Registration with the Institutional Biosafety Committee (IBC) is an essential & required element in assuring compliance with federal state, and local regulations and guidelines, including:

Materials that require registration

Microorganisms (including those considered low risk to healthy humans and that are contained at Biosafety Level 1 "BSL-1").

Human Derived Materials including blood, blood components, fluids, unfixed organs, tissues and cell lines (primary and established).

Non-Human Primate Derived Materials (including established cell lines).

Biotoxins with an LD 50 of less than 100 micrograms per kilogram of body weight in vertebrates.

Recombinant or Synthetic Nucleic Acid Molecule activities as required by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (more UVA information can be viewed here).

Select Agents as defined by CDC (42 CFR 73) or USDA (9 CFR 121).

Transgenic Animals with enhanced risk as required by Section III-D-4 (Experiments Involving Whole Animals) of the NIH Guidelines. This includes animals which have been genetically modified, that when infected, pose enhanced risks to personnel.

Activities that require IBC registration and review

All Principal Investigators who possess or use the materials described above are required to register those materials through the online system Log-in.

Click Here to complete the Inventory and Activity Registration (IAR) Log-in

However, not all activities require IBC review and approval, and some may be considered exempt. For work that requires review, the IAR must be approved by the IBC prior to initiation of the work. Additionally, individuals are not permitted to work until they are listed on an approved registration.

*To determine if your Recombinant or Synthetic Nucleic Acid Molecule activities are exempt, see http://dohs.ors.od.nih.gov/guide.htm or refer to UVA's information on Recombinant or Synthetic Nucleic Acid Molecules.

Principal Investigator Requirements

The following are the key requirements that all Principal Investigators must complete in order to obtain IBC approval for work with biological materials:

Inventory and Activity Registration (IAR) Log-in & Biosafety e-Manual Log-in

All Principal Investigators, at the University of Virginia, who use biological materials requiring IBC registration, must register these materials with the Institutional Biosafety Committee (IBC) through the online Inventory & Activity Registration Log-in. After the review, the IBC may request modifications in order to approve the IAR.

The Biosafety e-Manual automatically integrates PI-specific information from the Inventory and Activity Registration (IAR) into the existing Biosafety Manual template, creating one document that will streamline and simplify biosafety compliance efforts across the research community.

The most current version of the Biosafety e-Manual should be made available prior to the next BSL2 lab visit. Go here Log-in and find the "pdf" link associated with the PI to download, save, and print now or prior to your next lab visit.

Biosafety Training

Personnel listed on the IAR must complete all required training before they can be approved. Personnel receive specific instructions to complete required training via email upon submittal of the IAR.

Biosafety Inspection

The purpose of this requirement is to evaluate the laboratory’s practices, equipment and facilities for the safe use of the intended biological agents and compliance with all external regulations, and applicable University policies.

As a contingency for IBC approval, the laboratory must have a successful lab visit by an IBC member and a representative of the EHS Biosafety Office. The Principal Investigator must be present at this visit.

The IBC Approval Process

Principal Investigators (PIs) seeking IBC registration or approval are required to complete and submit a web-based Inventory Activity and Registration (IAR) Log-in. The online IAR prompts PIs to identify all personnel, biological agents he or she intends to acquire, as well as the nature of the experiments to be pursued in the forthcoming year. Completion and submission of the IAR all take place exclusively online.

Submitted IARs are reviewed by the IBC at the monthly IBC meeting. IBC meetings are generally held on the 2nd Tuesday of each month at 8:00 am. Meetings are open to interested members of the University community and to the public. Please contact the IBC Office to make arrangements to attend. IBC contact information is as follows:

Gloria Bowers, IBC Administrator
Email: gb4z@Virginia.EDU
ph: 434-243-0726
f: 434-924-1992
Mail: PO Box 800002 Charlottesville, VA 22908

Institutional Biosafety Committee requests for IAR modification will be communicated to the PI through the IBC Office, which will coordinate subsequent review of requested modifications.

IBC approval will be granted once the PI has, to the satisfaction of the committee, completed all of the items in Principal Investigator Requirements (see above). Approval is valid for one year. Modifications are subject to review as indicated below. After completion of all requirements, you will receive online approval via email, followed by a formal letter of approval through messenger mail.

If you have any questions about the approval process, contact Gloria Bowers at gb4z@virginia.edu or 434-243-0726.

Annual IAR Renewal

Principal Investigators must renew Inventory and Activity Registrations (IAR) at least annually. The IBC will contact the PI to prompt annual renewal at least 60 days prior to approval expiration. IBC review for annual submissions is identical to the initial approval process indicated above.

Modification of an Approved IAR

Following initial IBC approval, and prior to the annual IAR renewal date, PIs may submit IAR modifications to reflect changes in personnel, rooms, experiments or biological agents.

Personnel: IAR modifications involving personnel do not require IBC approval. PIs are responsible for ensuring that new personnel are properly trained in accordance with the IBC Policy on Biosafety Training. For assistance, refer to the Checklist for New BSL-2 Personnel.
Rooms: IAR modifications involving the addition of laboratory areas require IBC approval. IBC notification (via telephone or email) will prompt a visit by EHS Biosafety personnel to ensure that appropriate containment features (e.g. facility, equipment, work practice) are in place. Once appropriate containment measures are verified, IBC approval is granted.
Agents & Experiments: Substantive IAR modifications involving the addition of new biological agents (e.g. microorganisms, biotoxins, human or non human primate derived materials) or experiments (e.g. Recombinant or Synthetic Nucleic Acid Molecule experimentation subject to NIH guidelines; procedures involving aerosolization, significantly increased volumes or concentration of cultures; or procedures involving increased risk) require IBC approval. One copy of the IAR, along with a description of the proposed changes, should be submitted to the IBC for review.
Termination of experiments subject to IBC approval can be registered by modification of the IAR. Please notify the IBC Office. Contact EHS Biosafety personnel at 434-982-4911 for guidance regarding proper disposal and laboratory decommissioning.
Departing Faculty should advise the IBC Office for IAR termination. Contact EHS Biosafety personnel at 434-982-4911 for guidance regarding proper disposal and laboratory decommissioning. Departing faculty should refer to the Provost’s Faculty Departure Checklist for additional information.

Reporting

Reporting exposures and compliance issues should be done through the IBC.

The IBC will inspect previously approved laboratories at least every three years unless the Inventory and Activity Registration (IAR) indicates any of the following:

Any accident that results in inoculation, ingestion, and inhalation of biohazardous materials, Recombinant or Synthetic Nucleic Acid Molecules, or any incident causing serious exposure of personnel or danger of environmental contamination.
Any problems pertaining to operation and implementation of biological and physical containment safety procedures or equipment or facility failure.
Any new information bearing on regulations or guidelines such as technical information relating to hazards and safety procedures or innovations.

NOTE: Compliance issues may be reported directly to the IBC Chair, Administrator, Committee Members, or EHS Biosafety. Click here for contact information.

 
 
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