A policy tweak to the ban on foreign “subawards” should allow clinical trials worldwide to continue.
The National Institutes of Health (NIH) has softened a controversial change to its foreign funding policy that had put many clinical trials abroad in limbo. An alternative payment scheme announced this week could allow those studies to continue.
Science has also learned that several days ago the agency, without explanation, lifted a hold on payments for scores of existing grants to South Africa, an important location for research on HIV and other infectious diseases.
President Donald Trump’s policies recently imposed on NIH and other agencies had “largely halted” global health research, and “I am delighted” that some projects can now move forward, says HIV researcher Monica Gandhi of the University of California, San Francisco, who has three NIH grants backing work in South Africa. Ghandi was among researchers who had appealed to the agency’s director, Jayanta “Jay” Bhattacharya, to restore their funding. “This is progress and we are grateful for that after what seemed like a very long 2 months.”
Disruptions to foreign clinical trials, including layoffs by various groups, began in March, when NIH moved to freeze or terminate its nearly 280 grants for projects in South Africa. The action came in the wake of an order from Trump barring U.S. funding to the country because of his administration’s disputed allegations of discrimination and threats against Afrikaners, a white minority group there.
Then on 1 May, NIH announced it will no longer allow foreign “subawards”—money for scientists abroad carved out of a “prime” grant held by a U.S. principal investigator. Instead, the subawards must be converted to awards made directly to the foreign partner, who would have to submit their own grant proposals. The shift, NIH said, would improve tracking of grant money and better protect national security. But the agency warned its new system for such foreign partnership grants may not be ready until 30 September.
NIH in 2024 funded about 3600 subawards in foreign countries, totaling more than $400 million, and the policy change sparked panic among the affected researchers, including the U.S. leads. Researchers involved in NIH-funded clinical trial networks testing treatments for HIV and tuberculosis that were scheduled to receive their annual grant installment on 1 June braced to scale back or shut down trials.
Bhattacharya, a health economist whose research has involved work on foreign countries, has emphasized in public remarks that NIH will continue to support international research. He told Science in a 1 May interview that he had “turned … back on” the HIV research networks in South Africa, although researchers involved say they were still unclear that money would be forthcoming.
Now NIH appears to be following through. 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. 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.
“It’s still a huge administrative lift and unnecessary but will allow foreign projects with human subjects to continue,” said an NIH grants official who asked not to be identified. However, the exception apparently won’t apply to subawards for lab work or animal experiments done abroad.
University of Vermont epidemiologist Thomas Ahern, whose breast cancer research relies on a Danish cancer registry holding human health data and tumor specimens, said he’s optimistic his collaborators can get the special supplement. “I’ve been walking around with toes and fingers crossed. We can’t do this [research] well anywhere outside of Denmark. It is a truly unique resource for the question we’re trying to answer,” he says.
NIH-funded researchers in South Africa are also buoyed by a separate agency reversal. In a 27 June email viewed by Science, NIH official Michelle Bulls informed grants staff 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,” the memo states.
A spokesperson for NIH’s parent agency, the Department of Health and Human Services, did not respond to a request to explain why the policy change happened even though Trump’s directive remains.
South African researchers who have laid off employees in recent months got the good news yesterday in a call with NIH grant officials, says Glenda Gray, an HIV/AIDS researcher at the University of the Witwatersrand and chief scientific officer of South Africa’s Medical Research Council. “We have lost time and opportunity and have had to retrench critical staff,” she says. “We hope we can rapidly restart our research and fulfill our mission to contribute to science to mitigate HIV and TB [tuberculosis].”
It’s unclear, however, whether the policy will restore South Africa awards that were terminated—not just frozen—as part of NIH killing more than 2000 grants touching on politically sensitive topics such as diversity and transgender research. A judge recently ruled that NIH had to reinstate just a portion of those grants held by investigators in certain U.S. states.
By Jocelyn Kaiser
With reporting by Jon Cohen
Source : Science
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