Ask the Experts: IRB and IBC Approvals
This monthly feature presents questions from clinical trial professionals with answers from WCG experts. This month features insights from Institutional Biosafety Committee (IBC) Chair and Director of IBC Services Christopher Doyle.
Question: I was told my upcoming gene therapy trial needs IRB and institutional biosafety committee (IBC) approval. Does one need to come before the other?
Answer: Both IRB and IBC approval are required for most human gene transfer research subject to the NIH Guidelines. 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 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 review 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.
Question: We are thinking about starting a study that may need IBC review before we can begin. Do we need to buy any special safety equipment for studies needing IBC approval?
Answer: When reviewing a study that requires IBC approval before initiation, most IBCs expect basic safety precautions and equipment to be in place. Handwashing sinks, eyewashes, spill cleanup kits and appropriate biohazardous waste containers are good examples of such equipment.
The need for any additional “nonstandard” safety equipment, such as respirators, biosafety cabinets (BSC) or other containment devices, is driven by a combination of factors that have to do with the investigational product and how it is handled. For example, a replication-capable viral vector derived from an airborne pathogen, such as adenovirus, will often require a BSC for mixing, dilution or other activities with the potential to generate infectious aerosols. Lower-risk products, such as mRNA vaccines or other noninfectious agents, can usually be handled without special safety equipment. Sites should rely on their IBC or a similar safety committee as a resource that can be utilized to make safety-related determinations.
Lastly, investigators and their staff should be aware that product-handling instructions provided by clinical trial sponsors are not always written with IBCs and best biosafety practices in mind, often calling for unnecessary or inappropriate equipment. To ensure staff safety and avoid study startup delays, trial sites and their IBCs should always review sponsor-provided handling instructions and address any concerns as early as possible.
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