Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring an institutional biosafety committee (IBC) to provide additional oversight and risk assessment. In the clinical research community, we’re already familiar with institutional review boards (IRBs) and their review for ethical considerations and participant risks – so what’s the difference between an IBC and an IRB?
How are IBCs Different from IRBs?
While both committees focus on risk, they have contrasting responsibilities. IRBs are tasked with protecting research subject’s rights and welfare. 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 and how best to explain the unique risks of gene therapy and other genetically engineered treatments in the informed consent form (ICF).
What Does an IBC Review?
IBCs help researchers apply the necessary safety measures to ensure gene therapy research is conducted safely and responsibly.
Because of the risks involved, gene therapy research requires additional safety measures to ensure 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 utilized to deliver them. These safety measures go beyond the human subject protection requirements IRBs enforce and include a required 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 a comprehensive risk mitigation plan is in place prior to starting the research.
How is IBC Membership Composed?
While a single IRB (sIRB) can oversee research protections for a protocol being conducted at multiple sites, the IBC uniquely focuses on biosafety at the site level. This means IBCs are constructed to focus their risk assessment locally at each research site.
IBC membership must include involving two local community members who reside within 50 miles of the research site. This local membership requirement provides the IBC with the local community’s perspective and concerns as they assess the risks of utilizing genetically engineered products in research within a community. The IBC’s membership roster is therefore unique to the individual research location it oversees.
For the sake of efficiency, IBC meetings can be centrally coordinated and synchronized similarly to a sIRB. However, each IBC ultimately is its own entity with a unique roster of members who remain responsible for localized risk review.
It’s possible an IRB’s membership might be similar to an IBC’s; however, the committees are composed to conduct their reviews 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.
What do the Regulations Say about IBC Review?
Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations require IRB review for research involving human subjects. For IBCs, National Institutes of Health (NIH) Guidelines require IBC review for:
- Any genetic engineering research receiving NIH support
- Research taking place at sites currently receiving NIH support
- Research taking place at sites who have previously received NIH support
Even if no NIH support is 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).
| IRB | IBC | |
|---|---|---|
| Required when: | Research involves human subjects | Research involves gene therapy or genetic engineering of the treatments (e.g., mRNA) |
| 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 five members with varying backgrounds, including:
|
Minimum five members who collectively have the expertise to assess risks associated with recombinant DNA research, including:
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| Central vs local: |
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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.
Note: This article was originally published September 22, 2017, and has been updated to include new and clarifying information.
