I was told my upcoming gene therapy study needs IRB and IBC approval. Does one need to come before the other?
-Trial Specialist, Clinical Research Center
Both IRB and IBC approval are required for most human gene transfer research subject to the NIH Guidelines1. While many institutions require IBC approval before full IRB approval can be granted (or vice versa), there is no regulatory requirement as to which must be obtained first.
That said, there are times when it can be helpful to go through the IBC review process first, as IBCs often identify problems that IRBs may not even consider due to differences in their scope and composition. For example, most IBCs are better positioned to evaluate biosafety risks associated with genetically modified products – many of which are often derived from viral pathogens that are inherently hazardous. Similarly, most IBCs can easily assess the likelihood that a genetically modified product will be transmitted from study participants to others (children, coworkers, etc.), and evaluate the risks posed to those individuals if transmission were to occur. These and similar issues identified by the IBC during its review would be helpful for IRBs to consider as they conduct their reviews and request changes to consent documents or study procedures.
Whatever your choice – IRB or IBC approval first – communication between both entities is one of the most effective ways to accelerate study startup while ensuring the safety of research subjects and the public at large.