Registration with the Institutional Biosafety Committee (IBC) is an essential & required element in assuring compliance with federal state, and local regulations and guidelines, including:
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.
All Principal Investigators who possess or use the materials described above are required to register those materials through the online system 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.
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.
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.
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.
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:
Paul Skoglund, IBC Coordinator
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 Paul Skoglund at firstname.lastname@example.org or 434-243-0726.
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.
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.
Following any exposures, accidents or illnesses involving recombinant DNA or biohazardous agents, report immediately to your supervisor, followed by the IBC or EHS Biosafety. EHS Biosafety will conduct a follow-up accident investigation.
The NIH Guidelines require that any significant problems, violations, or any significant research-related accidents and illnesses be reported to the NIH Office of Science Policy within 30 days. Spills and accidents in BSL2 laboratories resulting in an overt exposure must be immediately reported to the OSP, as well as to the IBC or EHS Biosafety
A biosafety infraction occurs when established biosafety practices and procedures are not being followed as described in internal UVA policy or applicable external regulations. A new policy on Biosafety Infractions Is available here.
NOTE: Compliance issues may be reported directly to the IBC Chair, IBC Coordinator, IBC Committee Members, or EHS Biosafety. Click here for contact information.