IRB & IACUC Protocols

Awards that include the use of human subjects and/or animal subjects require review and approval of the research protocol by UF’s Institutional Review Board (IRB) or UF’s Institutional Animal Care and Use Committee (IACUC) before the Award can be released for spending. To expedite the release of funds, investigators should begin the protocol application or modification process as soon as they learn a project is likely to be funded.

Grant Congruency

During protocol review, IRB and IACUC verify congruence between the sponsored project’s proposed scope of work and the research protocol. The sponsored project source of funds is liked to the protocol via the UFIRST Proposal or Award number or sponsor award ID. At Award setup, the Division of Sponsored Programs (DSP) ensures the specific sponsored project source of funds is linked to the IRB and/or IACUC protocol entered on the Award. After the sponsored project is linked and the protocol is approved, funding can be released. If at any time during the life of the sponsored project the protocol lapses or expires, project spending will be stopped until the necessary protocol approval is obtained.

• Click here for more information on IACUC grant congruency. For questions or help with an IACUC protocol application or modification, contact the IACUC office at IACUC@research.ufl.edu.
• For questions on the IRB process or help with an IRB protocol application or modification, contact the IRB office at: http://irb.ufl.edu/contact-us.html

Select Sponsor Requirements for Additional Approval

In addition to these internal review requirements, some sponsors may require their own review and approval of UF’s human/animal research protocols. Common sponsors imposing this requirements are: the Department of Defense, the Florida Department of Health, and the National Institute of Justice. If the sponsor imposes additional approval requirements, DSP cannot release funding until the appropriate agency has approved the protocol or has authorized non-human and/or non-animal work to begin. The terms and conditions of each award must be reviewed to determine if additional approval is required.

Training Grants, Pilot Projects, and Changes in Scope

If you were awarded a NIH Training Grant, any planned or potential use of humans or animals requires completion of sponsor required forms and requires an institutional attestation to ensure that the work is covered by a specific protocol. When the trainee is selected and the trainee’s work includes human or animal contact, then the protocol will need to be provided in UFIRST Awards.  In cases where the trainee is working under their mentor’s protocol and only salary will be charged to the training grant, the funding source does not need to be added in myIRB or goIACUC.  The PI attesting to which protocol the student is engaging is sufficient. Note, UF’s IRB does not approve umbrella protocols and each study that stems from the training grant that might involve humans MUST seek IRB approval before the work starts. Any human or animal disclosures should also flow through to future RPPR’s.

For awards that anticipate creation of pilot projects at some future date during the period of performance, please see the protocol exception section below for additional information.

Throughout the life of the award, if it becomes evident that use of animals or humans is expected to occur when not originally disclosed, most sponsoring agencies (including all federal grants, regulations articulated at 200.308) recognize this as a change in scope. Prior to engaging in human or animal work, you must route a Compliance Modification (MOD) through UFIRST Awards in order to request sponsor prior approval. DSP will review and submit the prior approval request after the UFIRST MOD is routed to DSP.

Protocol Exceptions

Some sponsored projects include delayed onset work with humans/animals (including future pilot projects that may contain human and/or animal work). In these cases, certain aspects of the sponsored project may be able to begin before protocol approval is received. A protocol exception is used in UFIRST to facilitate setup of the Award and release funds for non-human and/or non-animal work to begin. A protocol exception is time-limited and is replaced with the final protocol information once approved by IRB/IACUC.

To request a protocol exception, email the following to the DSP Owner assigned to the UFIRST Award record:

• Justification for the request (i.e., why does the Award need to be released without an active protocol? What aspects of the work can begin if the request is granted?)
• Status of the protocol and estimated date of approval or initiation of human/animal work.
  • If the scope of work clearly indicates protocol development is part of the early phases of the project, or human/animal work will not commence until later stages of the project, provide a reference to the relevant section(s) of the scope.
  • Note that if the exception is for anticipated pilot projects, those projects will not be established without IRB or IACUC approval or an explicit and separate exception on the pilot project.
• Explicit confirmation from the PI that human/animal work will not begin until a protocol is approved. This direct confirmation from the PI must be included in the request.

If sponsor authorization is required in order to grant a protocol exception, DSP will submit the request to the sponsor.

Last updated 7/2/24