Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring additional oversight by an institutional biosafety committee (IBC). In the clinical research community, we’re already familiar with IRBs, which also reviews risks. So what’s the difference between an IBC and an IRB?
While both committees focus on risk, they have contrasting responsibilities. IRBs are tasked with protecting the rights and welfare of research subjects. IBCs, however, seek to protect study personnel, the community and the environment from exposure to engineered genetic material and other biohazardous agents. An IBC may also advise the IRB in assessing potential risks to the study subjects.
While one IRB can oversee research protections for multiple sites, IBCs are locally based at the research site, include the involvement of community members and can only oversee research at that location. For the sake of efficiency, local IBC meetings can be centrally coordinated and synchronized, but each IBC remains responsible for local review.
Because of the risks involved, gene therapy research requires additional safety measures to ensure that research subjects and study staff as well as the community and the environment surrounding the research site are not harmed by the modified genetic material or the infectious agents that may be utilized to deliver them. These safety measures go beyond the human subject protection requirements that IRBs enforce and always require a site inspection as part of the approval process.
The IBC’s review is intended to ensure a thorough risk assessment is performed regarding the risks associated with the genetically modified materials. The IBC also reviews to confirm that a comprehensive risk mitigation plan is in place prior to starting the research. IBCs help researchers apply the necessary safety measures to ensure gene therapy research is conducted safely and responsibly.
It’s possible that an IRB’s membership might be similar to that of an IBC, but remember that each committee is composed to conduct its review for different purposes. IBCs include members who possess expertise in genetic engineering, biological safety, infectious diseases and environmental protection. Each IBC is required to have at least two community members who are unaffiliated with the institution or research site and who represent the interests of the community and the local environment.
FDA and OHRP regulations require IRB review for research that involves human subjects. For IBCs, NIH Guidelines require IBC review for any genetic engineering research that receives NIH funding or takes place at sites receiving NIH funding. Even if no NIH funds are involved, NIH Guidelines suggest IBC review is a best practice for genetic engineering research: “[I]ndividuals, corporations, and institutions not otherwise covered by the NIH Guidelines are encouraged to adhere to the standards and procedures set forth” in the Guidelines (Section IV-D-1).
|Required when:||Research involves human subjects||Research involves gene therapy or genetic engineering|
|Responsibility (oversight for:)||Protecting human subjects participating in research||Protecting human subjects, study personnel, the community and the environment when conducting gene therapy or genetic engineering research|
|Composition||Minimum 5 members with varying backgrounds, including:||Minimum 5 members that collectively have the expertise to assess risks associated with recombinant DNA research, including:
|Central vs local|
There are many more distinctions we could explore, but hopefully this article has helped you understand the main differences between IRBs and IBCs. In a nutshell: IRBs are concerned with risks to human research subjects, and IBCs are concerned with risks to anyone who might come in contact with a study’s genetically modified material.
Want to learn more about IBCs? Read our blog Planning for Gene Therapy Research? Plan for IBC Review.