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Purpose

The Institutional Biosafety Committees (IBC) of Tufts University Cummings School of Veterinary Medicine (TCSVM) and Tufts University/Tufts Medical Center have the responsibility to ensure that all locations listed in IBC registrations are inspected 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). Inspections are designed to ensure that laboratory standards are followed according to the requirements and to provide technical advice to researchers in biosafety and biosecurity issues.

Policy

Inspections of all locations listed in an active IBC registration are to be performed, at a minimum, by a Biosafety Officer or a Biosafety Office designee.

Approval for Locations

All locations where the biohazardous agent will be used must be inspected prior to initial use to ensure the appropriate biosafety level for the work and the agent(s) proposed. Additional locations can be added to an approved registration via submission of an amendment to the IBC Office. Removal of previously approved locations does not require an amendment and can simply be removed by contacting the Biosafety Office.

Inspection Report for the Principal Investigator

Following the inspection, the Biosafety Officer will issue a report to the Principal Investigator that details the findings. If deficiencies are cited, the Biosafety Officer will propose corrective actions and deadlines. The Principal Investigator is responsible for ensuring the corrections are completed by the deadline and to provide confirmation to the Biosafety Office. If the deadline is passed and the citation has not been adequately addressed, it may become an issue of non-compliance that requires IBC involvement.

Committee Review

An IBC Inspection Report is presented to the Institutional Biosafety Committee. If the Committee votes to dismiss the citation or to change the deadline, the Biosafety Office will communicate the updated information back to the Principal Investigator. Inspection citations will remain on the IBC Inspection Report until they have been adequately addressed. The Committee will vote on whether or not the citation qualifies as a minor or significant infraction. Significant infractions may be reportable to outside regulatory bodies, and granting agencies, as required.

Requirement 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 procedures to be conducted. The IBCs can vote to exempt a laboratory/facility requirement based on this assessment. If an exemption is necessary, please work with the Biosafety Officer, so that he/she can provide the explanation on the IBC Inspection Report. The proposed exemption will be discussed and voted upon at the IBC meeting.

Deadline Extensions

A request for an extension of a correction deadline may also be necessary. Please alert the Biosafety Officer prior to the initial deadline with the reasons for the extension, so that it can be presented to the IBC for discussion and vote.

Additional Institutional Regulatory Group Involvement

During Biosafety inspections, Biosafety Officers could note potential citations 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), or Occupational Health and Safety].  If this occurs, the information will be communicated to these groups and the PI, outside of the IBC Inspection Report. This function is advisory only and does not confer responsibility to the Biosafety Office or the IBCs.