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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 the National Institutes of Health (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.

However, as noted, 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, the following:

• 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.
• 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?

To request approval to make a change in scope, the grantee should:

1. 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.

2. The letter should also include revised budget pages and curriculum vitae (CVs) as appropriate. Please send the letter via post, email, or fax, to the appropriate Grants and Program staff at the Institute or Center that issued the award (such as FIC staff for grants issued from Fogarty International Center).

For more information concerning changes in scope or other prior approval questions, please refer to the NIH Policy Statement.