Change in Scope

In general, the PI may make changes in the methodology, approach, or other aspects of the project objectives. However, the grantee must obtain prior approval from the NIH awarding office for a change in the direction, type of research or training, or other areas that constitute a significant change from the aims, objectives, or purposes of the approved project (hereafter “change in scope”). The grantee must make the initial determination of the significance of a change and should consult with the GMO as necessary.

Actions likely to be considered a change in scope and, therefore, requiring NIH awarding office prior approval 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.
  • Shift of the research emphasis from one disease area to another.
  • A clinical hold by FDA under a study involving an IND or an IDE.
  • Application of a new technology, e.g., changing assays from those approved to a different type of assay.
  • Transfer of the performance of substantive programmatic work to a third party through a consortium agreement, by contract, or any other means. If the third party is a foreign component, this type of action always requires NIH prior approval.
  • Change in key personnel (see “Change in Status, Including Absence, of Principal Investigator and Other Key Personnel” for requirements for NIH approval of alternate arrangements for or replacement of 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. For example, if the award budget for total costs is $200,000, any rebudgeting that would result in an increase or decrease of more than $50,000 in a budget category is considered “significant rebudgeting.” The base used for determining significant rebudgeting excludes the effects of prior-year carryover balances but includes competing and non-competing supplements.
  • Incurrence of research patient care costs if costs in that category were not previously approved by NIH or if a grantee desires to rebudget additional funds beyond those approved into or rebudget funds out of the research patient care category.
  • Purchase of a unit of equipment exceeding $25,000.