NIH Tightens Funding Requirements for Overseas Projects

NIH Tightens Funding Requirements for Overseas Projects

( – Federal agencies must jump through several hoops before establishing and enforcing new rules. They must announce the updated policy, publish it in the Federal Registry, and provide 30 days for comments from interested parties. Such was the case with a recently proposed change by the National Institutes of Health (NIH) to reporting requirements for primary funding awardee institutions and sub-awardees.

On May 19, the NIH published an updated grants policy guidance (GPG) for subaward/consortium written agreements. Federal law requires primary awardees of NIH-funded grants to require sub-recipients to allow auditors and pass-through entities periodic access to their “records and financial statements.” In short, research facilities receiving NIH-funded grants must obtain records from any groups/laboratories they subcontract with to perform research in the form of regular progress reports.

Additionally, the recipients of those grants must enter into signed agreements with those groups/labs to lay out the time stipulations and other terms of those reports. Previously, the government required them to include information contained in 15 bullet points. However, the new GPG added a new item involving overseas projects.

That new rule requires “foreign” sub-recipients to provide their respective grant awardees copies of all “lab notebooks… data, and… documentation” that supported their “research outcomes” described in their mandated progress reports. Additionally, they must submit those “scientific updates” at least once per fiscal quarter. The other requirements remained unchanged.

Then, on June 5, the NIH published the updated GPS on the Federal Registry, opening it up for public comment. Individuals wanting to do so have until July 5 to do so by using a form on the NIH’s website. The proposed effective date for the changes is set for October 1.

On June 8, Ropes & Gray LLP, a global law firm representing government agencies, healthcare organizations, and corporations, posted a brief statement regarding the NIH’s new GPG. It noted that the NIH appeared open to revising the proposed change “to reflect public comment.” Additionally, the notice said the NIH might push the effective date beyond October 1.

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