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 (IBC) reviews research activities involving biologically hazardous materials and/or recombinant DNA molecules/organisms.
The Office of Biological Safety and the IBC monitor and review research through the use of a Biological Safety Protocol. Biosafety Protocols are managed using the online system, ARROW. Many but not all research with biological materials requires oversight and a protocol.
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When do you need a Biosafety Protocol?
The UW-Madison Office of Biological Safety (OBS) monitors research on campus involving any found on the following list.
If your research involves any of the these, then you will need to complete a Biosafety Protocol; this includes work that is considered exempt from the NIH Guidelines.
The Bloodborne Pathogen Exposure Plan (BBP Plan) is now incorporated into the biosafety protocol. Please fill out a biosafety protocol in Bio-ARROW to submit a BBP plan.
- Recombinant (transgenic) or synthetic DNA/RNA materials, including human gene therapy
- Microbes and disease-causing agents including bacteria, viruses, fungi, prions, protozoa, and parasites
- Large scale propagation consisting of a volume greater than 10L or more in one vessel
- Human cells and cell culture, organs or tissues, or biological samples
- Non-human cells and cell culture, organ or tissues, or biological samples that are infectious, potentially infectious or recombinant
- Animals (vertebrate and/or invertebrate) that are recombinant (transgenic), exotic, and/or grown in association with pathogens and/or recombinant materials
- Plants that are recombinant (transgenic), exotic, and/or grown in association with pathogenic or recombinant microbes and/or pathogenic or recombinant small animals (insects, etc.)
- Biological Toxins (this does not include toxic chemicals or antibiotics)
Frequently Asked Questions
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I am working with a chemical that is used to elicit a biological response, but is not derived from an organism. Do I need a Biosafety Protocol for this?
No. These chemicals should be on your Chemical Hygiene Plan, but do not require a Biosafety Protocol. Examples of chemicals that would NOT require a Biosafety Protocol include isoflurane, ketamine, and ethers. Examples of biologically-derived toxins, which DO require a Biosafety Protocol, include diphtheria toxin, pertussis toxin, and cholera toxin.
I want to work with a Select Agent toxin in subthreshold amounts. What do I do? Is a Biosafety Protocol required?
Yes, a Biosafety Protocol is required for all permissible Select Agent toxin research. Protocol reviewers will work with labs to ensure that security and inventory requirements are met. If you are unsure what amounts are permissible for a select agent toxin, please see https://www.selectagents.gov/sat/permissible.htm
I am working with environmental samples that may or may not contain infectious agents. Do I need a Biosafety Protocol?
That depends! Samples that are from a general population that is not considered to be at an increased risk for contamination with pathogens do not need a Biosafety Protocol. Examples may include a random soil sample from the UW Arboretum. Samples that MAY be at an increased risk for contamination with pathogens would likely require a Biosafety Protocol. Examples may include a soil sample from a farmer’s field recently infected with a plant pathogen, or animal blood samples from a population known to harbor infectious animal/human pathogens. Many cases involving environmentally sampled materials are unique; please contact us to more adequately assess the risk potential of your samples if you are at all unsure.
I am working with transgenic mice, but I already have an Animal Protocol. Do I need a Biosafety Protocol?
What about work with genetically modified animals or embryos that doesn’t require an animal protocol (fruit flies, roundworms, Xenopus embryos, etc.)? Does this work need a Biosafety Protocol?
Yes, work with these animals and embryos requires a Biosafety Protocol even though an Animal Protocol is not needed.
Do I need a Biosafety Protocol if I wish to work with plants modified through genetic engineering techniques? Even if I won’t be actively breeding, propagating, or if I am using a sterile line?
Yes, under the NIH Guidelines research activities with any plant that has been modified through non-traditional breeding methods requires a Biosafety Protocol. This includes commercially available recombinant strains.
Can two PIs be listed on a Biosafety Protocol?
Only one person, the PI, can be ultimately responsible for work in a lab. See policy Principal Investigator on a Biosafety Protocol
I wish to start a separate protocol for additional work in my lab/I wish to split my work into more than one protocol. Is having multiple protocols allowed?
In order for the IBC and OBS reviewers to make a thorough risk assessment of proposed work, it is important that all work that is being done in a lab space is included on one biosafety protocol. As such, all work should be included in a single protocol; if new work is being proposed, it should be added to an already-approved protocol via an amendment. If you currently have more than one protocol, please contact Biosafety to determine if this is appropriate for your research.
Exceptions that warrant multiple protocols include clinical trial protocols, core facility protocols, or by IBC request.
Can my Biosafety Protocol be reviewed by Designated Review instead of waiting for the next IBC meeting?
The NIH Office of Science Policy stipulates that official IBC business, including review and approval of protocols subject to the NIH Guidelines, be conducted at a convened meeting (i.e., interactive and in real-time). Electronic exchanges such as email are not deemed acceptable, prohibiting a “designated review” model such as that used by the Animal Care and Use Committees. However, most protocols that are not subject to the NIH Guidelines, grant and personnel changes, and certain amendments deemed similar enough to previously approved work may be reviewed and approved by OBS on behalf of the IBC.
I am leaving the university. What do I need to do with my biosafety protocol?
If all work is complete, all materials have been disposed or transferred, and no personnel or students are continuing laboratory activities covered under the protocol, please inactivate your biosafety protocol. Information on inactivating a biosafety protocol may be found at Inactivate Approved Protocol. If you wish to transfer the biosafety protocol to another PI, please contact OBS for assistance.
Do I need to include summer students, rotating students, and visiting professors on my biosafety protocol?
Yes. All persons performing work covered under your protocol, must be listed on your registered biosafety protocol. Information on making changes to the personnel section may be found at Change Your Grant or Personnel section. All personnel listed on a biosafety protocol must complete required trainings before the grant/personnel change can be approved.
I am planning a clinical trial at UW-Madison that will fall under the oversight of an external Institutional Review Board. Can the Biosafety Protocol be reviewed by an external IBC instead of the UW-Madison IBC?
No. The UW-Madison Institutional Biosafety Committee will need to review and approve protocols for human clinical research involving biohazardous or recombinant materials, including human gene transfer studies. OBS staff would be happy to assist the study team with the Biosafety Protocol for their clinical trial.