The purpose of this Institutional Biosafety Committee (IBC) policy is to define requirements for IBC members, IBC meeting administration, investigators, and research with biological materials.
This policy applies to UW-Madison Institutional Biosafety Committee (IBC) members and consultants, UW-Madison employees, students, and staff engaged in research involving biological materials, and applicable employees and staff of affiliate organizations that fall under UW-Madison IBC oversight under cooperative agreement with UW-Madison (i.e., Morgridge Institute for Research, USDA-ARS Madison location, and the William S. Middleton Memorial Veterans Hospital).
1.1. Roles and responsibilities
1.2. Membership of the committee
1.3. IBC consultants
1.4. Appointment process and length of service
1.5. IBC member training
1.6. Conflicts of interest
2. IBC meeting administration
2.1. Conduct of meetings
2.2. Biosafety protocol
2.3. Access to IBC minutes and other records
2.4. Receipt and transmission of public comments
3.1. Principal investigator on a biosafety protocol
3.2. Compulsory biosafety training
3.3. Core facility registration responsibilities
3.4. Reporting biosafety concerns
3.5. Reporting exposures, injuries, releases, and other incidents
3.6. Reporting laboratory-acquired infections to state and local public health authorities
3.7. Biosafety protocol expiration
3.8. Suspension of previously approved research
3.9. Principal investigator requests for reconsideration process
4.1. Shared use of laboratory or animal facilities
4.2. Registration of transgenic animals
4.3. Animal waste and carcass disposal
4.4. Maintenance of ventilated cage racks
4.5. Biosafety cabinets, animal transfer stations, and clean air benches
4.6. Appropriate containment for Select Opportunistic and borderline pathogens
4.7. Vaccinia
4.8. Dengue virus
The IBC is charged with responsibility for oversight of research using biological materials that entails a potential risk to humans, animals, plants, or the environment. This research includes, but is not necessarily limited to, studies involving recombinant DNA, infectious agents, and biological toxins. The IBC is authorized to:
The IBC fulfills the functions set forth in Section IV-B-2-b of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). The IBC also provides expert advice, recommendations, and best practices for laboratories working with biological materials.
The UW–Madison IBC is composed of faculty, a laboratorian, 2 public members, ex officio members, and consultants as per NIH Guidelines Section IV. The committee shall at all times be composed of at least five members, including the UW–Madison Biosafety Officer, and typically has 18 voting members; consultants are not voting members. With the exception of ex officio members and the Associate Vice Chancellor for Research in Biological Sciences, there is no provision for designation of alternates to serve when a member cannot attend. Members and consultants sign confidentiality agreements. Regular members are selected for their expertise in subjects for which the committee will review protocols, as follows:
In accordance with NIH Section IV-B-2-a-(1), at least two members of the committee shall not be affiliated with the institution. They shall represent the interests of the community including health and protection of the environment.
Ex officio voting members:
Ex officio members may designate an alternate to attend committee meetings and vote in their stead in the event that they are unavailable. The designation of an individual as alternate for an ex officio voting member must be approved by the Office of the Vice Chancellor for Research (OVCR).
Consultants with the following expertise or role serve to advise the committee:
IBC consultants can be assigned to review biosafety protocols but cannot make motions or vote and do not count towards quorum.
The IBC members are appointed by the Vice Chancellor for Research on behalf of the Chancellor at UW–Madison. The BSO provides an annual update of the roster and recommendations to the Associate Vice Chancellor for Research in the Biological Sciences in the OVCR. Regular members serve a 3-year term. At the conclusion of the 3-year term, they may elect to continue for an additional 3-year term or rotate off the committee. The length of service for public members is indeterminate. Ex officio members serve as long as they are in their respective positions. The committee chairperson, a faculty member, usually serves in this capacity for at least 1 year.
All members must take the UW–Madison New IBC Member Training provided by the Office of Biological Safety (OBS), as well as the Biosafety Required Training modules required of all Principal Investigators (PIs) and laboratory personnel listed on biosafety protocols. This training is to be completed prior to the new member’s first protocol review.
Except when providing information at the IBC’s request, no IBC member or consultant with a conflict of interest with respect to research may be involved in the review or approval of such research, or in deliberations or voting on actions to suspend, revoke, or reinstate authorization for such research.
An Institutional Biosafety Committee (IBC) member or consultant, has a conflict of interest with respect to research when the IBC member or consultant, or an immediate family member:
When IBC members or consultants receive materials before a meeting, they are responsible for disclosing any potential conflict of interest to the Office of Biological Safety or the IBC Chair as soon as possible. IBC members or consultants are also responsible for disclosing any potential conflict of interest with respect to research to the IBC should issues arise during the course of a meeting.
All business conducted in IBC meetings, including the review of research protocols, shall be publicly noticed and conducted in open session, except that the following matters may be discussed in closed session as permitted or required by the Wisconsin Open Meetings law:
PIs or laboratory research staff can request to attend the IBC meeting when their protocols are discussed. The IBC may ask the PI or representative to attend the meeting in order to help clarify points and answer questions when their protocol is being reviewed.
Meetings are conducted according to Robert’s Rules of Order. Thus, the IBC cannot vote without a quorum present, which is defined as more than half of the voting members.
An IBC-approved biosafety protocol is required for the following:
cDNA that is generated via reverse transcription of extracted RNA during RT-PCR or deep sequencing procedures does not need to be listed on a biosafety protocol, nor do the primers or amplification products if they consist entirely of sequences that exist in the natural source and do not have infectious or toxic potential. PCR products in which sequences have been modified from the natural source, non-coding nucleic acids used to alter gene expression (e.g., siRNA, miRNA, antisense oligos), viral nucleic acids that are potentially infectious, and sequences encoding toxins must be covered under biosafety protocol.
Protocols submitted to OBS that do not require full IBC review (e.g., personnel amendments, low risk protocols that are exempt from the NIH Guidelines, and grant changes) are processed, reviewed, and approved by OBS staff. OBS has the discretion to withhold a protocol that needs IBC review from the IBC meeting agenda if the protocol is deemed not ready for review.
Previously approved protocols must be submitted for re-review and approval at least every three years.
Any member of the public interested in obtaining access to documents maintained by the IBC, such as minutes from IBC meetings and IBC correspondence with funding and regulatory agencies, may submit a request for these records to the University. Upon receipt of a request, the University will follow its procedures for responding to requests made under Wisconsin’s Public Records law.
The IBC encourages members of the public to submit comments to the IBC. Upon receipt of any such comments, the IBC will prepare a response that will be approved by a vote of the IBC. For comments related to research subject to the NIH Guidelines, the IBC will forward the public comments and IBC response to the U.S Department of Health and Human Services, National Institutes of Health Office of Science Policy (NIH-OSP).
The IBC defines a PI for biological safety protocols as University of Wisconsin–Madison tenure track faculty, Research Professors (all levels), or academic staff that have been granted Permanent PI Status.
A UW–Madison researcher that does not fall into one of the above categories or a researcher from an external entity may request to be a PI for the purposes of the biological safety protocol. This is requested of the IBC by filling out the "Request for Principal Investigator Status Form" form and submitting it to the IBC. These requests are subject to IBC approval. These persons may include (but are not limited to):
The completion and approval of the form by the IBC pertains solely to the ability to serve as Principal Investigator on a biosafety protocol. Although the same form may be used to apply for PI status on Institutional Review Board (IRB), Animal Care and Use Committee (ACUC), and Stem Cell Research Oversight (SCRO) protocols, approval of PI status on a biosafety protocol by the IBC does not confer PI status for IRB, ACUC, and/or SCRO protocols; approval for these must be granted by the relevant oversight committee(s). Submission of the form to the IBC does not replace the formal campus designation process to serve as a Principal Investigator on an extramural grant proposal, nor does it confer any of the benefits of campus-designated PI status.
The IBC may set additional conditions or determine that an individual cannot serve as PI on a biosafety protocol, even if the individual otherwise meets the criteria in this policy, if the committee determines the individual’s ability to fulfill the roles and responsibilities of a PI may be compromised due to existing circumstances. Examples may include lack of appropriate expertise or physical location that is not in proximity to where the research will be conducted.
All personnel listed on a biosafety protocol including the PI must take and pass the “Biosafety Required Training” course unless an exemption has been granted by the IBC/OBS. Active biosafety protocols may be suspended and new/renewal/amendment applications may not be processed, or may not be approved, if the PI and all listed personnel have not satisfied all training requirements. All personnel listed in the biosafety protocol must complete training prior to beginning research in the laboratory. PIs are responsible for verifying that all laboratory personnel listed on their biosafety protocols have completed the training modules as required under this policy, and for keeping training records for laboratory personnel. Personnel who are listed as “Administrator (does not perform lab work)” will be exempted from this training requirement. Personnel who are listed on protocols containing only human blood, blood components, or other potentially infectious materials (OPIM) that require a Bloodborne Pathogen (BBP) Exposure Plan may be granted an exemption from the course “Biosafety Required Training” on a case-by-case basis. An example of a situation when an exemption would be considered is the collection of human samples to be sent out for analysis without prior processing. An exemption from the “Biosafety Required Training” does not exempt personnel from annual training required by the Bloodborne Pathogen Exposure Program.
Core facilities incur inherent risks associated with the services they provide. The biological risks may include, but are not limited to, zoonotic diseases, aerosol generating activities, and exposure to infectious or potentially infectious agents. UW–Madison core facilities must account for risks associated with the activities performed in a biosafety protocol that describes the work they do and hazards they may encounter through the service they provide. The biological materials requiring a biosafety protocol are defined in the UW–Madison Researchers’ Biosafety Manual. The biosafety protocol must describe the types of materials handled, the activities performed by core personnel, and specify the materials that are not permitted in the core facility. The biosafety protocol must include steps taken to mitigate risks, including training, engineering controls (e.g., biosafety cabinets) and personal protective equipment. The IBC/OBS should be consulted to determine if a separate protocol needs to be submitted for PIs with research and core facility responsibilities.
Because a core facility may not have detailed knowledge of the research activities to accurately assess risk associated with biologicals materials supplied to them by a PI or user, the PI or user must communicate any potential hazards associated with the materials and provide the appropriate biosafety training. For UW–Madison investigators, biological materials must be accounted for on the protocol of the PI for whom the work is being performed. All work that is associated with a specific project must be accounted for on the biosafety protocol corresponding to the PI that is facilitating the work.
An intake process is required for sample submission for cores that are service oriented, accept samples/materials, or are overseeing equipment for people to use. This process must ensure that appropriate information is given to core personnel and should be documented by the core. The intake process needs to include contact information for the PI and/or user, a description of materials, occupational health considerations, and clearly define expectations for entry and/or use of equipment (e.g., training requirements, PPE, disposal of waste, disinfection/inactivation, emergency response). The process may include the use of an intake form that is completed by core facility personnel or by the user.
Training must be provided to persons using equipment or present in the facility while experiments are in progress. The training must include information about the biological agents potentially present, spill response procedures, and exposure response procedures. Training frequency and documentation are specified in the biosafety protocol.
Any individual who has concerns related to the research use of recombinant DNA, microbial pathogens, biological toxins, or any other material requiring a biosafety protocol is encouraged to express those concerns. UW–Madison will not tolerate any reprisal against an individual who has, in good faith, come forward with concerns or allegations of wrongdoing involving the use of such material.
This policy provides three separate avenues for individuals to express concerns relating to biosafety:
PIs are responsible for ensuring fulfillment of reporting requirements specified in their approved biosafety protocol. Exposures, potential exposures, injuries, releases, or other incidents involving biological materials must be reported using the First Report of Biological Exposure or Release Event form or other approved reporting mechanism. Reporting should be done as soon as possible but must be completed within 24 hours of the incident unless a different timeline is specified in the biosafety protocol.
The Biological Safety Officer (BSO) or designee will determine whether the incident should be reported to the NIH-OSP and in what timeframe according to the NIH Guidelines; the BSO or designee will fulfill this reporting obligation as required by the NIH Guidelines. Reportable incidents may include injuries, spills, exposures or potential exposures, and violations of the NIH Guidelines. All incidents that are reported to the NIH-OSP will also be reported to the IBC at the next convened meeting. In cases where incidents are reported to the NIH-OSP in an expedited fashion and the next convened IBC meeting does not occur within that timeframe, the IBC Chair will be notified.
UW–Madison will investigate any confirmed or suspected laboratory-acquired infections that occur in employees, visitors, or students and report any communicable disease within the prescribed time period as required by Wisconsin Statute and Wisconsin Administrative Code. In the case where the event involves a Select Agent, the Responsible Official or an Alternate Responsible Official will report the event directly to public health authorities.
PIs are responsible for reporting all laboratory-acquired infections to the Office of Biological Safety using the method specified in the biosafety protocol.
The IBC has set a three-year expiration date for a biosafety protocol. The PI will receive sufficient notifications of impending expiration, by Bio-ARROW notifications and email from OBS. It is the PI’s responsibility to submit a renewal in a timely manner.
UW–Madison upholds the fundamental principle that conducting work with recombinant nucleic acids, infectious agents, and other material that may be toxic to living organisms is a privilege and not a right.
The IBC has the authority to suspend previously approved research when the IBC determines that the research:
The IBC chair may suspend previously approved research before a determination is made by the full IBC if the IBC chair concludes that the suspension must be done immediately to protect safety, health, or the environment. If the IBC chair is unavailable, the BSO may exercise this authority.
The IBC recognizes that isolated instances of non-compliance can occur as the result of simple and minor oversight and error with no intent to circumvent applicable requirements. This policy is not intended to eliminate the ability or responsibility of an investigator to immediately report and correct a simple or minor oversight or error, but is intended to address serious compliance and safety, health, or environmental issues that, in the determination of the IBC, go beyond simple and minor oversight.
A PI may submit a request for reconsideration of an IBC decision based on the existence of relevant new information not previously provided to the IBC. The PI may submit such requests regarding biological safety protocols, DURC analyses and DURC reports. Upon receipt of any such request, the IBC will prepare a response that must be approved by a vote of the IBC and forward the IBC response to the PI. The PI may request or be requested to attend an IBC meeting in order to discuss the matter. The IBC’s decision on the request for reconsideration will be final.
All researchers who utilize multi-user laboratories or animal procedure/housing rooms must comply with the highest biosafety containment level for work in the shared space. For example, where both Biosafety Level (BSL)1/Animal Biosafety Level (ABSL)1 and BSL2/ABSL2 activities are performed, researchers must comply with BSL2/ABSL2 requirements. It is expected that the PIs who are assigned to a multi-user laboratory or animal procedure/housing room will work together co-operatively to ensure the safety of all workers, including custodial and animal care staff.
All researchers who utilize multi-user laboratories or animal procedure/housing rooms must abide by the following:
Unless all of the following are true, research involving transgenic animals must be registered with the UW-Madison IBC by inclusion on an approved biosafety protocol:
Carcass and waste disposal procedures must be described for all animals listed on a biosafety protocol.
BSCs, ATSs, and CADs may not be sent to UW–Madison’s Surplus With a Purpose (SWAP) to be sold. These units must be dismantled by the BSC Certification Program or an EH&S approved vendor prior to disposal by campus metal recycler. Gas decontamination is always required prior to disposal of a BSC and may be required for ATSs and CADs depending on their use. Gas decontamination must be done by trained personnel; through the BSC Certification Program or an EH&S approved vendor. There is a fee associated with the disposal of BSCs, ATSs, and CADs.
Prior to the disposal or removal from campus the PI must determine if the BSC is listed by Property Control as an inventory (capital) asset by their department. If so, the BSC must be removed from the inventory list. The Department’s Property Administrator will be able to help the PI with the list and inventory removal.
Open Flame Use in BSCs
Heat from a device (e.g., Bunsen burner, alcohol lamp, bacteria incinerator) affects the air flow in BSCs and as a result can compromise containment and increase contamination. The use of flammable gas inside a BSC is also an explosive hazard. Thus, the use of a continuous open flame (e.g., standard Bunsen burner) is prohibited. The use of an alternative heat-generating or intermittent flame source such as a safety Bunsen burner or a bacteria incinerator is strongly discouraged and requires approval from OBS/IBC for use inside a BSC. Non-flame and non-heat-generating alternatives should be used whenever possible.
Work with microorganisms in the laboratory setting may create situations whereby the normal route of transmission is circumvented. In the lab, the concentration and volume of microorganisms are typically higher than those encountered in nature, and procedures provide opportunities for infection via non-canonical routes such as splash to mucosa or needle stick. In the event of an exposure, some individuals will be at higher risk due to an immunocompromised, immunosuppressed, or susceptible immune status. Many things can reduce the immune response to opportunistic pathogens, such as very young or very old age, pregnancy, asthma, bone marrow or organ transplantation, immune deficiencies, AIDS, smoking, cancer treatment, and prolonged use of corticosteroids or certain other medications.
Based on risk assessments, the IBC has determined that Biosafety Level 2 (BSL-2) is appropriate for handling the following microorganisms:
Employees with questions or concerns related to their health, immune, or pregnancy status are encouraged to consult with Occupational Medicine.
PIs who conduct activities with vaccinia virus must complete a Lab Specific Occupational Health Plan for Vaccinia and direct any employees that will be working with vaccinia under their biosafety protocol to fill out the form. All laboratory employees working with vaccinia will receive an evaluation from UW-Madison Occupational Medicine. The laboratory PI is responsible for maintaining the signed record for all personnel working with vaccinia.
This policy requires researchers who conduct activities with dengue virus to consider IBC recommendations for work with the virus and to complete the “Understanding the Risk of Working with Dengue Virus” acknowledgment form.
The UW–Madison Researchers’ Biosafety Manual (Office of Biological Safety website)
Request for Principal Investigator (PI) Status
Bloodborne Pathogen Exposure Program (Office of Biological Safety website)
First Report of Exposure or Release form
BSC Manual (Office of Biological Safety website)
IBC Intake Form Example Core Facility
Lab Specific Occupational Health Plan for Vaccinia template
Understanding the Risks of Working with Dengue Virus Form
Select Agents and Toxins (Office of Biological Safety website)
