Ensure IRB And IBC Success For Your Gene Therapy With Strategic Planning

Gene therapies offer exciting possibilities for the treatment of neurological disorders. However, to design safe and successful trials for these conditions, drug sponsors must consider their neurodevelopmental and neurodegenerative nature and how that leaves trial participants vulnerable. Patient protection requires a commitment to informed consent planning and an awareness of the criteria required by institutional review boards (IRBs) and institutional biosafety committees (IBCs).

In a Q&A on best practices for conducting ethical gene therapy trials for neurological conditions, experts across the clinical space — including those from Harvard Medical School and the Biomedical Research Alliance of New York (BRANY) — spoke to their recommended best practices for designing ethical trials and ensuring IRB and IBC success. Download the full article to read their insights.