NIH Prior Approval

NIH prior approval is NIH’s mechanism for controlling a defined, enumerated set of higher-risk post-award changes — it requires the recipient institution to get the awarding Institute or Center’s written sign-off before making the change, rather than making the change and reporting it afterward. It sits inside the broader federal Prior Approval concept that the Uniform Guidance (2 CFR 200.407 and 200.308) establishes government-wide, but NIH adds its own agency-specific categories, thresholds, and request procedures on top of that floor, set out in Section 8.1.2 of the NIH Grants Policy Statement (NIH GPS). A request that satisfies the general Uniform Guidance floor does not automatically satisfy NIH’s more specific version, and vice versa — research administrators working an NIH award should treat the NIH GPS list, not the government-wide list alone, as controlling.

The main categories requiring NIH prior approval

• Significant rebudgeting. Moving more than 25 percent of a budget period’s total approved budget into a single direct cost category, or any amount into Alterations & Renovations (A&R) costs beyond NIH’s specific A&R threshold, or any rebudgeting — regardless of amount — that would itself constitute a change in scope. Rebudgeting trainee stipends, tuition, and fees to another category, and transfers between construction and non-construction work, require approval regardless of the percentage involved.
• Change of PD/PI or other named Senior/Key Personnel. Withdrawal of the PD/PI or another individual specifically named in the Notice of Award, a continuous absence of three months or more, a reduction in committed effort of 25 percent or more from the level approved at the time of the initial competing award, or a shift from a single-PI to a multiple-PI model (or the reverse). NIH’s stated practice is to submit these requests at least 30 days before the proposed change.
• Change in scope. Any change to the project’s specific aims, research objectives, or the nature of the research itself, even where no budget change is involved. NIH generally expects the recipient to consult the assigned Program Officer and Grants Management Specialist before submitting a formal request, since “scope” is a substantive judgment call rather than a fixed checklist.
• Carryover of unobligated balances. Most standard research grants carry automatic authority to carry forward an unobligated balance into the next budget period. Cooperative agreements, most research center grants, Kirschstein-NRSA institutional training grants, non-Fast-Track SBIR/STTR Phase I awards, clinical trials, and awards to individuals are routinely excluded from that automatic authority — for those mechanisms, carryover always requires prior approval unless a specific award term waives the requirement.
• No-cost extensions beyond the first year. The first no-cost extension — up to 12 months, self-implemented through the eRA Commons Status screen under expanded authority — does not require prior approval. Any subsequent extension, or an extension requested after the project period end date has already passed, requires a formal Prior Approval request with written justification. See the CASRAI No-cost extension (NCE) entry for the full request window and eligibility detail.
• Foreign component changes. Adding a new foreign component to a project — any significant scientific element performed outside the United States by a foreign investigator or organization, whether or not federal funds directly support it — requires prior approval and disclosure before the work begins. See Foreign component disclosure for what counts as a foreign component and the associated disclosure obligations.
• Change of grantee organization. Transferring a grant from one legal entity to another (for example, when a PI relocates institutions) requires prior approval and NIH’s stated practice is roughly three months’ advance notice.
• Equipment and other specifically flagged costs. Certain categories — for example, equipment purchases above a defined dollar threshold, or incurring research patient care costs not in the approved budget — require prior approval regardless of the percentage-of-budget test that governs general rebudgeting.

How to request it

Prior approval requests are submitted through the eRA Commons Prior Approval module where that request type is supported, or by email to the assigned Grants Management Specialist and Program Officer where it is not, with documentation showing sign-off from the institution’s Authorized Organization Representative or Signing Official — a PD/PI cannot submit a prior approval request directly, the same submission-authority rule that applies to no-cost extension requests. NIH’s stated practice across its Institutes and Centers is to expect a complete request at least 30 days before the proposed change takes effect, and to aim for a response within 30 days of receiving a complete request; a request should include the grant number, PD/PI name, a clear description of the proposed change, and a written justification. Individual Institutes and Centers may publish their own supplementary guidance on top of this baseline, so confirming the specific awarding IC’s current instructions before submitting is good practice.

Why it matters for compliance

Acting on one of these changes without the required prior approval does not automatically make the underlying cost unallowable under the Uniform Guidance’s own terms (2 CFR 200.407 states that the absence of prior approval doesn’t itself make a cost unreasonable or unallocable unless approval was specifically required), but for NIH awards specifically, these categories are enumerated precisely because NIH has determined it wants to evaluate them in advance rather than during monitoring or audit. An unapproved change in one of these categories is a common source of audit findings, and a pattern of unauthorized changes can factor into how NIH assesses an institution’s overall risk profile on future awards. This is also why most institutions route prior-approval requests through the same sponsored-programs or grants-management office that already manages no-cost extensions and other post-award actions — the sign-off chain and underlying regulatory logic are the same.

Related CASRAI resources

See Prior Approval for the general, government-wide Uniform Guidance concept this NIH-specific list sits inside, and NIH Grants Policy Statement (NIH GPS) for the source document’s overall structure. For the underlying regulatory floor, see Uniform Guidance (2 CFR 200). For two of the most common individual prior-approval categories in more depth, see No-cost extension (NCE) and Foreign component disclosure. For orientation to the broader NIH grants lifecycle this fits into, see the NIH Grants: An Overview guide and the Grants Management & Research Funding cluster hub.