As an NIH grantee, you have a certain amount of authority to take actions on your grant. This part details when you can act on your own and when you need to get prior NIAID approval.
Grantees Can Take Many Actions Independently
Without NIAID approval, most grantees can rebudget funds.
All grants have expanded authorities that give grantees some flexibility to make changes in their approved project or budget on their own, without asking for prior NIAID approval.
Without prior NIAID approval, foreign grantees can do the following:
- Extend a project period one time for up to 12 months beyond the original expiration date, if additional funds are not required and the original approved scope of the project does not change. There are some exceptions—read the No-Cost Extension SOP for details.
- Transfer work to a domestic third party through a subaward (provided the work does not constitute a change in scope), contract, or other means. See Subawards for Foreign Grants.
- Make cost-related changes, including the rebudgeting of funds, such as supply or personnel costs, unless these changes constitute a change in scope or involve a foreign subcontract. See Importance of Scope of Research below.
- Carryover unobligated balances (for research grants only).
Some Actions Require Our Prior Approval
You need our approval for some changes—know what they are.
While some changes don't require prior NIAID approval, we always need to approve the following actions before you make them:
- A clinical hold by the Food and Drug Administration (FDA) for a study involving an investigational new drug or investigational device exemption.
- Change in scope, including significant rebudgeting. Read What Constitutes a Change in Scope? below for details.
- Preaward costs charged more than 90 days before the projected start date of a new or renewal award.
- Prior approval is not required for you to charge preaward costs before the start of a noncompeting grant (the grant resulting from your progress report). Keep in mind that incurring preaward costs does not obligate NIH to make the award or provide budget increases.
- Change of organization (e.g., transfer from one organization to another). See below.
- Changes in status of key personnel, including the following:
- Full withdrawal of the principal investigator (PI) or any key personnel listed in the Notice of Award from the project.
- Absence of the PI or any key personnel from the project of three continuous months or more.
- Reduction of time that key personnel will work on the project by 25 percent or more from the level in the initial award.
- Change in grantee organizational status (change of institution, successor-in-interest, name, merger).
- Addition, removal, or transfer of a foreign subaward or foreign site.
- Deviation from terms and conditions of award including restrictions reflected in the Notice of Award.
- Spending on alterations and renovations.
- Carryover of unobligated balances. Most R01s and P01s have automatic carryover under expanded authorities. For more information, read the Carryover Requests SOP and Making a Carryover Request in Receiving and Spending Money.
- Request of a second no-cost extension or an extension greater than 12 months. For more information, read the No-Cost Extension SOP.
- Equipment purchase of over $25,000 per unit if it represents a change of scope.
- Need for additional NIH funds. Follow the instructions in the Administrative Supplements to Grants and Cooperative Agreements SOP.
Contact Us Early
Be sure to have your institution's authorized business official submit requests for prior approval from NIAID well in advance, at least 30 days before the proposed change. Some changes in scope may take up to two months. If you have questions, contact the grants management specialist or the program officer listed in the eRA Commons.
Only the grants management officer can approve prior approval requests. We usually notify you about your request through a revised Notice of Award.
See how to email a request for prior approval at Prior Approvals for Post-Award Grant Actions SOP.
Change of Grantee Organization
If the PI changes institutions, the grantee can either relinquish the award to the new institution, including to a foreign institution, or nominate a replacement PI.
NIAID does not pay additional costs, such as salary changes, caused by a transfer.
Transferring a domestic grant to a foreign institution or a foreign grant to a different foreign organization requires the approval of the NIAID advisory Council.
If your organization agrees, the PI may take equipment to a new site. The PI should ask the institution to submit an Official Statement Relinquishing Interests and Rights in a Public Health Service Grant (form PHS 3734). Grants management and program staff review the form and then send it to the NIAID advisory Council for approval.
Change of PI
Grantees must notify NIAID of a change in PI and get prior NIAID approval for a new PI. NIAID sends approval by issuing a revised Notice of Award.
Send your request for NIAID approval through the grants management specialist listed in the eRA Commons. The current PI, proposed new PI, and institutional business official should sign the request. Include the following information:
- Reason for the change
- Date the original PI will return, if applicable
- Biographical sketch of the proposed new PI
- For permanent replacements, include birth date, social security number, and other sources of support.
- For interim PIs, include only other sources of support.
- Certification of human subjects training if the proposed new PI will be working with human subjects
- Budget changes resulting from the change in PI
Contact your grants management specialist and read the Change of Principal Investigator SOP for more information.
Information for Multiple PIs
If your grant has multiple PIs, you have other actions that require prior approval:
- If a PI wants to withdraw from a grant, NIAID will evaluate the request considering how the withdrawal would affect the project, especially its scope of work and leadership plan.
- If a PI changes institution, the grantee may request to establish a subaward with the PI's new institution. Alternatively, the grantee may transfer the award to the new institution; the new grantee would then need to establish a subaward agreement with the former grantee.
- If the contact PI moves to a new institution, the remaining PIs must request a new contact PI, since this role must be filled by someone at the grantee institution. NIAID will not automatically transfer a grant if the contact PI moves.
You may also want to read NIH rules about changing your PI, organization, or project in Section 8 of the NIH Grants Policy Statement.
Importance of Scope of Research
The scope of a research project defines what you are approved to do with grant funds.
Scope of research—the scientific parameters of a funded research project—has important implications for what grantees can and cannot do.
The scope of a funded project reflects the research that 1) the peer reviewers evaluated in initial peer review, 2) our advisory Council recommended for funding, and 3) the award we made to you.
Initial peer review and Council recommendation are the legal basis for an NIH grant. For that reason, we take the scope of your research project seriously. We need to approve any changes that alter your project from the one that underwent these mandatory procedures.
What Constitutes a Change in Scope?
Request approval through your grants management specialist before changing Specific Aims or using a new technology.
NIH considers a change in the scope of the research as any change that significantly alters the peer-reviewed and Council-recommended project.
You need to get prior approval from your grants management specialist before making any of the following changes.
Here are some examples of changes that might change the scope of your research:
- Changing the Specific Aims.
- Changing to a different animal model.
- A clinical hold by FDA for a study involving an investigational new drug or investigational device exemption.
- Any change pertaining to research animals or human subjects in a way other than approved.
- Shifting the research emphasis from one disease area to another.
- Using a new technology.
- Rebudgeting funds in or out of a single budget category by more than 25 percent of the total costs of the award.
- Rebudgeting funds so that an alterations and renovations project exceeds $500,000. Regardless of cost, foreign grants need preapproval before spending on alterations and renovations.
- Making a change in key personnel, including if the principal investigator is on a leave of absence for more than 90 days.
- Purchasing a unit of equipment exceeding $25,000.
- Incurring research patient care costs if costs in that category were not previously approved.
- Transferring the performance of substantive programmatic work to a third party through a subcontract.
- Establishing a foreign component.
For a list of all actions that constitute a change in scope, see Section 8 of the NIH Grants Policy Statement.