Many U.S. biomedical researchers and their collaborators abroad are reacting with alarm to a new National Institutes of Health requirement that foreign groups send their NIH partners copies of their lab notebooks and other raw data at least every few months. It’s “crazy,” says Brazilian researcher Mauro Teixeira, who gets NIH funding through a U.S. university for a mosquito-borne disease study.
The 19 May policy change, sparked by concerns about U.S.-funded virology research in China, could impose a costly new paperwork burden on all NIH grants with foreign partners, from lab studies to clinical trials, scientists and a biomedical research advocacy group say. Currently, collaborators only share results used in publications and keep underlying data such as lab notebooks within their institutions.
“It could be a voluminous amount of data and information that’s being transferred” for reasons that “are very unclear,” says Heather Pierce, an attorney for the Association of American Medical Colleges, which plans to raise concerns about the policy.
Several global health researchers in the United States worry the mandate will damage long-standing relationships across the globe. The policy “further reinforces the mounting perception that the USA regards foreign scientists as problems and not as key collaborators in improving global health,” says immunologist John Moore of Weill Cornell Medicine.
Indeed, Teixeira, who is at the Federal University of Minas Gerais, is offended as well as annoyed by the coming data reporting burden. “I’m going to need many more people just to send things, and the U.S. government will need more people just to look at it in a professional way,” he says. The policy makes him wonder why he’s even participating in the NIH-funded study, which examines whether releasing mosquitoes infected with bacteria that reduce virus transmission will slash rates of dengue and other diseases in Belo Horizonte, Brazil. “You’re not trusting me to do the work. So why should you hire me anyway?”
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A spokesperson for NIH, which estimates fewer than 2% of the agency’s primary awards will be affected, explains that the rule “empowers” its grantees to obtain their foreign partners’ data “without having to worry that they will not be able to access materials when needed.” The new requirement, which takes effect on 1 October, should not be a burden for “well-run collaborations,” the spokesperson says, because they will “already have in place processes by which there is seamless information flow.”
NIH says the policy change resulted from a recent audit by the Department of Health and Human Services (HHS) that found problems with NIH’s oversight of an award to the nonprofit EcoHealth Alliance. A subaward from EcoHealth to the Wuhan Institute of Virology (WIV) funded bat virus studies that some scientists and politicians have claimed, without direct evidence, sparked the COVID-19 pandemic.
Under orders from then-President Donald Trump, NIH terminated the grant in April 2020. It reinstated the award 3 months later but suspended the funding until EcoHealth met conditions, such as getting lab records from WIV, that the nonprofit said were impossible. Since then the award has been restarted with no China activities and new oversight restrictions.
In a January report, HHS’s inspector general chided EcoHealth and NIH for failing to adequately monitor the WIV subaward and found that the China group did not turn over needed “scientific documentation” for the bat virus studies. To avoid similar standoffs, the watchdog advised NIH to step up reporting requirements for all grant subrecipients abroad.
NIH agreed and will now require the foreign grant partners to “provide copies of all lab notebooks, all data, and all documentation that supports the research outcomes as described in the progress report” no less often than every 3 months. The agency already requires that subaward recipients retain records related to the project and be ready to turn them over for audit purposes. But that is different from submitting all data to the main grant holder on a regular basis, Pierce says.
Yale University’s Amy Bei runs a malaria vaccine development project with colleagues in Senegal that collects lab and survey data and malaria test results from participants. “The burden of regularly transmitting all records at regular intervals will be incredibly taxing for our partners,” she says. And it’s unclear what the main U.S. grantee is supposed to do with the information, scientists say.
Yale’s Albert Ko, who collaborates with Teixeira on the mosquito release study, adds that for another project he’ll have to demand raw data from trainee scientists in 21 countries. He wonders whether NIH will even review the data and instead is “generating an enormous amount of work for its awardees which will be rarely acted upon.”
Pierce says the new mandate might make sense with “higher risk” projects in certain countries, but not as a blanket policy. NIH is taking comments on the policy change until 26 June and says the agency may update it “if determined necessary.”