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Exterior view of the main historical building of the National Institutes of Health (NIH) in Bethesda, Maryland, U.S.

The US National Institutes of Health is a major funder of biomedical research located in Bethesda, Maryland.Credit: Getty

Despite negative feedback from the research community, the US National Institutes of Health (NIH) will move forward with a policy requiring that foreign scientists receiving ‘subawards’ from the agency must share laboratory notebooks and other raw data with their research partner in the United States. Researchers blasted an earlier version of the policy, released in May, saying it will have a chilling effect on international collaborations.

Subawards are funds that a primary grant recipient can give to a collaborator to help complete a research project. After the NIH released its initial policy, it accepted public comments. Nearly 500 entries came in from individuals and organizations, most of whom expressed concerns over issues including the frequency with which data was to be shared — every few months — and the message the agency would be sending by singling out foreign, but not domestic, subawardees.

Gertrude Kiwanuka, a biochemist at the Mbarara University of Science and Technology in Uganda, wrote to the NIH that asking researchers to provide documentation several times a year is “asking for too much”, because institutions, particularly in low- and middle-income countries, are understaffed. “There should be a certain level of trust in ethical international collaborations,” she wrote.

In the final policy, released on 15 September, the NIH walked back the mandated data-sharing frequency to one year; stipulated that it would be mandating “access to copies of” notebooks and data, rather than originals; and delayed the policy’s implementation from 1 October 2023 to 2 March 2024.

These revisions are a step in the right direction, but they are “cosmetic changes”, says Gerald Keusch, associate director of the National Emerging Infectious Diseases Laboratory at Boston University in Massachusetts. The policy remains overly broad and suggests a lack of trust in foreign researchers, he says. “There are situations where greater scrutiny would be appropriate, but it should not extend to all subaward recipients of NIH,” says Keusch, who co-authored a 7 September comment in the New England Journal of Medicine critiquing the policy1.

In a blog post announcing the final policy, Mike Lauer, deputy director of extramural research at the NIH in Bethesda, Maryland, said that these changes “will ensure NIH remains a proper steward of taxpayer support”.

Responding to criticism

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The policy was developed, in part, as a response to federal auditors’ criticism of the NIH for deficiencies in its oversight of subawards to the Wuhan Institute of Virology (WIV) in China. Some have suggested that the COVID-19 pandemic could have started because of research the WIV was conducting on coronaviruses, one of which might have leaked from the lab. To address these concerns, which have so far not been supported by evidence, the NIH sought and failed to obtain WIV lab notebooks. As a result, in July, the agency barred the WIV from receiving any more funding.

Although the policy revisions give researchers more time to prepare before it’s enacted, they don’t “substantially change the volume of data” that will need to be made available to comply, says Heather Pierce, senior director for science policy at the Association of American Medical Colleges, an organization in Washington DC that represents 169 medical schools. Nor do they add a “risk-based approach that some institutions had hoped for”, she adds. During the comment period, some researchers proposed that increased scrutiny be mandated only for higher-risk projects, such as potential pandemic pathogen research.

David Relman, a microbiologist at Stanford University in California, says that he appreciates the policy’s goal to increase transparency and accountability, but that it should be applied to domestic researchers as well. “I’m sensitive to the appearance that we’re imposing certain requirements on our foreign collaborators that we’re not imposing on our own domestic awardees,” he says. “It would suggest differing degrees of trust.”

The NIH should also be open to adapting the mandate based on “early and regular assessments of whether this policy is achieving its stated goals, and if it has created burdens that haven’t been fully appreciated”, Relman adds.

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