In general, the Principal Director (PD)/Principal Investigator (PI) may make changes in the methodology, approach, or other aspects of the project objectives. However, a change in scope and/or expenditures almost always requires sponsor approval unless special permission is given within the award agreement. A change in scope is a change in the direction, aims, objectives, purposes, or type of research training, identified in the approved project. Please keep in mind, requests must be sent to agency from AOR no later than 30 days before proposed change. Please allow time for SPA to process.
Summary of Actions Requiring NIH Prior Approval
Actions likely to be considered a change in scope or objectives include, but are not limited to, the following:
- Change in the specific aims of the project and approved at the time of award.
- Substitution of one animal model for another.
- Any change from the approved use of animals or human subjects.
- Shifting the emphasis of the research from one disease area to another.
- Applying a new technology, or changing assays from those approved to use of a different type of assay.
- Transferring the performance of substantive programmatic work to a third party by contract or any other means.
- Change in key personnel whose expertise is critical to the approved project.
- Significant re-budgeting whether or not it requires approval under rules governing budget changes. Significant re-budgeting occurs when the cumulative amount of transfers among direct cost categories for the current budget period exceeds either 25 percent of the total amount awarded or $250,000, whichever is less.
- Incurrence of patient care costs not previously approved and/or when a grantee desires to re-budget funds out of the patient care category.
- Additional no-cost extension greater than 12 months
All requests for prior approval must be in writing, well-justified, and accompanied by supporting documentation to ensure that changes are reasonable and appropriate. The written requests have to be submitted to Pre-award to be reviewed, processed, and submitted.
To obtain sponsor approval, the PI must draft a justification letter on University letterhead. The letter must be signed by the department head and forwarded to the assigned Pre-award Sponsored Projects Administrator. Also include a signature block for a University authorized signing official.
Prior approval requests should include:
- Justification letter on University letterhead
- PI information
- Complete grant number
- Grants Management Officer listed in eRA commons
- Applicable approvals