Research Compliance and Tech Transfer

University of Montana Institutional Biosafety Committee (IBC) Charter

Effective Date: July 30, 2026 
Supersedes: Charter Adopted December 3, 2007; Revised June 1, 2018 
Responsible Office: Office of Research & Creative Scholarship, Office of Research Compliance 
Responsible Official: Vice President for Research and Creative Scholarship (Institutional Official) 
Administrative Contact: Biosafety Officer (BSO)

Charge

The University of Montana Institutional Biosafety Committee (IBC) provides formal governance for research involving biohazardous materials. The IBC ensures that research is conducted in accordance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, which outlines institutional oversight requirements for recombinant and synthetic nucleic acid research; the Centers for Disease Control and Prevention and NIH publication Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition, which provides national standards for biosafety practices and containment; applicable federal and state regulations; and University policies governing research compliance. The IBC reviews and oversees research projects involving, but not limited to, synthetic and recombinant DNA; wild-type pathogens; other potentially infectious materials (including human blood, tissues, body fluids, field-acquired and clinical samples); primary human and non-human cell lines; and transgenic animals. Through this review and oversight process, the IBC ensures appropriate risk assessment, containment, training, and regulatory compliance to protect research personnel, animal populations, the public, and the environment. 

IBC oversight applies to research, teaching, diagnostic testing and other activities conducted at, sponsored by, or on behalf of the University of Montana or affiliate campuses (University of Montana Western-Dillon (UMW), Montana Technological University (MT Tech). 

Authority

The IBC committee is established under the authority of the Vice President for Research and Creative Scholarship, who acts as the Institutional Official. 

The IBC is authorized to: 

1. Review, approve, require modifications to, or withhold approval of research involving biohazardous materials. 
2. Determine appropriate biosafety containment levels (BSL-1, BSL-2). The IBC may choose to implement additional guidelines based on risk assessments. 
3. Suspend or restrict research activities not conducted in accordance with approved protocols or federal and regulatory requirements. 
4. Establish institutional biosafety policies and procedural standards. 

The University of Montana does not currently conduct research involving Select Agents or Toxins regulated under the Federal Select Agent Program. Any request to participate in the Program must be approved by the Vice President of Research and Creative Scholarship.  

Biohazardous and Potentially Biohazardous Materials Overseen by the IBC

IBC review and approval are required prior to initiation of research involving: 

• Recombinant/synthetic nucleic acid molecules and gene-drive modified organisms (GDMO), as covered by the NIH Guidelines, including NIH exempt research. 
• Potentially infectious organisms (typically Risk Group 2 or higher) such as viruses, bacteria, or fungi that can cause disease in humans or cause environmental or agricultural impacts. 
• Infectious proteins (prions) and biological toxins 
• Human and non-human primate materials (including established cell lines).  
• Use of infectious agents in animals 
• Generation or use of transgenic animals  
• Dual Use Research of Concern (DURC) research 

Composition of Committee

In accordance with the NIH Guidelines (Section IV-B-2-a(1)), the IBC must comprise no fewer than five members who collectively have experience and expertise in recombinant or synthetic nucleic acid molecule technology and the capability to assess the safety of recombinant or synthetic nucleic acid molecule research and to identify any potential risk to public health or the environment. All members of the IBC shall have equal voting rights in all matters. All members will be registered with the NIH pursuant to the NIH Guidelines. The IBC at UM is comprised as follows: 

Required Positions 

• IBC Chair 
• UM Biosafety Officer (BSO), ex officio 
• At least one individual with expertise in animal containment principles, if applicable.  
• At least one individual with expertise in plant, plant pathogen or plant pest containment principles, if applicable.  
• At least two members who are not affiliated with the institution (apart from their membership on the IBC) 

The IBC may further comprise the following members: 

• Biological scientists who represent a diversity of disciplines relevant to biomedical research, infectious diseases, and recombinant or synthetic DNA technology. 
• Director or Representative of Environmental Health & Safety  
• Director of Research Compliance (e.g., Assoc. VP) 
• Representative from Curry Student Health Center 
• Additional subject matter experts as required  
• At least one member representing the laboratory technical staff 

Ad Hoc Consultants  

The Institutional Biosafety Committee (IBC) may engage ad hoc consultants when specialized expertise is required to adequately assess the biosafety, health, or compliance considerations of a protocol or issue under review. Ad hoc consultants are individuals with relevant scientific, technical, occupational health, or regulatory expertise who can provide clarification or insight beyond the knowledge base of the standing committee. 

Ad hoc consultants may participate in discussions, provide written or verbal recommendations, and assist the IBC in its risk assessments; however, they are not voting members of the committee and do not contribute to quorum. All ad hoc consultants are expected to adhere to the institution’s conflict‑of‑interest requirements and maintain confidentiality regarding the materials and discussions to which they are provided access.  

Conditions of Membership 

The Vice President for Research, in consultation with the IBC Chair and the Biosafety Officer, may remove members when necessary, for example, in the case of excessive absences, lack of contribution, or undeclared conflict of interest.  

Potential IBC members can be recommended by current IBC members, the Biosafety Officer, or the IBC Chair.  The BSO will contact recommended individuals to discuss the possibility of serving on the IBC and, if mutually agreeable, forward the nominee’s information to the Vice President for Research for official appointment on the committee.   

Conflict of Interest 

No member of the IBC may participate (other than to provide project-specific information at the request of the IBC) in the review or approval of a project in which he/she has been or expects to be engaged or has a direct financial interest or has any other conflict of interest.  

Responsibilities

IBC Committee  

The primary objective of the IBC is to ensure the safe, responsible, and compliant management of biological hazards used in research, teaching, and diagnostic testing. To achieve that objective, the UM IBC will: 

• Establish, communicate, and monitor policies, practices, and procedures covering biological hazards which are in accordance with applicable regulatory standards and guidelines. 
• Review biological hazard registrations to ensure compliance with regulations, guidelines, and adopted policies. Review will include an independent assessment of the risk(s), required safety practices, biological/physical containment and associated facilities, and training and expertise of affiliated personnel. The IBC will communicate registration review outcomes and necessary actions to the principal investigator (PI) or laboratory supervisor in a timely manner. 
• Maintain a protocol management system to track research proposals including modifications and committee decisions regarding the proposals. 
• Regularly assess safety practices and containment facilities to ensure they are appropriate for the proposed biological hazards and affiliated procedures. The IBC will use the biosafety levels published by the CDC, NIH, and USDA as the usual standards of containment to be set for work with a given biological agent. To the extent allowed by Federal law and regulation, the IBC may, at its discretion, increase or reduce the BSL depending on the circumstances presented by a specific project. 
• Adopt emergency plans covering accidental spills and personnel contamination resulting from recombinant or synthetic nucleic acid molecule research. 
• Investigate and recommend corrective actions for accidents, exposures, illnesses, environmental releases, or other adverse events involving biological hazards. The NIH Office of Science Policy (OSP), CDC, USDA, or other regulatory or funding agencies will be notified if required. 
• Investigate and set corrective actions for violations of policies, safety practices, or procedures. The IBC, at its discretion, may withhold, suspend, or terminate approval for use of biological hazards if such use poses a risk to personnel or public health and safety, or for issues of noncompliance. If necessary, recommendations for additional disciplinary actions may be made to UM administration. The NIH Office of Science Policy (OSP), CDC, USDA, or other regulatory or funding agencies will be notified if required. 
• Establish a framework for the identification, management, and reporting of Dual Use Research of Concern (DURC) and research that may involve Pathogens of Enhanced Pandemic Potential (PEPP) as defined in the United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential as applicable. If research falling under the policy is identified, an IBC‐approved panel will serve on the Institutional Review Entity (IRE) as described in the policy. 

Biosafety Officer (BSO) 

The BSO serves as the and is the primary intermediary between the IBC, PIs and/or laboratory supervisors. The BSO shall: 

• Manage the administrative tasks of the Biosafety Program and support implementation of IBC policies and procedures. 
• At the discretion of the IBC, establish/implement a framework for oversight of biological hazards and associated procedures in teaching and diagnostic testing labs. 
• At the discretion of the IBC, establish/implement a framework for oversight of regulatory permits (e.g., CDC, USDA APHIS, US FWS) and associated provisions. 
• Review registrations and amendments submitted by PIs. Review submitted projects and amendments to assess proposed containment levels, facilities, procedures, practices and training relative to the proposed work to ensure compliance with the NIH Guidelines and other pertinent regulations. 
• Develop and implement an exposure control plan for those research and teaching programs handling human-derived materials as stipulated by the OSHA Bloodborne Pathogens Standard. 
• Perform risk assessments and provide technical advice to the IBC, IACUC, IRB and EHS as required or requested. 
• Provide technical advice to PIs and the IBC on biological safety and biosecurity 
• Serve as a voting member of the IBC as per requirements of the NIH Guidelines. 
• Assist PIs, laboratory supervisors, staff and students in conforming to applicable regulations, standards, guidelines and IBC policies by communicating expectations, providing training and technical advice, conducting facility inspections, and providing hands-on assistance as necessary (e.g., shipping biological materials). 
• Perform annual inspections of facilities where biological hazards are being used or stored to ensure safety and containment measures as outlined in the NIH Guidelines, CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, 6th edition (BMBL) manual, the OSHA Bloodborne Pathogens Standard, and/or other standards as applicable. 
• Develop emergency plans for handling accidental spills and personnel contamination and investigate laboratory accidents involving biological hazards. 
• Report any significant problems, violations, or research, teaching, or diagnostic testing-related accidents or illnesses to the IBC, or other campus administrators as applicable. Notify U.S. Federal, State or local agencies as applicable. 
• Prepare periodic reports for institutional management regarding IBC activities and Biosafety Program status. 
• Screen protocols submitted to the IACUC for identification of occupational hazards; consult with animal facility management, veterinarians and PIs regarding appropriate containment procedures for biological hazards. Employ a similar mechanism of review, assessment, and implementation for other UM compliance committees (e.g., Institutional Review Board). 
• Prepare meeting agendas, meeting polls, send meeting invitations and record and prepare meeting minutes. 
• Maintain the list and curriculum vitae/resume of IBC Members and ensure the list is updated at least annually with NIH-OSP. 
• Coordinate IBC registration lifecycle management by notifying Principal Investigators (PIs) of meeting assignments and renewal deadlines; tracking and processing annual updates and administrative amendments; collaborating with the IBC Chair on project review and renewals; and maintaining associated training materials and website content. 

IBC Chair Responsibilities 

• Conduct meetings in accordance with institutional and NIH requirements. 
• Review and approve the meeting minutes. 
• Ensure that IBC members receive appropriate training. 
• Assign ad hoc subcommittees as needed to review an issue prior to bringing it to the full committee for review. 
• Communicate to the PI committee decisions on non-compliance issues 
• Recruit committee members as needed. 
• Assist the Biosafety Officer in communication with the NIH as necessary. 

IBC Member Responsibilities 

• Commit to attending scheduled meetings. Excessive absence may result in removal from the committee. 
• Complete biosafety member (CITI training) before participating in voting activities of the committee. Complete annual retraining covering IBC-related topics as necessary. 
• Attend meetings; notify the BSO if attendance is not possible. 
• Prescreen submitted registrations as assigned. 
• Review registrations and provide feedback to the IBC as necessary. 

Principal Investigator (PI)  

The PI is accountable for all activities occurring in the approved IBC registration and is responsible for full compliance with applicable regulatory standards, guidelines and policies/procedures set forth by the University. In the context of this policy, the PI is primarily responsible for the prudent management of biological hazards and the safety and health of laboratory staff, students, volunteers, and visitors. Although the PI may choose to delegate these aspects to other laboratory personnel or faculty, this does not absolve the PI of his/her ultimate responsibility. The PI shall: 

• Create and foster an environment in the laboratory that encourages open discussion of biosafety issues, problems and violations of procedure.  
• Comply with all regulations, standards, guidelines and University policies involving handling, storage, disposal, inventory, security/access, and transportation of biological hazards. 
• Develop, implement, and maintain written laboratory-specific biosafety procedures appropriate for the biological hazards used in the laboratory. The PI shall ensure that all laboratory staff, students, and visitors understand and comply with these laboratory-specific biosafety procedures. 
• Delay initiation of research involving biological hazards (including recombinant and synthetic nucleic acids) until the research protocol has been submitted to, reviewed, and approved by the IBC or BSO as required. 
• Maintain an inventory of all biohazards used or stored in the laboratory. Logs should include species/strain- specific details, approximate quantity on hand, and where they are stored in the laboratory. 
• Restrict access to the laboratory and stored biological hazards to authorized personnel only. 
• Ensure that all laboratory personnel, maintenance personnel and visitors who may be exposed to any biological hazards are informed in advance of the potential risk and of the practices required to minimize that risk. 
• Add staff, students, and visitors working on IBC-approved projects to the respective IBC registration(s). Regularly review listed personnel and provide updates to the IBC or BSO as applicable. 
• Complete training as required by the IBC or any other oversight agency, ensure that all staff, students, and visitors participating in biohazard related activities have completed appropriate training, and maintain documentation of training. The PI or designee must provide protocol-, agent- and laboratory-specific training. The PI should contact the BSO for assistance with all biosafety training needs. 
• Supervise the performance of the laboratory staff to ensure that required safety practices are employed. Errors and conditions that may result in accidental releases or exposures are to be corrected immediately. 
• Provide and maintain all personal protective equipment (PPE) designated by risk assessment, including routine cleaning and/or replacement of dirty or contaminated PPE as appropriate. Additionally, the PI shall ensure that all affected laboratory faculty, staff, students, and visitors wear PPE as prescribed. 
• Ensure that all safety and containment equipment is maintained in good condition and functionally verified as necessary. Maintenance work in, on or around contaminated equipment is to be conducted only after that equipment is thoroughly decontaminated by the laboratory staff or PI. 
• Properly segregate and decontaminate biohazardous wastes before final disposal. All laboratory faculty, staff, and students are to be familiar with the appropriate methods of waste disposal. 
• Coordinate with the BSO to develop emergency plans for accidental spills and exposures. 
• Immediately notify the BSO of any laboratory spills, accidents, containment failure or violations of biosafety practices that result in the release of biological hazards and/or the exposure of laboratory personnel (or the public). The IBC may be consulted by the BSO as necessary. 
• Inform affected personnel of signs/symptoms that may result from accidental exposures and ensure that they are informed of and receive medical surveillance or occupational health reviews as necessary. 
• Immediately notify the BSO if a laboratory-acquired infection is known or suspected, or if a spill of any quantity involving an agent infectious to humans, plants, or animals occurs in a public area. 
• Comply with shipping and permit regulations for biological hazards. The PI should contact the BSO to ensure that all applicable transportation safety regulations have been met prior to shipping microbiological cultures, tissues (human or animal) or body fluids. 
• Immediately notify the BSO if a Select Agent or other high-consequence pathogen (i.e. Risk Group 3 or 4) has been isolated and confirmed from environmental and/or diagnostic specimens. 
• Instruct and train laboratory staff in the practices and techniques required to ensure safety and the procedures for dealing with accidents. 
• Supervise laboratory staff to ensure that the required safety practices and techniques are employed. 
• Correct work errors and conditions that may result in the release of, or exposure to, recombinant and synthetic nucleic acid materials. 

For PIs who are new to UM or its affiliated campuses or those who are proposing novel or unique biosafety issues, the IBC encourages attendance at meetings to present their research and answer any questions pertaining to their research. 

Meeting Procedures

All meetings will be held in a hybrid setting (both in person and live interactive format (e.g., video conference). The IBC typically meets on the 3rd Wednesday of January, March, May, July, September and November.  Meetings will be conducted in accordance with Robert’s Rules of Order. The Chair will issue all points of order, summarize initiatives as necessary, moderate discussion, and call for motions. Motions, seconds, and/or other propositions may be made by any member of the IBC. Greater than fifty percent of the membership is necessary to establish a meeting quorum, and a quorum must be maintained for each vote to occur. In order for each vote to be approved, it must receive the approval of the majority of the members. 

All meetings are open to members of the public given adequate notice to accommodate attendance. Please see IBC Policy #IBC-POL-002, “Public Participation During IBC Meeting,” for additional information. The IBC reserves the right to restrict the disclosure of information, or to close a meeting session, in order to avoid the disclosure of information that is not subject to state or federal public records laws and for which the University is obligated to protect by virtue of policy, regulation, or statute. Such information includes, but is not limited to, proprietary information subject to the Bayh-Dole Act, and information that, if made public, could reasonably jeopardize the safety and security of University personnel or facilities. 

Protocol Review

No research requiring IBC oversight may begin until all required reviews and approvals are complete. 

All projects subject to IBC oversight must be submitted as an IBC Registration through the institution’s electronic compliance system. 

Preliminary Review (completed upon submission)

The BSO reviews the registration to ensure completeness, verifies completeness of training and performs a biosafety pre-review, which may include: 

1. Evaluation of proposed containment level 
2. Review of laboratory facilities, equipment, and procedures 
3. Confirmation of training and personnel qualifications 
4. Review of laboratory-specific standard operating procedures 
5. Laboratory inspection, as appropriate 

• Projects that remain incomplete or show no progress for an extended period may be administratively cancelled following notification to the PI. Research described in a cancelled submission may not be initiated. 
• The BSO may request revisions or clarifications through the electronic system. 
• Once all comments or concerns are adequately addressed, the project is placed on the agenda for a convened IBC meeting. 

 Committee Review

The IBC will review and assess the registration and perform the following:  

• Conduct risk-based review of submitted biosafety registrations. 
• Evaluate: 
  • Agent characteristics and risk group classification, proposed procedures, facility containment, engineering controls, PPE, training and competency, occupational health and safety requirements.   

Possible Outcomes 

All outcomes require a majority vote by the committee members present at the meeting.  

Approved: The registration document satisfactorily addresses all questions, and the work can be safely conducted as proposed.  No modifications to the registration document are needed. 

Modifications Required to Gain Approval: Minor revisions to the registration document are required.  The revised document will be approved by the BSO or sent back to the committee if applicable once all revisions are complete. 

Tabled/Withheld: There are significant issues with the registration document/proposed work.  Major revisions are required, and the project will need to be re-reviewed by the full IBC at a later meeting when all concerns have been addressed. 

• Prior to final approval, all administrative requirements (training, completed and signed hazard assessment) must be complete.
• Approval is valid for three years, after which the projects must be renewed.   
• Failure to renew results in suspension of IBC approval. 

Principal Investigators are notified in writing of the results of the Institutional Biosafety Committee's review. 

Changes/Amendments to IBC Registrations Following Approval 

Principal Investigators (PIs) are required to submit an amendment through the electronic system prior to implementing any change to an approved IBC registration that may affect biosafety risk, containment practices, personnel, or scope of work. Amendments are categorized as minor or major based on the scope and potential impact of the proposed change. Refer to IBC-PRO-001, “Registration Amendments.” 

Minor Amendments 

Minor amendments are changes that do not significantly alter the overall risk assessment or containment level of the approved project. Minor amendments are reviewed by the Biosafety Officer (BSO) and/or IBC Chair. If both determine that the proposed changes do not increase biosafety risk, the amendment may be approved administratively. Either may refer the amendment to the full IBC if additional review is warranted. 

Major Amendments 

Major amendments involve changes that may alter the original risk assessment, containment level, or NIH Guidelines classification. Major amendments require review and approval by the convened IBC prior to implementation. 

Inspections and Compliance

In coordination with Environmental Health & Safety, the IBC: 

• Conducts periodic laboratory inspections. 
• Reviews: 
  • Biological safety cabinet certifications 
  • Autoclave validation 
  • Waste management practices 
  • Decontamination procedures 
• Corrective actions may be required for deficiencies. 

Incident Oversight

The IBC Committee receives summary reports from the Biosafety Officer regarding: 

• Exposures and laboratory-acquired infections 
• Spills or containment breaches 
• Noncompliance 

Reportable events under NIH Guidelines are submitted to the NIH Office of Science Policy, as required, within the time period set forth by the NIH.  

Training and Occupational Health and Safety Oversight

Personnel must complete required biosafety training and occupational health and safety (OHS) requirements prior to engaging in research. The IBC ensures training programs are current and appropriate to risk level. OHS Program ensures appropriate risk assessments and facility inspections are completed and provide biosafety and occupational health guidance and maintain relevant documentation. 

Cross-Committee Workflow and Coordination

To ensure regulatory compliance and reduce duplicative review, the IBC coordinates with other institutional oversight committees such as follows: 

Coordination with the Institutional Animal Care and Use Committee (IACUC) 

When research involves infectious agents, recombinant DNA, or biohazardous materials in animals: 

Dual Review Requirement 

• IBC approval is required for biosafety aspects. 
• IACUC approval is required for animal welfare aspects. 
• Neither approval substitutes for the other. 

Coordination with the Institutional Review Board (IRB) 

When research involves human participants or identifiable human-derived materials: 

• Dual Review Requirement 
  • IRB approval is required for human subject protections.
  • IBC approval is required for biosafety containment and laboratory safety. 
  • Neither approval substitutes for the other. 

Record Retention

IBC records are maintained in accordance with University of Montana institutional records retention policies and applicable federal requirements. 

All IBC records, including but not limited to protocols, review documentation, correspondence, meeting agendas, will be retained for a minimum of three (3) years following the completion of the research activity or final action taken by the committee, unless a longer retention period is required by institutional policy, federal regulation, or sponsor requirements. 

Meeting Minutes and Public Posting

In accordance with the public transparency requirements of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, the University of Montana Institutional Biosafety Committee (IBC) will make approved meeting minutes publicly available. 

For all IBC meetings taking place on or after June 1, 2025, approved meeting minutes will be posted on the University of Montana’s publicly accessible website. Minutes will be posted after committee approval and after any appropriate and allowable redactions have been made to protect confidential, proprietary, or sensitive information. 

Publicly posted IBC meeting minutes will remain available on the institutional website for a minimum of five (5) years. 

Policy Review

This charter shall be reviewed at least every three (3) years or sooner if regulatory changes require revision. 

Reversion History