Institutional Biosafety Committee (IBC)
Biosafety: Frequently Asked Questions
How does an investigator acquire IBC approval for a research protocol?
The Principal Investigator (PI) for the research project completes and submits an IBC Protocol form by e-mail.
All project personnel must complete the following RPI Training modules prior to approval of any protocol
- The IBC will review the protocol submission at a regularly scheduled meeting or via an expedited review process and notify the PI of its decision in writing.
- All projects that involve the use of recombinant DNA, recombinant RNA, viruses, viral vectors, toxins, human cells or bacteria.
- Institutional Stem Cell Research Oversight (ISCRO) Committee approval must be acquired prior to IBC action for all projects that involve the use of human stem cells.
- Once approved, the IBC protocol must be signed by all project personnel, including the PI, and the PI’s supervisor (Department Chair or Dean) and returned to the IBC.
- The PI will receive an official IBC approval letter that will satisfy the requirements of all PHS funding agencies.
What is the duration of the approval period?
The approval period is three years pending annual review. The PI must submit a brief annual renewal form two months prior to the end of protocol years one and two and a more substantial three-year renewal form two months prior to the end of year three.
What if changes in the approved protocol are proposed?
All changes in project personnel (addition or deletion) must be reported to the IBC promptly at all times during the 3-year period using the Protocol Amendment form.
All proposed changes to the approved protocol methods must be submitted for IBC review prior to implementation, using the Protocol Amendment form.
Is information available regarding safety or medical concerns of investigators?
Yes. All researchers are encouraged to request information from the IBC and/or EH&S.
Is the IBC empowered to suspend approved research?
The IBC is empowered, by federal mandate, to suspend research activities for non-compliance with the approved protocol and/or PHS policies. The IBC must report major researcher non-compliance to all relevant federal funding agencies.
What about the Homeland Defense Perspective? Federal BioDefense/BioTerrorism Select Agents Regulation?
On December 13, 2002, the Department of Health and Human Services (DHHS)/Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA) published in the Federal Register the interim final rules which establish new stricter regulations for the possession, use and transfer of select biological agents and toxins that could pose a threat to human, animal and plant health and safety.
The new regulations have important implications for microbiology laboratories and research with select agents and toxins and require careful attention. The HHS and USDA regulations are complementary and implement Title II of Public Law 107-188, the Public Health Security and Bioterrorism Preparedness Response Act of 2002, signed into law on June 12.
The new rules (42 CFR 73 for HHS, 7 CFR 331 and 9 CFR 121 for USDA) establish the registration process for facilities possessing select agents and toxins, timeline dates for compliance, safety and physical security compliance requirements, exemptions, and procedures for approving entities and individuals with access to a select agent or toxin in accordance with the restricted person prohibition in Section 175b of the USA Patriot Act.