The National Institutes of Health has implemented a policy that prevents American scientists from allocating their funds to international research collaborators, raising concerns about the implications for studies on critical issues like malaria and pediatric cancer.
On Thursday, the new NIH director, Dr. Jay Bhattacharya, made this announcement. Coincidentally, Deputy Director Dr. Matthew J. Memoli criticized these so-called sub-awards in an email shared with the New York Times.
Dr. Memoli stated, “If you can’t clearly justify why you’re doing something overseas, you can’t do it anywhere else and can’t benefit Americans.”
The impending restrictions will also extend to domestic sub-awards in the future, coinciding with executive orders aimed at reshaping the nation’s scientific priorities amidst declining NIH funding and stalled federal grants at numerous premier universities.
On Monday, President Trump enacted an executive order to restrict experiments that could enhance the risks posed by pathogens and limit support for so-called gain-of-function research in nations like China.
Researchers receiving NIH grants have frequently employed sub-awards to foster international collaboration, a crucial component for studying diseases such as childhood cancer, malaria, and tuberculosis, which is less prevalent in the U.S.
Sub-awards are legal and financial arrangements between grant recipients and their international counterparts. This practice is widespread across the federal government and not exclusive to the NIH.
However, there has been increased scrutiny in recent years due to lax reporting and tracking of funds. Following a critical report from the Government Accountability Office (GAO) in 2023, the NIH introduced more stringent oversight requirements.
Proponents of scientific and medical research argue that as science grows more complex, collaborative efforts that engage participants and researchers globally are becoming increasingly vital.
“Competitiveness in science necessitates a collaborative approach,” stated Dr. E. Anderskolb, CEO of the Leukemia and Lymphoma Association. “No single lab, agency, or investigator possesses all the necessary tools to address the complex questions we’re facing.”
Many of these studies require a significant number of subjects. For instance, scientists can more precisely classify the types of pediatric cancers, leading Dr. Kolb to comment, “we’re entering a niche of diseases that are becoming progressively smaller.”
“Thus, if you’re aiming to conduct clinical trials for new treatments that could aid these children, attempting to only enroll U.S. children might prolong the trial duration by decades,” he added. “Collaborating with international partners allows us to expedite these trials and deliver treatments to our children much sooner.”
In unveiling the new directive, Dr. Bhattacharya referenced a GAO report criticizing the funding awarded to international universities, research institutes, and firms.
Dr. Bhattacharya added that the issues raised by the GAO “could undermine trust and safety for U.S. biomedical research entities.”
Tracking NIH expenditures for these international organizations is challenging. A notable obstacle pointed out by the GAO, as reported by journal Nature, estimated total funding to be about $500 million annually.
Dr. Monica Gandhi, a professor of medicine at the University of California, San Francisco, is utilizing NIH funding for HIV prevention and treatment research in Kenya and South Africa.
Researchers like her are required to furnish detailed information when applying for international sub-awards, she explained.
Currently, international partners must access lab notebooks, data, and other documents at least once annually, as noted by Dr. Gandhi. All expenses must comply with Foreign Awards and Component Tracking Systems.
“It’s extremely stringent, similar to using taxpayer funds,” Dr. Gandhi remarked.
“Each year, when submitting your progress report, you must account for every dollar spent on international locations. You’ll detail where it was allocated, how much laboratory testing costs, and who the principal investigators are—every facet.”
It remains unclear how the new policy will be implemented. The NIH has not responded to requests for further information.
The NIH stated it will not retroactively reverse foreign sub-awards that are already in effect “at this time,” and will continue to grant funding to international organizations.
However, the new policy prohibits the reissuance of new, competitive awards if they include proposals for sub-awards to foreign institutions.
“If the project is unfeasible without foreign sub-awards, the NIH will collaborate with the recipient to negotiate the bilateral termination of the project,” stated the agency.
The new policy seems to be slightly less comprehensive than what Dr. Memoli outlined in his internal email.
“Sub-awards to foreign sites cannot proceed,” he wrote. “This has been mismanaged horrendously in recent years and is utterly irresponsible. We must act immediately. If there is a foreign site involved in our research, we need to either start closing it or devise another method to track it properly.”
GAO reports indicate that several federal departments are seeking improved surveillance following criticism regarding lax reporting. However, the office did not advocate for the complete termination of such funding.
The 2023 GAO Report reviewed $2 million in direct and sub-awards, the majority coming from the NIH, awarded to three Chinese research institutions, including the Wuhan Virology Institute, between 2014 and 2021.
The Virology Institute received a sub-award from the University of California, Irvine and the non-profit EcoHealth Alliance. Collaborating with the Alliance and Chinese scientists led former President Joseph R. Biden Jr. to suspend funding last year. Recently, the Trump administration updated its government portal for COVID-19 information to suggest that a novel virus emerged from a lab in Wuhan.
According to a GAO report, NIH oversight has not consistently ensured that foreign agencies comply with requirements, including biosafety regulations.
Another GAO report indicated that one reason for the difficulty in tracking spending is a federal policy requiring the reporting of sub-awards of $30,000 or more.
The report examined approximately $48 million in NIH and State Department funding provided to Chinese companies and research institutions between 2017 and 2021.
“The full extent of these sub-awards remains unknown,” and the data retrieved were found to be incomplete and inaccurate, with numerous expenditures exempt from reporting.
Apoorva Mandavilli Reports of contributions.
Source: www.nytimes.com
