The National Institutes of Health (“NIH”) recently issued guidance related to the disclosure of “other support,” “foreign components,” and “financial conflicts of interest” for NIH grantees.  The new guidance, issued on July 10, 2019 by NIH through Notice NOT-OD-19-114 is framed by NIH as “reminders” and “clarifications” of existing policy, however it reflects an increasing focus by NIH on the disclosure of foreign activities when applying for and receiving NIH grants.

Last August, NIH’s Director, Dr. Francis Collins issued a statement to over 10,000 organizations that are recipients of, or applicants for, NIH grant awards and warned that “the robustness of the biomedical research enterprise is under constant threat by risks to the security of intellectual property and the integrity of peer review,” and that “these risks are increasing.”  Specifically, Dr. Collins identified the concerns as: 1) failure by some researchers at NIH-funded institutions to disclose substantial contributions of resources from other organizations, including foreign governments; 2) diversion of intellectual property in grant applications or produced by NIH-sponsored biomedical research to other entities, including other countries; and 3) sharing of confidential information by peer reviewers with others, including foreign entities, or otherwise attempting to influence funding decisions.

Dr. Collins also announced an NIH working group to develop recommendations addressing these concerns.  That working group, consisting of NIH’s Principal Deputy Director, Dr. Lawrence Tabak, and representatives from seven universities, issued its findings in December 2018.  While the working group’s report acknowledged the important role that foreign trainees, investigators, and employees play in NIH-sponsored research, it cautioned that “some foreign entities have mounted systemic programs to influence NIH researchers and peer reviewers and take advantage of the long tradition of trust, fairness, and excellence of NIH-supported activities.”  As an example, it discussed China’s Thousands Talents Program, consisting of 56,000 recruits with the self-stated mission to “gather the global wisdom and create the China great exploit.”

The working group provided a host of recommendations to both NIH and recipient organizations centered around: a) communication and awareness; b) risk mitigation; and c) monitoring, actions, and consequences.  Among its recommendations to NIH included a reevaluation of existing policies and for it to “make explicit what must be reported as other support.”

Other Support

This month, NIH made good on that recommendation and issued further clarification regarding the disclosure of “other support.”  While framed as simply a reminder of existing policy, many in the research field will see it as anything but.

Prior guidance on “other support,” contained in NIH Grants Policy Statement 2.5.1 instructed that “other support includes all financial resources . . . in direct support of an individual’s research endeavors . . . .” (emphasis added).  NIH’s newly issued guidance, on the other hand, appears to expand this description, stating that “other support includes all resources made available to a researcher in support of and/or related to all of their research endeavors, regardless of whether or not they have monetary value . . . .” (emphasis in original).

NIH provides several examples that it says applicants “must” disclose, including:

• All positions and scientific appointments both domestic and foreign held by senior/key personnel that are relevant to an application including affiliations with foreign entities or governments. This includes titled academic, professional, or institutional appointments whether or not renumeration is received, and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).
• All resources or other support for all individuals designated in an application as senior/key personnel including for the program director/principal investigator (PD/PI) and for other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they request salaries or compensation.
• All current project and activities that involve senior/key personnel, even if the support received is only in-kind (e.g. office/laboratory space, equipment, supplies, employees). This includes selection to a foreign “talents” or similar-type program.

NIH also issued a document titled “Frequently Asked Questions: Other Support and Foreign Components” that provides further information regarding these obligations.  In that document, NIH lists a number of items that would constitute other support, including laboratory space, research materials, staff, travel or living expenses, start-up packages, certain domestic research collaborations, and research conducted under a foreign award even if outside of the researcher’s appointment period.

NIH also reminded applicants that they remain responsible for promptly notifying NIH of any substantive changes to previously submitted Just-in-Time information up to the time of the award, including “other support” changes that must be assessed for budgetary or scientific overlap.

Foreign Components

NIH Grants Policy Statement (at I-22) defines a “foreign component” 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.”  Activities meeting this definition include: (1) the involvement of human subjects or animals, (2) extensive foreign travel by recipient project staff for the purpose of data collection, surveying, sampling, and similar activities, or (3) any activity of the recipient that may have an impact on U.S. foreign policy through involvement in the affairs or environment of a foreign country.  Examples provided by NIH in its Grant Policy Statement include “collaborations with investigators at a foreign site anticipated to result in co-authorship; use of facilities or instrumentality at a foreign site; or receipt of financial support or resources from a foreign entity.”  Foreign travel for consultation is not considered a foreign component.

NIH’s recent guidance repeats its existing definition of “foreign component,” and reminds recipients to focus on two questions: 1) Is the performance of a scientific element or segment of the NIH-supported project outside of the United States; and 2) is that activity significant?  If both criteria are met, then there is a foreign component that must be reported as such.

In its guidance, NIH provided examples for activity that would or would not constitute a foreign component.  As an example for activity that would constitute a foreign component, NIH described a situation in which a PD/PI of an NIH-funded grant has a collaborator outside of the United States who performs experiments in support of the project.  As examples for activity that would not constitute a foreign component, NIH listed: a) additional funding from a foreign source for the NIH-supported research of a PD/PI at a U.S. institution; b) research done by a PI at a foreign lab that is unrelated to the PI’s NIH project; and c) a visiting post-doctoral fellow working in the United States with his or her salary paid by a foreign government.

Although not considered foreign components, these activities would nonetheless need to be reported as “other support.”  In addition, NIH stressed throughout its guidance that recipients should “err on the side of disclosure” and consult with their Grants Management Officer when in doubt.

Financial Conflict of Interest (FCOI)

NIH’s guidance does not expand on its FCOI policy, however it reminds the extramural community of the requirements outlined in 42 C.F.R. Part 50, Subpart F, Objectivity of Research, which are designed to promote “objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be biased by any conflicting interest of an Investigator.”  Known as the FCOI Regulation, 42 C.F.R. Part 50, Subpart F details financial interests that must or must not be reported, institutional responsibilities for ensuring compliance, and remedies for noncompliance.  See also NIH Notice Number NOT-OD-18-160 regarding the FCOI regulation.

Conclusion

While framed by NIH as reminders or clarifications, its new guidance arguably expands on the obligations of NIH applicants and grantees to collect information from their researchers and to disclose more information to NIH about potential foreign involvement or influence in NIH-funded research.  Failure to properly disclose may result in NIH “imposing specific award conditions, disallowing costs, withholding future awards including the possibility of suspending or terminating the award.”  It also could result in an institution-wide assessment of the recipient organization or, worse, an investigation by the Department of Justice under the False Claims Act.

Scott S. Sheffler is a partner in the firm’s Federal Grants, Health Care, and Litigation and Government Investigations practice groups.  Scott advises clients on matters of federal grant law, including the Uniform Administrative Requirements, Cost Principles, and Audits Requirements for Federal Awards (Uniform Guidance), the Office of Management and Budget (OMB) Circulars, and program-specific statutory and regulator funding conditions.  He also assists grantees with audit resolution and represents them in administrative appeals before federal agencies such as the HHS Departmental Appeals Board.  Scott can be reached at ssheffler@feldesman.com or (202) 466-8960 if you have any questions.