Biological Safety
Overview
As a major research institution, the UW–Madison must provide assurances that its biomedical laboratory practices comply 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.
Guidelines
Biosafety Protocols
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. Contact OBS about requirements for protocols involving human gene therapy trials.
- 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)
Investigator Requirements
Investigators planning to work with the materials/organisms listed 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 Protocols
Protocol Guidance/Forms
- Biosafety protocol instructions and forms are available from the OBS website
- New and renewal protocols must be submitted through Bio-ARROW
- Some protocols do not require review by the IBC; these are reviewed by OBS staff on a rolling basis
- For protocols that require IBC review, protocols must be submitted at least one month before 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
Protocol Amendments
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 at 608-263-2037 or biosafety@fpm.wisc.edu.
Training
Required Training
All lab personnel (including PIs and graduate students) involved in biological research must complete these training courses within 30 days of beginning work on campus.
- Biosafety 101: Building Biosafety into Your Research – Risk Assessment
- Biosafety 104: Building Biosafety into Your Research – Safe Use of Sharps
- Biosafety 201: NIH Guidelines
These courses are completed online via Learn@UW and are available anytime. A valid UW–Madison NetID is needed to access the courses.
Instructions for completing courses: OBS Biosafety Training Courses
Optional Training
Additional biosafety courses are available via Learn@UW to all UW faculty, staff, and students. Visit OBS Biosafety Training Courses for more information.
Resources
UW–Madison 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
- OBS General Biosafety Information: Overview of biosafety guidelines and resources by topic
- 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 Guidebooks
- Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition: CDC biosafety guidebook
- Guidelines for waste disposal and campus services: OBS waste disposal guidebook
External Resources
- 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)
Contacts
Office of Biological Safety
608-263-2037
biosafety@fpm.wisc.edu
For individual OBS staff contacts, visit the Office of Biological Safety Staff page.