Gene therapy research is a recent addition to clinical studies, bringing unique requirements for trial sponsors and researchers. A crucial requirement is the review by an institutional biosafety committee (IBC).
IBCs focus on safety in this type of research by assessing risks tied to genetic changes and experimental processes, ensuring safety for personnel, the community, and the environment. While institutional review boards (IRBs) protect human participants, IBCs safeguard against exposure to genetic materials and biohazards, sometimes assisting IRBs in risk evaluation.
Navigating IBC demands can be tough for sponsors due to their unfamiliarity. Academic IBCs might lack clinical trial experience, primarily focusing on preclinical work. For efficient gene therapy studies, aligning IBC and IRB reviews is ideal. Some responsibilities overlap, and in some cases, personnel may be shared. However, dual reviews can complicate timelines, potentially stalling trials.
To streamline reviews, learn how sponsors can coordinate both committees through a vendor offering integrated resources.