July 01, 2021

Essential Guidance for NIH Project Directors and Principal Investigators

The National Institutes of Health is changing the formats and clarifying the requirements for submitting Biographical Sketches and Other Support. Some of these changes may affect Project Directors and Principal Investigators (PDs/PIs) now and others will impact PDs/PIs as of January 25, 2022.

As of Now:

Supplementary Documentation

It is now possible for NIH to request that PDs/PIs provide supplementary documentation for all foreign activities and resources reported by Senior/Key Personnel under “Other Support” in Just-in-Time (JIT) Reports, and Research Performance Progress Reports (RPPRs). Note: After January 25, 2022 this information will be required by NIH.

Supplementary documentation includes copies of contracts, grants or any other agreement specific to Senior/Key Personnel foreign appointments and/or employment with a foreign institution. If the contracts, grants or other agreements are not in English, recipients must provide translated copies. Note: NIH funds cannot be used to translate these documents, but Google translations are acceptable.

Although not a new requirement, PDs/PIs that discover that any Senior/Key Personnel listed in the proposal have failed to disclose this requested or required information at the JIT and/or RPPR stages should notify SPO as soon as possible. SPO will need to submit updated supplementary documentation for Other Support to the Grants Management Specialist named in the Notice of Award as soon as it becomes known.

Other Support

PDs/PIs are reminded 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 and regardless of whether they are based at the institution the researcher identifies for the current grant. This includes:

  1. Consulting agreements, when the PD/PI or other senior/key personnel will be conducting research as part of the consulting activities. Note: The definition of what is meant by “research” is important in this context. NIH has indicated that it uses the Common Rule’s definition of “research” [45 CFR 46.102(l)] as a benchmark for determining whether a researcher’s activities constitute research and commented that co-authorship on a publication stemming from activities may be an indicator that the activities constituted research.
  2. In-kind contributions, e.g., office/laboratory space, equipment, supplies, or employees or students supported by an outside source. If the time commitment or dollar value of the in-kind contribution is not readily ascertainable, the recipient must provide reasonable estimates. Note: There is no de minimis dollar or time commitment thresholds that would serve as a trigger for reporting in-kind contributions.

PDs/PIs also are reminded that NIH does NOT require that the following be reported as “Other Support”:

  1. Resources and/or financial support for non-research endeavors
  2. Non-research consulting activities
  3. Training awards, prizes
  4. Gifts, but only if the gift is clearly given with no expectation of anything in return
  5. Institutional resources, such as core facilities or shared equipment that are made broadly available

Foreign Components

NIH has not changed the definition of a “foreign component.” A foreign component is the performance of a significant scientific element of the NIH-supported project outside of the United States. This includes:

  1. Performance of work by a researcher or recipient in a foreign location, whether or not NIH grant funds are expended and/or
  2. 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.

Other indications of a foreign component are:

  1. Collaborations with investigators at a foreign site anticipated to result in co-authorship
  2. Use of facilities or instrumentation at a foreign site
  3. Receipt of financial support or resources from a foreign entity

Note: Foreign travel for consultation is not considered a foreign component.

If a foreign component is to be involved, the PI must attach a justification to the proposal describing why the facilities or other aspects of the proposed project are more appropriate than a domestic setting.

If the PI adds a foreign component after NIH makes the award, NIH prior approval will be required. See: NIHGPS, Section 8.1.2, Prior Approval Requirements. As stated above, a foreign component involves a “significant” aspect of the project. NIH does not specifically define what is meant by “significant.” However, when in doubt, always disclose!

For more information, consult:

  1. NIH Grants Policy Statement: 16 Grants to Foreign Organizations, International Organizations, and Domestic Grants with Foreign Components) and
  2. FAQs on Other Support and Foreign Components

As of January 25, 2022:

There will be changes to the Biographical Sketch and Other Support Format Pages and requirements. NIH encourages PDs/PIs to voluntarily use and become familiar with the new formats now. Failure to follow the appropriate format on or after January 25, 2022 may cause NIH to withdraw applications from or delay consideration of funding.

Changes to Biographical Sketches

  1. Personal Statement: Applicants will be allowed to include ongoing and completed research projects from the past three years to draw attention to (previously known as research support).
  2. Positions, Scientific Appointments , and Honor should be listed in reverse chronological order all positions and scientific appointments both domestic and foreign, 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).
  3. Scholastic Performance: “Research Support” will be removed. Section D will be solely present on the fellowship version of the Biosketch and will no longer includes research support, only Scholastic Performance.

Changes to Other Support

  1. Each PD/PI or senior/key personnel will need to electronically sign their respective Other Support form as a PDF prior to submission verifying that the information is true and accurate.
  2. As described above, the PD/PI will need to provide supplementary documentation in English (i.e., copies of contracts, grants or any other agreement specific to Senior/Key Personnel foreign appointments and/or employment with a foreign institution) for all foreign activities and resources reported by Senior/Key Personnel under “Other Support” in Just-in-Time (JIT) Reports, and Research Performance Progress Reports (RPPRs).
  3. The format page will be re-organized to separate funded projects from in-kind contributions.

See: Upcoming Changes to the Biographical Sketch and Other Support for more information.