When do you need a Biosafety Protocol?
The UW-Madison Office of Biological Safety (OBS) monitors research on campus involving any of the following:
- 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)
If your research involves any of the above, then you will need to complete a Biosafety Protocol; this includes work that is considered exempt from the NIH Guidelines. Biosafety Protocol information can be found on our website: https://ehs.wiscweb.wisc.edu/biosafety-protocol-arrow/. If you are unsure, contact the Office of Biological Safety for information firstname.lastname@example.org or (608) 263-2037.
Q: 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?
A: 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.
Q: I want to work with a Select Agent toxin in subthreshold amounts. What do I do? Is a Biosafety Protocol required?
A: Yes, a Biosafety Protocol is required for all subthreshold Select Agent toxin research. In addition, all work with Select Agents and Toxins (SATs), no matter the quantity, MUST go through the UW-Madison Select Agent Program. If you are unsure if a toxin is regulated as a SAT, please see the website http://www.selectagents.gov/SelectAgentsandToxinsList.html.
Q: I am working with environmental samples that may or may not contain infectious agents. Do I need a Biosafety Protocol?
A: That depends! Samples that are from a general population that is not considered to be at an increased risk for contamination 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 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 Biosafety to more adequately assess the risk potential of your samples if you are at all unsure.
Q: I am working with transgenic mice, but I already have an Animal Protocol. Do I need a Biosafety Protocol?
A: Yes. Since transgenic mice are recombinant, any work involving them is required to be listed on a Biosafety Protocol. It does not matter how the mice have been modified, when, or by whom (a vendor, another lab, your own lab, etc).
Q: What about work with genetically modified animals which doesn’t require an animal protocol (fruit flies, roundworms, etc.)? Does this work need a Biosafety Protocol?
A: Yes, work with these animals requires a Biosafety Protocol even though an Animal Protocol is not needed.
Q: 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?
A: Yes, work with any plant that has been modified through non-traditional breeding methods requires a Biosafety Protocol.
Q: I am currently a Co-PI on a Biosafety Protocol that is being renewed in ARROW. Do I need to do anything extra?
A: Only one person, the PI, can be ultimately responsible for work in a lab. Therefore, Co-PIs will no longer be allowed on Biosafety Protocols. Anyone who wishes to have their work covered under a Biosafety Protocol will need to fill out their own protocol through ARROW, with themselves as the sole PI. See IBC Policy #IBC-POL-011 for more information on how the IBC defines a PI.
Q: 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?
A: 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.