IBC Services

Sitero manages Institutional Biosafety Committees (IBC) for institutions externally that meet all NIH guidelines and requirements.

What is an IBC?

An Institutional Biosafety Committee (IBC) is an institution specific regulatory committee responsible for the review of research projects that use recombinant or synthetic nucleic acid molecules (r/sNA). An IBC ensures that research complies with the National Institute of Health (NIH) guidelines.

This review is required by NIH for any facility or project funded by state or local governments and is based at the location doing the research or administering the product.

The main responsibility of an IBC is to independently assess the biosafety of the recombinant material in research. IBC review is considered best-practice even if the project is privately funded.

Why Use External IBC Services?

IBC services are used when an organization does not have the resources or expertise to establish an internal IBC or when an independent review is desired for added assurance and transparency. An external IBC comprehensively evaluates the biosafety and biosecurity risks associated with using biological agents in research, production, and other activities.

They also review and approve proposals for the use of hazardous biological materials and provide guidance on compliance with regulatory requirements and best practices. External IBC services can provide an objective and expert evaluation of an organization’s biosafety program, ensuring that all aspects of the program comply with local, national, and international regulations and promoting the safe and responsible use of biological agents.

Sitero’s Complimentary NIH Registration

Sitero’s IBC experts will collaborate closely with your staff to guarantee the precise completion and prompt submission of all necessary forms to NIH. By taking advantage of this no-cost IBC registration with NIH, you can save significant time and resources, as it can help speed up the approval process and cut 4-6 weeks off your site activation for a gene therapy trial.

Sitero offers a distinctive Site Network Central IBC model for site networks with multiple locations that simplify IBC requirements across sites. This model ensures that all sites within a network comply with the same set of IBC requirements, reducing confusion and errors and improving overall trial outcomes.

If you are interested in discovering more about Sitero’s IBC solutions or wish to avail yourself of this offer for a free NIH registration, please contact us:

Client Testimonial

When ASLA Research needed help understanding what was required for their site network’s Institutional Biosafety Committee (IBC), Sitero guided them every step of the way. Hear directly from ASLA’s CEO, Jeff Stein, and Sitero’s VP of IRB, IBC & Biosafety, Sarah A. Ziegler, in this client testimony. 

Sitero’s IBC Services

Sitero IBC has the Biosafety experts to help review and ensure the safety of infectious biological material. We ensure compliance with the NIH Guidelines and partner to keep workers and the surrounding community safe.

Our customer focused services include:

  • Handling the committee setup, protocol review, NIH registration, risk assessment, and IBC charter

  • Guiding the site and investigator through the review and approval process

  • Coordinating the process for amendments and annual reviews

  • Managing the concurrent IRB/IBC review process in compliance with all NIH guidelines

IBC Coordination and Support

For institutions that manage their IBC internally, Sitero can provide committee support and coordination. This can be as little or as much support as an institution needs but can remove the need for a dedicated IBC coordinator on-site while also adding Biosafety expertise.

Sitero IBC can offer:

  • NIH Registration Management

  • Biosafety Reviews by Biosafety Subject Matter Experts

  • Risk Assessments

  • Recruitment and Management of Committee Members

  • Coordination of Committee Meetings

  • Protocol Life Cycle Management

  • Approval Memos

Biosafety Services

Biosafety Consulting

Sitero has biosafety professionals that can advise and assist in risk evaluation and mitigation. They can develop programs to promote safe microbiological practices, train on the proper use of containment equipment, and can provide advice on laboratory design.

Biosafety Training

Biosafety training is essential to a compliant and safe Biorisk management program. Education and training provides employers, managers, supervisors, and workers with the knowledge and skills needed to do their research safely.

IBC Resources

IBC resources, links, and FAQs to help understand how Sitero can help your IBC succeed.