NIH Disclosure Guidance

Background:

Over the course of the last two years, NIH has released a series of notices that have expanded requirements for transparency and updated instructions for Other Support and Biographical Sketches.   As part of the NIH effort to expand and enhance transparency, new Biographical Sketch and Other Support forms were released on 5/5/21.   The new forms will be required on 1/25/2022. However, NIH requires the disclosure of the information their new instructions request now.  

It is important that each researcher submitting Biographical Sketches and/or Other Support pages carefully review their own forms to assure that they are complete and accurate.   Researchers are encouraged to ask OSP for guidance if there are questions about what needs to be disclosed.  The OSP website is intended to serve as a resource, but individual scenarios can be complex or nuanced and we are happy to assist in talking through individual questions.  

Broadly, what does NIH require to be disclosed as 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.”  Further details on what needs to be disclosed can be found on Notice NOT-OD-19-114.

Detailed instructions, links to new form pages and FAQ can be found at this NIH link.

When do I need to disclose Other Support, updates to support, new appointments or affiliations?  

You will need disclose throughout the proposal and award lifecycle.  Reference the NIH Pre-award and Post-award Disclosures Relating to the Biographical Sketch and Other Support.    This NIH table provides a list of various activities and when they need to be disclosed. e.g. biosketch, other support, annual progress report.   Some activities, e.g. new support or a foreign component require notification or possibly approval during the award.   

Does OSP have a checklist to remind me of items to disclose in Other Support beyond just my current and pending awards?

OSP has created a checklist intended to be a high level decision making tool to assist Dartmouth researchers who are compiling and submitting information to fulfill NIH, NSF or other agency requirements for reporting other support.   

 OSP's NIH Disclosure Checklist

What steps are required to submit Other Support?

1.  Use NIH Format.   Follow NIH instructions and use current format page which can be found at this link.

2. Disclose ALL active and pending sources of Other Support after reviewing guidelines

​​​​​3.  Provide to OSP copies of contracts, grants or any other agreement specific to senior/key personnel appointments and/or employment for a foreign institutionto be submitted as part of the Other Support PDF.  –If not in English, copies must be translated

4.  Sign Other Support:

Each person must electronically sign their own Other Support
Wet/Scanned signatures WILL NOT be accepted by NIH


OSP recommends using Adobe Reader.   Basic instructions can be found at this link but contact OSP with questions.


*Adding signature image in Word document is not verification*

5.  Send completed and signed Other Support pages to OSP for record keeping and submission to NIH (for subawards also send to OSP prior to submission to prime grantee institution)

 

What is a foreign component and the associated requirements?

Per NIH Grants Policy Statement, a recent NIH Guide Memo, and other relevant sources, the definition of “foreign component” is outlined below:

A foreign component is defined as “[t]he 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 that would meet this definition include, but are not limited to,

(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 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.
     

Foreign travel for consultation is not considered a foreign component.” (Emphasis added above.)

According to the NIH Guide Memo referenced above that was issued as a reminder to the research community on July 10, 2019, “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”.”   Please also see NIH FAQ on Foreign Components.

Who can I contact if I have questions?

Please don't hesitate to contact your OSP Pre-award Team Lead or the Director of OSP with questions.  

Highlights from NIH Notices

NOT-OD-19-114, 7/10/19, Reminders of NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components.  Highlights below:

•Remind to report foreign activities in other support, foreign components, and financial conflict of interest 
•All resources made available to a researcher in support of and/or related to all of their research endeavors
•All positions, scientific appointments, domestic and foreign held by SKP relevant to application incl. affil. foreign entities or govt.
•Foreign component: existence of any “significant scientific element or segment of a project” outside of the United States

NOT-OD-21-073, 3/12/21, Upcoming Changes to the Biographical Sketch and Other Support Format Page for Due Dates on or after May 25, 2021

•Align Biosketch, Other Support format and Application with OSTP and other guidance
•Updated forms required after 5/25/21
•‘Positions and Honors’ now ‘Positions, Scientific Appointments, and Honors’
•Other support page reorganized to separate funded support from in-kind
•Signature block on OS 
•Supporting documentation for contracts, grants or agreements for foreign appts./employ.
Immediate notice of undisclosed other support

NOT-OD-21-110, 4/28/21, Implementation of Changes to the Biographical Sketch and Other Support Format Page:

•NIH expects updated biosketch, OS format for applications, JIT, and RPPR as of May 25, 2021; require by 1/25/22
•Responsible for disclosing all research endeavors regardless of the forms used; must still capture all the necessary information

 

NIH Pre-award and Post-award Disclosures Relating to the Biographical Sketch and Other Support

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