Institutional Biosafety
Committee – IBC Services

Pearl IRB partners with an established Independent Biosafety Committee (IBC) services provider to deliver comprehensive review and oversight of clinical trials involving recombinant DNA (genetic engineering), synthetic nucleic acid molecules, gene therapy, infectious microorganisms, and hazardous biological materials.

What is an Institutional Biosafety Committee?

Institutional Biosafety Committees were established under the National Institutes of Health (NIH) Guidelines to provide local review and oversight of nearly all forms of research utilizing recombinant or synthetic nucleic acid molecules.

When is an IBC review necessary?

Per the NIH Guidelines, institutions that have either received NIH funding or are conducting NIH-funded studies involving recombinant or synthetic nucleic acid molecules are required to seek IBC oversight. Even if only a single research project involving recombinant or synthetic nucleic acid molecules at an institution receives NIH support, all such projects conducted at or sponsored by that institution must comply with the NIH guidelines.

IBC services and resources include:

• Establishment of local Institutional Biosafety Committee
• Gene therapy and Biosafety experts
• IBC administration
• IBC registration with NIH Office of Science Policy (OSP)
• Local representation
• Workflow review and recommendations
• Ongoing oversight
• Notifications, alerts, and reporting
• Site inspections
• IBC training

 

For more information regarding IBC services, please contact us at info@pearlirb.com.