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IBC Charter and Bylaws

APPROVED DECEMBER 2022

 

IBC Charter [PDF]

 

The University of Tennessee, Knoxville (UTK) is required to establish and commission an Institutional Biosafety Committee (IBC) for the oversight of recombinant and synthetic nucleic acid research as per the  NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (hereafter NIH Guidelines). Other purview areas may be included at institutional discretion. The UTK IBC is commissioned by the UTK Chancellor and reports to an appointed biosafety administrator. The biosafety administrator, in collaboration with other Knoxville-area stakeholders:

  • Ensures that the IBC is appointed as per the NIH Guidelines.
  • Establishes the scope, purview, and core objectives and responsibilities of the committee in accordance with the NIH Guidelines, UT System biological safety policy (SA0450), and other germane regulations and policies.
  • Supports and sustains the core objectives and responsibilities of the committee.

Delegation of authority

Unless otherwise prohibited by regulation or mandate, the IBC may delegate administrative authority to the UTK Biosafety Officer (BSO) and supporting staff at its discretion. Administrative management by the BSO will follow the policies, procedures, and general oversight framework established by the IBC. The BSO will provide the IBC with regular updates relative to administrative oversight.

The IBC is committed to protecting faculty, staff, students, visitors, the general public and the environment from exposures (or potential exposures) to biological hazards, and to ensuring that activities involving biological hazards and the facilities used to conduct such follow applicable U.S. Federal, Tennessee State and local laws, regulations, and guidelines. The IBC defines biological hazards as the following:

  • Recombinant or synthetic nucleic acids as defined in Section I the NIH Guidelines, including transgenic plants, animals and microorganisms.
  • Biological agents (bacteria, viruses, fungi, protozoa, parasites, and prions) and/or or vectors that carry biological agents (arthropods, snails, etc.) which: 1) cause or are reasonably expected to cause disease in immunocompetent humans; or 2) cause or are reasonably expected to cause significant disease in local livestock (including poultry), agricultural crops, or indigenous wildlife; or 3) otherwise require containment and safeguards at biosafety level (BSL)-2 or higher.
  • Acute biological toxins having an LD50 < 100 ng/kg in mammals and/or those listed as Select Toxins (Department of Health & Human Services).
  • Human or nonhuman primate blood, blood products, tissues, secretions, excretions, or cell lines unless documented to be free of bloodborne pathogens or otherwise are low risk as per written risk assessment.
  • Venomous animals posing a risk to humans through bite or sting and housed and/or manipulated in laboratories or other indoor facilities (e.g., greenhouses).
  • Poisonous plants posing a risk to humans via dermatological contact, inhalation, or other route of exposure and housed and/or manipulated in laboratories or other indoor facilities (e.g., greenhouses).
  • Novel nanoparticles conjugated to biologically active or cell-modifying molecules.
  • Diagnostic specimens or environmental samples likely to contain any of the above and posing a significant risk to humans or local livestock (including poultry), agricultural crops, or indigenous wildlife as per documented risk assessment, including materials requiring a federal or state permit (e.g., foreign soils, noxious weeds, etc.).

IBC oversight applies to research, teaching, diagnostic testing, and other activities conducted at, sponsored by, or on behalf of the Knoxville-area campuses: UTK, Institute of Agriculture (UTIA), College of Veterinary Medicine (CVM), and Graduate School of Medicine (GSM).

Exclusions to the purview of the IBC:

  • Allergens, zoonoses, and other biological risks associated with the routine care and use of research or teaching animals are deferred to the Institutional Animal Care & Use Occupational Health Program. (Note: research, teaching, and diagnostic testing involving zoonotic agents are subject to IBC oversight as described above).
  • Use/exposure to human blood, tissues, and body fluids external to research, teaching, or diagnostic testing settings (e.g., medical/first-aid, law enforcement, facilities maintenance, athletics, custodial services, etc.) is deferred to the respective Environmental Health & Safety general/occupational safety policies and procedures.
  • Patient clinics and procedural areas at GSM, UTK Student Health Center, and the Veterinary Medical Center are deferred to the respective administration’s oversight.

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 UTK 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 deny, 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 UTK administration. The NIH Office of Science Policy (OSP), CDC, USDA, or other regulatory or funding agencies will be notified if required.
  • In conjunction with the BSO and/or Select Agents Responsible Official:
    • Review and approve design specifications and certification criteria for high-containment laboratories (i.e., BSL-3).
    • Review and approve policies and procedures related to Select Agents (or others categorized as Risk Group 3), including access, inventory management, laboratory protocols and emergency response plans.
    • Review and assess compliance with permit or license-related requirements for biological materials subject to USDA APHIS (Animal and Plant Health Inspection Service), FDA (Food and Drug Administration), and/or EPA (Environmental Protection Agency) regulations.
  • Establish a framework for the identification, management, and reporting of dual use research of concern as defined in the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern as applicable. If dual use research of concern is identified, an IBC-selected panel will serve as the Institutional Review Entity (IRE) as described in the policy.

Membership of the IBC will be based on the NIH Guidelines (section IV-B-2-a). Members are appointed by the designated official for a renewable term of three years. New committee members may be recommended by current members or research administrators. An effort is made to represent all major units served, to have a mix of tenured and non-tenured faculty, to have collective expertise to cover the scope and purview, and to represent the diversity of the university community. Committee composition will be reported annually to the NIH Office of Science Policy as required. The committee generally includes voting members and ex officio non-voting members as follows:

  • Voting members:
    • Committee Chair
    • Committee Vice-chair
    • Plant containment expert
    • Animal containment expert
    • At least two members with no affiliation to the university and who represent the interest of the surrounding community with respect to health and protection of the environment
    • One or more faculty members from each unit: UTK, UTIA, CVM and GSM
    • Laboratory technician or other technical staff member
  • Ex officio (non-voting) members:
    • Assistant Vice Chancellor for the Responsible Conduct of Research and Research Integrity Officer (AVC RCR/RIO)
    • UTK EHS director
    • UTK BSO (note: if recombinant or synthetic nucleic acid experiments will occur at BSL-3, BSL-4, or in large scale, the BSO will become a voting member as required by the NIH Guidelines)
    • Biosafety staff at the discretion of the IBC and/or BSO
  • Ad hoc subject matter expertise: if a registration or topic falls outside the expertise of IBC members, the IBC Chair is authorized to seek counsel from an individual knowledgeable in the subject matter. This person(s) can be someone external to the university, as necessary.

Prior to service, all IBC members will receive training covering the NIH Guidelines and other applicable regulations and guidelines, including NIH review categories, risk assessment, risk groups, biosafety levels, prudent safety practices, and stakeholder roles/responsibilities. Refresher or topical training will be provided at least annually. IBC member training will be documented.

IBC members are expected to attend and participate in meetings. Members will be advised to notify the Chair, Vice-Chair or BSO if they will be absent from the upcoming meeting(s). Members who will miss a meeting may share their notes and comments with the Chair, Vice-Chair or BSO; however, they cannot cast an absentee vote or vote by proxy.

All meetings will be held in person or alternative live interactive format (e.g., video conference). 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 voting member of the IBC.

Review outcomes and recommendations will be reported in writing to affected registrants in a timely manner. Likewise, where meeting outcomes create (draft) changes in policy or (draft) changes in procedure that affect research, teaching or diagnostic testing operations, the changes will be communicated promptly to the affected constituencies. The communication mechanism may vary due to circumstances and/or needs but will include electronic distribution through the IBC’s web-based registration system, the BSO listserv and/or other campus-specific distribution lists, or the UTK EHS-Biosafety Program website.

A quorum for a meeting will be a simple majority of the voting membership, including at least one non-affiliated representative. Approval of registrations, policies, or other resolutions may be granted by a simple majority of committee members attending a meeting.

Ad hoc subcommittees may be established, as necessary, to address matters related to biological hazard use or associated oversight. The scope, brief, and duration of such a subcommittee will be determined by the committee leadership. Subcommittees may be composed solely of members from the UTK IBC or may include non-members, as determined by the committee leadership.

Agendas are assembled by the IBC Chair in collaboration with the BSO and distributed to the committee approximately one week in advance of a scheduled meeting. However, sudden changes in circumstances or emergency events may require an updated agenda at the meeting. Agendas will include a review of the previous meeting’s minutes, registrations (or amendments) called to full committee, old business recaps or updates, and new business items. Any IBC member may request an item to be included on the agenda.

Minutes of the meeting shall include: the time, date and location of the meeting; a copy of the meeting agenda; a list of members present and members absent; notes about the sequence of items discussed; the substance of the discussions, including any concerns and respective resolutions; NIH review categories (where appropriate); vote outcomes; approved biosafety level(s); and any action items and responsible parties.  Minutes shall be:

  • Taken by a BSO representative.
  • Provided approximately one week before the next meeting and reviewed at the beginning of that meeting for correction and/or approval.
  • Maintained on the webpage for the UTK IBC.
  • Accessible to the public (note: in rare cases, the IBC may redact sensitive or proprietary information prior to posting in order to protect the university’s interests).

The UTK IBC will be scheduled to meet on a monthly basis, though meetings may be added or canceled according to volume or special circumstances. An updated meeting calendar will be maintained on the UTK Biosafety Program website. Usually, meetings are open to the public and are announced on the UTK Biosafety Program website (and other outlets as necessary). However, the IBC, at its discretion, may close the meeting, or part of a meeting, consistent with protection of privacy; proprietary interests; health and safety of University employees, the environment, and the community; or as required by law or regulation.

A conflict of interest is defined as financial involvement with a commercial sponsor or personal relationship with an investigator or a sponsor. The University’s conflict of interest policy is published in the University’s fiscal policies (Policy number FI0125). Any IBC member with financial or other interests with the investigator or a research sponsor should inform the IBC and, if necessary, follow the procedures in the policy to manage or resolve the conflict, if any. All members, including non-affiliated representatives, should have a conflict-of-interest statement on file with the University. Committee members may participate in discussion but must abstain from voting on registrations associated with the conflict of interest.

Section 8 of the University’s Code of Conduct requires that all employees protect the confidentiality of information that they receive in the course of their employment, as required by applicable laws, contracts, and policies:

“Responsible Use and Protection of Confidential Information: Employees are entrusted with a variety of confidential information about students, faculty, staff, alumni, donors, research sponsors, licensing partners, patients, and others. Employees must access, use, protect, disclose, preserve, and dispose of confidential information in compliance with applicable laws, regulations, contracts, and university policies.”

Specific non-disclosure agreement requests made by granting agencies, corporations, other commercial entities, or individuals will be submitted to the Office of the General Counsel for review.

The University provides legal protection against liability for its employees in the conduct of their job functions. State law, Tenn. Code Ann. §9-8-307(h), provides that state employees, including employees of The University of Tennessee, have immunity from liability for acts or omissions within the scope of their employment, unless the acts or omissions are willful, malicious, criminal, or done for personal gain. The full policy may be viewed at:  https://counsel.tennessee.edu/liability/. For more information on University Employee Protections against Liability, contact the Office of the General Counsel.

Non-employees on the IBC (i.e., non-affiliated members) are encouraged to become a registered volunteer through the UT Office of Risk Management. A registered volunteer is defined as a person who is not an employee of the University but provides service to the University in an approved program. Registered volunteers are reported to the Division of Claims Administration, State of Tennessee and receive the same civil immunity from liability as University employees under the Tennessee Claims Commission Act (note: volunteers under the Claims Commission Act are not covered for Worker’s Compensation). Additional information is available at https://riskmanagement.tennessee.edu/volunteers/.

The UTK IBC charter will be reviewed at least every three years but may be reviewed more frequently as necessary. Acceptance of the Charter and any future revisions must be approved by the voting members of the IBC and the designated official. A two-thirds (⅔) majority of the voting membership of the IBC is required to accept the charter and any revisions to the document. This vote may be submitted by a written proxy if necessary.

The following section summarizes the roles and responsibilities of UTK administration, IBC members, research investigators, laboratory supervisors, and research personnel. Roles and responsibilities are appointed at the discretion of UTK administration and in accordance with the NIH Guidelines and other relevant regulatory standards (CDC; USDA), as well as UT System and UTK Campus procedures relative to the employee Code of Conduct, responsible conduct of research, and research integrity.

Chancellor

The UTK Chancellor, as the University’s Institutional Official, shall:

  • Establish an Institutional Biosafety Committee (IBC) to oversee the safe and responsible use of biological hazards at the UTK-area campuses.
  • Appoint the IBC Chair, Vice-Chair, and committee members in accordance with the NIH Guidelines Section IV-B-2-a-(1) and other university requirements as applicable.
  • Establish a Biological Safety Administrator (e.g., Biological Safety Officer) with the authority to carry out the duties specified below.
  • Appoint a Responsible Official (RO) to oversee the possession, use and transfer of CDC/USDA-listed Select Agents and Toxins (as applicable).

 Assistant Vice Chancellor for the Responsible Conduct of Research (AVC RCR) and Research Integrity Officer (RIO)

The AVC RCR/RIO ensures that research, teaching, diagnostic testing, or other activities involving biological hazards are conducted safely and in compliance with applicable regulations, standards, and guidelines. In order to fulfill this responsibility, the AVC RCR/RIO shall:

  • Verify that all IBC-approved projects include the necessary resources for the construction and operation of safe research and for the implementation of the Biosafety Program.
  • Provide adequate resources for the dissemination of information on biosafety policies and procedures, including training programs and workshops.
  • Coordinate or provide resources for medical surveillance measures or occupational health programs to protect the health and safety of faculty, staff, students, and visitors.
  • Impose or uphold disciplinary actions or sanctions on principal investigators (PIs) or laboratory supervisors who fail to comply with established regulations, standards, guidelines, or university policies.
  • Serve as an ex officio member to the IBC.

Biosafety Officer/Biosafety Administrator

The BSO serves as the Biological Safety Administrator 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
  • 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.
  • Administratively review proposals and protocols submitted by PIs and laboratory supervisors (as authorized by the IBC) and make recommendations to the IBC Chair.
  • 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, AVC RCR/RIO, and/or Select Agents RO as required or
  • Serve as an ex officio member of the If the university conducts research involving recombinant or synthetic DNA materials requiring BSL3 or BSL4 containment or engages in large-scale research or production involving viable organisms containing recombinant or synthetic nucleic acid molecules, then the BSO shall become 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, 5th (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, AVC RCR/RIO, RO, 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
  • 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 UT compliance committees (e.g., human subjects research involving biological hazards submitted to the Institutional Review Board).

Institutional Biosafety Committee Members

The IBC Chair shall:

  • Set meeting agendas and establish meeting
  • Conduct
  • Prescreen submitted registrations as
  • Approve
  • Review and approve amendments and updates, as
  • Ensure member training; this task may be delegated to the Biosafety Officer or other qualified

The Vice-Chair shall:

  • Substitute for the Chair, as necessary.
  • Coordinate the periodic review and revision of the IBC Charter.
  • Prescreen submitted registrations as assigned.
  • Approve registrations in the absence of the Chair.

The IBC members shall:

  • Complete biosafety regulatory awareness training (IBC training) before participating in voting activities of the committee. Complete annual retraining covering IBC-related topics, as necessary.
  • Attend monthly meetings; notify the IBC Chair if attendance is not possible.
  • Prescreen submitted registrations as assigned.
  • Review registrations and provide feedback to the IBC, as necessary.

Select Agents Responsible Official

The RO is the University delegate with the legal authority and responsibility to oversee the possession, use and transfer of Select Agents. The RO is appointed by the Chancellor, approved by applicable federal agencies, and charged with the legal authority and responsibility to oversee the possession, use and transfer of Select Agents. The RO shall:

  • Possess a detailed knowledge of the Select Agent regulations to the extent that he/she can ensure the University is compliant with all of the programmatic requirements.
  • Conduct annual inspections for each laboratory and all other registered areas where Select Agents are stored or used in order to determine compliance with the Select Agent regulations. The results of each inspection must be documented, and any deficiencies identified during an inspection must be corrected by specified date.
  • Conduct annual emergency preparedness, spill response, and/or security drills as
  • Have a physical presence at the University to maintain compliance with the Select Agent regulations and be able respond in a timely manner to onsite incidents involving Select Agents.
  • Be granted sufficient authority to speak and act on behalf of the University.

 Principal Investigator

The PI is defined as the faculty member or other University employee in whose assigned space a research activity is conducted. The PI is accountable for all activities occurring in his/her lab and 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. Per Tennessee State labor laws and University policies (e.g., HR0580, UT Code of Conduct), the PI will not discipline or take any adverse action against any person for reporting problems or violations to the IBC, BSO, AVC RCR/RIO, Risk Management, or State or Federal agencies.
  • 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 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
  • 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 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 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 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 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
  • 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 BSO conducts shipping training for affected PIs and personnel, as necessary. 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. 

Laboratory Supervisor

The laboratory supervisor is the individual (faculty member or departmental designate) with primary responsibility for the use of biological hazards in the University’s teaching or diagnostic testing laboratories. The laboratory supervisor shall:

  • Comply with all regulations, standards, guidelines, and University policies involving handling, storage, disposal, inventory, security/access, and transportation of biological hazards.
  • Register biological hazards with the IBC or BSO (as designated).
  • Complete training and ensure that all teaching or diagnostic testing staff have completed training, as required by the IBC or any other oversight agency as Training should be documented. Comparable information or training materials should be provided to students and trainees.
  • As necessary, communicate to teaching or diagnostic testing staff and students/trainees the signs and symptoms which may result from accidental exposures to the biological hazards in use.
  • Stipulate the safety precautions to be followed by teaching or diagnostic testing staff, students, and trainees and ensure that these are followed. Work errors and conditions that may result in accidental releases or exposures are to be corrected immediately.
  • Determine the proper PPE to be worn for designated The laboratory supervisor (or designate) shall ensure that PPE is worn as directed and cleaned/replaced as appropriate.
  • Immediately notify the BSO of any laboratory spills, accidents, containment failures, or violations of biosafety practice which result in the release of biological hazards and/or the exposure of laboratory personnel or students/trainees. The IBC may be consulted by the BSO, 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. 

Department Head

The Department Head shall:

  • Review and approve IBC registrations submitted by departmental faculty
  • Verify that appropriate facilities are available to control biological
  • Verify that the PI or teaching lab supervisor has competency commensurate with the proposed project and/or assigned laboratory course(s).
  • Ensure that any reported safety deficiencies or compliance concerns/violations are corrected by the PI or teaching supervisor in a timely fashion.
  • Notify the BSO of new faculty hires, preferably before the new PI arrives on campus, if he/she plans to work with biological hazards.
  • Notify the BSO/IBC if a PI can no longer carry out his/her responsibilities (e.g., leaves the University, retires, ). If this is the case, the Department Head must select one of the following actions within 30 days of the PI’s departure:
    • Assume responsibility for a PI’s registration(s) and manage it under his/her own This change in proprietorship must be reported to the BSO/IBC, and the Department Head must comply with all IBC provisions; or
    • Assign the registration(s) to another This change in proprietorship must be reported to the BSO/IBC, and the designated PI must comply with all IBC provisions; or
    • Inactivate/destroy the registered materials and terminate the
  • Ensure that the PI and/or designated staff follow laboratory commissioning/decommissioning procedures (see EHS LS-003 Guide), including the appropriate disposal of biological hazards and disinfection of affected surfaces and equipment. 

Laboratory Personnel

Laboratory personnel (staff, students, volunteers) shall:

  • Participate willingly in biosafety orientation and training programs offered by the University.
  • Become familiar with lab-specific biological hazards.
  • Abide by all biosafety precautions that are relevant to the assigned duties.
  • Use prescribed personal protective equipment directed by the supervisor.
  • Report any observed unsafe conditions and unsafe practices to the University administration (e.g., PI/laboratory supervisor, department head, dean, or associate dean, BSO, IBC Chair, or DO).
  • Exercise good judgment and ask questions regarding lab practices where you question the level of risk.
  • Look out for the safety of others in the lab and lab facilities.