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April 30, 2020

Impact of COVID-19 on Reporting Foreign Components

In addressing the ever-growing list of obstacles posed by the COVID-19 pandemic, academic research centers with grants from the National Institutes of Health (NIH) must not lose sight of their continuing obligation to accurately report sources of foreign support provided to US-funded research, including whether any research conducted in the United States has a “foreign component.” With more and more research now being conducted remotely or at a social distance, NIH grant recipients must be proactive in identifying those activities that effectively transition work outside the United States and timely report any added foreign components to NIH for approval.

The need to track foreign influence on US-based research is not new. Heightened scrutiny over foreign influence and potential espionage first emerged in 2018, prompting the NIH to underscore the need for federally-funded research institutions to protect the integrity of biomedical research funded by the United States amidst a growing number of international, scientific collaborations. What followed was a series of guidance and Congressional hearings aimed at clarifying the expectations of NIH, the agency responsible for distributing over $25 billion in federal grant awards each year, that institutions report all sources of foreign and/or domestic research support – whether in-kind, monetary or by selection to a foreign “talents” program – as well as financial interests and affiliations of all senior or key personnel who contribute to the scientific development of a NIH-funded project (no longer limited to program directors or principal investigators).

As part of the general reporting structure, NIH requires recipients to determine if US-based research projects include “foreign components.” A foreign component is traditionally defined as the “performance of any significant scientific element or segment of a project outside of the United States, either by the recipient or by a researcher employed by a foreign organization, whether or not grant funds are expended.” NIH Grant Policy, Section 1.2. This often includes collaborations with investigators at a foreign site expected to result in co-authorship, use of foreign facilities or instrumentation and/or receipt of financial support or resources from a foreign entity. Id. If research will include a foreign component, it must be reported to the NIH for prior approval.

With social distancing becoming the norm, largely bringing international travel to a stand-still, research institutions face new questions about how to classify remote research activities taking place outside the U.S. While foreign travel on its own does not typically constitute a foreign component, NIH has recently opined that relocation of research outside the United States – including research performed only remotely – may be enough for a foreign component. A new FAQ provides some guidance on where to draw the line for identifying foreign components given the practical realities of today’s research environment. Section V.1. clarifies NIH’s view that a post-doc (or, we assume, any investigator) on an active NIH grant that must return home to a foreign country to work remotely is a foreign component that must be reported to NIH. This view is not backed by statutory or regulatory authority and is open to potential disagreement. Moreover, categorizing exclusively remote work on a federal grant is a departure from prior NIH guidance opining that, as a general matter, research conducted within the United States will not be deemed to have a foreign component, even if a visiting post-doc contributing to the grant is paid by a foreign government. See NIH Grants & Funding, FAQ, B.4 & 6 As the law continues to evolve, NIH’s interpretation of remote work remains the only guidance on the books.

As always, research institutions should be mindful of the standard reporting procedures dictated by NIH as well as NIH’s preliminary views on how those standards are met in today’s current virtual environment. As all industries explore new, and in some cases permanent, avenues for a remote workforce, the current views expressed by NIH will be tested and the NIH will have to confront the practical realities facing foreign researchers who hold NIH grants. Right now, NIH’s Grant Policy 8.1.2, requiring institutions adding a foreign component to an ongoing NIH grant obtain prior approval of NIH, remains mandatory for all grantee institutions. While some institutions and researchers may not have advance notice of a need to return home to a foreign country due to COVID-19 concerns – making it difficult to seek prior approval of the relocation of certain research – institutions should make every effort to contact NIH and notify it of the hardship and seek appropriate relief, where necessary.


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