6,511: Policy on the Use of or Exposure to Biological Agents Including Recombinant DNA
Revised: November 2016
The University of Nevada, Reno employs various biological agents in scientific research, clinical medicine, and medical diagnostic activities. Additionally, UNR personnel may have exposure to biological agents while performing duties as maintenance personnel, athletic trainers, first aid providers, and a multitude of other activities. This policy provides guidelines for use of or exposure to biological agents to ensure a safe campus environment through the auspices of the Institutional Biosafety Committee (IBC).
The IBC was created in response to the NIH Office of Biotechnology Activities guidelines for the use of recombinant DNA (rDNA). The scope of IBC was expanded to include all risks associated with biological agents that arise as a result of UNR activities, or the activities of UNR affiliates. The IBC will consider all consequences resulting from these risks including: (a) adverse effects to humans, animals, plants and the environment; (b) regulatory compliance; (c) legal liability; and (d) moral and ethical responsibilities. Biological agents include:
Recombinant and synthetic nucleic acid molecules (includes work with DNA and transgenic animals and plants)
Microorganisms (bacteria, chlamydiae, rickettsiae, fungi, parasites, viruses, prions or other infectious agents)
Biological toxins or toxic products
CDC or USDA select agents
Human blood, human body fluids, human tissues or human cells/cell lines
Non-human blood, body fluids, tissues, or cells
Plants, plant tissues or plant cell cultures
Insect tissues or insect cell cultures
Animals infected with human pathogens and animals as sources of zoonotic diseases
The IBC policies and procedures are in accordance with guidelines and regulations established by the National Institutes of Health, the Centers for Disease Control, the Occupational Safety and Health Administration, the United States Department of Agriculture, and the applicable state and local authorities.
The IBC is responsible for overall administration of the Biosafety Program through establishment of university biosafety policies and administrative oversight of activities involving biological agents. Specifically, the IBC is responsible to:
- Advise the Vice President for Research & Innovation, Executive Vice President & Provost, and President on matters related to biological agents and biosafety.
- Develop, recommend and implement policies and procedures for biological risk assessment and biological risk reduction.
- Develop emergency plans for the containment and resolution of accidental spills and other related emergencies with an emphasis on risk reduction, personnel, and environmental protection.
- Oversee all biosafety issues associated with laboratory research and teaching activities, the Nevada State Public Health Laboratory, and university affiliates, including approval prior to initiation, reviews and updates, and compliance with regulations, CDC/NIH recommendations, and university policies governing the use of biological materials. The IBC will provide biosafety oversight of human clinical research projects as requested by UNR IRB.
- As an agent of the institution, evaluate the biosafety training and experience of principal investigators, co-investigators and directors. The IBC can refuse, suspend or cancel authorization to use biological agents when training and/or experience is deemed inadequate.
- Advise and provide technical expertise on matters regarding biosafety to the Institutional Biosafety Officer or other members of the UNR community.
- Conduct investigations of potential incidents involving any biological agent, violations of UNR policies or procedures, or regulatory violations and make recommendations to the Vice President for Research & Innovation and other appropriate university administrators for the resolution of continued non-compliance or serious infractions. The IBC can refuse, suspend, or cancel authorization to use biological agents in the event of non-compliance or serious infractions.
- Review the biosafety protocol form known as the Memorandum of Understanding and Agreement (MOUA) and modify as needed. Review MOUAs submitted by all principal investigators (PIs) at a convened meeting with a quorum of members present. Inform PIs of all required modifications to their MOUA. Make final approval of all MOUAs.
To conduct this responsibility effectively, the President of the University has appointed the Vice President for Research & Innovation as the Institutional Officer to ensure that the IBC is appropriately supported. The Institutional Official has the authority to act for the institution and to assume, on behalf of the institution, the obligations imposed by federal, state, and local regulations pertaining to the use of and exposure to biological agents. However, the Institutional Official or other organizational officials may not approve the use of biological agents in research, teaching, extension or testing that have not been previously approved by the IBC as a Memorandum of Understanding and Agreement (MOUA).
The Institutional Official appoints IBC members and also designates the committee chair. Each member will serve three years with the opportunity for re-appointment. Vacancies within the IBC will be evaluated by the current chair and the Institutional Official to determine appropriate replacement(s). The one exception to membership is the Biosafety Officer, who is a permanent member of the IBC. The Biosafety Officer will be a staff member of the Environmental Health and Safety Department (EH&S) and will be designated by the Director of EH&S.
The Standard Operating Procedures (SOP) on file with the Chair of the IBC and the Institutional Official provide details regarding: (a) training/qualifications; (b) membership terms, qualifications, responsibilities; (c) committee meeting attendance; (d) MOUA review (approval, amendment, modification and periodic review); (e) incident reporting and review; and (f) complaints and adjudication processes.