Institutional Biosafety Committee Services (IBC Services) administers IBCs for biomedical institutions engaged in research using recombinant DNA or related genetic material. Biological safety review by the IBC helps protect the safety of the research subjects and staff, the community, and the environment by promoting safe storage, handling, and disposal of gene-modified biohazardous materials. The IBC is also part of the Federal regulatory system for overseeing gene transfer research—the deliberate introduction of recombinant DNA (or RNA derived from recombinant DNA) into a human.

Each local institution registers its own IBC, because local membership is required—there is no such thing as a “central IBC” analogous to a “central IRB”. For information about whether IBC review is required go to Is IBC Review Required.

On behalf of the institution, IBC Services establishes a local IBC to comply with the requirements of the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines). The typical IBC will have 6-9 members. The IBC roster brings together prominent and experienced biosafety experts from around the country, with local members representing the institution and the surrounding community. Collectively, the membership is structured to provide scientifically sound review of the research that takes into account biosafety best practices as well as the current regulatory environment. The IBC provides periodic on-site visits to help promote and maintain a sound biosafety research setting.

Each site-specific IBC will provide prompt, expert reviews of recombinant DNA research to include:

• Evaluation of protocols, and any modifications to the research that may affect biosafety
• Assessments of the facility (physical capability, staff training, written procedures, biosafety practices, etc.)
• Assignment of biological safety containment levels
• Assessment of long-term follow-up plans
• Medical assessment of serious adverse events
• Assessments of the facility and staff
• Biosafety assessment of research-related incidents (exposures, illnesses, loss of containment, etc.)

The staff of IBC Services of WIRB provides the following services for each site-specific IBC:

• Constitute and register IBC roster in compliance with NIH Guidelines
• Obtain confidentiality agreements and conflict of interest statements from members
• Train members on review and compliance functions, as well as scientific background of research
• Provide compensation (honoraria) to members unaffiliated with the institution
• Schedule all IBC meetings
• Distribute review materials to members
• Generate and distribute minutes to designated recipients
• Ensure IBC review of all modifications to the research that affect biosafety, in accord with NIH Guidelines.

Is IBC review required?

Generally, NIH funding is what triggers the requirement for IBC review and compliance with the NIH Guidelines. Voluntary compliance is encouraged by the NIH Office of Biotechnology Activities.

If research is sponsored by or conducted by an institution that receives NIH funding for recombinant DNA research, the institution or clinical trial site must be reviewed and approved by an IBC before initiation of the research. Voluntary compliance by other institutions or sponsors is encouraged by NIH because it promotes safe conduct in recombinant DNA research and gives the public confidence that important safety matters are being addressed. Regardless of NIH funding, institutions or sponsors may be subject to local ordinances, federal or state regulations, or agency guidelines that require compliance with the NIH Guidelines. Vaccine trials exempt from Recombinant DNA Advisory Committee (RAC) review under Appendix M-I of the NIH Guidelines still require IBC review.

For more information about what recombinant research requires IBC review, contact the NIH directly at: Phone: (301) 496-9838 or Email: oba@od.nih.gov