The following links are intended to help PIs, lab managers, and other lab personnel to determine the needs for their research facility. It is the responsibility of each research group to utilize these resources to complete the IBC Registration form for research or teaching.
Biosafety in Microbiological and Biomedical Laboratories, 5th Edition: The 5th edition of this manual is the most current version used in facilities across the U.S., including here at UWM. Information regarding biosafety levels, risk groups, laboratory design, biological safety cabinet selection and maintenance, and biosecurity can be found in this guide.
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (April 2016): The NIH has set forth guidelines for working with recombinant DNA (rDNA), synthetic nucleic acids, pathogens in a risk group 2 or higher, human cells and tissues, work with animals, work with plants, and viruses/ viral vectors. The latest revision was completed in April 2016. Section III outlines all the types of research that must be approved by the NIH prior to commencing, and what types of research is exempt from NIH and IBC approval prior to commencing. All PIs doing work with any kind of biological material must complete an IBC Registration form for submission to the IBC.
- Use this short guide published by the NIH to determine what sub- section of Section III your rDNA animal research falls under to determine what type of approvals are required.
- FAQs Regarding Experiments Involving the Cloning of Toxin Molecules from the NIH
Select Agents List, CDC and USDA APHIS: The Select Agent Program identifies agents that are of particular concern to the health and safety of the public and the environment. Any agents on this list require additional inspection and approval by the Federal Select Agent Program.
Additional Helpful Links
ABSA Risk Group Database This searchable database of international risk group classifications for bacteria, viruses, fungi, and parasites provide information to be used as a starting point for the risk assessment and the determination of the biosafety level to be used when working in the laboratory. There is also an app available for Apple and Android Devices to make it easy to determine on the go what the needs may be for your research facility.
Pathogen Safety Data Sheets: Public Health Agency of Canada: Health Canada provides these MSDS sheets for workers in the life sciences to use as a safety reference for work with infectious microorganisms. To be used in conjunction with the above risk group classifications to determine appropriate biosafety levels and safety precautions.
WHO Laboratory Biosafety Manual, 3rd Edition. World Health Organization: This is a comprehensive document that is useful in developing standard operating procedures and a research facility biosafety manual. There are resources for good laboratory practices, risk assessment, and more that are utilized worldwide.
ASM Guidelines for Biosafety in Teaching Laboratories: This is an excellent resource when determining the biosafety needs in a teaching laboratory. Teaching laboratories that handle pathogens and recombinant DNA need to have the same training, education, and reporting process as research laboratories.
Helpful UWM Biological Safety Program Guides
BSL-1 and BSL-2 Laboratory Biosafety Inspection Template These are the general questions you will be asked and what will be observed when conducting the lab audits for the biosafety program.
Pathogen Information and Pre-Prepared UWM SOPs and Exposure Control Plans for general use. Information found here include pathogen safety data sheets for commonly used microorganisms, risk groups of commonly used microorganisms, etc.