Office of Biological Safety

Protocol Registration Process

As a major research institution, the UW-Madison provides assurances that its sponsored research activities are in compliance with state and federal regulations and guidelines. In this context, the Institutional Biosafety Committee reviews research activities involving biologically hazardous materials and/or recombinant DNA molecules/organisms.

Biosafety protocols must be submitted to the Office of Biological Safety (OBS) for research activities involving:

• Microbiological agents infectious to humans and/or animals; provide a copy of any required federal permit.

• Exotic plants, animals, and microbes (e.g., non-indigenous plants or insect pathogens, or biological control agents); provide a copy of any required federal permit.

• Potentially infectious materials derived from humans (e.g., established cell lines) and from animals, including their blood, tissues, and cell lines, for which a reasonable potential for transmission of zoonotic agents exists, e.g., wild-trapped animals, sheep, and rhesus macaques.

• Potentially hazardous chemicals administered in vivo or in vitro to induce a biological outcome (e.g., carcinogens, mutagens, teratogens, drugs, and toxins).

• Select agents. CDC regulates these microbes and toxins due to their threat to public health and safety. The list of select agents is available here and upon request from OBS.

• Recombinant DNA molecules and recombinant DNA-containing organisms or cell cultures which are subject to the NIH Guidelines for Research Involving Recombinant DNA Molecules. Please contact OBS about requirements for protocols involving human gene therapy trials. (Many rDNA experiments are considered to be low-risk yet still are subject to the Guidelines.)

To ensure protocols remain current with research activities, the Office of Biological Safety (OBS) requests that protocol descriptions be submitted every three years. We encourage project-based protocol consolidation, even if funded by multiple agencies, to facilitate a comprehensive risk assessment and to reduce paperwork.

The protocol form requests a detailed description of the research elements and containment practices and provides a basis for risk assessment. This form is used for all new and updates to on-going research projects. The first page of the form also serves as the equivalent of the former Statement Regarding Use of Biological Materials (yellow, OBS1). Once registered and assigned a safety committee number (SC#), the protocol is valid for three years. Please note that the signature of the Principal Investigator (PI) is always required.

If the biosafety protocol has not changed significantly since it was last reviewed, the PI may resubmit their previous biosafety protocol by resigning it with the current date. Minor changes to the protocol, such as addition of grant applications, or staffing and location changes, may be noted as an amendment to the original submission by submitting just the Core Registration Information section of the protocol form. If necessary, please contact us for a copy of the existing protocol. However, if the protocol has changed significantly, please complete a new biosafety protocol form.

Training Grants and Research Center Support Grants may be registered using the first page of the protocol form. If applicable, the names of involved PIs should be attached.

Assurances are routinely processed once a month, in conjunction with the IBC meeting scheduled for the first Wednesday of each month. We will try to accommodate requests for expedited processing. Protocols that will be reviewed by the IBC must be submitted to OBS two weeks prior to an IBC meeting. Materials received less than one week (five working days) before a scheduled IBC meeting will not be considered until the following meeting.

Please call or email us if you have any questions.

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Useful References

Biohazard Recognition and Control: Guidelines for handling pathogenic microorganisms and disposing biohazardous waste. 1999. Institutional Biosafety Committee, UW-Madison. http://www2.fpm.wisc.edu/biosafety/resources/docs/biohazard_recognition_control.pdf

Biosafety in Microbiological and Biomedical Laboratories. CDC/NIH. 5th edition, September 2007. http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm

Bloodborne Pathogens: Reference and Training Manual. 1997. University of Wisconsin - Madison. Occupational Health Program, EH&S Department. http://www.fpm.wisc.edu/bbp/

Chemical Safety and Disposal Guide. 2005. University of Wisconsin - Madison. Chemical & Environmental Safety Program, EH&S Department. http://www2.fpm.wisc.edu/chemsafety/table_of_contents2005.htm

Laboratory Standard. 1990. Department of Labor, Occupational Safety and Health Administration. 29 CFR, Part 1910.1450. Fed. Reg. Vol. 55, No. 21.

NIH Guidelines for Research Involving Recombinant DNA Molecules. April 2002 and subsequent amendments. National Institutes of Health. http://oba.od.nih.gov/rdna/nih_guidelines_oba.html

Occupational exposure to bloodborne pathogens; final rule. 1991. Department of Labor, Occupational Safety and Health Administration. 29 CFR, Part 1910.1030. Federal Register 56(235).

Proposed Guidelines for Research Involving the Planned Introduction into the Environment of Organisms with Deliberately Modified Hereditary Traits. 1991. USDA. Federal Register Vol. 56, No. 22.

Recommendations for the Safe Handling of Chemical Carcinogens and Mutagens. 1990. Biological Safety Committee, UW-Madison.

Sharps and Laboratory Glass Disposal Poster: http://www2.fpm.wisc.edu/biosafety/Docs/Sharps%20Poster_2_2009.pdf

Syringe Use Guidelines: https://fpm-www3.fpm.wisc.edu/safety/occupationalHealth/LinkClick.aspx?fileticket=goC7hkAydzg%3d&tabid=64&mid=609

Toxicology Data Network (TOXNET). http://toxnet.nlm.nih.gov/ (A cluster of databases on toxicology, hazardous chemicals, and related areas.)

Traynor et al. 2001. A Practical Guide to Containment: Greenhouse Research with Transgenic Plants and Microbes. Information Systems for Biotechnology. http://www.isb.vt.edu/cfdocs/greenhouse_manual.cfm

Waste Disposal Guidance Document: http://www2.fpm.wisc.edu/biosafety/waste_disposal.htm