Frequently Asked Questions (FAQ)

Yes. PIs who work with biological materials will need to register their work with the IBC through SciShield (formerly BioRAFT) to ensure compliance with Federal and Local Regulations and Policies.

The following categories of work require review and approval by the IBC.

• Non-exempt recombinant or synthetic nucleic acid molecules research (according to NIH guidelines).
• Studies using human or animals pathogens, including materials known to harbor pathogens (for example, blood from HBVpositive patients).
• Generation of de novo transgenic animals. The breeding of transgenic animals to generate additional transgenic offspring does not require IBC approval. Those transgenic animals that already exist or which have been purchased also do not require IBC approval.
• Work with Acute Biological Toxins.
• Human Subjects research involving the introduction of recombinant molecules or biohazards into human subjects: these studies must be approved by the IBC and by the IRB.
• Animal Subjects: All research involving the use of recombinant molecules or human or animal pathogens in whole animals requires both IBC and IACUC approval.

The following categories require administrative review and approval by the Biosafety Officer and/or IBC Chair.

• Exempt recombinant or synthetic nucleic acid molecules research (according to NIH guidelines).
• Materials potentially containing human pathogens (for example, unfixed human specimens, human blood).
• All cell and organ cultures of human origin (including established cell lines), human embryonic stem cells, and pluripotent cells and their derivatives. Cells that undergo comprehensive pathogen testing can receive approval for BSL-1 containment after administrative review.
• The administration of human or non-human primate cells (primary cultures and established cell lines) or tumors into whole animals requires both IBC and IACUC approval.

A detailed description of PI responsibilities can be found in the University of Utah Biosafety Manual.  In summary:

• Ensure compliance with all pertinent policies and requirements as indicated by the Biosafety Program within your laboratories.
• Perform risk assessments of all research projects and lab activities involving biological materials and addressing specific hazards associated with each project
• Draft, maintain and ensure laboratory staff training on a laboratory-specific Biosafety Manual
• Establish appropriate safety practices within your laboratory
• Train laboratory staff and any visitors on laboratory specific safety practices, potential hazards and emergency responses (e.g., spill, potential exposure) as it relates to their research activities.
• Ensure that laboratory staff have the necessary resources to perform their work safely
• Maintain your laboratory facility and equipment
• Submit research protocols for review and approval to the Biosafety Program, IBC , IACUC and the IRB, depending on the type of research being performed
• Ensure that staff who handle animals, animal tissue or have vivarium access participate in the Occupational Medicine Surveillance Program
• Report emergencies to EHS within the required timeframe
• Notify the Biosafety Program (biosafety@oehs.utah.edu) of plans to commission laboratory space for use with biohazardous material and of plans to clear or renovate laboratory space that previously was used for biohazardous material

NIH has produced a useful brochure that describes the Investigator Responsibilities under the NIH Guidelines.  This can be downloaded at: "Investigator Responsibilities under the NIH Guidelines for Research Involving Recombinant DNA Molecules" (National Institutes of Health Office of Biotechnology Activities)

For more information regarding investigator responsibilities EHS Fact Sheet.

An Institutional Biosafety Committee (IBC) is required at institutions that receive funding from the National Institutes of Health (NIH) for research involving recombinant or synthetic nucleic acid molecules (r-sNA). All non-exempt recombinant DNA and synthetic nucleic acid research at the University of Utah, regardless of funding source, must be conducted in accordance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules and must be registered with the IBC.  At the University of Utah, as at many other institutions, the IBC also has the responsibility of reviewing a variety of experimentation that involves biological materials, such as risk group (RG) 2 or higher pathogens, hazardous biological materials, and other potentially hazardous agents, such as acute biological toxins.

The IBC works in conjunction with the University of Utah Office of Environmental Health and Safety (EHS) to advise the Vice President for Research on policies concerning the safe conduct of research involving recombinant or synthetic nucleic acid molecules in living cells, human gene transfer, microbial pathogens, acute biological toxins, select microbial agents and biological toxins produced by microorganisms that are listed as potential bioterrorism agents, and restricted microbial pathogens of domestic animals and plant crops, and to ensure compliance with current University, local, state, and federal regulations. 

The committee consists of a Chair, Vice Chair, Director (the University of Utah Biosafety Officer), Administrator (the University of Utah Assistant Biosafety Officer) and a minimum of 5 additional members. In order to ensure the competence necessary to review and approve recombinant or synthetic nucleic acid molecule activities, the IBC includes: 

1. At least one practicing scientist with experience in microbiology, molecular biology, or virology.
2. At least one practicing scientist with expertise in recombinant or synthetic nucleic acid molecule technology, biological safety, and physical containment.
3. At least one practicing scientist with expertise in human gene transfer experiments
4. At least one member representing laboratory technical staff.
5. At least two community members, not affiliated with the University of Utah in any way other than as a member of the IBC, and who does not have an immediate family member who is affiliated with the University of Utah. At least one community member has primary experience in a nonscientific area (for example, an ethicist, lawyer, or member of the clergy).

Committee members serve at least one 3 year term.  Members each have a personal commitment to laboratory safety in general and biosafety in particular. 

The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules.

In the context of the NIH Guidelines, recombinant and synthetic nucleic acids are defined as: 

1. molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids;
2. nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids, or
3. molecules that result from the replication of those described in (i) or (ii) above.

All projects (independent of whether they are funded by NIH) involving recombinant or synthetic nucleic acid molecule conducted at or sponsored by an institution that receives NIH funds for projects involving such techniques must comply with the NIH Guidelines.  Noncompliance may result in:  (i) suspension, limitation, or termination of NIH funds for recombinant or synthetic nucleic acid molecule research at the institution, or (ii) a requirement for prior NIH approval of any or all recombinant or synthetic nucleic acid molecule projects at the institution.

A Laboratory-specific Biosafety Manual, as described in the CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition, is required for all laboratories working at BSL2 or higher. This should include laboratory-specific Standard Operating Procedures (SOPs) for all experiments involving biological agents, risk assessments for the agent, descriptions of personal protective equipment, procedures for using and decontaminating equipment, spill procedures and post-exposure plans, waste disposal and emergency equipment and practices. In addition, the PI should develop SOPs describing experimental procedures for working with r-sNA agents and human or animal pathogens.

1. The manual can be used for laboratory specific training.
2. The IBC has developed Biosafety Manual/SOP templates for BSL1, BSL2, and BSL2-enhanced laboratories that may be used by PIs as the basis for laboratory-specific SOPs and can be found here. These address most areas of review by the IBC but should be customized to reflect the work being performed in the laboratory and the facilities available.
3. The manual must be reviewed annually by all lab personnel and up-dated as appropriate.
4. The manual must be readily available to all laboratory personnel and EHS personnel during laboratory inspections.

For laboratories working with materials that may harbor Bloodborne Pathogens (BBP), such as blood, tissue, potentially infected materials and human and non-human primate cell lines, an Exposure Control Plan is required.  This plan is designed to eliminate employee exposure to BBP. All human blood and other potentially infectious materials (OPIM) are considered to be infectious for Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV), and other BBP, and will be treated as if infectious, i.e. with universal precautions. Since animal blood is not readily distinguished from human blood by appearance, this document's guidance for handling and disposal of human blood and sharps is recommended for all blood.  A template for a Laboratory Exposure Plan can be downloaded here.

Laboratories that use Risk Group (RG) 2 or higher biological agents (see ABSA Guidelines for risk group designations) are required to register with the Institutional Biosafety Committee (IBC) prior to commencing work with the agent. Note agents that are RG2 or higher in animals but RG1 in humans need to be registered only if the work involves exposure of susceptible animals to the agent. For example, work with murine cytomegalovirus in mice requires IBC registration.

 

The Public Health Agency of Canada has generated a series of Pathogen Safety Data Sheets (PSDSs), which are technical documents that describe the hazardous properties of human pathogens and recommendations for work involving these agents in a laboratory setting, including appropriate disinfection protocols and personal protective equipment. These PSDSs can be found here.

The University of Utah enforces the requirements of the Occupational Safety & Health Administration (OSHA) Bloodborne Pathogen Standard, 29 CFR 1910.1030, which specifies practices to limit occupational exposure to blood and other potentially infectious materials, including human and non-human primate cell lines. Following the Standard is crucial, since exposure could result in transmission of bloodborne pathogens, potentially leading to disease and/or death. This protocol is mandatory for all University of Utah employees who could reasonably be anticipated, as the result of performing their job duties, to contact blood or other potentially infectious materials. Where exposure to human blood may occur, adherence to the controls, decontamination and disposal sections of this policy is mandatory for students and visitors.

PIs and Supervisors must ensure that the procedures of this policy are followed. This includes maintaining an Exposure Control Plan for their lab or work area, making it available to the workers, enforcing compliance with the plan, ensuring new employees are trained and vaccinations offered, performing follow-ups on incident exposures and providing personal protective equipment as needed. Training must be repeated annually.

Depending on the agents being used and the requirements of the facility where the lab(s) are located, training may be required for approval of your IBC protocol.  Listed below are some of the commonly required training programs, as well as links to information regarding the type of training offered and how to register for the specific training.  If you have any questions regarding biosafety training that you may be required to complete, please contact the IBC administrator (biosafety@oehs.utah.edu).        

1. Bloodborne Pathogens (BBP) Training: This is a 1.5 hour class required for anyone working with human or non-human primate cell lines, blood, tissue, body fluids, as well as other potentially infectious material (OPIM) of human origin: this includes work with established cell lines. Training must be completed prior to working in the laboratory and repeated annually. Information regarding the class, and how to register for a class, can be found using this link (https://utah.bridgeapp.com/learner/category/100
2. Biosafety Level-2 (BSL-2) and Bloodborne Pathogens (BBP) Training. This is a 2 hour class required for anyone working with recombinant or synthetic nucleic acids or pathogenic/toxic materials requiring BSL2 containment. This class also includes information on Bloodborne Pathogens for those working with human or non-human primate cell lines, blood, tissue, body fluids, as well as other potentially infectious material (OPIM) of human origin: this includes work with established cell lines. Training must be completed prior to working in the laboratory and repeated whenever IBC registrations are submitted (initial and renewal). However, personnel working with human or non-human primate samples or cell lines must repeat BBP training annually by either retaking this class or taking the BBP Training class (See #1).  Information regarding the class, and how to register for a class, can be found using this link (https://utah.bridgeapp.com/learner/category/100
3. BSL-2, Viral Vectors, and Bloodborne Pathogens Training. This is a 2 hour class required for anyone working with recombinant or synthetic nucleic acids or pathogenic/toxic materials requiring BSL2 containment and includes information on commonly used recombinant viral vectors. This class also includes information on Bloodborne Pathogens for those working with human or non-human primate cell lines, blood, tissue, body fluids, as well as other potentially infectious material (OPIM) of human origin: this includes work with established cell lines. Training must be completed prior to working in the laboratory and repeated whenever IBC registrations are submitted (initial and renewal). However, personnel working with human or non-human primate samples or cell lines must repeat BBP training annually by either retaking this class or taking the BBP Training class (See #1).  Information regarding the class, and how to register for a class, can be found using this link (https://utah.bridgeapp.com/learner/category/100
4. Animal Biosafety Level 2 Training. This is a 30 minute class required for anyone working with animals requiring ABSL-2 containment. Training must be completed prior to working in the laboratory and repeated whenever IBC registrations are submitted (initial and renewal). Information regarding the class, and how to register for a class, can be found using this link (https://utah.bridgeapp.com/learner/category/100
5. Laboratory/Protocol-Specific training. All personnel working at BSL-2 or higher must receive training from the Principal Investigator, at the time of assignment and at least annually thereafter.  This training must include a risk assessment for the agents being used in the lab (including routes of infection, signs and symptoms of exposure and options for vaccinations or post-exposure prophylaxis), engineering and work practice controls, PPE requirements, spill clean-up procedures, and post-exposure procedures. Laboratories with a comprehensive, IBC-approved Biosafety manual may use this for training, with signatures documenting review.  In person trainings, for example during lab meetings, can be documented using “Site-Specific Training Checklist and Record SOP” in the IBC Fact Sheets and SOP library.
6. Shared-Space Training. All BSL2 (or higher) lab spaces that are shared by 2 or more PIs using different biohazardous agents, who are not co-PIs or co-investigators on an approved IBC protocol(s), must conduct a joint “Biohazards Awareness and Training” session for all the personnel working in the space. See “Training on Biohazards in Shared Spaces SOP” in the IBC Fact Sheets and SOP library.

Yes. There is potential risk of exposure while working with primary and commercially available cell lines.  Cell lines may carry unknown agents that are potentially infectious to humans and animals.  Human cell lines may carry agents directly infectious to humans.  Animal cells may carry zoonotic agents.   Work with human cell lines must adhere to the OSHA Bloodborne Pathogen Standard and must be conducted at Biosafety Level 2 and Animal Biosafety Level 2.  Human and animal cell lines that are not well characterized or are obtained from secondary sources may introduce an infectious hazard to the laboratory. For example, the handling of nude mice inoculated with a tumor cell line unknowingly infected with lymphocytic choriomeningitis virus resulted in multiple laboratory acquired infections.

Animals injected with well-characterized established cell lines that are from a commercial vendor (or other source) with documentation of being free of pathogens (ATCC tests for HBV, HCV, HIV, CMV, and EBV for cell lines accessioned into their inventory since 2010), may be handled at ABSL-1 after IBC approval of the risk assessment. Cell lines can also be tested: IDEXX BioAnalytics and Charles River offer a comprehensive pathogen service. This is still at the discretion of both the IBC and IACUC and each protocol will be risk assessed for any factors that may warrant a higher level of containment. PIs should provide documentation to support the determination that cells are pathogen free.

Lentivirus vector stocks generated with 2^nd generation packaging systems AND transfer plasmids with wild type LTRs (i.e., not self-inactivating transfer plasmid constructs) must be tested for replication competent virus (RCV) by serial transfer in a cell line documented to be capable of propagating wild type HIV if:

1. The PI proposes to reduce biocontainment after target cell transduction,
2. The PI proposes to transduce mammalian cells capable of supporting lentiviral replication, introducing the cells into animals (e.g., xenografts) and maintain the animals at ABSL1, or
3. The PI proposes to introduce lentiviral vectors or transduced mammalian cells capable of supporting lentiviral replication into animals that could support viral replication.

Testing should be conducted on the initial preparations of viral stocks.

Lentivirus vector stocks generated with 3rd generation (4 plasmid, including self-inactivating transfer vectors) or with 2^nd generation packaging systems and 3^rd generation transfer vectors (SIN) are typically exempt from these requirements. However, if the PI proposes to introduce lentiviral vectors, or transduced mammalian cells capable of supporting lentiviral replication, into animals that could support viral replication, then the PI should provide a complete risk assessment to the IBC.

If none of these criteria apply RCV testing will not typically be required.  However, the Institutional Biosafety Committee (IBC) may determine that, following the risk assessment, RCV testing is still required.

The vector stock should be tested for RCV at a limit of sensitivity of 1 infectious unit per milliliter (mL). Several sensitive RCV assays have been described, including an ELISA-based p24 Gag antigen assay, a product enhanced reverse transcriptase (PERT) assay that involves the vector’s reverse transcriptase, a PCR-based assay that detects Psi-Gag sequences from a recombination event between vector and packaging constructs, and PCR-based assays to detect the VSV-G Env used for pesudotyping. All represent acceptable methods for RCV testing. The protocol must be provided to the IBC for approval.

Multiple technologies exist to create permanent genomic modifications in cell culture and organisms, the most popular of which is CRISPR/Cas. The vast majority of gene editing studies require IBC review and approval since they are covered by the NIH Guidelines, including plasmid and viral vector-based systems.  As part of your IBC registration, the Biosafety Office will supply you with a Gene Editing Questionnaire to understand the risks and precautions to be taken in your gene editing work.

IBC oversight of gene editing encompasses human clinical studies that include either direct gene modification, the administration of donor cells that have been genetically modified, and the administration of genetically modified organisms. Such work must be registered with both the IBC and the Institutional Review Board (IRB), which is charged with the review of all Human Subjects Research. Registrations will be performed in ERICA.

In the updated NIH guidelines, released in September 2024, there are new regulations on “gene drive” modified organisms (GDMOs), in which genetically modified organisms pass on their modification at a rate greater than standard Mendelian inheritance. Gene drive research is a technique easily applied to insects such as mosquitos and holds promise for eradicating insect-borne diseases such as malaria. Another model organism amenable to gene drive research is drosophila. The new regulations indicate research with GDMOs must be reviewed by the Institutional Biosafety Committee (IBC) prior to initiation and will require a minimum of ABSL2 containment. Special care must be taken in the risk assessment to consider consequences of an unplanned release. The NIH does not support research involving the release of GDMOs outside of the laboratory environment. For any research groups considering gene drive research, it is critical to obtain IBC review prior to initiating the work.

Have them immediately wash affected areas with soap and water, or if exposure to eyes or mucous membranes occurred, immediately flush affected area with water for 10-15 minutes. Go directly to the RedMed Clinic at the Student Union Building or the Occupational Medical Clinic at the Redwood Health Center for medical evaluation and follow-up. However, if the injury is life threatening call 911.

Any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses must be reported to the Institutional Biosafety Committee (IBC), so that a report can be sent to the NIH Office of Science Policy (OSP). Some incidents must be reported on an expedited basis, so contact the Biosafety Officer as soon as possible after the incident.

Reportable incidents include skin punctures with needles containing recombinant or synthetic DNA, the escape or improper disposition of a transgenic animal, or spills of high-risk recombinant materials occurring outside of a biosafety cabinet. Failure to adhere to the containment and biosafety practices articulated in the NIH Guidelines must also be reported to IBC and OSP.

Minor spills of low-risk agents not involving a breach of containment that were properly cleaned and decontaminated generally do not need to be reported. If the investigator or other institutional staff is uncertain whether the nature or severity of the incident warrants reporting, contact the University of Utah Biosafety Officer (BSO), Dr. Debbie Eckert, or Associate BSO, Chris Hunter, at (801) 581-6950 or biosafety@ehs.utah.edu, who can assist in making this determination, with guidance from OSP, if necessary.

Biological toxins are toxic substances produced by bacteria, fungi, protozoa, insects, animals, or plants that have the capability of causing harmful effects when inhaled, ingested, injected or absorbed. They may be transmitted via surface contact with contaminated object(s) and subsequently spread to mucus membranes (eyes, nose, and mouth) and/or to open sores on skin. Some biological toxins can be absorbed through intact skin, especially if solubilized in substances such as dimethyl sulfoxide (DMSO). Accidental needle-stick is a mode of transmission within research laboratories. Accidental ingestion of contaminated materials and inhalation are other routes of transmission. While they cannot replicate and are not infectious they can be extremely hazardous, even in minute quantities. The health effects of exposure can vary greatly depending on the toxin, the amount, and the route of exposure, ranging from minor (skin or eye irritation, headache, nausea) to severe (respiratory distress, muscle weakness, seizures, death).

The University of Utah Institutional Biosafety Committee (IBC) reviews registrations for work with, possession of, use of, and transfer of acute biological toxins (mammalian LD50 <100 µg/kg body weight) or toxins that fall under the Federal Select Agent Guidelines, as well as the organisms, both natural and recombinant, which produce these toxins

The following is a list of toxins that are required to be registered with the IBC.  However, the list is not comprehensive and principal investigators can confirm that toxins they propose to work with do not require IBC registration (LD50 >100 µg/kg body weight and not on Select Agent list) by contacting the Biosafety Office (biosafety@ehs.utah.edu or 801-581-6590).

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Subtitle A of Public Law 107–188 requires the Department of Health and Human Services (HHS) to establish and regulate a list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. The Agricultural Bioterrorism Protection Act of 2002 requires the United States Department of Agriculture (USDA) to establish and regulate a list of biological agents that have the potential to pose a severe threat to animal health and safety, plant health and safety, or to the safety of animal or plant products (Select Agents). CDC and APHIS share responsibility for some agents because they potentially threaten both humans and animals (overlap agents). The laws require HHS and USDA to review and republish the lists of Select Agents and toxins on at least a biennial basis. Please visit the CDC/USDA website on select agents for more information.

Experiments that fall under the potential Dual Use Research of Concern (DURC) guidelines must be registered with the IBC, and be reviewed by the University of Utah Institutional Review Entity (IRE) for risk assessment and mitigation, as necessary. The PI should contact the BSO or Associate BSO immediately experiments covered by these guidelines are considered.

Research that uses one or more of the agents or toxins listed in section (i) below, and produces, aims to produce, or can be reasonably anticipated to produce one or more of the effects listed in section (ii) below, must be evaluated for DURC potential.

Agents:

1. Avian influenza virus (highly pathogenic)
2. Bacillus anthracis
3. Botulinum neurotoxin: For the purposes of this Policy, there are no exempt quantities of botulinum neurotoxin. Research involving any quantity of botulinum neurotoxin should be evaluated for DURC potential.
4. Burkholderia mallei
5. Burkholderia pseudomallei
6. Ebola virus
7. Foot-and-mouth disease virus
8. Francisella tularensis
9. Marburg virus
10. Reconstructed 1918 Influenza virus
11. Rinderpest virus
12. Toxin-producing strains of Clostridium botulinum
13. Variola major virus
14. Variola minor virus
15. Yersinia pestis

Categories of experiments:

1. Enhances the harmful consequences of the agent or toxin
2. Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification
3. Confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies
4. Increases the stability, transmissibility, or the ability to disseminate the agent or toxin
5. Alters the host range or tropism of the agent or toxin
6. Enhances the susceptibility of a host population to the agent or toxin
7. Generates or reconstitutes an eradicated or extinct agent or toxin listed above

 

Strict government regulations must be followed when transporting hazardous materials, which include dry ice. Shipments must arrive at their destination in good condition and present no hazard during shipment. All individuals who ship hazardous materials must undertake training. Training for the shipment of Category B substances is provided by EHS: register here. Category A shipments and any Exports must be made by EHS.

To read the regulations concerning the transport of a diagnostic or infectious specimen, see:

• Department of Transportation, Office of Hazardous Materials Safety, 49 CFR Regulation 173.134.
• International Air Transportation Association (IATA) Dangerous Goods.

Prior to shipping any hazardous materials, please contact the Biosafety Officer at 801-581-6590.