Human trials conducted outside the United States with funding from the US National Institutes of Health (NIH) halted by the Trump administration in May, may be permitted to continue.

On 1 May, the NIH outlawed US researchers from making subawards to foreign research partners, jeopardising billions of dollars of research throughout the world. As a result, some clinical trials on humans were halted midway despite dangers to trial participants and the huge waste of money.

However, the payment freeze to several NIH subawardees in South Africa was recently lifted, according the journal, Science, which reported that “an alternative payment scheme … could allow those studies to continue”.

Over the past two decades, South Africa has become a “preferred site” for HIV and tuberculosis research, both because of its high burden of HIV and TB and the excellence of its scientific community, according to Professor Ntobeko Ntusi, head of the South African Medical Research Council (SAMRC).

It has been disproportionately affected by the NIH’s change in policy towards subawards, which jeopardised at least 27 HIV trials and 20 TB trials, according to an analysis by the Treatment Action Group (TAG) and Médecins Sans Frontières (MSF).

In 2024, the NIH funded about 3,600 foreign subawards worth more than $400 million, according to Science.

The NIH wants to control allocations to foreign research groups, stipulating that they will need to apply directly to NIH for grants, not go via third parties. However, it will only have the new award procedures in place by 30 September, leaving thousands of research projects in limbo.

Explaining its position in an announcement on 1 May, the NIH said that it wants to “maintain strong, productive, and secure foreign collaborations” and  “ensure it can transparently and reliably report on each dollar spent”.

As a result, NIH “is establishing a new award structure that will prohibit foreign subawards from being nested under the parent grant. This new award structure will include a prime with independent awards that are linked to the prime that will allow NIH to track the project’s funds individually,” according to the announcement.

However, it now appears to have made exceptions for clinical trials involving people in the interim. 

“Staff guidance dated 30 June maintains that grant renewal and new applications including a foreign subaward submitted after 1 May will not be reviewed until the new tracking system is in place,” according to Science.

“But the document describes an exception for human subject research in applications submitted earlier, and for ongoing human studies. As a temporary measure, NIH grants staff can convert the subawards within these projects to special ‘supplements’ to the main grant that will go directly to the foreign collaborator, the document says.”

NIH official Michelle Bulls informed grants staff in a memo on 27 June that, although no new awards can be made to South Africa, “existing subawards with clinical research can continue under the new ‘supplement’ plan… and ongoing prime awards to South African researchers, which make up about 100 of the country’s NIH grants, ‘may proceed’,” according to Science.

Prof Ian Sanne, co-principal investigator of the Wits HIV Research Group Clinical Trials Unit, earlier described navigating the US funding cuts as a “major regulatory and ethics nightmare”.

One of the studies Sanne oversaw that was terminated involved a trial of microbicide rings filled with slow-release antiretroviral medication to prevent HIV that were inserted vaginally in trial participants, many of whom were at high risk of HIV infection.

However, restarting the research is not a simple matter as, in the two-month pause in NIH payments, trial participants have dispersed and research staff have been retrenched.  In addition, there is no guarantee that current subawards will qualify for awards under the new system.

NIH targets journal fees

Meanwhile, the NIH announced this week that it was cracking down on “excessive publisher fees for publicly funded research”.

The NIH claimed that “some major publishers charge as much as $13,000 per article for immediate open access, while also collecting substantial subscription fees from government agencies. 

“For example, one publishing group reportedly receives more than $2 million annually in subscription fees from NIH, in addition to tens of millions more through exclusive article processing charges (APCs). These costs ultimately burden taxpayers who have already funded the underlying research.”

In 2026, the NIH will introduce a cap on “allowable publication costs” (APC) to ensure that  publication fees “remain reasonable across the research ecosystem”. 

“This policy marks a critical step in protecting the integrity of the scientific publishing system while ensuring that public investments in research deliver maximum public benefit,” said NIH director Dr Jay Bhattacharya.

Image Credits: TB Alliance.