Navigating changes to NIH foreign subawards

The NIH Notice from May 1, 2025, stated that the NIH will no longer issue awards that include a subaward to a foreign entity. This substantially impacts a large portfolio of global research across the University, with about 170 active grants with JHU as prime with current year expenditures of about $28 million.

Since this initial notice, the NIH released implementation guidance on July 18, 2025. This guidance states that the NIH will allow in-country offices to renegotiate awards, whether new, renewal or non-competing, to remove subawards to foreign entities and, where the work can be performed domestically, allow the funds to be rebudgeted for use by the prime recipient (domestic or foreign) or a domestic (U.S.) subrecipient, or to restructure awards to provide NIH ICO's financial reporting specific to the foreign subaward. If a project is no longer viable without the foreign subaward, NIH will work with the recipient to negotiate a bilateral termination of the project, taking into consideration any need to support patient safety and/or animal welfare.

Where do you go from here?

Consider the below restructuring options, which we have developed in reflection of the updated policy guidance. Then, review a list of resources from the NIH as well as internal and external guidance (below). In this evolving situation, we will attempt to update the site with new information as it becomes available. Further, we have added a chat feature for those impacted to share their individual experiences, relate what their program officer has communicated, and how they are navigating this process (access the chat below the resources section of this article).

As we learn more about what is acceptable from the NIH, the options will evolve. If you have additional suggestions or know of alternative options in specific countries, please leave a comment in the thread below.

Options for Restructuring

Institutes, centers and offices must take action to remove foreign subawards on all ongoing multiyear funded projects at the time of the next RPPR submission. For multiyear funded awards, the subaward must be negotiated out of the project either altogether or a domestic subrecipient identified who can take over the work. When there are human subjects involved, the institute may use the foreign supplement model below, but it must end on the same date as the multiyear funded project (i.e., same period of performance end date as the parent award).

The institute, center or office must initiate negotiations to remove the foreign subaward using the below options:

Submit a type 3 supplement

Institutes, centers and offices may restructure the award and issue the foreign subaward(s) as a separate Type 3 supplement record to the parent/prime award for human subject research only (to include clinical trials and clinical research). This is the most likely the best option for your award. The NIH will allow you to send supplement money to the foreign institution as you would in a subcontract. The foreign partner institution will receive funds from your grant and will be responsible for reporting back to the NIH. Some limitations to consider are that the foreign institution should be capable of providing this information to the NIH, the same way they would be providing it to JHU in your partnership. Additionally, there should be a familiarity with the budget limitations, because there won’t be any automatic funding carryover guaranteed from the original grant.

Terminate the award

For studies that have largely completed their work or are nearing the end of the award, this may be a reasonable option.

Drop the foreign component of your award and move it to the U.S.

In some cases, the work to have been conducted in the foreign country may have largely been completed. Continuation of data analysis or laboratory testing in the US may be appropriate. In some cases, the work may be transitioned to a domestic setting. The expectation would be that the scope of work would be similar. It remains unclear how transition to different study populations will be interpreted by program officials as meeting the expectation that the scope of work remains similar.

Change the prime recipient from a U.S institution to a foreign institution

Technically, this appears to meet the restrictions against foreign subawards and would allow for direct NIH financial monitoring. The foreign institution then could provide a subaward back to JHU. There has been inconsistent guidance on whether new US-based subawards would be allowable. Change of prime recipient of an NIH grant from the US to a foreign institution appears to require approval by the Institute Advisory Council, which has been suggested by some program officials as unlikely to be allowed.

Use a vendor/consultant model

There is skepticism by the NIH and program officers on using vendors and/or consultants to fully replace your subcontract. There may be some opportunity for targeted consultants or direct vendors providing specific needs of the study, like samples or data, but this would likely need to be a very limited role. For example, it seems unlikely that you will be able to change from a co-PI from key personnel to a consultant.

Move the foreign component of your work to be implemented through a JHU-related entity in that country

JHU has a recognized presence in 45 foreign countries which includes an official government-recognized registration and allows conduct of business including having a banking account and tax registration. These elements may take notable amounts of time, and without them already, there would be significant delays to a study. As a first step, please review whether JHU has a presence in your study’s country.
JHU has official registrations in many countries, albeit these vary greatly in terms of capacity. Some may reflect historical registrations with limited current physical presence while others may represent more substantive country activities.

Move the foreign component work to be implemented through another non-JHU, U.S.-based entity

Similar to conducting work in the foreign country through a JHU-based entity, other academic institutions, nonprofits, and research-contracting organizations may have registrations in foreign countries to conduct business. This approach would require a new US-based subcontract with implementation by your US partner. Several universities have these types of foreign sites (e.g., UNC in Malawi, the Fred Hutch in Uganda). If you have an existing partnership as part of this grant, this may be a very viable option. While there have been rumors of some ‘Beltway Bandit’ organizations with international footprints developing this model for broad access as a business line, we have yet to hear of concrete examples of implementation.

We recognize that many of these options will likely have dramatic impact on our foreign collaborators. In many cases, relationships between JHU investigators and foreign partners have developed over decades. PI's have appropriately expressed strong reservations to restructuring decisions that may minimize the important scientific contributions and financial needs of partners. As part of this information-gathering process, we will identify in-country partner organizations heavily impacted. We also hope to leverage this information sharing to identify best practices on how these changes can be implemented while maintaining support and connection for foreign partners. As this restructuring process becomes clearer, several groups around the University are planning to initiate discussions with our foreign partners and we will certainly support these efforts.

Other Resources

NIH guidance related to foreign subawards

JHU information related to foreign subawards

Resources and guidance from other institutions / sources