What Is an Institutional Biosafety Committee?
An institutional biosafety committee (IBC) is a panel of experts that assesses risks associated with gene therapy research to ensure the research is conducted safely and in compliance with the NIH Guidelines. Watch this video to learn what an IBC is and when IBC review is required.
00:08-00:24: An Institutional Biosafety Committee or IBC is a panel of experts that assesses the risks associated with gene therapy research to ensure the research can be conducted safely and in accordance with NIH Guidelines.
00:24-00:36: While IRBs focus on risks to human research subjects, IBCs focus on risks posed by engineered genetic materials to research subjects, study personnel, the community, and the environment.
00:38-00:51: IBCs must ensure NIH Guidelines compliance. NIH Guidelines require IBCs to be comprised of at least 5 members who collectively possess the expertise to assess the risks for the proposed research.
00:51-01:09: At least two of those members must be members of the community surrounding the research site and must be unaffiliated with the site and the research. These two members represent the interests of the community and the environment around the site, seeking public health and environmental protection.
01:09-01:22: Advarra maintains a large network of community members to avoid review delays. If a proposed research site lacks community member coverage, Advarra immediately recruits and trains members to ensure coverage.
01:23-01:40: NIH Guidelines also require site inspections. Since the start of the COVID-19 pandemic, Advarra has conducted site inspections remotely through web conferencing software. The inspections focus on the facilities and safety practices involved with the proposed research.
01:40-02:11: Gene therapy research involves the delivery of engineered genetic material to humans, with a few goals in mind. Researchers are looking to compensate for genetic mutation, confer the capability to produce potentially therapeutic substance, or they are attempting to elicit immune responses to fight disease. When discussing engineered genetic material, we’re referring to recombinant or synthetic nucleic acid molecules as defined by NIH Guidelines.
02:11-02:47: Part of the reason IBC review is beneficial is such engineered genetic materials often involve using infectious agents either as the investigational product or in the manufacture of the investigational product. Common types of research requiring IBC oversight include gene therapy, gene modified cellular therapy, such CAR T cells and cell-based immunotherapy, and gene-based vaccines, such as genetic vaccines against cancer and infectious diseases.
02:47-03:12: IBC review is required when research involving engineered genetic materials is either: Supported by the NIH, taking place at a site receiving NIH support, or the NIH supported the research and development of the investigational product at one time. Support can mean collaboration, research performed at the NIH, or NIH funding.
03:12-03:32: Sites conducting NIH-sponsored research are considered to have NIH support. If NIH supported the development of the compound either through direct funding or through collaboration, then all sites conducting experiments with that compound require IBC review.
03:32-03:49: Other US federal government agencies besides the NIH as well as some private funding agencies also require research funded by their agency to follow the NIH guidelines. Check the terms and conditions in your notice of award to be certain.
03:49-04:08: Even if there are no fiduciary requirements for IBC review, the NIH considers IBC review an industry best practice and encourages voluntary compliance.
04:08-04:26: If you have a gene therapy-related trial, it is recommended to get IBC review in conjunction with IRB review. Advarra provides the world’s leading integrated IRB and IBC service. When you think gene therapy, think Advarra.
Ready to get started? Contact us at www.advarra.com.