The Institutional Biosafety Committee (IBC) at the University of Florida is the body responsible for reviewing research with recombinant or synthetic nucleic acid molecules conducted at or sponsored by the University for compliance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. Additionally, the IBC reviews and approves research involving select agents or toxins subject to 42 CFR Part 73, 9 CFR part 121 or 7 CFR part 331 and research conducted at biosafety level 3 (BSL-3/ABSL-3/ACL-3). The IBC has authority to inspect research facilities and to take actions to enforce safe research practices or halt research activities in the event of noncompliance with the requirements of the NIH Guidelines.
The University of Florida maintains IBCs for each site that performs research requiring IBC oversight according to the NIH Guidelines. The main IBC oversees research at the Gainesville campus. Additional IBCs registered with the NIH include, but are not limited to, Jacksonville, Orlando, Whitney Laboratories, Wimauma, Lake Alfred, and Pensacola/Milton.
Composition of Committee
In accordance with the NIH Guidelines (Section IV-B-2-a), the IBC must comprise no fewer than five members who collectively have experience and expertise in recombinant or synthetic nucleic acid molecule technology and the capability to assess the safety of recombinant or synthetic nucleic acid molecule research and to identify any potential risk to public health or the environment. The IBC at UF is comprised as follows:
- The IBC Chair, a UF faculty member appointed by the Vice President for Research
- The UF Biosafety Officer
- Two Biosafety Coordinators, at least one of whom is the Responsible Official for Select Agents if that role is not fulfilled by the Biosafety Officer
- At least two members who are not affiliated with UF and who represent the interest of the surrounding community with respect to health and protection of the environment
- At least one individual with expertise in plant, plant pathogen or plant pest containment principles
- At least one individual with expertise in animal containment principles
- At least one individual with expertise in human gene transfer studies
- At least one individual with expertise in human infectious diseases
- Additional representatives from UF programs that conduct research with recombinant or synthetic nucleic acids and/or conduct research in high containment laboratories.
Terms of Membership
IBC members are appointed for a term of two years by the UF Vice President for Research. Members may be appointed for subsequent two-year terms if they are willing to continue to serve and have been active and engaged members during their previous term. The Vice President for Research, in consultation with the IBC Chair and the Biosafety Office, may remove members when necessary, for example, in the case of excessive absences (8 or more absences in a calendar year), lack of contribution, or resignation.
Potential IBC members can be recommended by current IBC members or Biosafety Office staff to the IBC Chair. The IBC Chair will contact recommended individuals to discuss the possibility of serving on the IBC and, if mutually agreeable, forward the nominee’s information to the UF Vice President for Research for official appointment on the committee.
- Review recombinant or synthetic nucleic acid molecule research conducted at or sponsored by the University and approve those research projects that conform with the NIH Guidelines. The review shall include: 1) independent assessment of the containment levels required by the NIH Guidelines for the proposed research and 2) assessment of the facilities, procedures, practices and training and expertise of personnel involved in the research. The IBC does not review projects for scientific merit.
- Review all research projects involving select agents and those conducted in a BSL-3 facility.
- Notify the Principal Investigator (PI) of the results of the IBC review.
- Lower containment for certain experiments as specified in Section III-D-2-a, Experiments in which DNA from Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents is Cloned into Nonpathogenic Prokaryotic or Lower Eukaryotic Host-Vector Systems.
- Set containment levels as specified in Sections III-D-4-b, Experiments Involving Whole Animals and III-D-5, Experiments Involving Whole Plants.
- Periodically review recombinant or synthetic nucleic acid molecule research conducted at UF to ensure compliance with the NIH Guidelines.
- Adopt emergency plans covering accidental spills and personnel contamination resulting from research covered under the NIH Guidelines.
- Report any significant problems with or violations of the NIH Guidelines and any significant research-related accidents or illnesses to the appropriate institutional official and NIH OSP within required time frames.
- Establish, monitor and enforce policies and procedures involving recombinant or synthetic nucleic acid molecules and other biohazardous materials.
IBC Chair Responsibilities
- Conduct meetings in accordance with institutional and NIH requirements.
- Assign members as primary reviewers on projects submitted to the IBC.
- Review and approve the meeting minutes.
- Ensure that IBC members receive appropriate training.
- Assign ad hoc subcommittees as needed to review an issue prior to bringing it to the full committee for review.
- Communicate to the PI committee decisions on non-compliance issues
- Recruit committee members as needed.
- Review annual committee member self-assessments and provide feedback as needed.
- Assist the Biosafety Officer in communication with the NIH as necessary.
IBC Member Responsibilities
- Commit to attending at least 2/3 of scheduled meetings in a calendar year. Missing 8 or more meetings in a calendar year. Excessive absence may result in removal from the committee.
- Review all projects on the agenda and log any comments or questions for the PI in Gator TRACS in advance of the meeting.
- If the IBC member has been assigned as a primary reviewer of the project, that member is expected to review all submitted forms for accuracy and completeness and to work with the PI to get the science properly represented in the project prior to consideration by the whole committee.
- The assigned IBC member reviewer will present the project at the IBC meeting.
- Actively participate in the discussion of projects during scheduled meetings.
- Vote to approve, table, or reject projects submitted to the IBC.
- Participate in ad hoc subcommittees as needed to discuss issues or non-compliance.
- Complete an annual self-evaluation.
IBC Administrator Responsibilities
- The IBC Administrator is an employee of Environmental Health & Safety (EH&S). The IBC Chair participates in the interview process and selection of this individual, along with key individuals from EH&S.
- Perform initial administrative review of submitted protocols.
- Assign protocols to a Biosafety Coordinator for review of the proposed biosafety containment level and the facilities, procedures, practices and training and expertise of personnel involved in the research.
- Prepare meeting agendas, meeting polls, send meeting invitations and record and prepare meeting minutes.
- Notify PIs when their project has been assigned to a meeting and provide them with the meeting invitation.
- Notify PIs when projects are due for renewal. Track and process annual updates or administrative amendments.
- Maintain the list and curriculum vitae/resume of IBC Members and ensure the list is updated at least annually with NIH-OSP.
- Work with the IBC Chair to manage the review and renewal of IBC projects. Maintain training materials and update the IBC website as needed.
Biosafety Office Responsibilities
- Review submitted projects and assess proposed containment levels, facilities, procedures, practices and training relative to the proposed work to ensure compliance with the NIH Guidelines and other pertinent regulations.
- Periodic safety surveys of research laboratories.
- Investigate lab accidents involving recombinant/synthetic nucleic acids as well as those involving infectious materials, biological toxins, and select agents.
- Report to the IBC, UF administration, and NIH any problems, violations, research-related accidents or illnesses.
- Develop emergency plans for handling spills and personnel contamination
- Provide technical advice to PIs and the IBC on biological safety
- Provide advice on biosecurity
Principal Investigator (PI) Responsibilities
- Fully comply with the NIH Guidelines and institutional policies when conducting experiments utilizing recombinant/synthetic nucleic acids.
- Prior to initiating research subject to the NIH Guidelines, PIs must:
- Determine whether the research is subject to Section III-A, III-B, III-C, III-D or III-E of the NIH Guidelines.
- Propose physical and biological containment levels in accordance with the NIH Guidelines.
- Propose appropriate microbiological practices and laboratory techniques to be used for research.
- Submit a Biohazard Project Registration in Gator TRACS for review and approval.
- Obtain IBC approval before initiating, or at the time of initiating research as applicable, based on the section of the NIH Guidelines the research is subject to.
- Be adequately trained in good microbiological techniques.
- Ensure laboratory staff have access to and have read all approved biohazard project registrations.
- Instruct and train laboratory staff in the practices and techniques required to ensure safety and the procedures for dealing with accidents.
- Supervise laboratory staff to ensure that the required safety practices and techniques are employed.
- Correct work errors and conditions that may result in the release of, or exposure to, recombinant and synthetic nucleic acid materials.
Conflict of Interest
No member of the IBC may participate (other than to provide project-specific information at the request of the IBC) in the review or approval of a project in which he/she has been or expects to be engaged or has a direct financial interest or has any other conflict of interest according to UF regulations (https://research.ufl.edu/wp-content/uploads/UF-Policy-on-Research-Conflicts-of-Interest.pdf).
If the IBC Chair has a conflict of interest, another IBC faculty member will be appointed to facilitate review and approval of the project.
Procedure for Project Registration and Review
PIs are responsible for ensuring they obtain IBC review and approval of all research that falls under Sections III-A, III-B, III-C, III-D and III-E of the NIH Guidelines. This includes both new research projects and amendments to existing projects. Experiments covered under Sections III-A, III-B, III-C, and III-D may not be initiated until IBC approval has been granted. Experiments covered under Section III-E can be initiated at the time the project is submitted to the IBC for review. Projects involving certain experiments that are exempt from the NIH Guidelines (Section III-F, Appendix C) must still be registered in Gator TRACS but they are reviewed and approved only by the Biosafety Office.
Project submissions are processed through the Gator TRACS Biohazard Project Registration module.
Project reviews focus on the risks of the proposed work and mitigations in place to minimize the risk as well as the suitability of the facility and personnel to conduct the work safely. The IBC does not review projects for scientific merit.
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.
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.
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.
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.
All outcomes require a majority vote by the committee members present at the meeting, either in person, via teleconference, or by phone.
Approved: The registration document satisfactorily addresses all questions, and the work can be safely conducted as proposed. No modifications to the registration document are needed.
Conditionally Approved: Minor revisions to the registration document are required. The revised document will be approved by the IBC chair once all revisions are complete.
Tabled: There are significant issues with the registration document/proposed work. Major revisions are required, and the project will need to be re-reviewed by the full IBC at a later meeting when all concerns have been addressed.
Rejected: The proposed work is not approved and will not be further considered for approval by the IBC.
Prior to final approval, all administrative requirements (training, completed and signed hazard assessment) must be complete. Approval is valid for five years, after which the projects must be renewed. Technical (new genes, new vectors, etc.) and administrative (changes in personnel, change in project location, etc.) amendments to the research must be made as changes occur.
The IBC Administrator will be responsible for recording and distributing minutes and scheduling meetings for the IBC. IBC meetings are currently held on the first and third Wednesday of the month at 1pm. Meetings are currently held via Zoom (or other university-sanctioned teleconference method) but can also be held in person at the discretion of the IBC Chair. IBC meetings are open to the public – contact email@example.com to request information about attending a meeting. IBC meeting minutes are also available to the public upon request.
A quorum for the meeting is defined as one more than half of the voting members. The IBC Administrator will ensure that quorum has been met prior to beginning each meeting. If quorum has not been met, the meeting will be cancelled.