One of the most frequent compliance questions in post-award administration is whether a planned adjustment to a project's personnel, timeline, or budget can be approved internally by the institution or requires prior written approval from the NIH Grants Management Officer (GMO).

Under 2 CFR 200.308 and NIH Grants Policy Statement (GPS) Section 8.1, the answer depends on two things: the baseline prior-approval triggers in the regulations, and whether the authority has been delegated to the recipient under the NIH Standard Terms of Award (formerly referred to as expanded authorities) without an overriding restriction on the Notice of Award (NoA).

Authority Delegated Under NIH Standard Terms of Award (NIH GPS 8.1.1)

Unless the Notice of Award includes a specific condition removing an authority, NIH Standard Terms of Award generally allow the recipient to take the following actions without prior NIH approval:

  1. Pre-award costs up to 90 calendar days prior to the effective start date of the initial budget period of a new or competing continuation award, incurred at the recipient's own risk and only if the costs are necessary to conduct the project and would be allowable under the potential award (pre-award costs more than 90 days before the start date require prior NIH approval).
  2. One-time no-cost extension (NCE) of the final budget period of up to 12 months submitted electronically via the eRA Commons Status No-Cost Extension feature before the project period expires—provided no term of award prohibits it, no additional federal funds are required, and the project's originally approved scope will not change. (Once a prior-approval request is required—for example, a second NCE or an extension exceeding 12 months—written GMO approval is required.)
  3. Carryover of unobligated balances from one budget period to the next when Section III of the Notice of Award states that automatic carryover is authorized. Always check the NoA: certain mechanisms (such as fellowships, training grants, cooperative agreements, clinical trials, or specifically restricted awards) require prior GMO approval for carryover.
  4. Rebudgeting among allowable direct cost categories as long as the rebudgeting does not represent a change in scope, does not violate a specific NoA restriction, and does not transfer funds out of categories restricted by regulation (such as participant support costs).

Actions That Require Prior Written NIH GMO Approval (NIH GPS 8.1.2 & 2 CFR 200.308)

1. Change in Scope

Any change in the direction, aims, objectives, purposes, or type of research training, identified in the approved project, requires prior NIH approval. Under NIH GPS 8.1.2.5, potential indicators of a change in scope include:

  • Change in the specific aims approved at the time of award;
  • Substitution of one animal model for another, or any shift from the approved involvement of human subjects or vertebrate animals;
  • Shift of the research emphasis from one disease area to another;
  • Application of a new technology (e.g., changing from one assay to a substantially different platform) unlike that approved in the application;
  • Transferring the performance of substantive programmatic work to a third party through a consortium agreement/subaward not already approved; and
  • Significant rebudgeting, which NIH treats as an indicator of a potential change in scope: a single direct cost budget category increasing or decreasing by more than 25% of the total costs awarded for the budget period (for non-modular awards, or based on total direct/total awarded baseline per NIH GPS guidance).

2. Change in Status or Effort of the PD/PI or Other Senior/Key Personnel Named in the NoA

Under 2 CFR 200.308(f) and NIH GPS 8.1.2.6, the recipient must obtain prior written approval from the NIH GMO for:

  • Withdrawal of the PD/PI or other senior/key personnel specifically named in the Notice of Award;
  • Continuous absence / disengagement for 3 months or more from the project by the PD/PI or other individuals named in the NoA; or
  • Reduction of time devoted to the project by 25% or more from the level that was approved at the time of the initial competing year award (or as noted on the NoA) for the PD/PI or other senior/key personnel named in the Notice of Award.

Remember two critical details tested in scenarios:

  • At NIH, this prior-approval requirement applies to the PD/PI and other individuals specifically named in the Notice of Award (not every unnamed technician or postdoctoral researcher listed in the budget justification).
  • The 25% reduction is measured relative to the approved effort level. Dropping from 4.0 calendar months to 3.0 calendar months is a $(4.0 - 3.0) \div 4.0 = 25%$ reduction and requires prior approval.

3. Adding a Foreign Component or Certain Subawards

  • Foreign component: Adding a foreign component (any significant scientific element or segment of a project outside the United States, whether or not grant funds are expended) under a domestic grant always requires prior NIH approval.
  • New domestic subaward/consortium: Under NIH GPS, issuing a subaward to a domestic organization that was not included in the competing application does not require prior approval unless it constitutes a change in scope (such as transferring substantive programmatic work) or is restricted by specific policy/terms on the Notice of Award.

4. Participant Support Costs

Keep incurring participant support costs distinct from transferring funds out of participant support costs:

  • Under NIH GPS Section 7.9.1, participant support costs are generally allowable on NIH research grants only when specified in the Notice of Funding Opportunity (NOFO) or with prior approval as applicable.
  • When participant support costs are approved on a federal award, 2 CFR 200.308(f)(5) requires prior written approval from the federal agency to transfer funds budgeted for participant support costs to other budget categories.

5. Additional No-Cost Extensions or Capital Expenditures

  • A second no-cost extension, any extension exceeding 12 months, or a late extension after the project period has expired requires prior written GMO approval.
  • Capital expenditures for general-purpose equipment or rearrangements/alterations exceeding agency thresholds (such as $25,000 for individual A&R projects under NIH GPS) require prior approval as specified in 2 CFR 200.439 and NIH GPS Section 8.1.2.

How Prior Approval Requests Must Be Submitted

Under NIH GPS 8.1.3, all requests for NIH prior approval must be submitted in writing (typically through the Prior Approval module in eRA Commons or signed institutional correspondence to the Grants Management Officer named on the Notice of Award) no later than 30 days before the proposed change and must be endorsed by the institution's Authorized Organizational Representative (AOR) / Signing Official (SO). An informal email from a Principal Investigator to an NIH Program Official does not satisfy the prior-approval requirement.