Disclosure Requirements Remain Focus of NIH

Federal funding agencies continue to emphasize the importance of researchers—and research institutions—disclosing all foreign funding and ties in federal grant applications. On May 17, the Cleveland Clinic Foundation (CCF), the nonprofit that operates the Cleveland Clinic, became the most recent research institution to experience the impact of government enforcement in this area, when it agreed to pay $7.6 million to settle charges it violated the False Claims Act for failing to disclose foreign sources of funding on federal grant applications.

The settlement resolves allegations that, between November 1, 2013, and May 31, 2020, CCF made false statements to the NIH in three grant applications and subsequent updates. The three grants were associated with the work of Qing Wang, a researcher who was terminated in 2020 following federal charges that he had misrepresented the sources of some of his grant funding. According to the settlement, CCF’s failure to disclose Wang’s foreign funding, compounded by its improper use of NIH’s eRA Commons system, led to multiple false grant submissions. Of the $7.6 million settlement, $3.8 million is restitution. As part of the settlement, CCF will also be subject to NIH-imposed Specific Award Conditions on all of its grants for a one-year period.

Although CCF did not admit liability, the settlement highlights the critical need for compliance with NIH requirements regarding foreign funding disclosures and serves as a cautionary tale for research institutions nationwide. In announcing the settlement, HHS Office of the Inspector General (OIG) Agent Mario Pinto stated: “The accuracy of information reported in applications and other documentation related to federal grants is critical to ensuring that these limited funds are utilized in the most efficient and effective manner and that the integrity of the application process is upheld.”

The NIH maintains strict foreign funding disclosure requirements—mandating the disclosure of all sources of research support, foreign components, and financial conflicts of interest for senior/key personnel on research applications and awards. NIH uses this information when making its funding decisions to determine if the research being proposed is receiving other sources of funding that could be duplicative, has the necessary time allocation, or if financial interests may affect objectivity in the conduct of the research. Other funding agencies, such as the NSF, employ similar requirements.

To ensure your organization is apprised of where (and how) it must reveal foreign support when applying for NIH grants, we list key reporting requirements below.  Policies are changing every year, and the NIH recently created a “Foreign Interference” page on its website, which includes a detailed chart for the disclosure of pre-award and post-award requirements.

• Other Support: “Other Support” includes all resources, regardless of whether they have monetary value or are based at the institution the researcher identifies for the current grant, available in support of or related to an investigator’s research endeavors. Investigators and Senior/Key personnel must disclose all foreign and domestic sources of support, including grants, contracts, and in-kind contributions (e.g., office/laboratory space, equipment, supplies, employees). These disclosures are required during the application process, in annual progress reports, and whenever there are changes of support.
• Current and Pending Support: Investigators must provide detailed accounts of all active and pending support, including any foreign involvement (e.g., support) that could impact the NIH-funded project.
• Foreign Components: A “foreign component”, i.e., any significant scientific element or segment of a project conducted outside of the U.S., must be identified and disclosed. This includes collaborations with foreign researchers and activities such as data collection, data analysis, and use of facilities or resources outside the U.S. NIH approval must be obtained before incorporation into an NIH-funded project.
• Just-in-Time Updates: Before an award is made, the NIH may request updated information on Other Support, including details on foreign support, to ensure there are no conflicts or overlapping commitments.
• Research Performance Progress Reports (RPPR): Investigators must update their Other Support information in the RPPR, detailing any changes or new foreign support received since the last report.
• Data Sharing and Intellectual Property: Investigators must disclose any agreements related to data sharing and intellectual property rights with any foreign entities, such as material transfer agreements and collaborations that could affect the data generated by NIH-funded research.

Relating to the Specific Award Conditions imposed on CCF, the settlement requires that a high-level CCF employee personally attest to the truth, completeness, and accuracy of all “other grant support” information that CCF provides to NIH. CCF must also develop a corrective action plan that includes an assessment of internal controls related to other grant support and foreign-component reporting; create a mandatory training program addressing requirements for disclosing other grant support, research security, and cyber security; and develop an improvement plan for its internal controls, ensuring that CCF maintains oversight at the institutional level to confirm that information its investigators are disclosing remains true, complete, and accurate.  The Specific Award Conditions will remain in effect through Sept. 30, 2025.

The CCF settlement serves as a crucial reminder that all research institutions must check their protocols and procedures for reviewing grant applications prior to submission and throughout the grant lifecycle, as malign foreign influence in research remains a primary enforcement priority.

If you have any questions regarding False Claims Act investigations or litigation, please contact Enforcement Insider Editors Rosie Dawn Griffin (rgriffin@feldesman.com) and Mindy B. Pava (mpava@feldesman.com) or call 202.466.8960. Be sure to also check out our Enforcement Insider blog to stay up to date on the latest enforcement actions and court decisions of interest to federal grantees and other recipients of federal funding.