APPROVED MAY 2019
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 and reports to a designated official (DO) as appointed by the UTK Chancellor. The DO, 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 and associated biosafety program in accordance with the NIH Guidelines, UT System biological safety policy (SA0450), and other germane regulations and policies.
- Provides appropriate resources to support and sustain the core objectives and responsibilities of the committee and associated biosafety program.
Delegation of authority
Unless otherwise prohibited by regulation or mandate, the IBC may delegate administrative authority to the UTK Biosafety Officer and supporting staff (hereafter, BSO) 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 an 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 work are in compliance with applicable U.S. Federal, Tennessee State, and local laws, regulations, and guidelines. The IBC defines biological hazards as the following:
- Recombinant DNA molecules or synthetic nucleic acids as defined in Section I the NIH Guidelines, including transgenic plants and animals.
- Biological agents (bacteria, viruses, fungi, protozoa, parasites, and prions) and/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 are otherwise 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-Knoxville).
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.
- CVM, GSM, and UTK Student Health Center patient clinics and procedural areas 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. In an effort 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.
- 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.
- 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, FDA, and/or EPA 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. In the event that 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 2 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:
- Designated Official
- 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: in the event that 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 other 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 generally include electronic distribution through web-based registration system (iMedRIS), the BSO listserv and/or other campus-specific distribution lists, or the UTK 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 particular matters related 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 UTK Biosafety Program website at a weblink 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.