Protocol Application Forms & Instructions
Types of Biohazard Research Permitted
Risk Group 1
Research involving biohazardous agents deemed to be Risk Group 1 (RG-1) and requiring Biosafety Level 1 (BSL-1) containment/handling must be registered with the Institutional Biosafety Committee (IBC) via completion of the Biosafety Research Protocol Form. Once the RG-1/BSL-1 registration has been acknowledged and approved by the IBC, 5-year de novo applications are required.
Risk Group 2 or Risk Group 3
Research involving biohazardous agents deemed to be Risk Group 2 (RG-2) or Risk Group 3 (RG-3) agents requiring Biosafety Level 2 (BSL-2) or Biosafety Level 3 (BSL-3) containment/handling must be registered with the IBC, submit a completed Biosafety Research Protocol Form and any applicable appendices which must be approved by the IBC prior to use of such agents. (NOTE: See below for protocol form completion/submission instructions.)
Work with RG-2 or RG-3 agents requiring BSL-2 or BSL-3 containment/handling requires submission of annual renewal/progress reports to the IBC for up to 3 years. After 3 years, a de novo Biosafety Research Protocol Form for the continuation of work at these levels is required to be submitted and approved by the IBC.
Possession and use of biohazardous agents deemed to be Risk Group 4 (RG-4) or requiring BSL-4 containment/handling is prohibited on UNC Charlotte campus.
Biosafety Research Submission Process and Paperwork
It is an investigator’s responsibility to conduct an initial risk assessment of proposed work with biohazards using federally promulgated guidelines PRIOR to submission of a biosafety research application.
To access the Biosafety in Microbiological and Biomedical Laboratories (BMBL, 6th Edition) document, click here. For work with recombinant or synthetic DNA, consult the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) click here.
Tips for Assessing Agent Risk Classifications
In the BMBL, focus particularly on the following sections:
- Section II “Biological Risk Assessment” on how “risk” is determined,
- Section IV “Laboratory Biosafety Level Criteria” which contains information on containment and handling for the four biosafety levels for activities involving infectious microorganisms.
- Section VIII “Agent Summary Statements” is divided into eight (8) parts which include descriptions of the hazards, recommended precautions, and levels of containment appropriate for handling specific human and zoonotic pathogens in the laboratory and in facilities that house laboratory vertebrate animals. Agent Summary Statements are included for agents that meet one or more of the following three criteria:
- The agent is a proven hazard to laboratory personnel working with infectious materials;
- The agent has a high potential for causing Laboratory Acquired Infections (LAIs) even though no documented cases exist; and
- The agent causes grave disease or presents a significant public health hazard.
NOTE: Section VIII is not considered to be comprehensive, so not finding your agent listed does not mean it is not a BSL-2 or higher agent. This is why information on how to assess risk is provided, and why the responsibility for initial classification rests with the PI. The Association of Biosafety Professionals (ABSA) also maintains a Risk Group Database to help guide your assessment. For research involving infectious agents refer to the pathogen data safety sheets managed by the Public Health Agency of Canada.
Protocol eForm and Appendices (Updated Septemeber 2021)
As of September 27, 2021, all new and continuing Biosafety protocols (and renewals/amendments of current protocols) must be initiated and submitted electronically through the Niner Research system. Word-based protocol forms are no longer accepted. If you have an active protocol that was approved on Word-based forms and you need to amend or renew your protocol, please contact the IBC Coordinator (x7-1875 or email@example.com) for help. A one-week lead time is required. Please note that consultation with the Biosafety Officer is recommended prior to the submission of an application.
Protocol eFORM – The Biosafety and Biosecurity Protocol eFORM will register relevant information related to your work including:
- Genearl Information including Principal Investigator (PI) contact information, funding and locations
- Identification of Material(s) or Agent(s), and Biological Safety Assignment
- Protocol Description, PI experience, aerosol exposure, and PPE
- Decontamination, waste, and disposal procedures
- Transportation, shipping, and receiving
- Laboratory Personnel
- Occupational health requirements
Appendix I – Human/Non-Human Primate Materials (Including Established Human Cell Lines)
Complete if you plan to work with human materials [blood or blood by-products, tissues, other human bodily fluids/secretions and/or human or non-human primate cell lines (primary or established).
NOTE: Per Federal OSHA guidelines, people working with these materials are required to enroll in a Bloodborne Pathogen Exposure Control Program PRIOR to acquiring and using them. Please notify the Biosafety Officer immediately with a list of personnel that will need online training.
Appendix II – Infectious Agents (e.g., Bacteria, Virus, Fungus, Parasitic Agents), CDC/USDA Select Agents and/or Biological Toxins
Complete if you plan to work with organisms that have the potential to infect humans or which have the potential to be used for bioterrorism (i.e. Select Agents and/or Biological Toxins).
NOTE: Select Agents are regulated on the Federal and state level. Please consult the following page for all requirements related to Federal regulations or State regulations. Select Agents which are NOT exempt from Federal regulations require a series of pre-acquisition requirements/assurances; you are required to be pre-authorized at the Federal level for possession and use of non-exempt Select Agents BEFORE engaging in the approval process through the UNC Charlotte IBC.
Appendix III – Non-Exempt Recombinant or Synthetic Nucleic Acids and Host-Vector Systems
Complete if you are proposing work involving non-exempt rDNA or synthetic DNA under the NIH Guidelines. Not sure your proposed use of rDNA or synthetic nucleic acid molecules is exempt from review under the NIH Guidelines? Click here for a FAQ on Experiments that are exempt from the NIH Guidelines.
Appendix IV – Biological Materials in Animals
Complete if you plan to introduce any biohazardous agents in animals. NOTE: Concurrent approval for animal research is required; to learn more about requirements involving research with animals and to submit animal care and use application click here.
Appendix V – Biological Materials in Human Subjects
Complete if you plan to introduce any biohazardous agents into humans. NOTE: Concurrent approval for human subjects research is required; to learn more about requirements involving research involving human subjects and to submit a human subjects research application click here.
NOTE: Any proposed gene therapy research involving human subjects requires the following: submission of a proposal to the NIH’s Recombinant DNA Advisory Committee (RAC) AND concurrent submissions to the UNC Charlotte IRB and IBC PRIOR to screening and enrollment of such subjects. This work may NOT be conducted without prior review or approval from these three committees.