The National Institutes of Health will no longer allow American scientists to direct their funds to overseas research partners, raising questions about the future of research on subjects, including malaria and pediatric cancer.
NIH's new director, Dr. Jay Bhattacharya, announced his policy Thursday. On the same day, Deputy Director, Dr. Matthew J. Memoli, condemned these so-called sub-awards in an email obtained by the New York Times.
“If you can't clearly justify why you're doing something overseas, you can't do it anywhere else and can't benefit Americans,” writes Dr. Memoli.
The new restrictions that will also apply to domestic sub-awards in the future will come even within the executive orders that seek to restructure the country's scientific agenda amid the depths of NIH funding and the freezing of federal grants at many top universities.
On Monday, President Trump signed an executive order that restricts experiments that could make pathogens more dangerous to humans and limits ending support for so-called gain-of-function research in countries like China.
Researchers funded by NIH Grants have historically used sub-awards to promote international cooperation. This is essential for studying diseases such as childhood cancer and diseases such as malaria and tuberculosis, and is not common in the United States.
A sub-award is a legal and financial agreement made between the grant recipient and its overseas partners. This practice is used throughout the federal government and is not unique to the NIH
However, they have been firing in recent years due to loose reports and tracing funds. After a critical report by the government's Accountability Office in 2023, the NIH introduced stricter surveillance requirements.
Advocates of scientific and medical research said that as science becomes more complicated, joint initiatives that attract participants and scientists from around the world are becoming more important.
“Competition science requires a team approach,” says Dr. E. Anderskolb, CEO of the Leukemia and Lymphoma Association. “We don't have a lab, an agency or investigator who has all the tools we need to solve the very complicated questions we are asking.”
Many of these studies require a large number of subjects. For example, scientists can more accurately define the type of pediatric cancer, so Dr. Kolb said, “entering a subset of diseases that are becoming increasingly smaller and smaller.”
“Therefore, if you want to conduct clinical trials for new treatments that could benefit those children, if you only enroll in US children, it could take decades to complete the trial,” he added. “When we work with international partners, we can complete these trials more quickly and get treatment for our children as soon as possible.”
In the announcement of the new directive, Dr. Bhatacharya cited the government's accountability department's report critical of the funding granted to international universities, research institutes and businesses.
The issues highlighted by GAO “can lead to a breakdown of trust and security for US biomedical research companies,” added Dr. Bhattacharya.
NIH expenditures for these international groups are difficult to track. This was one of the obstacles pointed out in Journal Nature, the first reported Journal Nature, which estimated the total to approximately $500 million a year.
Dr. Monica Gandhi, a professor of medicine at the University of California, San Francisco, has NIH funding to study HIV prevention and treatment in Kenya and South Africa.
Researchers like her must provide detailed information when international sub-awards apply for grants, she said.
Currently, international partners need to access lab notebooks, data and other documents at least once a year, Dr Gandhi noted. All expenditures are tracked by foreign awards and components tracking systems, or systems called facts, she said.
“It's very strict, like when you're using taxpayer dollars,” Dr. Gandhi said.
“Every year, when you enter your progress report, you'll explain every penny spent on foreign sites. You'll explain where it went, how much lab tests it was, what payment investigators are, all aspects.”
It was not immediately clear how the new policy would be implemented. The NIH did not respond to requests for additional information.
The NIH will not retroactively halt foreign Saba West, which has already been introduced “at this time,” and will continue to award the award directly to international groups, the agency's statement said.
However, the new policy prohibits reissuing new and non-competitive awards if they propose sub-yards to foreign institutions.
“If the project is no longer feasible without foreign Saba West, the NIH will work with the recipient to negotiate the bilateral termination of the project,” the statement said.
The new policy appeared to be slightly lower than the total that Dr. Memory presented in the internal email.
“Sub-awards to foreign sites cannot continue,” he wrote. “This has been horribly mismanaged over the years and was completely irresponsible. We have to take action immediately. If there is a foreign site in our research, we need to either start closing it or find another way to properly track it.”
GAO reports that various federal departments were seeking better surveillance as they were criticised for LAX reports. However, the office did not recommend terminating such funds entirely.
In 2023, the GAO report reviewed $2 million in direct awards and sub-awards from the NIH between 2014 and 2021, awarded to three Chinese research institutions, including the Wuhan Wirology Institute.
The Virology Institute received a savaward from the University of California, Irvine and the nonprofit EcoHealth Alliance. Working with the Alliance and Chinese scientists has led former President Joseph R. Biden Jr. to suspend funds last year. The Trump administration recently changed its government portal for Covid Information on a website suggesting that a new virus has emerged in Wuhan's lab.
According to a GAO report, NIH surveillance did not always ensure that foreign agencies were complying with conditions, including biosafety requirements.
According to another GAO report, one reason why spending is difficult to track is due to the federal policy that requires you to report savawords of $30,000 or more.
The report investigated approximately $48 million with NIH and State Department funding delivered to Chinese companies and research institutions between 2017 and 2021.
“The full scope of these savawards is unknown,” and the data were found to be incomplete and inaccurate, as many expenditures were exempt from reporting.
Apoorva Mandavilli Reports of contributions.
