Ready to Meet All Required Pre-Approvals?
During the course of managing a sponsored program (SP), many circumstances can change. Minor changes are expected and accommodated within most award agreements, allowing a degree of flexibility in carrying out the study or service program. Nonetheless, major changes require a formal request by BMC and often result in a formal amendment to the award.
Therefore, identifying ahead of time what items require prior approvals will save time. Changes in key personnel, subrecipients, period of performance, committed effort, and/or research, as well as excessive budget deviations, are often considered significant changes that require a formal request to the sponsor by BMC.
Changes in domestic subrecipients do not necessarily require changes prior approval if there is no change in the scope of work. However, addition of foreign subrecipients do require prior approval. Changes in committed effort depend upon whether or not the sponsor considers the percent change to be significant. The NIH requires prior approval if effort is intended to be reduced by ≥25%, either from the initial approved level of effort or subsequent upon a previously approved reduction.
Other elements are restricted, meaning that spending against certain budget categories will require sponsor review and approval. Restricted budget categories include foreign travel as well as procurement/repair/replacement of equipment/lab instrumentation of >$5,000 and collaborations with foreign individuals and entities, e.g.. All require a formal request, including justification and revised budget.
The following are examples of major deviations that require prior approval from the NIH, BMC's foremost funder. For more information, please consult section 8 of the NIH Grants Policy Statement.
No Cost Extensions
The NIH Standard Terms of Award provide BMC with the authority to extend the final budget period of a previously approved project period, up to 12 months beyond the original completion date stated in the Notice of Award (NoA). Additional project period extension requires NIH prior approval. The Principal Investigator/Program Director or designated department administrator (DA) must submit a formal request to Sponsored Programs Administration (SPA) using the No-Cost Extension Request Form.
Budget Revisions
Significant re-budgeting occurs when expenditures in a single direct cost budget category deviate from the categorical commitment level established for the approved budget period by 25 percent or more of the total costs awarded. Significant re-budgeting may include increases or decreases and require NIH prior approval.
Carry Forward of Unobligated Balances
Carryforward is a process through which unobligated funds remaining at the end of one budget period may be carried forward to any subsequent budget period. While many NIH award mechanisms allow carryforward without grants management approval, some require a formal request. The following should be included in that request:
- A detailed budget by direct cost category along with the indirect cost (IDC) information (base and rate) for the proposed use of the carryover funds
- If personnel costs are requested, include a detailed breakdown of personnel costs, including base salary, salary requested and effort to be spent on the project during the extension
- In general, carryover action requiring prior approval will be approved using the IDC rate in effect at the time the initial funds were awarded for the year to which the funds are being carried over; however, actual expenditures are still based on the rate applicable when the cost is incurred
- A scientific justification for the use of funds, and
- The reason for the unobligated balance.
Changes in Key Personnel
Staffing plans and actual staffing levels may change during the course of a project. Individuals identified as key personnel are justified and included in the proposal, and factor into the funding decision made by the sponsor. When key personnel change from what was originally proposed and awarded, it’s considered a significant change that requires sponsor prior approval. Changes in key personal may also be reported on RPPRs.
In addition, BMC must now notify the NIH of removal or disciplinary action involving PI/PDs and other senior or key personnel. Notification is initiated by the department, requires an institutional signature, and communications is led by SPA to the NIH.
Change of Recipient Organization
NIH prior approval is required for the transfer of the legal responsibility for a grant-supported activity from one legal entity to another. This applies to subrecipients as well, and can occur when subrecipient PI/PDs change institutions.
Changes to Research Plan
PI/PDs may make changes in the methodology, approach, or other aspects of the project objectives. BMC must obtain NIH prior approval for a change in scope, which is a significant change in the direction, aims, objectives, purposes, or type of research training, as proposed and approved. BMC must make an initial determination of the significance and consult with the NIH as necessary.
Steps in the Process
Step 1: DA reviews the NOA to determine if prior approval is required, and confirms required elements of the request (consults SPA GCA if needed).
Step 2: PI/PD notifies the program officer of the anticipated change.
Step 3: PI/PD and DA prepares required documentation.
Step 4: DA routes documentation and request form to the SPA assigned to their respective department at least three business days prior to deadline, or intend submission date.
Step 5: SPA reviews documentation and request form, routes for signatures, and submits request to the sponsor on behalf of the PI/PD by the intended deadline. SPA will copy the PI/PD and DA on request.
Step 6: SPA uploads documentation and form to InfoEd.