Institutional Biosafety Committee (IBC)

The University of Nebraska-Lincoln Institutional Biosafety Committee (IBC) is charged with oversight of research, clinical/diagnostic and teaching activities involving recombinant and synthetic nucleic acids, human-derived materials, bloodborne pathogens and other biological agents including bacteria, viruses, parasites, fungi, and toxins. The scope, requirements, and roll of the IBC is described in the UNL Biosafety Guidelines.

News/Announcements

About the IBC

Covered Activities
The UNL Biosafety Guidelines apply to clinical/diagnostic, research, and teaching activities involving any of the following items individually or in combination with each other:
  • Recombinant or Synthetic Nucleic Acid molecules (see definitions in Section 1.2 of the UNL Biosafety Guidelines
      Exception: Experiments conducted in academic teaching lab courses for demonstrative purposes and not considered "research projects" are not subject to IBC Review.
  • Human, animal, and plant pathogens (bacteria, virus, yeast, fungus, prions, & parasitic agents) including growth, manipulation and/or other handling and use in vitro or in vivo.
  • Toxins of biological origin, when the originating organism is grown for the purpose of obtaining toxin. Toxins obtained in pure form commerically are not covered, except for Select Agent toxins. Any amount of a Select Toxin requires submission of an IBC protocol.
  • Human blood and other potentially infectious materials, as defined by the United States Occupational Safety and Health Administration (OSHA) and the UNL Exposure Control Plan.
  • Human and non-human primate cells and organ/tissue cultures
  • Select Agents and Toxins, as defined by the United States Departments of Agriculture Or Health and Human Services, including Dual Use Research of Concern, involving agents and research categories as defined in the UNL Biosafety Guidelines.
  •  Genetically-modified animals and plants including growth, breeding, manipulation or other use of the organism. Field trials of transgenic plants authorized by the United States Department of Agriculture - Animal and Plant Health Inspection Service (USDA-APHIS) are not subject to review by the IBC.  For additional information see document Plant Research and UNL IBC Protocol Clarification.
  • Field Collection or Sampling of Wild Animals, when there is risk of exposure to zoonotic diseases. See section 4.7 of the UNL Biosafety Guidelines for detailed parameters regarding these types of studies.

Activities not subject to IBC Review

Clinical/diagnostic, research, and teaching activities that:

  • Are properly conducted at biosafety containment level 1 (BSL-1); and
  • do not involve human, animal, or plant pathogens capable of causing disease in healthy organisms; and/or
  • involve only the in vitro use of nucleic acids (i.e., PCR, naked siRNA, sequencing) and do not involve the cloning and propagation of recombinant or synthetic nucleic acid molecules in cells or organisms; and
  • the nucleic acid molecules are not able to produce infectious forms of a biological select agent or encode for the functional form of a select agent toxin. (See EHS SOP "Select Agents" for details.)

Important: Contact the BSO if you are unsure if you are in need of an IBC protocol.

Roles and Responsiblities

  •  

    • Adhering to and training all personnel in all applicable rules, regulations and standard practices, including but not limited to NIH and CDC (BMBL) guidelines.
    • Maintaining IBC protocol forms by submitting Amendment, Minor Modification and Annual Update Forms as needed and terminating protocols that are no longer active. (See the IBC Protocol Development page for more information)
    • Adhering fully to UNL policies and procedures for work activities subject to the UNL Biosafety Guidelines.
    • Adhering fully to other UNL policies related to the responsible conduct of research (https://research.unl.edu/researchcompliance/responsible-conduct-of-research/).
    • Restricting activities to those that are approved by the IBC and abstaining from initiating or modifying research/experiments, as applicable under these Guidelines.
    • Making available to all laboratory personnel a copy of the biosafety manual; training and supervising laboratory workers in good microbial techniques and other practices and procedures related to safety, security, personal protective equipment (use, limitations, and maintenance), accidents, and emergency preparation/response. See the EHS SOP, Biosafety Training, for further training guidance/requirements. NIH encourages PIs to retain training records.
    • Routinely supervising the performance of laboratory workers to assure a safe workplace and correct work errors and conditions that are a risk to the worker or the environment.
    • Maintaining a current and accurate inventory of all pathogenic agents in his/her possession at UNL and submitting inventory documentation as described in the EHS SOP Pathogen Inventories to the UNL Biosafety Officer at least annually.
    • Immediately reporting violations of the NIH Guidelines, injuries and illnesses attributable to occurrences in the laboratory, personnel contamination, spills, and loss of containment to the Biosafety Officer or Chair of the IBC. See EHS SOP Incident Reporting – National Institutes of Health (NIH) Guidance for more information.
    • Complying with applicable shipping regulations, permit requirements, and Material Transfer Agreements.
    • Ensuring that facilities and equipment are maintained to support the required biosafety containment level and enforcing laboratory access limitations to maintain adequate security.
    • Informing laboratory staff of the reasons and provisions for any precautionary medical practices advised or requested (e.g., vaccinations or serum collection).
    • Other stakeholder roles and responsibilities are described in the UNL Biosafety Guidelines.

     

Laboratory Worker Responsibilities
  • Completing relevant training as provided by EHS and the PI.
  • Restricting activities/experiments subject to the UNL Biosafety Guidelines to those that are authorized under an approved IBC protocol.
  • Being familiar with hazards posed by all agents used in the laboratory regardless of whether he/she directly works with them.
  • Keeping a current and accurate inventory of the pathogenic agents used and notifying the PI of any inventory changes.
  • Knowing and adhering to all emergency procedures established by the PI.
  • Reporting all occupational accidents, illnesses, and injuries to the PI and in accordance with UNL policy, as described in the EHS SOP, On-the-Job and Student Injuries.
  • Following all laboratory practices established by the PI.
UNL Biosafety Guideline Violations

The IBC has authority from the Office of Research to suspend and/or terminate existing IBC protocols related to violation of the UNL Biosafety Guidelines.

More details about policies and procedures related to violations of the UNL Biosafety Guidelines can be found here.

Committee Members

A list of current IBC members can be accessed here: Committee Members

Contacts

IBC Protocol Development

Protocol Development and Maintenance

IBC protocols and forms are submitted through the NuRamp electronic research administration system. NuRamp is a secure electronic research administration system developed by the Office of Research and administered by Bolero, Inc., to help University of Nebraska-Lincoln faculty, staff and administrators manage research projects.  Access to NuRamp is granted by using your UNL TrueYou credentials. 

NuRamp

  • Preparing a New Protocol
    You will need the following information prior to beginning an IBC form in NuRamp:
    • Research Description.  This should be a summary of proposed research, using non-scientific terminology.  A copy of an abstract is usually not a substitute for a research description.  Information entered in the protocol should be referenced in the research description.
    • List of any applicable grants or permits.  These should be available for reference in NuRamp.
    • List of any laboratory staff or collaborators,  These individuals will be directly involved with the proposed research.
    • List of related protocols from other research compliance committees.  This includes any IACUC, RSC, SROC, or IRB protocols.
    • Specific sections of the NIH Guidelines indicated.  The PI must indicate which section(s) of the NIH Guidelines apply to the experiments to be conducted under the protocol.
    • List of all microorganisms to be manipulated.  All microbes and their traits such as pathogenicity and host range that are part of the protocol must be listed.  This includes proposed host vectors.
    • List of all genes to be manipulated.  If the list includes multiple genes which share the same function (e.g., decarboxylase enzyme), you may list the genes by function.
    • List of plasmids to be manipulated.  As with genes, you may group these if from the same host (e.g., pBR322, K12 derived).
    • List of organs, tissues, cells and cell lines, body fluids and byproducts to be manipulated.
    • List of research organisms.  These refer to animals (including invertebrates) or plants used in research.  Human research participants are generally not included in this section.
    • Facilities used for the research.  Include core facilities and field sites.
    • PPE, SOPs, and risk assessment information.
    • Disinfection/ decontamination/ disposal methods and procedures.
  • Protocol Pre-review
    • After initial submission, IBC protocols are pre-reviewed to assure accurate and complete description of proposed research in addition to correctly referenced NIH Guidelines.  In the event the referenced NIH Guidelines are incorrect, the PI will be notified and corrective action will be taken if needed (cessation of work, etc.).
    • It is advisable that the PI respond to any discrepancies in the protocol as soon as possible to facilitate a timely committee review.
  • IBC Review
    • As indicated in the NIH Guidelines and the university Biosafety Guidelines, the IBC is charged with reviewing the submitted protocol, establishing final biosafety containment as applicable, and helping ensure compliance with the NIH Guidelines.  The PI is responsible to address any questions, concerns, or other issues promptly.  PIs will be notified of the meeting date at which their protocol will be reviewed.
    • PIs are strongly encouraged to attend IBC meetings when their protocols are being reviewed to answer any questions posed by the committee.  
  • Laboratory Safety & Compliance Surveys

    New PIs are required to have a "preapproval" safety and compliance survey to ensure the lab space is adequate for the proposed research.  Results of safety surveys are reported to the IBC during protocol review

    PIs with approved IBC protocols will receive an annual safety and compliance survey of their laboratory spaces, administered by EHS, to ensure compliance with biosafety guidelines in addition to applicable safety regulations (OSHA, NFPA, etc.).
  • Protocol Maintenance
    • At the university IBC protocols do not have a termination date, but Annual Update Forms are required to be submitted each year after approval of a New Protocol Form.
    • Major changes to a protocol after initial approval must be reviewed and approved by the IBC through submission of an Amendment Form.  Amendments can be submitted at any time after a protocol is approved.  They also supersede the requirement for an Annual Update Form is submitted within 60 days of the Annual Update due date.
      • For details about what constitutes a "Major Change," consult Section 5.5.2 of the university Biosafety Guidelines.
  • Minor Modifications
    • Changes to a protocol that are considered "Minor" in nature can be requested through submittal of a Minor Modification Form through NuRamp.  This form can be submitted at any time after initial approval.  Below is a list of the categories of changes that are considered "Minor" by the IBC.  The Minor Modifications Forms are reviewed and can be approved by the BSO without full committee review:
      • Changes to personnel (except the PI; this change requires a full Amendment)
      • Changes to facilities (Facility inspection by the BSO is required)
      • Changes to funding
      • Changes to decontamination/disinfection or disposal procedures
    • The Minor Modification Form does not replace the requirement for submission of the Annual Update Form.
  • Protocol Terminations
    • When projects that require IBC approval are terminated or a faculty member leaves the university, the IBC protocol must be terminated by submitting a Termination Form.  This form asks about the final disposition of the biological materials, samples and specimens used in the project.  Submission of this form must be completed immediately upon project completion and prior to faculty leaving the university. 
    • If a faculty member is leaving the university and shutting down his/her lab, other requirements for lab decommissioning apply and are detailed in the EHS SOP Laboratory Decommissioning. 
Post-approval Monitoring (PAM)
  • To help PIs maintain compliance with biosafety and NIH guidelines, an informal visit will be conducted by members of the EHS biosafety team.  This visit is separate from the annual safety and compliance surbeys and is designed to discuss any future research plans of the PI and assist in submitting any applicable IBC forms if needed.  Post-approval monitoring is conducted on a variety of timelines (annual, biannual), at the discretion of EHS and the IBC.
  • All PIs with new IBC protocols will receive a PAM visit approximately 6 months aafter protocol approval.  This visit will function mainly as a means of providing lab start up assistance to the PI related to safety procedures and practices and to offer assistance with lab personnel training as requested by the PI.

IBC Meetings

IBC meetings are scheduled once per month during the academic year from September through May and as needed during the summer months.  Meetings are conducted in a manner that facilitates discussion, public attendance, and PI participation.  Committee business is always conducted in a live meeting and never conducted by email or other electronic means. The current schedule is shown below and is posted on the University calendar accessed at http://events.unl.edu.  Meetings are held at the Environmental Health & Safety office training room.  PIs are notified of the meeting date at which their protocol will be discussed and are invited to attend at their discretion.

Protocols and Amendment forms to be reviewed by the full committee must be submitted at least 3 weeks prior to the scheduled meeting date.  See the document below for the current schedule of meeting dates and submission deadlnes:

IBC Meeting Schedule and Submission Deadlines

NuRamp IBC Meeting page 

HELP / F.A.Q.

What do I put in the research description? Do you want an abstract?

The IBC protocol is essentially a risk assessment of proposed research with biological materials.  The research description should be a brief summary of experiments proposed with emphasis on applicable pathogenicity, toxicity of any gene product(s) along with handling and decontamination of materials at the conclusion of experiments.  IBC Review focuses on the biosafety aspects of a protocol, not scientific merit.  

Is an IBC protocol a blanket approval for any experiment which fall under a certain section of the guidelines?

No.  The researcher is ONLY approved for experiments described in the protocol.  Additional or changes in experiments must be submitted subsequently using protocol amendments.  Although a protocol can be written with a fair amount of scope, it is never all-inclusive.

I've made the revisions requested. Why didn't the revised protocol get submitted for review?

After revisions are made, you must electronically resubmit the protocol (i.e., hit the SUBMIT button).  It is advisable to check "my projects" often when logging into NUgrant.  You may notify EHS if experiencing any technical difficulties.

I've submitted the protocol for pre-review. May I begin the experiments?

Typically, protocols require full committee approval before commencing any work.  However, you may contact the Biosafety Officer to inquire about any permissible experiments prior to full committee approval.

What happens if I conduct unapproved work with recombinant or sythetic nucleic acids?

Conducting unapproved experiments can result in a non-compliance report sent directly to the NIH for review.  This can jeopardize federal funding opportunities not only for the PI, but for the university as a whole.

I want to use the CRISPR/ Cas9 gene editing system. Do I need to submit an IBC protocol?

Depending on the type of system used, a protocol may be required.  Often, when using the CRISPR system, work may not begin until full committee approval is obtained.  Please contact the Biosafety Officer to assist with a determination.

My work is exempt from the NIH Guidelines. Is an IBC protocol still required?

Yes.  Even though the work may be exempt from the NIH Guidelines, IBC registration is still required.

I am a department head/chair, whom should I list as the Department Head/Chair/Dean/Director on my IBC protocol?

Department heads/chairs should list the Research Dean for their college in the Department Head/Chair/Dean/Director role on their research protocols.  The purpose of having this role listed on the IBC protocol and as part of the protocol routing/approval process is to ensure that supervisors are aware of the research being conducted by faculty under their purview and that those faculty have the necessary support and facilities to conduct the work safely.

I'm not sure what section of the NIH Guidelines my animal experiment(s) fall under. Is there an easy reference to help?

Yes! The NIH Office of Science Policy has published a reference table that should help you figure out what section of the Guidelines your experiment(s) fall under.

Animal Activities Table (NIH)

You can also contact the Biosafety Officer or email ibc@unl.edu with questions.

IBC contact info
  • UNL Interim Biosafety Officer, Rebecca Cederberg
  • UNL EHS Technician, Anna Jungck
  • IBC Chair:  J. Dustin Loy, PhD, DVM, Associate Professor, School of Veterinary Medicine and Biomedical Sciences
  • IBC Email Account:  ibc@unl.edu