Prior Approval Needed to Modify Aims and Approaches in NCI-Funded Studies


Purpose

It is sometimes necessary for a Principal Investigator (PI) to make modifications to the methodology, approach, or other aspects of study objectives from an initial peer-reviewed application. Although a PI for an NCI-funded study is permitted to make modifications limited in scope from the initial funded application without prior program approval, it is strongly recommended that the PI contact their NCI Program Director (PD) if such a modification is anticipated. However, the Epidemiology and Genomics Research Program (EGRP) now requires that PIs request prior approval from NCI if those modifications result in a change of scope, specific aims, objectives, purpose, or type of research. The PI must make the initial determination of the significance of a change and must consult with the PD or Grants Management Specialist as necessary.

Potential indicators of 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.
  • Change from the approved use of live vertebrate animals or involvement of human subjects.
  • Shift of the research emphasis from one disease area to another.
  • 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.
  • Significant rebudgeting, when expenditures in a single budget category deviate from the commitment level established for the budget period by 25 percent or more of the total costs awarded for that year.
  • Addition of a foreign site.

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Steps to Request Approval

Principal Investigator

  • Submit request to modify research project through institution's Office of Sponsored Research to NCI
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NIH Staff

  • Grants Management Specialist & Program Director will review request for compliance with NIH/NCI funding policies
  • NIH Staff will request additional information as needed & notify PI of decision
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Principal Investigator

  • Proceed with modifications to research project once NIH approval is received

The PI is not permitted to proceed with these changes without prior approval of an NIH Grants Management Specialist and PD. To request a modification of the methodology, approach, and/or specific aims, the PI should submit a request through their Office of Sponsored Research to the NCI Grants Management Specialist and the PD. The request should not be part of the annual non-competing (type-5) progress report; instead, a separate request prior to submission of the annual progress report is preferred. This will allow adequate time for review, and for the PI to address any concerns without causing delays in the next non-competing award. The request should describe the modification(s) in detail, noting any resultant changes to the study objectives or budget.

The Grants Management Specialist will review the request to make sure the proposed modifications are in compliance with NIH and NCI funding policies. The PD will review the request to determine if:

  • The overall study objective will still be met;
  • The budget is appropriate for the proposed modifications;
  • There is sufficient time remaining on the study to complete the original and modified aims.

If the PI anticipates that a foreign site will be added to the study, it is important to inform your PD as soon as possible, as the addition of a foreign component requires that the PD submit a foreign clearance requestExternal Web Site Policy. Clearance must be received before the request can be fully processed by NCI's Office of Grants Administration.

If questions or concerns are raised during the review, the PD will request additional information and may request a teleconference to discuss the request. PIs should direct any questions about this policy to their PD or the Grants Management Specialist noted on their last Notice of Grant Award.

OGA will inform the PI of NCI's decision about the request, and when the foreign clearance request has been approved and processed. At that time the PI may proceed with the modifications.

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Additional Information

Learn more about activities and/or expenditures that require NIH prior approval.External Web Site Policy

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