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Changes in Scope on NIH Grants and Cooperative Agreements
What is a change in scope?
In general, the Principal Investigator (PI) may make changes in the methodology, approach or other aspects of the project objectives. However, the grantee must obtain prior approval from NIH for changes in scope, direction, type of training or other areas that constitute a significant change from the aims, objectives or purposes of the approved project. The grantee must make the initial determination of the significance of a change and should consult with the Grants Management Officer (GMO) as necessary. Please read the Notice of Grant Award to determine if any restrictions or conditions have been placed on the award.
Certain actions in the following list always require NIH prior approval under the circumstances specified. Actions that are likely to be considered a change in scope include, but are not limited to:
- Change in the specific aims approved at the time of award.
- Substitution of one animal model for another.
- Any change from the approved use of animals or human subjects.
- Any addition or change in the involvement of human subjects that would result in changing the human subjects or clinical trial designation of the award.
- Shifting the research emphasis from one disease area to another.
- A clinical hold by Food and Drug Administration (FDA) under a study involving an IND or an IDE.
- Applying a new technology, e.g., changing assays from those approved to a different type of assay.
- Transferring the performance of substantive programmatic work to a third party through a consortium agreement, by contract or any other means. Note: If the third party is a foreign component, this action always requires prior approval.
- Change in key personnel.
- Significant rebudgeting, whether or not the particular expenditure(s) require prior approval. Significant rebudgeting occurs when expenditures in a single direct cost budget category deviate (increase or decrease) from the categorical commitment level established for the budget period by more than 25 percent of the total costs awarded.
- Incurrence of patient care costs if not previously approved by NIH, or if a grantee desires to rebudget additional funds into or rebudget funds out of the patient care category.
- Purchasing a unit of equipment exceeding $25,000.
What should a grantee do if there is a change in scope?
All requests for NIH awarding IC prior approval must be made in writing (including submission by email) to the GMO no later than 30 days before the proposed change, and signed by the AOR. If the request is emailed, it must provide evidence of the AOR’s approval. To request approval to make a change in scope, the grantee should:
Prepare a letter, signed by the institutional business official, that provides the reason and rationale for the change and addresses any budgetary impact to the grant or cooperative agreement. The request must clearly identify the complete grant number.
While the PD/PI signature is no longer required as part of the submission to NIH, the recipient must secure and retain such a signature for each prior approval request and make it available to NIH or other authorized DHHS or Federal officials upon request. When multiple PD/PIs are recognized for a particular grant, this requirement applies to all PD/PIs.
Include in the letter revised budget pages and other supporting documentation as appropriate (e.g. biosketches/other support, revised aims or program plan, or human and animal subjects protection information).
Send the letter to the appropriate grants and program staff at the Institute or Center (IC) that issued the award (such as Fogarty staff for grants issued from Fogarty International Center).
Failure to obtain required prior approval from the appropriate awarding IC may result in the disallowance of costs, termination of the award, or other enforcement action within NIH's authority.
The GMO will review the request and provide a response to the AOR indicating the final disposition of the request, with copies to the PD/PI and to the cognizant NIH PO. Only responses provided by the GMO are considered valid. Recipients that proceed on the basis of actions by unauthorized officials do so at their own risk, and NIH is not bound by such responses.
For more information concerning changes in scope or other prior approval questions, please refer to the Prior Approval Requirements section (8.1.2) of the current NIH Grants Policy Statement.
Updated May 2017