Publications

Last week, the Department of Health and Human Services’ Office of the Inspector General (OIG) published the report Most Institutions That Received NIH Funding Did Not Fully Understand When They Must Report Monetary Donations (OEI-03-22-00570). The Report examines whether recipients of National Institutes of Health (NIH) awards understand their responsibility to report monetary donations and whether the guidance NIH provides to institutions and their investigators is adequate in communicating such responsibility.

Awardees of NIH funding are required to report on funding applications any other support received by their investigators. To prevent scientific, budgetary, or commitment overlap between an investigator’s other support and an award, NIH requires recipients to report their other support. “Other support” includes any resources provided to an investigator in support of or related to their research.[1] It may also cover non-monetary support (for example high value materials or in-kind contributions) or support assisting the specific research that is not directly associated with the institution applying for the NIH grant.[2]

Monetary donations to institutions or investigators may be categorized as either other support or gifts. Gifts, unlike other support, are not required to be reported to NIH.[3] If monetary support is provided with no conditions, for example, time, services, specific research activities, or money, it would be characterized as a gift. If monetary support is provided with conditions, it will be characterized as other support regardless of the dollar amount of the donation.

The OIG sent an anonymous survey to U.S.-based institutions that received NIH funding in 2022 and were subject to NIH’s other support reporting requirements. Participants were shown twelve scenarios, as vetted by NIH, depicting examples of monetary donations as other support or gifts and participants had to categorize the donation as a gift or other support. Participants were also asked whether they requested additional guidance from NIH, other than the information listed on the NIH website, for determining when a monetary donation must be reported as other support and whether additional guidance from NIH would aid their reporting compliance. Responses from 886 institutions that received funding from NIH in 2023, were analyzed and the Report found that:

• Under one-fifth (170 of 886) of institutions correctly identified all scenarios that described monetary donations required to be reported to NIH as other support.
• A quarter (220 of 886) of institutions either incorrectly identified the scenarios as gifts or indicated that they did not know whether the scenarios described gifts or other support.
• 35% (309 of 886) of institutions correctly identified all gift scenarios.
• 75% (661 of 886) of institutions reported that a better understanding of the distinction between monetary donations that are other support and those that are gifts would aid their compliance with the reporting obligations.
• 6% of institutions reported that they requested or received additional guidance from NIH.

Based on the survey results, the OIG concluded that NIH needs to clarify which monetary donations must be reported as other support in their funding applications in the following four ways:

(1) the information needed to categorize monetary donations as other support or a gift;

(2) the definition of a gift;

(3) that there is no dollar threshold that monetary donations have to meet or exceed to qualify as other support; and

(4) how to report monetary donations that are other support on the appropriate forms. In May 2025, NIH will be revamping the forms to report other support, and NIH will add monetary donations to its instructions regarding NIH disclosure requirements.

If an institution does not comply with Federal statutes, regulations, or terms and conditions of an award, NIH may take the following enforcement actions: disallowing costs, withholding further awards, or fully or partially suspending or terminating the grant.[4][5]  The Federal government may pursue administrative, civil, or criminal action under a variety of statutes relating to making false statement or claims. Even if a grant is not awarded, an applicant may be subject to penalties if an application, including its certifications and assurances, is found to be false, fictitious, or fraudulent.  The Program Fraud Civil Remedies Act of 1986, 31 U.S.C. 3801 et seq., provides for the administrative imposition by HHS of civil penalties and assessments against any person who knowingly makes false, fictitious, or fraudulent claims to the Federal government for money, including money representing grants. The Criminal False Claims Act, 18 U.S.C. 287, and 18 U.S.C. 1001, provides for criminal prosecution of a person who knowingly makes or presents any false, fictitious, or fraudulent statements or representations or claims against the United States. NIH awards, like other federal grants, are also subject to the False Claims Act, 31 U.S.C. 3729 et seq., meaning recipients can face penalties and potential treble damages for knowingly making false claims or submitting false information to obtain funding.

If you have any questions about this advisory, please contact Jolie Apicella at japicella@wiggin.com or Courtney Suggs at csuggs@wiggin.com.

[1] NIH, NIH Grants Policy Statement, Section 2.5.1, April 2024.

[2] NIH, NIH Grants Policy Statement, Section 2.5.1, April 2024.

[3] NIH, Upcoming Changes to the Biographical Sketch and Other Support Format Page for Due Dates on or after May 25, 2021, NOT-OD-21-073, March 2021.

[4] NIH, NIH Grants Policy Statement, Section 8.5.2, December 2022.

[5] 45 CFR 75.371-2.