An institutional biosafety committee (IBC) is a regulatory body responsible for reviewing and overseeing research involving biohazardous materials, including recombinant or synthetic nucleic acid molecules (such as gene therapy products), infectious agents, and other potentially hazardous biological agents. The primary purpose of IBC review is to protect researchers, the community, and the surrounding environment while ensuring compliance with all relevant regulations and guidelines.
Preparation equals opportunity. Why wait?
Establish your IBC today to streamline your study start-up process!
Partner with Univo IBC or consulting services that put you on the path to IBC approval:
- Local IBC committee setup and management
- IBC specific training
- Site assessments
- …and much more
Do I Need an IBC Review?
Institutions receiving National Institutes of Health (NIH) funding for research involving recombinant or synthetic nucleic acid molecules must comply with NIH guidelines regarding IBC review. This requirement applies to all of the institutions’ research that involves r/s NA’s, even if only one project is NIH-funded. Other federal agencies or private funders might require adherence to these guidelines, and institutions may also be subject to local, state, or federal regulations that mandate compliance, regardless of NIH funding.
IBC review is required for any research that involves:
- Recombinant or synthetic nucleic acid molecules
- Gene therapy clinical trials subject to NIH guidelines
- Other biohazardous materials as required by federal, state, or institutional policies
- Voluntary compliance with NIH guidelines
What is the Difference Between a Local IBC and an Externally Administered IBC?
A local IBC is managed by the institution conducting the research, while an externally administered IBC is managed by an external organization, such as a university or commercial entity. Both ensure compliance with NIH Guidelines; however external IBCs are typically able to review studies much faster!
Not sure if your project requires IBC approval? Our team is here to help.
Additional Resources to Get You to IBC Approval
- NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
- FAQs on Institutional Biosafety Committee (IBC) Administration – April 2024 – Office of Science Policy
- Biosafety in Microbiological and Biomedical Laboratories—6th Edition
- Biosafety program management: Canadian biosafety guideline – Canada.ca
