Protocol Application Forms & Instructions

Biosafety Research Protocol Form (.docx)
APPENDIX I: Non-Exempt Recombinant or Synthetic Nucleic Acids and Host-Vector Systems (.docx)
APPENDIX II: Biological Materials in Animals (.docx)
APPENDIX III: Biological Materials in Human Subjects (.docx)
APPENDIX IV: Infectious Agents (e.g., Bacteria, Virus, Fungus, Parasitic Agents), CDC/USDA Select Agents and/or Biological Toxins (.docx)
APPENDIX V: Human / Non-Human Primate Material (Including Established Human Cell Lines) (.docx)

The UNC Charlotte Biosafety Program acknowledges that, in the course of research, biohazards are regularly used in biomedical and applied science research settings on campus. All research investigators planning to use biohazardous agents should be knowledgeable about the characteristics of these agents and apply lab-based risk assessments of potential for adverse health or safety issues for research personnel regardless of agent biosafety or risk level classification.

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, 5th 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.

For research involving infectious agents refer to the pathogen data safety sheets managed by the Public Health Agency of Canada.

Protocol Form and Appendices

Biosafety Research Protocol Form

Appendix I – 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 which are exempt from the NIH Guidelines.

Appendix II – 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 an animal care and use application click here.

Appendix III – 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 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.

Appendix IV – 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 which have the potential to infect humans or which have the potential to be used for bioterrorism (i.e. Select Agents).
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 UNCC IBC.

Complete if you plan to work with biological toxins.

Appendix V –  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. Contact the Environmental Health & Safety Office at 704‑687‑1111 to learn more about enrolling in the program.