Registering Work with Biologicals
All UF research or clinical projects involving the biological materials listed on the Biosafety Forms web page must be registered and approved by the Biosafety Office or Institutional Biosafety Committee prior to initiation. The purpose of the registration process is to identify and assess risks associated with the project and to then communicate specific guidance and requirements for the appropriate containment, technologies and practices needed to prevent accidental exposures or unintended releases of these materials. Registrations are project specific. What constitutes a project is at the discretion of the PI. In general, a project would cover a specific scope of work with specific aims. An “umbrella” registration for all the work done in the laboratory does not provide sufficient detail for a useful risk assessment, whereas registration of individual experiments requires too frequent upkeep of the registrations. Consult the Biosafety Office for guidance as needed.
- Submit the appropriate registration form to the EH&S Biological Safety Office.
Registration forms must be in the name of a Principal Investigator, as defined in the Office of Research, Researcher’s Handbook.
- Certain categories of projects (rDNA/synthetic nucleic acid projects that are non-exempt from NIH Guidelines, BSL-3 projects, and Select Agent projects) require full Institutional Biosafety Committee (IBC) review and approval. The committee meets monthly and the registration form submittal deadline is 5 pm on the first Wednesday of each month. [IBC Meeting schedule]
- Projects or experiments involving deliberate transfer of recombinant/synthetic nucleic acids into human subjects must also be reviewed by the NIH Office of Science Policy (Appendix M of the NIH Guidelines) and a UF IRB.
- Projects involving any animal work must also be approved by the UF 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.
- Projects may be approved, denied or tabled until all necessary information is provided.
- The laboratory or research area must be in compliance with local, state, and federal requirements and guidelines.
- It is the responsibility of the PI to obtain and maintain all state and/or federal permits that may be required for the work.
- PIs will be notified annually and asked to complete an annual update form for continuation of the project. This includes NIH-exempt projects.
More information on the registration process and forms, as well as helpful resources can be found in the Registration Information for Researchers section of our Biosafety Manual.