Biosafety Protocol

Criteria & 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).
  • Potentially infectious materials derived from humans and from animals, including blood, tissues, and cell lines (this would also include established humans cell lines), for which a reasonable potential for transmission of zoonotic agents exists (e.g., wild-trapped animals, pregnant sheep, and primates).
  • Toxins from a biological source (i.e., biological toxins).
  • Select Agents. CDC and USDA regulate these microbes and toxins due to their threat to public health and agriculture as potential biological weapons. The consolidated list of Select Agents is available at the OBS website {LINK}
  • 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. Note that many rDNA experiments are considered to be low-risk yet still are subject to the Guidelines.

Once registered and assigned a safety committee number (SC#), the protocol is valid for three years.
OBS will send a reminder to the PI prior to the expiration date indicating that the protocol is due for renewal. Protocols (new, renewal, or amendments) are also assigned a record number (Rec#) for tracking each time they are submitted to OBS.

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.

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. OBS tries to accommodate requests for expedited processing. Protocols to be reviewed by the IBC must be submitted to OBS one month prior to an IBC meeting. Materials received less than one month before a scheduled IBC meeting will not be considered until the following meeting.

Renewal

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.

Protocol Amendments

The protocol, once approved by OBS, may be amended. The process for amending an existing biosafety protocol depends on the type of change(s) being made. The amendment may involve changes in research elements, microbes utilized, and/or laboratory location or room updates. The changes should be noted in the biosafety protocol using bold, underlined, or highlighted text.

Submission methods for amendments are similar to submission methods for a new or renewal protocol. The amendment should be emailed to OBS for review and approval; these changes may also require IBC review and approval. It may also be helpful to include a brief description of the change in the submittal email to OBS.

Administrative Amendments

Grants, proposals, and material transfer agreements (MTA) that utilize the materials, locations, and methods of the existing protocol may be added using one of two methods: The first is to enter the required information (title, funding agency and, if known, grant number) into Section I (Core Registration Information) of the protocol form, then email this section to the UW-Madison OBS at biosafety@fpm.wisc.edu. The second is to simply include the same information in the text of an email that is then sent to OBS. Be sure to include PI’s name and protocol (SC) number in the email. Please inform OBS if the grant addition needs to be expedited for administrative (funding) purposes.

Personnel Changes

Addition or removal of laboratory personnel in a protocol can be accomplished by either modifying the protocol form (as mentioned above) and emailing it to OBS or including the information in the text of an email sent to OBS. Be sure to include PI’s name and protocol (SC) number in the email. Please remember to include all people in your lab involved with work covered under your research protocol (e.g., this also includes undergraduate students, independent study students, summer students, visiting scientists, etc.).

Questions?  Contact Biosafety at 263-2037 or biosafety@fpm.wisc.edu