Last updated: March 9, 2022
NIH requires the disclosure of biographical, other support and foreign component information as part of the grant application process and, as requested, in post-award progress reports. The information below summarizes key NIH disclosure requirements and provides links to more detailed information.
Effective January 25, 2022:
- Supporting documentation for outside contracts, agreements and other working arrangements with foreign entities must be submitted with Other Support. See “Supporting Documentation” in the Other Support section below for instructions on how to comply with these requirements at MIT.
- The new FORMS-G for Other Support has an added signature block for the PI/KP to certify the accuracy of the information submitted. Each form must be electronically signed by the PI/KP and submitted as a flattened PDF. Electronic signatures can be generated using DocuSign or Adobe Pro DC (requires external license); wet signatures and image files are not acceptable. RA Support has prepared instructions for preparing and flattening PDF attachments.
What to Disclose
The biographical sketch (biosketch) provides an opportunity for each senior/key person listed in an NIH grant application to describe why they are well-suited for their role(s) in the project. All senior/key personnel are required to provide biosketches. Senior/Key personnel includes Investigators, Other Significant Contributors (OSC), plus could include consultants and technical staff if they meet the definition of senior/key personnel. Senior/Key personnel do not necessarily need to be paid from the grant, but they do require effort. The only exception is the role of OSC, they do not need to commit effort by definition of that particular role. OSCs should also certify in the MIT Kuali Coeus (KC) system. Required information in the biosketch may vary depending on the solicitation type, so please review the solicitation details.
When to Disclose
Biographical sketches (biosketches) are required in new and competing grant applications.
“Other Support” is sometimes referred to as “current and pending support” or “active and pending support”. Information on other support may be requested (often as part of Just-in-Time procedures for grant applications or in progress reports) to ensure there is no scientific, budgetary, or commitment overlap. The following information is excerpted and adapted from the NIH Other Support website and NOT-OD-19-114: Reminders of NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components. Please refer to these resources, NIH FAQs on Other Support, or contact your RAS administrator if you have questions.
What to Disclose
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 and regardless of whether they are based at the institution the researcher identifies for the current grant. This includes resource and/or financial support from all foreign and domestic entities, including but not limited to, financial support for laboratory personnel, and provision of high-value materials that are not freely available (e.g., biologics, chemical, model systems, technology, etc.).
NIH applicants must:
- List 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 remuneration is received, and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).
- Report all resources and 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. Information must be provided about all current support for ongoing projects, irrespective of whether such support is provided through the applicant organization, through another domestic or foreign organization, or is provided directly to an individual that supports the senior/key personnel’s research efforts.
- Report all current projects and activities that involve senior/key personnel, even if the support received is only in-kind (e.g. office/laboratory space, equipment, supplies, employees). All research resources including, but not limited to, foreign financial support, research or laboratory personnel, lab space, scientific materials, selection to a foreign “talents” or similar-type program, or other foreign or domestic support must be reported.
- Provide the total award amount for the entire award period covered (including facilities and administrative costs), as well as the number of person-months (or partial person-months) per year to be devoted to the project by the senior/key personnel involved.
When to Disclose
All pending support at the time of application submission and prior to award must be reported using “Just-in-Time Procedures” by providing all information indicated above. Applicants are responsible for promptly notifying NIH of any substantive changes to previously submitted Just-in-Time information up to the time of award, including “Other Support” changes that must be assessed for budgetary or scientific overlap.
Further, if other support, as described as above, is obtained after the initial NIH award period, from any source either through the institution or directly to senior/key personnel, the details must be disclosed in the annual research performance progress report (RPPR). Post-award, recipients must address any substantive changes by submitting a prior approval request to NIH in accordance with the NIHGPS section on “Administrative Requirements—Changes in Project and Budget—NIH Standard Terms of Award.”
Supporting Documentation (effective January 25, 2022)
MIT has developed the External Contract Depository (ECD) to help MIT researchers and their administrators meet the newly-enacted National Institutes of Health (NIH) requirement that principal investigators and senior/key personnel provide copies of outside contracts, or other agreements, with foreign entities as part of their Other Support submission. Uploaded documents will receive a high-level review by MIT’s Office of the Vice President for Research and the Office of the General Counsel to help ensure compliance with NIH requirements. In order to maintain consistency of reporting, only contracts that have been uploaded to this depository and reviewed should be included in submissions to NIH.
What to Disclose
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. This includes:
- 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.
When to Disclose
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. If both criteria are met, then there is a foreign component that must be disclosed in Item 6 of the Research & Related Other Project Information Form. See item B2 in the NIH FAQS for further guidance how about to determine if activities are significant.
The addition of a foreign component to an ongoing NIH grant continues to require NIH prior approval, as outlined in the NIH Grants Policy Statement, Section 8.1.2, Prior Approval Requirements.
Note: 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. For example, if a PD/PI of an NIH-funded grant has a collaborator outside of the U.S. who performs experiments in support of the PD/PI’s NIH-funded project, this would constitute a foreign component, regardless of whether the foreign collaborator receives funding from the PD/PI’s grant. Additional funding from a foreign source for the NIH-supported research of a PD/PI at a U.S. institution would not constitute a foreign component but would necessitate reporting as other support.
The following links to the NIH Blog also describe the purpose and obligation to disclose properly and fully:
- Addressing Foreign Interference and Associated Risks to the Integrity of Biomedical Research, and How You Can Help
- Clarifying Long-Standing NIH Policies on Disclosing of Other Support
See the MIT Office of the Vice President for Research Foreign Engagement page for recent updates and additional resources regarding foreign engagements.
Portions of the contents of this page were adapted from materials prepared by UCLA Research Policy and Compliance and are provided here with their permission.