An Institutional Biosafety Committee (IBC) is a federally mandated review body that provides local oversight of research involving recombinant or synthetic nucleic acid molecules. Established under the NIH Guidelines, an IBC assesses a study's biosafety risks, including the study agent, the containment levels and procedures required to conduct the work safely, the preparedness of the facility and its personnel, and the potential impact on the environment. Every IBC includes members with relevant scientific expertise along with non-affiliated members who represent the interests of the surrounding community.
IBC Services
“We provide the know-how needed to effectively establish and execute IBC review for your organization.”
Vanessa Rodriguez, CIP IRB/IBC Coordinator CONTACT US
Our IBC Services can help expedite the review process for recombinant DNA or human gene transfer research while providing rigorous biosafety oversight.
Gene Transfer & Biosafety Experts
Institutional Biosafety Committee (IBC) review is required when NIH research involves human gene transfer or use of recombinant or synthetic nucleic acid molecules and is NIH-funded or conducted at an institution receiving NIH-funding. IBCs facilitated by BRANY benefit from the expertise of IBC chairs and biosafety officers from our nationally ranked academic medical centers. Our IBC Services experts can help your team navigate NIH Guidelines and focus on the risk assessment for areas including:
• Study agent
• Containment levels and procedures required to safely conduct the research
• Preparedness of the facility and its personnel
• Potential impact to the environment
We also add the required non-affiliated members to represent the interests of the surrounding community and local environment.
Expedited Initiation & Coordinated Review
Our IBC Services help expedite the initiation of recombinant DNA or human gene transfer trials and maintain scrupulous biosafety oversight. We can also coordinate IBC review with IRB review when appropriate. Site inspection visits are scheduled as needed.
Personalized & Responsive Service
Our experienced IBC Administrators manage the overall process working side-by-side with your team in a way that suits your institution’s needs. This includes administering all aspects of IBC; from forming and registering the IBC Committee, to running meetings and preparing documentation. Your staff will also have access to IRBManager™ for online submission and recordkeeping.
Frequently Asked Questions
When is IBC review required?
Institutional Biosafety Committee review is required when research involves human gene transfer or the use of recombinant or synthetic nucleic acid molecules and is NIH-funded or conducted at an institution that receives NIH funding. The reach is broad: if even one such project at an institution benefits from NIH support, all recombinant or synthetic nucleic acid research conducted at or sponsored by that institution must comply with the NIH Guidelines and undergo IBC review.
What is the difference between an IBC and an IRB?
Both committees review research, but they safeguard different things. An Institutional Review Board (IRB) protects the rights and welfare of human research participants. An Institutional Biosafety Committee (IBC) focuses on biosafety, evaluating the risks that recombinant or synthetic nucleic acid molecules and gene transfer research may pose to researchers, the public, and the environment. Many gene transfer trials require both reviews, and BRANY can coordinate IBC review with IRB review when appropriate.
How does BRANY register an IBC?
BRANY manages the full registration process with the NIH Office of Science Policy (OSP). Our experienced IBC administrators form and register the committee, recruiting qualified biosafety and gene transfer experts and adding the required non-affiliated members who represent the local community and environment, and handle submission through NIH's IBC Registration Management System (IBC-RMS). We also manage annual registration updates, meeting documentation, notifications, and ongoing reporting so your institution stays compliant with the NIH Guidelines.
What types of research require IBC oversight?
IBC oversight applies to research involving recombinant or synthetic nucleic acid molecules, including human gene transfer and gene therapy trials. While the NIH Guidelines center on recombinant and synthetic nucleic acids, many institutions extend their Institutional Biosafety Committee's scope to related biohazards such as pathogens, infectious materials, and biological toxins. BRANY's IBC experts help your team determine which work falls under the Guidelines and identify the appropriate containment level for the study.