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Biosafety – IBC

The Institutional Biosafety Committee (IBC) ensures that research involving biohazardous agents, including recombinant DNA and other potentially infectious materials (OPIM), follows designated guidelines. The IBC follows the guidelines established by the National Institutes of Health (NIH) Office of Biotechnology Activities and The Center for Disease Control (CDC). Work with biological materials and synthetic or recombinant nucleic acid molecules at UNC Greensboro must be conducted in accordance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH GUIDELINES), the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL), and the UNCG Biosafety Manual found on the UNCG Lab Safety website. 

IBC meetings are open to the public. Please contact the UNCG Office of Research Integrity at [email protected] for more information. 

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Cayuse Hazard Safety

IBC Application

UNCG has implemented an electronic IBC submission system, Cayuse Hazard Safety. For helpful resources for navigating it, visit the Cayuse Hazard Safety Resource page. Before completing an IBC application, you must determine your risk group and laboratory biosafety level and submit a departmental scientific merit review.

New, non-exempt protocols are typically reviewed by the full committee. Exempt protocols are reviewed using a designated member review process. To determine whether or not your work is exempt, please review the IBC review categories below. Protocols will be approved for three-year periods. To renew a protocol, a de novo submission is required (a new application prior to the beginning of the fourth year of work). Any changes to an approved protocol, both major and minor, should be reviewed by the IBC via an amendment. Amendments can be submitted using Cayuse Hazard Safety (IBC Application). 

UNCG Working Definitions of Biohazards

  1. Biohazards are infectious agents or hazardous biological materials that present a risk or potential risk to the health of humans, animals, or the environment. The risk can be direct through infection or indirect through damage to the environment. Any organism or virus listed in CDC/NIH Risk Group (RG) two, three, or four, or that requires Biosafety Level (BL) two, three or four containment, is considered biohazardous. 
  2. Biohazardous materials include certain types of recombinant DNA (e.g. that express potentially infectious entities or potent toxins), or organisms and viruses infectious to humans, animals or plants (e.g. parasites, viruses, bacteria, fungi, prions, rickettsia); and agents of biological origin (e.g. toxins, allergens, venoms) that may cause disease in other living organisms or cause significant impact to the environment or community. 
  3. Biological materials are any materials containing genetic information and capable of reproducing itself or being reproduced in a biological system. 

Risk Group Determination

A critical step in planning the use of a biohazardous material is to make an initial determination regarding the appropriate level of risk associated with the agent and its proposed uses. Agents are classified into four Risk Groups (RGs) according to their relative pathogenicity for healthy adult humans by the following criteria:

  • Risk Group 1 (RG1) agents are not associated with disease in healthy adult humans.
  • Risk Group 2 (RG2) agents are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available.
  • Risk Group 3 (RG3) agents are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available.
  • Risk Group 4 (RG4) agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available

Biosafety level

Biological Safety Levels (BSL) are a series of protections relegated to autoclave-related activities that take place in particular biological labs. They are individual safeguards designed to protect laboratory personnel, as well as the surrounding environment and community.

These levels are selected based on the agents or organisms that are being researched or worked on in any given laboratory setting.

As the lowest of the four, biosafety level 1 applies to laboratory settings in which personnel work with low-risk microbes that pose little to no threat of infection in healthy adults. An example of a microbe that is typically worked with at a BSL-1 is a nonpathogenic strain of E. coli.

This laboratory setting typically consists of research taking place on benches without the use of special contaminant equipment. A BSL-1 lab, which is not required to be isolated from surrounding facilities, houses activities that require only standard microbial practices, such as:

  • Mechanical pipetting only (no mouth pipetting allowed)
  • Safe sharps handling
  • Avoidance of splashes or aerosols
  • Daily decontamination of all work surfaces when work is complete
  • Hand washing
  • Prohibition of food, drink and smoking materials in lab setting
  • Personal protective equipment, such as; eye protection, gloves and a lab coat or gown
  • Biohazard signs

BSL-1 labs also requires immediate decontamination after spills. Infection materials are also decontaminated prior to disposal, generally through the use of an autoclave.

This biosafety level covers laboratories that work with agents associated with human diseases (i.e. pathogenic or infections organisms) that pose a moderate health hazard. Examples of agents typically worked with in a BSL-2 include equine encephalitis viruses and HIV, as well as Staphylococcus aureus (staph infections).

BSL-2 laboratories maintain the same standard microbial practices as BSL-1 labs, but also includes enhanced measures due to the potential risk of the aforementioned microbes. Personnel working in BSL-2 labs are expected to take even greater care to prevent injuries such as cuts and other breaches of the skin, as well as ingestion and mucous membrane exposures.

In addition to BSL 1 expectation, the following practices are required in a BSL 2 lab setting:

  • Appropriate personal protective equipment (PPE) must be worn, including lab coats and gloves. Eye protection and face shields can also be worn, as needed.
  • All procedures that can cause infection from aerosols or splashes are performed within a biological safety cabinet (BSC).
  • An autoclave or an alternative method of decontamination is available for proper disposals.
  • The laboratory has self-closing, lockable doors.
  • A sink and eyewash station should be readily available.
  • Biohazard warning signs

Access to a BSL-2 lab is far more restrictive than a BSL-1 lab. Outside personnel, or those with an increased risk of contamination, are often restricted from entering when work is being conducted.

Again building upon the two prior biosafety levels, a BSL-3 laboratory typically includes work on microbes that are either indigenous or exotic, and can cause serious or potentially lethal disease through inhalation. Examples of microbes worked with in a BSL-3 includes; yellow fever, West Nile virus, and the bacteria that causes tuberculosis.

The microbes are so serious that the work is often strictly controlled and registered with the appropriate government agencies. Laboratory personnel are also under medical surveillance and could receive immunizations for microbes they work with.

Common requirements in a BSL-3 laboratory include:

  • Standard personal protective equipment must be worn, and respirators might be required
  • Solid-front wraparound gowns, scrub suits or coveralls are often required
  • All work with microbes must be performed within an appropriate BSC
  • Access hands-free sink and eyewash are available near the exit
  • Sustained directional airflow to draw air into the laboratory from clean areas towards potentially contaminated areas (Exhaust air cannot be re-circulated)
  • A self closing set of locking doors with access away from general building corridors

Access to a BSL-3 laboratory is restricted and controlled at all times.

UNCG IBC Policy 

BioSafety

Biosafety levels at UNCG

Importance of Biosafety/Dual Use

Departmental Scientific Merit Review prior to application

It is required by the IBC that a new protocol have a Departmental Scientific Merit Review completed prior to submission. A Departmental Scientific Merit Review can be helpful in order to evaluate the proposal for adequacy of the following areas: 

  • Significance: Does the project address an important problem in the field? 
  • Investigator: Are the PIs and other researchers capable of carrying out the project? 
  • Approach: Are the overall strategy, methodologies, and analyses appropriate to accomplish the specific aims of the project 
  • Environment: Is the scientific environment adequate for successful completion of the work? 

Please discuss these specifics with someone in your department prior to submitting an IBC application.

IBC Review Categories

The IBC is specifically responsible for the review and approval of research protocols involving the use of biohazardous agents including, but not limited to: 

  • Recombinant or synthetic nucleic acid molecules in organisms including their use in animals (including arthropods) and plants, 
  • Human and other non-human substances (blood, body fluids, cell lines or tissues), 
  • Organisms and viruses infectious to humans, animals or plants (e.g. parasites, viruses, bacteria, fungi, prions, rickettsia), 
  • Biologically active agents (i.e. toxins, allergens, venoms) that may cause disease in other living organisms or cause significant impact to the environment or community. 

All such work at UNCG falls within one of categories outlined below. Review the regulatory documents and descriptions below to determine the appropriate category and corresponding registration or review process for your work. A flow chart is also available to aid in this determination: IBC-Determination-chart. 

    Work that involves: 

    • Recombinant or synthetic nucleic acids; 
    • BSL-2 or Risk Group 2 materials; 
    • Unfixed human sourced materials, cell lines, or OPIM (OPIM includes: human primary cells, cell lines, unfixed tissues, semen, vaginal secretions; cerebrospinal, synovial, pleural, pericardial, peritoneal, and amniotic fluids; and body fluids visibly contaminated with blood or in situations where it is difficult to differentiate between body fluids.) 

    Register via Cayuse Hazard Safety

    Exempt Requiring Registration with IBC: 

    Biohazard work with recombinant or synthetic nucleic acids is exempt from full IBC review if it meets any of the following conditions: THE PI MUST CONSULT WITH THE IBC CHAIR OR THEIR DESIGNEE  (Dr. Yashomati Patel [email protected]) 

    • E.coli K-12 strains are BSL-1 and as such do not require IBC approval
    • Experiments involving the generation of transgenic rodents that require BSL≤1 (Requires IACUC Approval). 
    • The purchase or transfer of transgenic rodents. It is not required to register transgenic animals modified only by gene knock-outs (Requires IACUC Approval). 
    • Experiments that DO NOT involve use of a biological toxins or live infectious microorganism classified by the CDC as requiring Biosafety Level 2 or higher (Consult CDC/NIH BMBL). 
    • Recombinant or synthetic DNA or RNA molecules that are not in organisms or viruses. 
    • Only E. coli or Saccharomyces cerevisiae are used to clone and propagate DNA from an organism; AND 
    • Recombinant nucleic acids are derived entirely from non-viral sources; AND 
    • Fermentations do not exceed 10-liter volumes at any one time; AND 
    • The E. coli strain does not contain a conjugation proficient plasmid or a generalized transducing phage. 
    • For experiments with whole animals, the recombinant DNA vectors used either do not contain viral sequences or contain less than two-thirds of a eukaryotic viral genome. (Requires IACUC Approval). 

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    IBC Training

    Before working with recombinant DNA, other potentially infectious materials (OPIM), or any other biohazards, you must complete IBC CITI training.

    There are four types of IBC training.

    • required training for researchers
    • additional required training for researchers working with bloodborne pathogens.
    • additional required training for researchers working with dual-use materials
    • required training for IBC members

    IBC Guidelines

    There are several policies and safety procedures related to IBC work. Access them on our Policies and Guidelines page.

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