Division of Sponsored Programs

Prior Approval Requirement for Changes to Domestic Subawards

This guide notice updates the NIH requirements for obtaining prior approval for changes to domestic subawards on all NIH grants and cooperative agreements. (NIH previously had a longstanding policy of not requiring prior approval for the addition of domestic subawards to ongoing projects.)

Effective June 1, 2026, all prime recipients are required to obtain NIH prior approval when adding a new domestic subaward to a project post-award, when the arrangement was not originally a part of the peer-reviewed and approved application.

The new prior approval requirement is intended to ensure that NIH is aware of all subaward activities for each NIH project, so that NIH can monitor the prime recipient and ensure compliance with subaward monitoring and reporting requirements.

Requests must be submitted in the eRA Commons Prior Approval Module using the “Other Request” type.

University of Iowa Applicants

Please send Prior Approval Requests to nih@uiowa.edu. DSP staff will upload the required documents and send the requests to NIH through the eRA Commons.

Foreign Subaward Reminder

Effective May 1, 2025, NIH no longer recognizes foreign subawards. Recipients seeking to initiate a new international collaboration must utilize the new application structure for NIH-funded international collaborations (PF5/UF5).

Full Notice
National Institutes of Health
NOT-OD-26-062
March 25, 2026

Components of a Collaborative International Research Project (PF5) Application

If you are preparing a Collaborative International Research Project (PF5) application, understanding what belongs in each required and optional component can help ensure your submission is complete, responsive, and clearly structured for review.

This site includes a table that provides a detailed overview of the required components, page limits, budget scope, and review considerations for the PF5 mechansim.

More helpful hints and reminders:

Follow the PF5 NOFO instructions carefully.
Workaround instructions have been provided in the NOFO for any foreign organization with pending registrations.
Include an International Project component for each foreign organization.
Each International Project component must have a Letter of Support from the International organization’s authorized organizational representative that addresses requirements in the NOFO.
Include a Dispute Resolution Plan in the Overall component.
Review of the application occurs together as a whole consistent with existing procedures (see NOT-OD-25-104 )
Contact relevant NIH staff if you are interested in learning more about how this funding opportunity may align with your research ideas.

Resources:

Harmonizing the NIH Definition of “Intervention” with the Common Rule

In 2014, the NIH revised its definition of a clinical trial (NOT-OD-15-015) to increase transparency and accountability and enhance the precision of the information NIH collects, tracks, and reports on clinical trials. In the context of the NIH clinical trial definition, the NIH also defined an intervention as:

A manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints.

These efforts preceded the 2018 Common Rule (45 CFR 46, Subpart A [Protection of Human Subjects]), which defined an intervention as:

Both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

NIH adopted an implementation approach that operationalized these definitions in a similar manner. However, to ensure consistency and harmonize implementation of the Common Rule across federal agencies, effective with the publication of this Notice, NIH is adopting the definition of an intervention as defined in 45 CFR 46, Subpart A, above. The NIH will make revisions to its websites and forms, as needed, to reflect this change.

Guidance on determining whether a research study with human subjects is considered by the NIH to be a clinical trial, a basic experimental study involving humans (BESH), or an observational study can be found on the Is My Project a Clinical Trial, Basic Experimental Study Involving Humans (BESH), or an Observational Study Involving humans webpage.

Full Notice
National Institutes of Health
NOT-OD-26-063
March 27, 2026