Ensuring Compliance In Gene Therapy Trials For Neurological Disorders: IRB And IBC Perspectives

Gene therapy trials targeting neurological disorders present a complex landscape of ethical, regulatory, and biosafety considerations, particularly when involving populations with heightened vulnerability, such as pediatric patients and individuals with cognitive impairment. These studies require rigorous oversight mechanisms that extend beyond conventional frameworks. This on-demand webinar convenes experts from Institutional Review Boards (IRBs) and Institutional Biosafety Committees (IBCs), alongside a guest with interdisciplinary expertise in medical ethics, neuromuscular neurology, and rare disease drug development, to examine the multifaceted challenges inherent in these trials.

The discussion emphasizes the necessity of adapting oversight protocols to address nuanced informed consent procedures, the role of caregivers, and long-term safety monitoring. It also explores the collaborative functions of IRBs and IBCs to ensure ethical integrity and biosafety compliance throughout the research lifecycle. Designed for sponsors, CROs, investigators, and research coordinators, the session offers evidence-based strategies for navigating regulatory complexities and safeguarding participant welfare in high-risk gene therapy studies.