- 1 Policies and Guidelines
- 2 Biosafety Level Determination
- 3 Risk Group Determination
- 3.1 NIH Guidelines
- 3.2 Policy & Procedure Manual
- 3.3 University of Chicago Biosafety Manual
- 3.4 Guidelines on the Use of Humanized Mice
- 3.5 IBC Training Policy
- 3.6 Biological Toxins Requiring an IBC Protocol
- 3.7 Guidelines for the Transport of Research and Clinical Specimens
- 3.8 TAT Protein Guidelines
- 3.9 Viral Vector Testing Requirements
Biosafety Level Determination
The IBC requires that you identify the biosafety level appropriate for the agents with which you are proposing to work. Depending upon the risk group to which a biohazardous agent and its uses belong, there are varying precautions that must be taken to ensure laboratory or clinical safety. An important step is to determine the appropriate biosafety level. To assist you in this determination, the NIH Guidelines and the Biosafety in Microbiological and Biomedical Laboratories (BMBL) – CDC have developed a matrix, which describes four recognized biosafety levels (BSL). Each level consists of combinations of laboratory practices and techniques, safety equipment and laboratory facilities, specifically appropriate for the operations performed, documented, or suspected routes of transmission of the infectious agent, and for the laboratory function or activity. To make the determination of what precautions are recommended as easy as possible, please contact the Office of Research Safety.
In requesting approval of the IBC to use a particular agent(s), it is important to recognize that you are agreeing to ensure the integrity of physical containment of these agents by complying with the requirements and precautions outlined by the federal government. The Office of Research Safety can assist with this.
Risk Group Determination
A critical step in planning the use of a biohazardous material is to make an initial determination regarding the appropriate level of risk associated with the agent and its proposed uses. It is the investigator’s responsibility to make an initial risk assessment based on the Risk Group (RG) of an agent. Agents are classified into four Risk Groups (RGs) according to their relative pathogenicity for healthy adult humans by the following criteria:
1. Risk Group 1 (RG1) agents are not associated with disease in healthy adults with competent immune systems.
2. Risk Group 2 (RG2) agents are associated with disease which is rarely serious for healthy adults with competent immune systems and for which preventive or therapeutic interventions are often available.
3. Risk Group 3 (RG3) agents are associated with serious or lethal disease for healthy adults with competent immune systems for which preventive or therapeutic interventions may be available.
4. Risk Group 4 (RG4) agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available, even for healthy adults with competent immune systems.
The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) (PDF) detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules.
Policy & Procedure Manual
University of Chicago Biosafety Manual
The UChicago Biosafety Manual (PDF) provides guidelines for handling pathogenic microorganisms and other potentially infectious materials at BSL2.
Guidelines on the Use of Humanized Mice
The Guidelines on Humanized Mice (PDF) provides occupational safety guidelines for using humanized animal models. Humanized mice is a general term that refers to immunodeficient mice that are engrafted with human cells, tissues, or organs, which closely replicates human physiologic, cellular, and immune system functions. Due to the use of human derived substances in modeling the human immune system, these mice are permissive to bloodborne pathogens (BBP). Due to potential BBP exposure, humanized mice should be housed at ABSL1 with BBP precautions which necessitates the proper disposal of sharps into a sharps container and practices to minimize exposures (e.g. donning 2 pairs of gloves, handling mice with forceps). Cages housed in current ABSL1 facilities must be tagged with a humanized mouse cage card.
IBC Training Policy
It is the policy of the University of Chicago IBC and SA-IBC (PDF) that all investigators, technicians and students involved with research activities described on a given IBC protocol be appropriately trained to mitigate research-associated risks as well as to ensure compliance with applicable local, State and Federal regulations and guidelines. This training will include IBC mandated training elements, developed and provided by the Office of Research Safety (ORS) as well as lab-specific training, provided by the Principal Investigator (PI) for each of their IBC research protocols.
Biological Toxins Requiring an IBC Protocol
Please read the UChicago IBC Toxin List (2018) for a list of biological toxins (PDF) equiring an IBC protocol. Please note that toxins denoted with a double-asterisk (**) are considered Select Agents by the Federal Government if kept by an individual PI at or above the specified thresholds. For more information on Select Agents and Toxins please refer to the list of Select Agents and Toxins and the permissible toxin amounts that can be maintained in a lab.
Guidelines for the Transport of Research and Clinical Specimens
These guidelines are for the proper packaging of biohazardous research and clinical specimens for transport by investigators and research support staff within and between University of Chicago research facilities including the Medical Center at the University of Chicago. These guidelines are designed to prevent the exposure of staff, visitors and the environment to biohazardous agents (defined as potentially infectious agents or organisms, recombinant DNA and other genetically altered organisms and agents) during transport.
IMPORTANT NOTE: The following protocol is not sufficient if the specimens are to be transported by a commercial carrier (e.g. FedEx) or transported in vehicles via public roads.
Transport within or between University of Chicago Research Facilities
- Research/clinical specimens must be double packaged when utilizing a corridor for transport
- Double packaging consists of a sealed, leak-proof primary container within a sealed, leak-proof secondary container (e.g. Tupperware container).
- For liquid materials, the secondary packaging must contain absorbent material in sufficient quantities to absorb the entire contents of all primary receptacles.
- The outside of the secondary container should be disinfected so that the use of personal protective equipment is not required.
- Label the secondary container with the universal biohazard sticker.
- Public areas and elevators should be avoided if at all possible. If public area/elevators must be used, gloves must NOT be worn. If necessary, the hand holding the specimen may be gloved, but under no circumstances should gloves be used on common surfaces
such as elevator buttons, phones, door handles, etc.
- In the event of a spill, follow the University of Chicago “Infectious Agent Spill Response” protocol available at Infectious Agent Spill Response . For assistance, please contact University Safety at 773-834-2707.
TAT Protein Guidelines
TAT Protein research approval
TAT Protein use may be pursued at the University of Chicago if the guidelines developed by the IBC are followed. The Committee’s mandate is to review all research being conducted at the University of Chicago which involves the use of biohazards including all recombinant DNA, agents infectious to humans, animals or plants and other altered (e.g. transgenic) organisms. Expression of a TAT-fusion-protein, even in bacteria, is considered rDNA work and falls under the purview of the IBC as Risk Group 2. In addition, the TAT protein has potentially unique and unknown infectious qualities. As such, the use of the TAT protein is categorized as biosafety level 2 (BSL2) and accidental spill procedures must be outlined in a protocol submission to the IBC. Protocols using TAT will be required to develop a safety manual and include it with the protocol submission.The IBC reserves the right to approve exceptions to the guidelines described below on a case by case basis. A protocol or an amendment to an existing protocol must be submitted to purchase, synthesize or express TAT proteins. The protocol or amendment must indicate:
- What peptide you are linking on to
- What you are using as target cells
- What are the harmful consequences, if any, when expressed
Containment of work with TAT Protein
Laboratory Containment, Practice, and Technique:
- TAT Protein must be handled as a potentially hazardous material.
- Some proteins are more toxic and/or immunogenic and should be identified.
- Plastic backed absorbent lab paper should be used on all laboratory bench surfaces to absorb spills and splashes. All things that come in contact with TAT proteins should be regarded as contaminated.
- Biological safety cabinet (preferred) or designated space is recommended
- Avoid aerosol-generating activities or use appropriate safety equipment such as biological safety cabinets and sealed centrifuge tubes
- Mouth pipetting is not allowed
- Lab coats
- Disposable latex, nitrile, or equivalent gloves
- Safety goggles
- Avoid direct contact with the skin, cuts, mucous membranes
- Wash well after working with TAT material.
In the event of a spill while donning the appropriate PPE,
- Decontaminate work surfaces using a detergent with a protease enzyme (like Terg-A-Zyme) for 10-20 minutes
- Followed by washing with water and then wipe with a 70% ethyl alcohol solution.
- Deactivate and dispose of TAT solutions and cultures using standard autoclave.
- Dilute solutions can be deactivated using a 1:10 dilution of bleach (sodium hypochloride solution) in a 1:1 mixture with the TAT solution, let sit for five to ten minutes. Dispose by sewer drain with copious amounts of water.
Backus, B.D., Dowdy, S.F., Boschert, K.R., and Richards, T.L, Becker-Hapak, M. (2000). Safety Guidance for Laboratory Personnel Working with Trans-Activating Transduction (TAT) Protein Transduction Domains. American Chemical Society Journal of Chemical Health and Safety (submitted).
Viral Vector Testing Requirements
The Testing Requirements for Viral Vectors (PDF) lists the most commonly used viral vectors, the appropriate biosafety levels that must be employed and the requirements for testing for replication competent virus (RCV). The test methods are indicated; however, other assays with similar specificity and sensitivity may be accepted. Please provide the appropriate references or details on the alternative assay methods in your protocol where applicable (see: Section 3.2 in the IBC Smartform).