Recent criminal cases against scientists at the University of Kansas, Harvard University, and Emory University who allegedly did not follow the rules for the disclosure of relationships with foreign entities have prompted an important examination within the scientific community to ensure researchers are abiding by the law. While federal agencies claim that the rules for disclosing such ties are “not new, but rather a long-standing requirement,” many academic groups, including the Counsel on Governmental Relations, argue that agency enforcement and interpretation of those rules have changed dramatically since 2018.
To help scientists make sure their relationships to foreign governments are above board, we outline here the requirements of the National Institutes of Health (NIH) and note where significant differences among agencies exist. NIH requires the disclosure of financial conflicts of interest, foreign components, and “other support.” Alleged failures to disclose other support have come under the most scrutiny to date.
Foreign talent programs
Nondisclosure of an affiliation with a foreign talent program is alleged by the Department of Justice (DOJ) in all three criminal cases brought against university scientists since last summer. The riskiest offer to accept may be membership in China’s Thousand Talents Plan, launched in 2008, with its accompanying salaries, research funding, lab space, and other incentives to purportedly “lure experts into researching for China,” according to a US Senate report. Scrutiny has also expanded to other government-funded, and even non-government funded, talent plans.
When in doubt, disclose. Nondisclosure of foreign ties, especially those with China, increases the risk that US funding may be lost, or that other actions may be taken.
Federal agencies differ in what they permit grant recipients or employees to accept. NIH, the National Science Foundation, and the Department of Defense require disclosure but do not prohibit membership for their grantees. NIH Notice Number: NOT-OD-19-114, issued July 9, 2019, specifies that NIH grant applicants must report “selection to a foreign ‘talents’ or similar-type program.” Importantly, affiliation with a foreign talent program must be disclosed regardless of whether it results in any monetary support.
Since January 31, 2019, the Department of Energy (DOE) expressly prohibits its employees, including contractors and grantees, from participating in foreign talent recruitment programs of certain countries, namely, China, Russia, Iran, and North Korea. The DOE is currently the only agency to prohibit federal grant recipients from being members of a talent program.
Longstanding guidance from NIH states that “other support includes all financial resources . . . in direct support of an individual’s research endeavors . . . .” From our discussions with academics, it appears that some scientists may have understood this to mean that money received in direct support of an individual’s research must be disclosed, while non-monetary support, such as laboratory or office space, equipment, supplies, or employees, may not have to be disclosed. Examples of non-monetary support would include a scientist’s “appointment” or title without compensation at a laboratory overseas. Another example is a non-US entity supporting a US-based scientist as a co-investigator by covering the costs of staff or postdocs in a foreign lab during a summer in support of the US-based scientist’s work.
In July 2019, NIH issued guidance “clarifying” that all resources must be disclosed as other support, even if those resources do not include monetary support or if the research performed with those resources has nothing to do with the NIH funded project at issue. Thus, the provision of access to a laboratory, support staff, and supplies, even without an employment contract or salary, must be disclosed.
Appointments and other activities
Whether or not renumeration is received, and whether “full-time, or voluntary (including adjunct, visiting or honorary),” all positions and scientific appointments must be disclosed. NIH’s form PHS 398/2590 for the disclosure of other support, however, is generic and does not provide specifics regarding categories of required disclosure. Universities have begun to institute additional forms to ensure that all relevant information is captured for key personnel on a grant.
Critically, activities performed outside of a researcher’s appointment period must also be disclosed. In other words, summer and other outside activities must be included in the disclosures. For example, a researcher with a nine-month appointment who spends 10 weeks at a university abroad during the summer supported by a foreign entity must disclose that research support—even if the researcher does not work on the federally funded research project during those 10 weeks abroad.
A foreign component is defined by NIH as any “significant scientific element or segment of a project” outside of the United States. This would include collaborations with investigators at a foreign site anticipated to result in coauthorship, the use of facilities or instrumentation at a foreign site, or the receipt of financial support or resources from a foreign entity.
This may seem fairly straightforward, but collaborations can be fluid and complicated. As an example, an anticipated coauthor may continue to consult on the research project by reviewing slides or images, even after leaving a lab in the US. This may trigger obligations by the remaining US-based scientist to disclose—and seek approval for—a new foreign component. In certain circumstances, working with a postdoc when they are in a foreign country could be considered a “foreign component.” The definition of foreign component may include such situations, “whether or not grant funds are expended” to cover such a postdoc.
When in doubt, disclose. Nondisclosure of foreign ties, especially those with China, increases the risk that US funding may be lost, or that other actions may be taken. As we’ve seen over the past six months, the DOJ has brought criminal charges, dozens of employees have been terminated, and a research institution entered into a False Claims Act settlement. In the current law enforcement atmosphere, seeking help from experts at your university, and from legal counsel, has never been more important.
Nothing in this article is intended to constitute legal advice. Readers should consult with an attorney regarding the specific facts and circumstances that apply to a given situation.
Derek Adams is a former trial attorney with the Department of Justice and a partner in Feldesman Tucker Leifer Fidell LLP’s Litigation and Government Investigations Practice group. He serves as practice lead of the firm’s False Claims Act defense practice, representing universities, health care organizations, and others.
Kristen Schwendinger serves as senior counsel in the firm’s Federal Grants, Health Law, and Litigation & Government Investigations practice groups. She represents universities as well as nonprofit and for-profit organizations facing legal actions under federal health-care and grant regulations in addition to the False Claims Act and Civil Monetary Penalties Laws. Prior to joining the firm, she served for nearly eight years as an attorney and senior counsel in the US Department of Health and Human Services, Office of Inspector General.