This policy describes planning and implementation of control practices for the prevention of laboratory-acquired infections in all UNC Charlotte research programs involving biohazardous agents. The policy has been established to ensure safe handling of biohazardous agents and the appropriate assessment of potential risks.
I. Policy Statement: Purpose and Scope
This policy establishes the framework of control practices for the safe handling of biological materials and the appropriate assessment of potential risks in UNC Charlotte research and academic programs. Biological materials include biohazardous agents, recombinant or synthetic nucleic acid molecules, and human tissue or materials that may cause disease or injury to other living organisms or cause significant impact to the environment or community. Control practices are based on the applicable regulatory requirements or current safety guidelines, including:
The purpose of the Biosafety Policy is to ensure protection of all faculty, staff, and students who generate, store, process, and dispose of potentially hazardous biological materials at UNC Charlotte, as well as others who may become exposed to biological hazards within the University environment.
The scope of this policy governs the review and conduct of all research and instructional activities involving potentially hazardous biological materials conducted: a) in facilities or on property owned, leased or operated by UNC Charlotte regardless of funding source; b) through the complete or partial sponsorship of UNC Charlotte; c) by faculty, researchers, staff, students, and employees.
Any work with hazardous biological materials can pose health risks to persons handling or near the materials or to the environment where such materials are being handled or stored, should the materials escape the containment procedures established for the laboratory. This policy, therefore, sets forth the University’s responsibilities to ensure the safe handling of these materials, the appropriate assessment of potential risks, and the reduction of potential personnel exposure or accidental environmental release.
Furthermore, as a recipient of National Institutes of Health (NIH) research funding, UNC Charlotte must ensure that all research involving recombinant or synthetic nucleic acid molecules, including research involving genetically modified plants and animals and human gene transfer research, conducted at or sponsored by the University, irrespective of the source of funding, is in compliance with NIH Guidelines.
UNC Charlotte is committed to planning and implementing control practices for the safe handling of biological materials in its facilities and to protecting the surrounding community and environment. This policy is implemented through the UNC Charlotte Biosafety Manual and the UNC Charlotte Institutional Biosafety Committee (IBC). The Biosafety Manual sets forth practices and procedures to ensure that the University operates its facilities in compliance with all applicable biosafety regulations and good laboratory practices.
The IBC will establish training requirements for all faculty, staff and students involved in the use of biological materials and research. The IBC will also establish procedures for the registration and review of biological materials and the use of recombinant or synthetic nucleic acid molecules. Researchers who plan to use or distribute biological materials such as biohazardous agents, human-sourced materials or recombinant or synthetic nucleic acid molecules are responsible for knowledge of and compliance with this policy, the Biosafety Manual and IBC procedures.
Academic and research areas that use hazardous biological agents or recombinant or synthetic nucleic acid molecules must comply with all aspects of the UNC Charlotte Biosafety Program, this Policy, and the Biosafety Manual.
Risk Group 4 (RG4) agents are agents likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available. Risk Group 4 (RG4) agents are prohibited at UNC Charlotte.
A. Institutional Biosafety Committee
The UNC Charlotte Institutional Biosafety Committee (IBC) is appointed by the Vice Chancellor for Research and Economic Development. Committee members serve in staggered terms not to exceed three (3) years per term, with no limit on the number of terms one can serve.
The Committee consists of at least five (5) members selected so that they collectively have (1) experience and expertise in biological materials and recombinant or synthetic nucleic acid molecule technology, (2) the capability to assess safe practices for the use of such agents, and (3) the ability to identify any potential risk to public health or the environment. Consideration for Committee appointments is also given to faculty in departments where work or research is being done with biohazardous agents and recombinant or synthetic nucleic acid technology.
The UNC Charlotte IBC must include a minimum of two (2) members who are not otherwise affiliated with the University and who represent the interest of the surrounding community with respect to health and protection of the environment.
The Committee may also include the following in voting or non-voting ex officio capacities: University Biosafety Officer (BSO), University Attending Veterinarian, Environmental Health and Safety Office representative, Director of Laboratory Animal Resources and an occupational healthcare professional, as well as personnel designated from the Office of Research Compliance.
Exceptions to this policy may be granted by the Vice Chancellor for Research and Economic Development on a case-by-case basis based on unusual circumstances. Such exceptions must be requested in advance in writing from the Vice Chancellor for Research and Economic Development and provided to the responsible department head in writing prior to the implementation of the approved procedures.
Failure to abide with this policy shall be considered a violation of University Policy in accordance with University Policy 801, Violation of University Policy.
III. Roles and Responsibilities
A. Institutional Biosafety Committee
B. Biosafety Officer (BSO)
D. Office of Research Compliance
IV. Policy Implementation
The Vice Chancellor for Research and Economic Development is responsible for overseeing the implementation of this policy and delegation of responsibilities for submitting reports to NIH in compliance with federal regulations regarding recombinant and synthetic nucleic acid molecules and other programmatic aspects.
Responsible Office: Academic Affairs