IBC Procedures & Practices
- To ensure that all recombinant DNA (rDNA)/synthetic nucleic acid (sNA) research conducted at the University of Florida or sponsored by the University of Florida is conducted in compliance with the National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), and to review and approve research that is in conformity with the Guidelines;
- To assist the Biosafety Office in evaluating work done at BSL3 and work with select agents, even if the work does not involve recombinant DNA or synthetic nucleic acids;
- To help interpret guidelines and/or regulations pertaining to biological materials, and provide technical assistance to the University of Florida (UF) Biological Safety Office and University Community on these matters, such as the safe handling, transport, use, and disposal of biological materials, including recombinant DNA/synthetic nucleic acid molecules.
The Institutional Biosafety Committee (IBC) works in conjunction with the University of Florida Biological Safety Office to monitor, and enforce policies or procedures for work with biohazardous materials. The IBC is authorized to inspect research facilities; register, review, and approve research protocols; and to take actions to enforce safe research practices or halt research activities in the event of unsafe practices that endanger worker, community, or environmental health.
Structure and Function
- Membership consists of two community members (non-UF), a non-doctoral member, the University Biosafety Officer, and other members with expertise in biosafety, plant science, animal science, virology, bacteriology, pathology, and human gene therapy. Membership and qualifications are in compliance with Sections IV-B-2-a and –b of the NIH Guidelines. Ad hoc members may be called upon for specific expertise. The membership term is 2 years, and terms are automatically renewed at the discretion of the Vice President for Research. For research being conducted at sites distant from the Gainesville campus, two additional community members will be added to the membership roster, only when projects in their community are reviewed. For review of projects in Jacksonville, a separate IBC community has been formed, which consists of a subset of the Gainesville campus IBC plus two community members.
- Nominations to the Institutional Biosafety Committee (IBC) are solicited by the committee. Appointment to the committee is made through the Office of Research. The IBC Chair is solicited by the committee.
- Meeting Schedules, Protocol Review and Voting
- The IBC meets every month, usually on the third Wednesday of the month at 1:00 for review and approval of protocols and to discuss other business relevant to the charter of the IBC. Meetings are currently being held by Zoom. Meetings are held on the first Wednesday of the month as needed.
- The Biological Safety Office will be responsible for registering protocols, keeping records, recording and distributing minutes, and scheduling meetings for the IBC. Biological Safety Office staff:
- conduct a pre-review of submitted protocols with the laboratory for completeness of information required for IBC review and will provide recommendations for containment and safe practices,
- coordinate with other relevant committees (e.g., IACUC and IRB) as to the status of IBC protocol review and approval and concordance of study documents,
- forward questions or concerns identified by IBC members during the review process to the PI for comment, clarification, or resolution,
- Meeting procedures
- A quorum for the meeting is defined as at least one more than half of the committee roster for the meeting. For meetings in which off-campus projects are reviewed, the IBC member roster will include the 2 community members for determining quorum only during review of the off-campus project.
- Minutes from the previous meeting are approved by the IBC chair, but are available to all committee members.
- The IBC approves protocols by a majority vote of the members. Although information regarding protocols may be communicated by e-mail, voting must occur at the designated meeting, either in person, by Zoom, or by phone.
- Protocols may be approved, denied, or, in instances where more information (e.g., from the PI, ad hoc members, other committees) is required by the IBC, tabled for re-review at a future meeting.
- No member of the IBC will review or vote on a protocol with which he or she has any connection or in which he or she has a personal or professional interest other than as a member of the IBC. In those cases, the member must abstain from review and voting.
- No project requiring IBC approval before initiation will commence prior to IBC approval of the protocol.
- The committee Chair will notify the Principal Investigator (PI) of the results of the IBC’s review.
- Meeting minutes
- Minutes are recorded by Biological Safety Office Staff and document protocol specific information such as: PI name, project title, project registration number, classification of the project in the context of the applicable section of the NIH Guidelines, the biosafety level at which the project was approved, as well as any other specific approval requirements, outcome of the voting, and discussion points during the review and approval process.
- A draft of the minutes and chair-approved minutes are available to IBC members for review.
- Minutes are available to the public upon request.
- Follow-up on approved projects
- PIs will be required to complete an annual update form for continuing projects to document that information regarding gene constructs, agents, work procedures, locations, animal use, new personnel training, or other significant changes are current with the IBC records. This includes exempt projects.
- Any significant problems associated with the work or adverse events (in the case of human clinical trials) must be reported to the IBC. The Biosafety Office and/or IBC will evaluate the incident and require appropriate changes to prevent a reoccurrence. A change or amendment and re-review of the protocol by the IBC may be required as well. The Biosafety Officer or IBC Chair will report significant incidents to the NIH Office of Biotechnology Activities (OBA). “Significant” reportable events include
- Spills or accidents in BL2 laboratories resulting in an exposure to hazardous recombinant DNA or synthetic nucleic acids (rDNA/sNA), e.g. a skin puncture from a sharp containing rDNA/sNA
- Spills in BL3 laboratories resulting in an exposure or potential exposure to rDNA/sNA, e.g. outside of a containment device such as a biosafety cabinet or safety centrifuge cup
- The escape of a transgenic animal or improper disposition such that it enters the food chain,
- A release of transgenic pollen, seed, or plants through failure of biological or physical containment,
- Failure of an investigator to adhere to the containment and biosafety practices articulated in the NIH Guidelines
- IBC projects expire 5 years after approval. If they are being continued, they must be submitted as a new project, referencing in the submission that the project is a continuation of the previous iteration of the project.
Upon appointment to the IBC, new members are provided with the following training materials:
- Printed copy of the NIH Guidelines for Research Involving Recombinant DNA Molecules
- Other materials or media provided by the Chair or BSO
Members are expected to be familiar with these materials.
All work involving the following must be registered through the Biological Safety Office:
- Known human, animal, or plant pathogens or pathogenic material, BSL-2 or greater
- Suspected human, or animal pathogens or pathogenic material
- Select Agents
- Biological toxins having an LD50 of ≤100 mg/kg body weight
- Primary human tumor cells
- Cell lines transformed with a virus
In addition, the following rDNA/sNA experiments must be reviewed and approved by the IBC:
- 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
- The cloning of toxin molecules with LD50 of Less than 100 ng/kg body weight, and
- 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.
- The use of Risk Group 2, 3, or 4 or restricted organisms as Host-vector systems,
- The cloning of DNA from Risk Group 2, 3, or 4 or restricted organisms into non-pathogenic prokaryotic or lower eukaryotic host-vector systems,
- The use of infectious or defective DNA or RNA viruses in the presence of helper virus in tissue culture systems,
- rDNA/sNA experiments involving whole animals,
- rDNA/sNA experiments involving whole plants consistent with Section III-D-5 of the Guidelines,
- rDNA/sNA experiments involving more than 10 liters of culture,
- Experiments involving recombinant or synthetic influenza viruses,
- Experiments requiring BSL3 containment,
- 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:
- Those not included in the above categories in which all components are derived from non-pathogenic prokaryotes and lower eukaryotes,
- Those involving the formation of rDNA/sNA molecules consisting of no more than two-thirds of the genome of any eukaryotic virus
- rDNA/sNA experiments involving whole plants consistent with Section III-E-2 of the Guidelines,
- 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:
- 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.
- 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
- rDNA/sNA molecules that are not in organisms or viruses, and not modified to penetrate cells
- 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,
- 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,
- 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),
- 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,
- Genomic DNA that has acquired a transposable element, provided the element does not contain rDNA/sNA,
- 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
- Principal Investigators must submit a registration form for all protocols requiring IBC review, as detailed above, to the Biological Safety Office at least 2 weeks prior to the IBC meeting.
- After initial review of the protocols by the Biological Safety Office staff, investigators may be asked to modify or correct protocols. All modifications and corrections must be submitted to the Biological Safety Office prior to the IBC meeting.
- IBC registration deadlines and meeting dates are posted on the IBC and Biosafety Office websites.
- IBC approvals must be renewed every five years.
- Experiments involving deliberate transfer of rDNA/sNA into human subjects must also be reviewed by the NIH OBA (Appendix M of the NIH Guidelines) and an appropriate Institutional Review Board (IRB), as determined by University of Florida policy.
- Transfer of rDNA into human subjects studies also require the submission of:
- RAC approval letter and/or relevant RAC correspondence
- Completed NIH Guidelines Appendix M, a.k.a. “points to consider” (http://osp.od.nih.gov/sites/default/files/NIH_Guidelines.html#_Toc351276401)
- Investigator Study Brochure
- Investigator Study Protocol
- Informed Consent document
- Status of IRB review (IRB approval is not required prior to IBC review)
- Transfer of rDNA into human subjects studies also require the submission of:
- 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.
Use of Human Cells and Tissues in Animals
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 has reverted to 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.