FAQ - NIH GRANTS MANAGEMENT

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[NOTE: Click on Links for Definitions or Explanations of Terms]

Q1) When do changes in an NIH funded project require PRIOR APPROVAL by NIH?

A1) A list of changes which require Prior Approval is available in the NIH Grants Policy Statement (NIHGPS) (Click Here, then see Exhibit 4 on NIHGPS web page). If NIH approval is required, it must be requested of, and obtained from, NIH in advance of the change or obligation of funds as specified under “Requests for Prior Approval” in NIHGPS. Note that one thing that requires NIH prior approval is a "Change in Scope."

IMPORTANT NIH DEFINITIONS AND EXPLANATIONS:

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 NIH Grants Management Office 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.

[Source: NIH Grants Policy Statement <http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm>]

Co-Investigator: A co-investigator (collaborator) is an individual involved with the principal investigator in the scientific development or execution of the project. These individuals would typically devote a specific percent of effort to the project and would be identified as key personnel. The individual(s) may be employed by, or affiliated with, either the grantee organization or an organization participating in the project under a consortium or contractual agreement. [Source: PHS 398 Instructions <http://grants2.nih.gov/grants/funding/phs398/section_3.html#a_definitions>]

Consultant: An individual hired to give professional advice or services for a fee, normally not as an employee of the hiring party. In unusual situations, a person may be both a consultant and an employee of the same party, receiving compensation for some services as a consultant and for other work as a salaried employee. In order to prevent apparent or actual conflicts of interest, grantees and consultants must establish written guidelines indicating the conditions of payment of consulting fees. Consultants may also include firms that provide paid professional advice or services. [Source: PHS 398 Instructions <http://grants2.nih.gov/grants/funding/phs398/section_3.html#a_definitions>]

Key Personnel: Key Personnel are defined as individuals who contribute to the scientific development or execution of the project in a substantive way, whether or not salaries are requested. (For a more detailed discussion of Key Personnel, contained in the PHS 398 Form instructions, click here to view). [NOTE: All changes in the status of Key Personnel REQUIRE NIH prior approval (such changes include withdrawal from the project; absence for any continuous period of 3 months or more; reduction of time devoted to project by 25 percent or more from level in the approved application)]

Other Support: Other Support includes all financial resources, whether Federal, non-Federal, commercial or institutional, available in direct support of an individual's research endeavors, including but not limited to research grants, cooperative agreements, contracts, and/or institutional awards. Training awards, prizes, or gifts are not included. [Source: PHS 398 Instructions <http://grants2.nih.gov/grants/funding/phs398/section_3.html#a_definitions>]

Principal Investigator, Program Director, or Project Director: The one individual designated by the applicant organization to direct the project or program to be supported by the grant. The principal investigator is responsible and accountable to applicant organization officials for the proper conduct of the project or program. [Source: PHS 398 Instructions <http://grants2.nih.gov/grants/funding/phs398/section_3.html#a_definitions>]

Page Updated: 3/24/2004

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