Protocols

Awards that include the use of human subjects and/or animal subjects require review and approval of the proposed 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. The Division of Sponsored Programs (DSP) ensures that the specific sponsored project is correlated to the protocol in question on the IRB or IACUC application. This is generally done by matching the funding source on the IRB or IACUC application. After protocol approval is obtained, funding can be released. If at any time during the life of the sponsored project, the protocol has lapsed or expired, the project funds will be stopped until the necessary approvals are obtained.

Select Sponsor Requirements

In addition to these internal compliance measures, sponsors such as the Department of Defense, the Florida Department of Health, and the National Institute of Justice may require their own review and approval of UF’s protocols. If the sponsor imposes additional review requirements, DSP cannot release funding until the appropriate agency has approved the protocol, or has given approval for work unrelated to humans or animals to begin. The terms and conditions of each award should be reviewed to determine if additional review is required.

If sponsor approval is required to begin any portion of the project while the protocol is pending approval, please submit all supporting documentation to DSP for review and submission to the sponsor. Documentation should be submitted through UFIRST and must include a brief summary detailing the portions of the project that can commence while protocol approval is pending.

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 Exception

In cases where your project has a delayed onset of human and/or animal work (including potential for pilot projects that include human and/or animal work), DSP is happy to consider setup of the UFIRST Award with the understanding that certain aspects of the project may be able to proceed before UF’s IRB or UF’s IACUC provides an approved protocol. In order to request an exception, please send the following to the DSP Owner assigned to the UFIRST Award record:

• Estimated date of protocol approval or initiation of work. Please reference the location in the scope of work if it is clearly articulated in the aims.
  • 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.
• Justification for the release of funding (I.E. the aspects of the project that can occur if funding is released)
• Explicit confirmation directly from the PI that confirms only non-human or non-animal related work will occur prior to protocol approval must be included.