OverviewBack to TopAs a major research institution, the UW-Madison must provide assurances that its biomedical laboratory practices are in compliance with state and federal regulations and guidelines.
Office of Biological Safety
At UW-Madison, the Office of Biological Safety (OBS) provides oversight and assistance in assuring compliance with all laws, regulations, and rules governing biomedical laboratory practices and facilities.
The OBS is the administrative office of the Institutional Biosafety Committee (IBC), which reviews research activities involving biologically hazardous materials and/or recombinant DNA molecules/organisms.
GuidelinesBack to Top
OBS requires submission of a Biosafety Protocol for research activities involving:
- Microbiological agents infectious to humans and/or animals.
- Exotic plants, animals, and microbes (e.g., nonindigenous plants or insect pathogens, or biological control agents)
- 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.
- Select agents. CDC regulates these microbes and toxins due to their threat to public health and safety.
- 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 for Research Involving Recombinant DNA Molecules.)
- Prions: proteins that reproduce independently and cause spongiform diseases (chronic wasting disease in deer, elk; mad cow disease in cattle; Creutzfeld-Jakob disease in humans)
Investigators planning to work with materials/organisms listed above must:
- Submit a Biosafety Protocol for review by OBS and/or the Institutional Biosafety Committee
- Ensure that lab personnel complete appropriate Training
- Report potential exposures to or releases of organisms/biological toxins within 24 hours of the event using the online First Report of Exposure/Release form
Submitting ProtocolsBack to Top
- Forms and instructions are available from the OBS website: Biosafety Protocol Instructions and Forms
- New and renewal protocols must be submitted through Bio-ARROW
- Some protocols do not require review by the IBC; these are reviewd by OBS staff on a rolling basis
- For protocols that require IBC review, protocols must be submitted at least 1 month prior to an IBC meeting (typically held on the first Wednesday of each month)
- Protocols are approved for a maximum of 3 years. Protocols for longer projects must be renewed every 3 years.
- For additional information, visit the OBS Biosafety Protocol Page.
In certain situations, a protocol may need to be changed during the course of a project. There are three types of changes, or amendments, to protocols:
- Administrative Amendments are needed when funding sources are added or changed.
- Personnel Amendments are needed when lab personnel are added or removed.
- Protocol Amendments are needed when the scope of work changes.
Examples include changes in research elements, microbes utilized, and/or laboratory location or room updates.
Amendments can be submitted online through Bio-ARROW. Note: During transition process not every protocol will need to convert to online Bio-ARROW right away. If you need to make an amendment contact Biosafety for more information, phone: 608-263-2037; email: firstname.lastname@example.org
TrainingBack to Top
All lab personnel (including PIs and graduate students) involved in biological research must complete the training courses below within 30 days of beginning work on campus.
- Biosafety 101: Risk Assessment
- Biosafety 104: Safe Use of Sharps
- Biosafety 201: NIH Guidelines
These courses are completed online via Learn@UW, and are available 24 hours a day, 7 days a week. A valid UW-Madison NetID is needed in order to access the courses.
Instructions for completing courses: OBS Biosafety Training Courses
Additional biosafety courses are available via Learn@UW to all UW faculty, staff, and students. See OBS Biosafety Training Courses for more information.
ResourcesBack to Top
|UW-Madison Campus Resources|
|Biosafety Protocol Instructions and Forms||OBS biosafety protocol instructions and forms|
|First Report of Exposure/Release Form||Online form for reporting potential exposures to or releases of organisms/biological toxins|
|UW Madison Office of Biological Safety (OBS)||Office of Biological Safety main site|
|UW Madison Select Agent Program||Forms, links, and training information for researchers using Select Agents|
|Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition||CDC biosafety guidebook|
|Guidelines for waste disposal and campus services
||OBS waste disposal guidebook|
|NIH Guidelines for Research Involving Recombinant DNA Molecules|
|CDC Regulation of Select Agents and Toxins||Information on the regulation of Select Agents, from the Centers for Disease Control website|
|USDA Animal and Plant Health Inspection Service (APHIS)||Information on regulations and permits for import/export and transport of exotic plants, animals, and microbes (e.g., nonindigenous plants or insect pathogens, or biological control agents).|
ContactsBack to Top
General Compliance Questions
CALS Research Compliance Specialist
Office of Biological Safety
For individual OBS staff contacts, see Office of Biological Safety Staff page