The NIH 25 rule is a critical National Institutes of Health (NIH) policy that requires researchers to obtain prior approval for significant changes in the effort dedicated to an awarded grant. This rule ensures that the principal investigator (PI) and other key personnel maintain adequate commitment to the scientific objectives of their NIH-funded projects.
Specifically, prior NIH approval is required under two main conditions related to a reduction in effort:
- A reduction of 25 percent or more from the level of effort that was approved at the time of the initial competing year award.
- A change of 25 percent or more from a previously approved reduced effort level.
This rule applies to the PI and any other individual designated as "key personnel" by the NIH in the Notice of Award.
Understanding the Importance of Effort
Investigator effort refers to the time commitment of a project's personnel, typically expressed in person-months (e.g., calendar, academic, or summer months). The NIH funds projects based on a proposed level of effort, believing that a certain amount of time is necessary for successful project execution and stewardship of public funds.
If a PI or key personnel's involvement decreases substantially, it could jeopardize the project's progress or completion. The NIH 25 rule serves as a safeguard to ensure that projects remain adequately staffed and managed.
Key Aspects of the NIH 25 Rule
To provide a clearer overview, here are the essential components of the NIH 25 rule:
| Aspect | Description |
|---|---|
| Purpose | Ensures sufficient investigator effort and commitment on NIH-funded projects to achieve scientific aims and maintain accountability for federal funds. |
| Threshold | A reduction of 25 percent or more in the approved level of effort for the PI or designated key personnel. |
| Baseline | The comparison point for the 25% reduction is either the effort level approved in the initial competing year award or a previously approved reduced effort level. This means the rule applies to changes from the current, most recently approved effort. |
| Requirement | Requires prior written approval from the NIH Grants Management Officer or other authorized NIH official. This is not an after-the-fact notification; approval must be sought before the reduction in effort occurs. |
| Personnel | Applies primarily to the Principal Investigator (PI) and any other individuals specifically identified as "key personnel" in the official Notice of Award. |
| Implications | Failure to obtain prior approval for a significant effort reduction can lead to audit findings, questions about allowability of costs, potential disallowance of costs, or even termination of the award. It is crucial for institutions and investigators to monitor effort levels. |
When Does the Rule Apply?
The NIH 25 rule is triggered when:
- A PI or key personnel takes on new commitments that reduce their time on the current NIH grant by 25% or more. This could include starting a new project, taking a sabbatical, or assuming new administrative duties.
- An unexpected event (e.g., illness, personal leave) significantly reduces an individual's availability for the grant.
- The institution or PI decides to reallocate effort among various projects, leading to a substantial decrease on the NIH-funded grant.
It's important to note that the rule applies to the originally approved effort or the most recently approved effort if a prior reduction was already approved by the NIH. For instance, if a PI was approved for 40% effort and now plans to reduce to 29%, this is an 11% reduction (from 40% to 29%), which does not trigger the rule. However, if they reduce from 40% to 25%, this is a 37.5% reduction (15/40), which would trigger the rule.
How to Request Prior Approval
When an effort reduction of 25% or more is anticipated, the grantee institution (not the individual investigator) must submit a prior approval request to the NIH. This request typically includes:
- A clear justification for the reduction in effort.
- An explanation of how the project's aims will still be met despite the reduced effort.
- Details on who will take over any responsibilities or tasks no longer handled by the individual with reduced effort.
- The revised effort commitment for the individual.
This request is usually made through the eRA Commons system, often via a "Prior Approval" module or by contacting the assigned Grants Management Specialist and Program Officer. For detailed guidance on submitting prior approval requests, grantees should consult official NIH policies and their institutional research administration office. More information on general NIH grants policy can be found on the NIH Grants Policy Statement website.
Conclusion
The NIH 25 rule is a fundamental aspect of managing NIH grant awards, designed to ensure appropriate dedication of personnel to research projects. Adhering to this rule is crucial for maintaining compliance and the successful execution of federally funded research.
