IBC Procedures & Practices

All work involving the following must be registered through the Biological Safety Office:

  1. Use of Risk Group 2 or Risk Group 3 infectious biological agents pathogenic to otherwise healthy humans.
  2. Analysis of samples known or highly suspected to be contaminated with Risk Group 2 or Risk Group 3 infectious biological agents pathogenic to otherwise healthy humans (clinical specimens from presumed healthy individuals do not meet this definition).
  3. Culturing/propagating unknown or uncharacterized microorganisms.
  4. Analysis of specimens (e.g., blood, tissues, saliva, feces) from Old World monkeys (macaques, baboons).
  5. Use of a virus (e.g., EBV, SV40) to immortalize cell lines or use of immortalized cell lines capable of producing infectious virus(es).
  6. Use of acute biological toxins (LD50 ≤ 100 µg/kg body weight) or export-controlled toxins.
  7. Work that requires federal or state permits/notifications pertaining to regulated infectious materials (plant, animal, human pathogens), vectors or genetically modified organisms.

In addition, the following rDNA/sNA experiments must be reviewed and approved by the IBC:

  1. The deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally, if such acquisition could compromise the drug to control human, animal, or plant diseases, even in a niche population
  2. The cloning of toxin molecules with LD50 of Less than 100 ng/kg body weight
  3. The deliberate transfer of rDNA/sNA into humans.  NOTE: The 3 types of experiments above must also be approved by the NIH RAC and/or OBA.
  4. The use of Risk Group 2, 3, or 4 or restricted organisms as Host-vector systems
  5. The cloning of DNA from Risk Group 2, 3, or 4 or restricted organisms into non-pathogenic prokaryotic or lower eukaryotic host-vector systems
  6. The use of infectious or defective DNA or RNA viruses in the presence of helper virus in tissue culture systems
  7. rDNA/sNA experiments involving whole animals
  8. rDNA/sNA experiments involving whole plants consistent with Section III-D-5 of the Guidelines
  9. rDNA/sNA experiments involving more than 10 liters of culture
  10. Experiments involving recombinant or synthetic influenza viruses
  11. Experiments requiring BSL3 containment
  12. Experiments involving Select Agents (also requires approval from USDA and/or CDC)

IBC approval prior to project initiation by the PI is not required for the following, however, the IBC reviews and approves these projects:

  1. Those not included in the above categories in which all components are derived from non-pathogenic prokaryotes and lower eukaryotes,
  2. Those involving the formation of rDNA/sNA molecules consisting of no more than two-thirds of the genome of any eukaryotic virus
  3. rDNA/sNA experiments involving whole plants consistent with Section III-E-2 of the Guidelines,
  4. The generation of transgenic rodents de novo.

The following rDNA/sNA experiments are EXEMPT from the NIH Guidelines but may require registration with the Biological Safety Office:

  1. Synthetic nucleic acids that (1) can neither replicate nor generate nucleic acids that can replicate in any living cell, and (2) are not designed to integrate into DNA, and (3) do not produce a toxin that is lethal for vertebrates at an LD50 < 100 ng per kg bw.
    1. If a synthetic nucleic acid is deliberately transferred into one or more human research participants and meets the criteria of Section III-C, it is not exempt under this Section
  2. rDNA/sNA molecules that are not in organisms or viruses, and not modified to penetrate cells
  3. Those that consist entirely of a single DNA segment from a single non-chromosomal or viral DNA source, though one or more may be a synthetic equivalent that exists in nature,
  4. Those that consist entirely of DNA from a single prokaryotic host (including its plasmids or viruses) when propagated only in that host (or closely related strain) or when transferred to another host by well established physiological means,
  5. Those that consist entirely of DNA from a single eukaryotic host (including chloroplasts, mitochondria, or plasmids) when propagated only in that host (or closely related strain),
  6. Those that consist of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent,
  7. Genomic DNA that has acquired a transposable element, provided the element does not contain rDNA/sNA,
  8. Those that do not present a significant risk to health or the environment (see NIH Guidelines Appendix C).

Procedure for IBC Protocol Registration and Review

  1. Principal Investigators must submit a registration form for all protocols requiring IBC review, as detailed above, to the Biological Safety Office via Gator TRACS.
  2. New submissions receive an initial review by the IBC Administrator to ensure all required fields are completed and any required training is current.  Incomplete submissions that remain “in-progress” but not submitted will be administratively cancelled after 60 days. A notice of cancellation will be sent by the IBC Administrator to the PI in advance.  Research contained in a cancelled submission may not be initiated in a laboratory because the work does not have Biosafety/IBC approval.
  3. The IBC Administrator will assign each project to a Biosafety Coordinator who will focus their review on the evaluation of the proposed biosafety containment level and the facilities, procedures, practices and training and expertise of personnel involved in the research, in addition to ensuring that the documents are complete for scientific review.
  4. Once the Biosafety Coordinator has issued their approval, each project that requires full committee review is assigned by the IBC chair to a primary IBC reviewer based on the nature of the research described in the registration document and the expertise of the IBC members.  Reviewers will request revisions or clarifications from the PI or designated laboratory personnel directly through the Gator TRACS Biohazard Project Registration module.  Once the PI/applicant has adequately responded to all reviewer comments, the IBC reviewer will notify the IBC Chair that project can be added to the agenda for the next IBC meeting.
  5. At any time in the review process, if a PI or the designated laboratory representative (“applicant”) fails to make progress on the completion of a submitted project in response to Biosafety or IBC queries or comments in a timely manner, e.g., lack of communication for two weeks, the project will be subject to cancellation after notification is sent to the PI and the applicant.
  6. IBC projects expire after five years and must be renewed by that time.
  7. Experiments involving deliberate transfer of rDNA/sNA into human subjects must also be reviewed by an appropriate Institutional Review Board (IRB). The specific IRB is determined by University of Florida policy.
    1. Transfer of rDNA into human subjects studies also require the submission of:
      1. Investigator Brochure
      2. Study Protocol
      3. Informed Consent document
      4. Status of IRB review (IRB approval is not required prior to IBC review)
  8. Experiments involving any animal work must also be approved by the University of Florida IACUC. IACUC protocols will not receive final approval until Biological Safety Office and/or IBC approval is obtained. Biological Safety Office staff advise the IACUC staff of approved, denied, or tabled projects.
  9. Experiments involving Select Agents as defined by the USDA or CDC must be registered with the CDC or USDA. These protocols must be submitted to the Biological Safety Office to begin the CDC/USDA registration process and to obtain approval from the IBC.
  10. The implantation of human cells, tissues, and tumors into laboratory animals, e.g., Patient-Derived Xenograft (PDX) models, involves the biohazard of active or latent pathogens from the patient being propagated in the animals.  This poses a potential hazard to laboratory researchers and animal care staff.Regulation of experiments where human cells or tissues are injected or implanted into experimental laboratory animals that do not involve recombinant nucleic acid are under the purview of the Biosafety Office.  Human cells and tissues have the potential to harbor a number of infectious agents, including bloodborne pathogens such as HBV, HCV, HIV, HTLV, EBV, HPV and CMV, as well as agents such as Mycobacterium tuberculosis that may be present in human lung tissue.  The intent of this policy is to protect Animal Care Services staff and research staff from potential biological hazards associated with these types of experiments.

    Unless noted otherwise by the Biosafety Office, in accordance with those described in the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th edition and the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogen Standard, 29 CFR 1910.1030, research animals injected or engrafted with human cells or tissues must be housed at Animal Biosafety Level 2 (ABSL-2).

    Note that Animal Care Services may have its own policies on the handling of animals with implanted exogenous cells from humans and other animals, in addition to the policies of the IBC.