Institutional Biosafety Committee Procedures & Practices
- To ensure that all recombinant DNA/synthetic nucleic acid 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 members may serve up to 3 consecutive terms. The Vice President for Research may limit or extend the terms as needed.
- Nominations to the Institution 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, currently on the third Wednesday of the month at 1:15 at the Environmental Health & Safety Building, for review and approval of protocols and to discuss other business relevant to the charter of the IBC. For those members that cannot attend the meeting in person, a call in number is available for members to participate in the meeting.
- 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 for completeness of information required for IBC review,
- distribute the protocols to IBC members along with a summary of the protocols and 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,
- arrange for additional ad hoc member review for those protocols requiring such specialized review,
- forward questions or concerns identified by IBC members during the review process to the PI for comment, clarification, or resolution,
- advise PIs of the outcome of the voting.
- Meeting procedures
- A quorum for the meeting is defined as at least 8 IBC members, at least one of which must be an external (community) member.
- Minutes from the previous meeting are voted for approval or revision.
- 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.
- 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 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.
- 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 is distributed to IBC members for review and ratification at the following meeting.
- Minutes entries from protocols involving sensitive (e.g. select agent research) or proprietary information are recorded and distributed such that protected information is kept confidential.
- Minutes are available to the public upon request.
- Follow up on Approved Projects
- PIs will be notified annually and asked 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
- All projects will be re-registered every 5 years.
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
- An electronic copy of UF Policies and Requirements for BSL-3 Research
- An electronic copy of UF Select Agent Policy, Security Plan, Biosafety Plan, and Emergency Response Plan
- 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
Biological toxins having an LD50 of ≤100 μg/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,
- those 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 do 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 Safety Office prior to the IBC meeting.
- IBC registration deadlines and meeting dates are be posted on the IBC and Biosafety Office websites.
- 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 a University of Florida IRB.
- If UF has an INSTITUTIONAL conflict of interest, such as owning the technology, the Western Institutional Review Board (WIRB) can be the IRB of record, but the UF IRB must be allowed to comment prior to submission to the WIRB; the WIRB will take those comments into consideration.
- Per IRB policy, if the trial is industry-sponsored and utilizes FDA regulated articles (drugs and devices), the WIRB is used, but the UF IRB must be allowed to comment prior to submission to the WIRB; the WIRB will take those comments into consideration.
- Transfer of rDNA into human subjects studies also require the submission of:
- a study protocol
- informed consent
- investigator brochure
- copies of relevant RAC correspondence
- 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.