complementary roles in protecting participants, managing risk, and maintaining ethical standards, while also learning how CROs, sponsors, institutions, and regulators can work together to uphold trust and transparency in advanced therapies.

Key Topics:

• Regulatory evolution and expectations for long-term follow-up in gene therapy.
• The impact of early study termination on patients and communities.
• The importance of transparent communication and informed consent.
• CRO and institutional perspectives on collaborating to ensure integrity and transparency.
• Practical solutions for reducing burden on sites and sponsors.

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