Clarifying guidance from NIH about disclosing other support and foreign components.
Over the past year, the FBI and federal lawmakers have raised concerns regarding undue foreign influence on federally funded research. As a result, many federal funding agencies, including the National Institutes of Health (NIH), are revisiting what information they require from investigators to appropriately assess other sources of support. A summary of NIH’s efforts to address foreign influence concerns can be found at their webpage Protecting U.S. Biomedical Intellectual Innovation. As part of this effort, NIH issued Policy Notice NOT-OD-19-114, Reminders of NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components and the accompanying FAQs in July 2019. This clarifying guidance from NIH outlines requirements that differ from what was previously understood to be required of applicants and awardees. A summary of these current NIH requirements follows.
Disclosure of Other Support
NIH policy now requires applicants and awardees to disclose “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 and regardless of whether they are based at the institution the researcher identifies for the current grant.” With this clarification, NIH researchers are now required to disclose other support as follows;
- Positions, Appointments, and Affiliations. Any position or scientific appointment held by investigators that is relevant to the application must be disclosed
- Financial Support. This includes sponsored awards held at Cornell, held at another institution/entity, or held as an individual that support an investigator’s research efforts. This also includes start-up packages from entities other than Cornell, and institutional awards at Cornell or other institutions that are separately budgeted and accounted for. Investigators do not need to disclose Cornell start-up packages, gifts, or endowed chairs, nor do NIH training grants need to be disclosed.
- Non-Financial Resources. This includes non-monetary resources that are uniquely available to key personnel such as office or laboratory space, equipment, supplies, employees, scientific materials, and selection to a foreign “talents” or similar-type program. Non-financial resources that are available to the Cornell community at large, such as core facilities or shared equipment, do not need to be reported. Non-financial resources that are provided by entities other than Cornell are of particular interest to NIH, and investigators should take care to ensure that all necessary disclosures are made.
NIH policy remains consistent regarding location and timing of such disclosures;
- All other support and affiliations must be reported at Just-in-Time (JIT) stage via the Other Support document.
- Applicants are responsible for promptly notifying NIH of any substantive changes to previously submitted JIT information up to the time of award. Please contact your Grant & Contract Officer in the Office of Sponsored Programs for assistance.
- Other support obtained after the initial NIH award period must be disclosed in the annual research performance progress report (RPPR).
It should be noted that NIH has not yet updated the Other Support template to reflect these clarified requirements. Investigators and administrators should modify the current template as needed to ensure compliance with the expanded disclosure requirements, including the reporting of total award amount for any financial support.
NIH requires applicants and recipients to determine whether project activities include a foreign component, defined as the existence of any “significant scientific element or segment of a project” outside of the United States. In other words;
- Performance of work by a researcher or recipient in a foreign location, whether or not NIH grant funds are expended and/or
- Performance of work by a researcher in a foreign location employed or paid for by a foreign organization, whether or not NIH grant funds are expended.
Applicants and recipients should first identify whether a portion of a project will be conducted outside of the U.S. before determining whether such activities are considered significant. Significance should be measured by the investigator within the context of the project as a whole. Examples of a foreign component include collaborations with investigators at a foreign site anticipated to result in co-authorship, the use of facilities or instrumentation at a foreign site, and the receipt of financial support or resources from a foreign entity. Foreign vendors (i.e. relationships that result in a procurement agreement) do not constitute a foreign component.
Foreign components must be disclosed in a proposal as a Foreign Justification attached to the R&R Other Project Information Form. The addition of a foreign component to an awarded project requires NIH’s prior approval.
Additional information regarding federal agencies’ responses to foreign influence can be found on Cornell Research Services webpage Disclosing International Partnerships to Cornell and External Sponsors and in the video recording of the November 2019 OSP Roundtable, Disclosing Foreign Relationships and Activities. Additionally, a letter to Cornell researchers from the Vice President for Research and Innovation, and the Vice Provost for International Affairs regarding foreign influence can be found on Cornell Research Services webpage Guidelines for the Cornell University Faculty on Academic Integrity and Undue Foreign Influence.
For questions regarding NIH other support and foreign component requirements, please contact your assigned Grant & Contract Officer (see https://researchservices.cornell.edu/gco for current assignments).