C13 - Bridging the Gap: Gene Therapy Research From the Perspectives of IRBs and Patient Advocates

Gene therapy research is emerging at a fast and exciting pace. Oversight of this research faces many unique challenges from the perspectives of IRB review (e.g., inherent conflicts of interest, complex consent forms, unique risk considerations, unique withdrawal considerations, etc.). In addition, it is a field where much of the patient population are knowledgeable, invested, and often desperate, making it important to bring IRBs and gene therapy patient populations together to ensure responsiveness to each other’s needs and to ensure the research that is approved is both ethical and appropriate. This session will bring these two groups together to discuss ways to best approach gene therapy research review on these key topics.