Before getting started, however, the proposed research should be reviewed to ensure that no changes have occurred since submission, and that the work can move forward at the recommended funding level and within the terms and conditions of the award. This effort requires collaboration between the Principal Investigator (PI), Duke University and the sponsor, and can be facilitated by the Grants and Contracts Administrator (GCA).
Duke’s central offices will handle award negotiations and will work with the PI to finalize the award. All award documentation must be signed and approved by Duke’s central offices.
Just in Time (JIT)
When funding is recommended, the sponsor will often request that Duke and the PI provide certain assurances and documentation prior to official award notification. If the sponsor is the National Institutes of Health (NIH), a process called Just In Time, or JIT, is utilized to request additional or updated information. This request can be an automated electronic message or a formal request from the NIH Grants Management Specialist (GMS) assigned to the grant mechanism or Institute/Center. If an automated JIT from NIH is received, this means that the proposed research is under consideration to be funded, but it is not a guarantee of an award. Forward all JIT request e-mails to the GCA, so that preparations may begin in advance of receiving the formal JIT request directly from the GMS. The official JIT will be requested via e-mail and/or phone from the GMS. JIT information should be submitted for all designated key personnel. The turnaround time for a JIT request is usually two weeks, unless another date is requested by the sponsor GMS.
JIT notifications usually request:
- Updated Other Support (OS) for key personnel with Active and Pending support.
- Institutional Review Board (IRB) approval date and concordance for projects including human subject research. The eIRB protocol should be submitted (if new) or revised/checked for approval (if existing). If using an existing protocol, a letter of concordance is needed for submission to sponsor.
- Human Subjects Education Documentation is required for all key personnel on any project involving human subjects. Documentation of completed CITI training modules, which can be found on the Duke Health IRB website, is needed for submission to sponsor.
- Institutional Animal Care & Use Committee (IACUC) approval date and concordance for projects including animal research. The IACUC protocol should be submitted (if new) or revised/checked for approval (if existing). If using existing protocol, a letter of concordance is needed for submission to sponsor.
PIs should work with the GCA to gather the materials requested. When the GCA has received all requested JIT documents, they will submit documents to ORA for review and approval. ORA will then submit the documents to the sponsor on Duke’s behalf.
Award Review and Negotiation
In order to accept an award, it is essential that the PI revisit the original submitted proposal to consider any possible changes since submission, and review it against the funding level and terms and conditions outlined in award document. This provides Duke the opportunity to negotiate any potential changes with the sponsor, and ensures that the research proposed to the sponsor can and will proceed as planned. Once an award is accepted, the sponsor expects the work proposed to be executed with the funds awarded, so careful review is recommended prior to acceptance of award. The PI should review the following for accuracy:
- Scope of work and its feasibility at the funded level
- Sponsor’s terms and conditions of award (review with the GCA)
- Proposed budget (work with the GCA if a rebudget is needed)
- Project Dates (awarded project dates may differ from proposed dates)
- Subaward collaborations (if any) and any related scope of work and/or budget modifications
If changes or modifications are identified, work with the GCA to make the necessary revisions and notify the sponsor. Changes to the scope of work and certain budget modifications require sponsor approval and should be submitted through the GCA. NIH, for example, requires prior approval for budget changes in excess of 25% between single direct cost budget categories because it is considered a change in the scope of work. For guidance, refer to sponsor guidelines and talk to the GCA to determine if prior approval is needed. If the research requires a subaward to an external institution, the PI should notify the subrecipient that the award is forthcoming, review the scope of work and budget, and discuss any relevant changes.
If the funding mechanism is through a contract or agreement then more negotiation is typically required. Duke’s pre-award offices will work with the PI and the sponsor to negotiate the details of the contract or agreement. Remember, all award documentation must route to the appropriate Duke central offices before an award can be accepted. PIs, lab staff and grant managers do not have signing authority to accept an award on behalf of Duke University. When in doubt, contact the GCA for advice on the award negotiation and approval process at Duke.
Contracts and Sponsored Research Agreements
Contracts and Sponsored Research Agreements (SRA) require review and approval by Duke central offices before they can be finalized and processed. Negotiation with the sponsor on the terms and conditions outlined in the contract or agreement may also be necessary. Central offices at Duke University will help navigate this process. When in doubt about the PI’s role in finalizing an award, contact the GCA.
All contracts or agreements, whether Federal, foundation, industry or Sponsored Research Agreements, should be provided to the GCA for processing through Duke’s institutional channels. Duke University signing authorities and the PI will sign and approve an agreement, and the GCA will send the document back to the sponsor. PIs should never sign anything unless requested by ORA or OCRC, including Confidential Disclosure Agreements and other Federal forms. Industry contracts and SRAs must be submitted to the Office of Corporate Research Collaborations (OCRC) for review and negotiation. Duke University accepts faxed and scanned signed documents as original documents; however, some sponsors require original signatures.
Once Duke, the PI and the sponsor are in agreement about the proposed research and the terms and conditions, the award can be accepted. At this time, the PI should confirm that they have an updated conflict of interest disclosure form, current CITI training and have completed the PI Continuing Education module. Once confirmed, the GCA will request that a fund code (WBSE) be established and work on the project may begin. If the research involves a subaward collaboration, the PI should notify the subrecipient institution that the award has been officially accepted. The GCA will then begin the Subcontract Initiation Request (SIR) process to establish a subaward agreement.
In general, spending for a project should not begin until an award is fully approved by Duke University. In some circumstances, pre-award spending may be permitted if the expenses are necessary for the conduct of the project and are allowable under the terms of the grant. Pre-award expenses are incurred at Duke’s own risk until the official award notification is received. Written sponsor approval may be needed for pre-award spending. NIH allows pre-award spending up to 90 days before the start date of the budget year. For other sponsors, confirmation of pre-award spending is required. Check with the GCA to determine if pre-award spending is allowed and if prior approval is needed. If pre-award spending is allowed, a fund code (WBSE) can be set up by the GCA. Divisions are required to provide back-up fund codes with the understanding that preliminary spending is at their own risk until the official Notice of Award (NOA) is received.