This Guidance was updated on September 9, 2021.
Memorandum: Update on NIH Foreign Influence Disclosure Obligations (2/24/21) from Vice President for Research Christopher J. Cramer and Associate Vice President for Research Pamela Webb, to Council of Research Associate Deans, Senate Research Committee, Department/Central Grant Administrators, and all PIs of active NIH awards and proposals submitted within the last 12 months.
Memorandum: New NIH Guidance on Foreign and Domestic Activities (9/13/19) from Vice President for Research Christopher J. Cramer and Associate Vice President for Research Pamela Webb to NIH investigators regarding the need to report foreign and domestic activities related to their research. See our summary of NIH Guide Notice NOT-OD-19-114 requirements below.
Background & Importance
Federal funding agencies seek to understand the degree to which the PI or other senior key personnel have support and/or resources from other sources for their research activities. The primary drivers cited by agencies for seeking this information are to ensure proper commitment of time (avoiding both under-commitment and over-commitment) by the senior personnel working on the project and avoiding duplication of funding for research requests. More recently, heightened scrutiny of foreign influence by federal officials has led federal agencies to request additional information from researchers. These requirements continue to evolve, and this page will be updated to reflect the latest information.
National Institutes of Health (NIH) Foreign Influence Guidance
Other Support & Biosketch
Definition of “Other Support” (NIH Grants Policy Statement, 10/1/2019):
[…]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 and regardless of whether they are based at the institution the researcher identifies for the current grant.”
Data that is requested for each reportable activity includes:
- Project number (if available)
- Principal Investigator (contact PI if multi-PI study)
- Source of support (fund source)
- Project or subproject title
- Dates of approved/proposed project
- Person months devoted by reporting investigator (see NIH guidance)
- Award amount (see below)
For each reportable activity, include the total award amount (including Facilities and Administrative Costs) for the entire award period covered as well as the number of person-months per year to be devoted (e.g., 1.5 months). If some information is not available or easy to discern (particularly likely for in-kind contributions) current guidance is that the investigator should estimate value to the best of their ability. Further guidance from NIH is expected.
Who Must Report
- Principal Investigator
- All other senior/key personnel listed in a grant application except Other Significant Contributors and Program Directors, training faculty, and other individuals involved in the oversight of training grants
- Any 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
When to Report
- Just-in-Time (upon request by NIH after proposal submission but prior to award)
- After Just-in-Time but prior to receipt of award (reporting required only if changes are substantive* in nature; consult SPA if you are uncertain)
- Via Prior Approval Request for substantive* changes that occur during the award period but prior to the due date of the next RPPR
- Research Performance Progress Reports (annual progress reports) – report changes only
- Upon request by NIH
*While NIH does not define “substantive,” the concept is that the change is of a magnitude that NIH might prudently need to review the new arrangements to ascertain whether the existence, timing or the amount of NIH’s award might need to change in light of the new information (e.g. substantive new support that alters the reporting investigators availability or where a prudent person might question whether there is scientific or financial overlap)
Forms for Reporting
Forms currently being updated by NIH:
These forms do not currently contain all required elements – follow NIH’s updated guidance rather than the forms themselves for what to report.
- NIH Current application form (not fully compliant version) (download)
- NIH Current progress report form (not fully compliant version) (download)
What to Report
The following items must be included in “Other Support:”
- Other proposals under consideration, ongoing externally funded projects (whether or not UMN is the recipient of those sponsored projects), and internal proposals or awards to conduct a specific research project (e.g. internal grant competitions)
- Start-up packages, research-related support, or laboratory support from entities other than the University of Minnesota, regardless of where the research will be located. This includes travel support, living expenses, or access to lab facilities or personnel.
- High-value materials or equipment that are provided from a third party for use in the investigator’s research endeavors (e.g., provided via a material transfer, data use agreement or loan, such as biologics, chemical, model systems, technology, etc.)
- NIH has not formalized guidance for when or if to report outside consulting, but at this stage, we believe that if a consulting activity meets the overarching requirement of “related to and/or in support of” the faculty member’s research endeavors it needs to be reported, regardless of whether or not remuneration is received. An example of this kind of consulting might include helping to write an industry sponsor’s protocol with the presumption that the investigator will become a site PI. See below for the types of consulting that we believe need not be reported.
- Resources or support made available for research conducted during the summer semester for faculty members with an Academic Year appointment, regardless of whether or not remuneration is received.
- Participation in a foreign government “talents” or similar program. If you are not sure whether a program qualifies, contact SPA.
- Financial support for laboratory employees or visitors conducting research involving the reporting investigator (but see also trainees, below). This includes cases where those employees or visitors are participating in research related to the research of the reporting investigator (e.g. the reporting investigator may be a co-author or a co-inventor or the reporting investigator contributes to the scientific development or execution of a project in a substantive, measurable way).
The following items may be excluded from reporting in “Other Support:”
- Activities that are not research-related (e.g., practice plan salaries covering clinical care, payments for teaching, guest lectures, etc.)
- Financial support for laboratory personnel or visitors conducting research independently of the research of the reporting investigator. This includes but is not limited to cases when a laboratory is being shared or if access to a lab is driven primarily by need for specialized equipment housed there. See above for when the work of visitors or laboratory personnel should be reported.
- Startup packages, cost-sharing, or laboratory support from the University of Minnesota. See above for when certain internal research funding allocations should be reported (e.g. internal research grant competitions).
- NIH has not formalized guidance for when or if to report outside consulting, but at this stage, we believe that consulting that does not relate to the faculty member’s research endeavors but instead constitutes professional services provided to support the activities or research of a third party need not be reported. We anticipate that most consulting will fall into this definition.
- Gift funding accepted by the University of Minnesota Foundation or another UMN-affiliated foundation and later allocated to the reporting investigator without obligation or donor expectation for its use for a research purpose.
- Training grants involving the reporting investigator as mentor or project director
- Prizes given to the investigator
- Royalty income received personally by the investigator
The following items must be included in the Biosketch:
- Positions and scientific appointments both domestic and foreign, that are relevant to the application, including affiliations with non-U.S. entities or governments, regardless of whether or not remuneration is received. This includes unpaid appointments that provide access to lab space, research materials, and research personnel.
Additional Guidance from NIH
- NOT-OD-19-114: Reminders of NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components
- Mike Lauer’s blog post (7/11/19): Clarifying NIH Long-Standing Policies on Disclosing Other Support
- NIH Protecting Biomedical Innovation (including a reporting at-a-glance chart)
(Excerpted in part from NIH Guide Notice NOT-OD-19-114)
Prior NIH approval is required for any work that is considered a “foreign component” as defined here. Approval may be requested via inclusion in the initial grant application or, if added at any point during the lifecycle of an award, follow the instructions for prior approval at: NIHGPS, Section 8.1.2, Prior Approval Requirements.
NIH requires recipients to determine whether activities it supports 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.
If a recipient determines that a portion of the project will be conducted outside of the U.S., the recipient then will need to determine if the activities are considered significant. Examples of other grant-related activities that may be significant are:
- collaborations with investigators at a foreign site anticipated to result in co-authorship;
- use of facilities or instrumentation at a foreign site; or
- receipt of financial support or resources from a foreign entity.
If both criteria are met, then there is a foreign component. If an activity does not meet the definition of foreign component because all research is being conducted within the United States, but there is a non-U.S. resource that supports the research of an investigator and/or researcher, it must be reported as other support.