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Purpose

The Institutional Biosafety Committee (IBC) has the responsibility to ensure that all locations listed in IBC registrations are inspected regularly and meet certain regulatory expectations.

Regulations

All inspections will be performed in accordance with requirements published in the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules (NIH Guidelines) and the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) and institutional policies. These are designed to ensure that laboratories, facilities, and practices are followed according to the requirements and to provide technical advice to users in biosafety and biosecurity issues.

Institutional Policy

All locations where biological materials will be used must be evaluated prior to use and regularly thereafter to ensure the appropriate biosafety containment level, equipment, and work practices are appropriate for the work described on the IBC registration. This policy covers two types of inspections, the Biosafety Walkthrough and the IBC Audit.

Biosafety Walkthrough

Before approval can be granted, a member of the Biosafety Office must evaluate the location(s) proposed. These evaluations are provided as a service by the Biosafety Office and are not reported to the IBC unless an exemption is necessary from the Committee in order to address regulatory requirements (see Exemptions below). Otherwise, if any deficiencies are observed during the walkthrough, the Biosafety Officer will communicate the recommended corrective actions to the PI and follow up visits may be scheduled to assist the PI with how best to address the safety concerns prior to an official IBC audit.

IBC Audit

Following IBC approval, all locations listed on the IBC registration must be audited on a routine basis (often annually). The results of these audits are reported to the IBC at a convened meeting, so that the Committee can ensure that appropriate practices and procedures are in place for all registered work during the lifetime of the registration. Additional information on the Audit Report can be found below. Citations will remain on the IBC Audit Report until they have been resolved. The Committee will vote on whether each citation qualifies as a minor or significant infraction. Significant infractions are reportable to outside regulatory bodies, and granting agencies, as required.

It is important to be aware that the Biosafety Office has the authority to require that work be halted if a Biosafety Officer identifies any unsafe practices, inappropriate facilities, or failure of equipment that could result in an imminent exposure risk.

Audit Report for the Principal Investigator

Following the IBC Audit, the Biosafety Office representative will issue a report to the Principal Investigator that details the findings. If deficiencies are cited, the Biosafety Office representative will propose corrective actions and deadlines. It is the responsibility of the Principal Investigator to promptly provide documentation that any issues have been resolved with the proposed corrective action by the deadline provided or work with the Biosafety Office to request an exemption or a deadline extension (see below for procedural explanation of exemptions/extensions). If the deadline has passed, and the citation has not been adequately addressed, it may become an issue of non-compliance that requires IBC involvement.

NOTE: If a repeat citation is noted in consecutive audits, it may also be handled as a compliance issue for the Principal Investigator.

Exemptions

There may be situations that require an exemption from one or more of the requirements in the BMBL or the NIH Guidelines. Exemptions are determined based upon a risk assessment of the biological materials in use and the procedures to be conducted. The IBC can vote to exempt a requirement based on this assessment. If an exemption is necessary, work with the Biosafety Office to provide justification for the IBC to review and vote upon.

Deadline Extensions

A request to extend the deadline for a correction may also be necessary. Work with the Biosafety Office so that the extension request can be presented to the IBC for discussion and vote.

Addition/Deletion of Location

Locations must be listed in an approved IBC registration before use. If locations need to be added after the registration has been approved, an amendment can be submitted to the IBC Office. Removal of previously approved locations can be removed by contacting the IBC Office.

Additional Institutional Regulatory Group Involvement

During Biosafety inspections, the Biosafety Office representatives could note potential issues that may fall under the purview of other institutional regulatory groups or offices [such as Environmental Health and Safety (EHS), Institutional Animal Care and Use Committee (IACUC), Radiation Safety, Occupational Health and Safety (OHS), etc].  If this occurs, the Biosafety Office will communicate the issue to the appropriate party. This function is advisory only and does not confer responsibility to the Biosafety Office or to the Institutional Biosafety Committee.