The National Institutes of Health (NIH) is adhering to a new regulation that requires international partners to regularly share laboratory records and other raw data with primary grant recipients in the United States.
Numerous organizations and hundreds of researchers have called on the government to abandon or amend the regulation, concerned that it could hinder international partnerships, especially in developing countries.
While the final policy announced today has a few changes, such as requiring ledgers and other data to be shared annually rather than every few months as originally proposed, it is largely the same as the plan released in May, which sparked intense debate and was expected to go into effect in October.
“We appreciate the explanations, but I'm not sure they solve the problem,” according to Yale University infectious disease expert Albert Ko, who co-authored an editorial criticizing the policy published Sept. 7 in The New England Journal of Medicine.
According to a May update to NIH's grant policy, foreign subrecipients will soon be required to submit “copies of all laboratory notebooks, all data, and all documentation supporting research results described in the progress report” at least every three months (or every six months if there is a later notice from NIH). monthly) to the primary grant recipient. Unless there is an NIH audit, researchers generally share with partners only data necessary for anticipated publications and retain laboratory records and other raw data.
Concerns about a subgrant provided by the agency to China's Wuhan Institute of Virology prompted reports from government watchdogs, which led to the change in policy, according to the NIH.
Without any concrete evidence, some eyewitnesses have claimed that SARS-CoV-2 leaked from the Wuhan laboratory. WIV was barred from receiving NIH funding earlier this year after the organization failed to comply with a request for laboratory notebooks.
But many American academics believe that forcing all foreign grant recipients to share laboratory records is an overreach. The requirement to submit all raw data, including de-identified patient data, records, and handwritten field notes, has been criticized by some who study infectious diseases and public health in regions such as Africa and Brazil as unnecessary, expensive, and damaging to long-standing collaborations .
Ko and five co-authors said in their comments that the regulation “sends the message that NIH does not trust scientists in other countries to meet the highest standards of ethical and responsible research practices.” They asked NIH, along with several others, to limit the policy to certain scientific areas, such as dangerous pathogen trials.
Researchers in Europe, Australia, Israel, Canada and Japan also expressed concern about the policy change, according to Science magazine's analysis of nearly 500 comments submitted to NIH. For example, some scientists have warned that this power could violate European laws protecting personal data and intellectual property.
In today's blog post announcing the final guidance, NIH notes that it is reducing the frequency of data reporting to “no less than once per year”—the same frequency as the progress reports it previously required. Rather than simply requesting “copies” of data, the policy now requires “access to copies” of that data and “access may be entirely electronic.” Additionally, the requirement goes into effect on March 2, which is later than the original start date. Additionally, if U.S. grant recipients need additional time to comply, they may request an extension.
NIH officials state in the FAQ that they “understand” that some foreign subrecipients “may have fewer facilities than others,” but advise that “using widely available online tools will be helpful.”
The FAQ adds that NIH “expects all recipients, including subrecipients, to comply with all applicable state and local laws.” Grant recipients and subrecipients should “consult their general counsel” if they have any questions.
Ko says he is still concerned about the uncertainty of the policy and the pressure it will put on businesses – for example, do “all documents” require all emails to be shared? According to Ko, “this still does not address fundamental issues such as the idea of balance and the volume of work that will be demanded from all partners.”
📩 18/09/2023 12:08