Contact

Boston
Providence

Boston

One Beacon Street
Suite 1320
Boston, MA 02108

T 617.720.5090
F 617.720.5092

Providence

One Richmond Sq.
Suite 165W
Providence, RI 02906
T 401.454.0400
F 401.454.0404

April 30, 2020

Impact of COVID-19 on Reporting Foreign Components

By

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.

About the Author

News

Health Law

Litigation

Corporate

Research Misconduct

Notice

This website presents general information about Barrett & Singal and is not intended as legal advice nor should you consider it as such. You should not act upon this information without seeking professional counsel.

Please note that contacting Barrett & Singal by email, telephone or facsimile will not establish an attorney-client relationship, obligate us to act as your attorney or impose an obligation on either the law firm or the receiving lawyer to keep the transmitted information confidential. Completion of Barrett & Singal’s new client intake protocol, including without limitation the firm’s conflicts checking process and an engagement letter, is necessary to establish an attorney-client relationship. Absent a current attorney-client relationship with Barrett & Singal, any information or documents communicated or transmitted by you to Barrett & Singal will not be treated as confidential, secret or protected in any way. If you are not a current client of Barrett & Singal, please do not send any confidential information to us through this web site or otherwise concerning any potential or actual legal matter you have. Before providing any confidential information to us, you must obtain permission to do so from one of the firm’s lawyers. By clicking "Accept," you acknowledge that we have no obligation to maintain the confidentiality of any information you submit to us unless we already represent you or unless we have agreed to receive limited confidential material/information from you as a prospective client.

If you would like to discuss becoming a client, please contact one of our attorneys to arrange for a meeting or telephone conference. If you wish to disclose confidential information to a lawyer in the firm before an attorney-client relationship is established, the protections that the law firm will provide to such information from a prospective client should be discussed with the firm attorney before such information is submitted. Thank you for your interest in Barrett & Singal.