Complying with National Institutes of Health Policy

Information about NIH Foreign Disclosure and Risk Management can be found on their website.  There, you will find NIH guidance on disclosure requirements, foreign risk case studies, post-award monitoring and reporting requirements and more.  The NIH notices detailing the requirements can be found below.

July 31, 2024:  National Institutes of Health releases NOT-OD-24-163 NIH's Adoption of Common Forms for Biographical Sketch and Current and Pending (Other) Support by May 25, 2025
The National Institutes of Health (NIH) has announced that by May 25, 2025, it will adopt Common Forms for Biographical Sketch and Current and Pending (Other) Support, aligning with a broader federal initiative for standardized disclosure requirements. These forms, managed by the U.S. National Science Foundation (NSF), are part of efforts to enhance transparency in research activities. The NIH will continue to collect certain agency-specific data elements, such as the "Personal Statement" and "Contributions to Science," through a new NIH Biographical Sketch Supplement. All researchers submitting applications after May 25, 2025, must use these Common Forms, which will be integrated with the Science Experts Network Curriculum Vitae (SciENcv) system for digital certification and submission.

July 3, 2024:  National Institutes of Health releases NOT-OD-24-149 Prior Approval Requirement for Changes to Domestic Subawards for the SBIR and STTR Programs  The NIH notice NOT-OD-24-149 requires prior approval for changes to domestic subawards in the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. This requirement mandates that recipients seek approval when adding a new domestic subaward post-award, aligning with existing policies for foreign subawards. The change ensures compliance with the SBIR and STTR Reauthorization Act of 2022, aimed at mitigating risks associated with foreign relationships. Recipients must submit a foreign risk assessment and updated disclosure forms to obtain approval before finalizing any new subaward agreements.

November 14 2023:  National Institutes of Health releases NOT-OD-25-029  Clarification of Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements  The NIH notice NOT-OD-24-029 clarifies the requirements for disclosing foreign affiliations and involvement in SBIR and STTR programs. It emphasizes the need for transparency regarding any foreign ties of individuals involved in these grants, particularly those related to countries of concern. All competing applications submitted on or after September 5, 2023, must include comprehensive foreign disclosures pre-award, and maintain these disclosures throughout the award period. Failure to appropriately disclose foreign affiliations can lead to denial of awards, especially if these affiliations pose risks related to conflicts of interest or national security

June 12, 2023:  National Institutes of Health releases NOT-OD-23-139 Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements  The NIH's policy, outlined in NOT-OD-23-139, requires small business concerns (SBCs) applying for SBIR and STTR programs to disclose all relationships with foreign countries, including funded and unfunded ones. This includes details about owners, senior key personnel, foreign talent recruitment programs, and any business ties to foreign entities. These disclosures must be submitted during the Just-In-Time process for applications due on or after September 5, 2023. The NIH, CDC, and FDA have also implemented a due diligence program to assess security risks, which may lead to the denial of awards if any concerns are found. Post-award, recipients must continuously monitor and report any changes in their foreign relationships that could pose security risks throughout the duration of the award.

May 17, 2021: PIs have asked for more guidance on reporting research collaborators as NIH Other Support. Please review UC’s guidance on when to report collaborators to the NIH (need link), which includes several examples.

May 11, 2021: In response to concerns raised by the academic community, NIH is deferring implementation of its new Other Support and Biosketch formats and the other new requirements imposed in Notice NOT-OD-21-073 which was issued on March 12. The changes will now go into effect on January 25, 2022 instead of May 25, 2021.

You still must disclose all Other Support as described in that Notice and in Notice NOT-OD-19-114 in your just-in-time submissions and RPPRs. And you should contact the COI Office if you have any previously undisclosed other support.

HELPFUL NIH RESOURCES

1. UC Other Support Questionnaire to Faculty
2. UC Other Support Checklist
3. UC RPPR
4. Collaborative Relationships and Foreign Components
5. NIH FAQ PAGE: BIOSKETCH
6. NIH FAQ PAGE: OTHER SUPPORT and FOREIGN COMPONENTS
7. UC NIH Biosketch Training Video
8. UC NIH Other Support Training Video

5/4/2021 UPDATE: NIH Issues Announcement on the Implementation of Changes to the Biographical Sketch and Other Support Format Page

NIH has issued a follow-up notice to NOT-OD-21-073 on the upcoming changes to the biographical sketch and other support format pages. Per the new announcement NOT-OD-21-110, “NIH expects* applicants and recipients to use the updated biosketch and other support format for applications, Just-in-Time (JIT) Reports, and Research Performance Progress Reports (RPPRs) as of May 25, 2021. NIH will require* the use of the updated format pages for the previously mentioned submissions for anything on and after January 25, 2022.”
*emphasis added.

In addition, NIH states:

“Please note, applicants and recipients remain responsible for disclosing all research endeavors regardless of the version of the forms used. Therefore, if applicants and recipients choose not to use the updated format pages before they are required, applicants and recipients must still capture all the necessary information.”

As of this most recent Notice, NIH has not specified a limited lookback period for disclosures under Section B of the biographical sketch, “Positions, Scientific Appointments and Honors. As we have previously advised, for biographical sketches being submitted with NIH institutional training grants due May 25, if you are pressed for space, we encourage you to prioritize disclosure of Scientific Appointments held during the last three years, both domestic and foreign, including any affiliations with foreign entities or governments.  A scientific appointment can include participation in study sections, membership in a scientific society, board membership, and some consulting appointments.

All positions, however, should be included. This includes employment history or any kind of institutional appointment, whether or not remuneration is received, and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).

4/5/2021: NIH Upcoming Changes to the Biographical Sketch and Other Support Format Page Starting May 25, 2021

On March 12, 2021, the National Institutes of Health (NIH) announced the following information:

In an effort to support strong collaboration between Federal research agencies, NIH has made every effort to align the Biographical Sketch (Biosketch), Other Support format page and Application Form Instructions with the guidance issued by the Office of Science and Technology Policy Joint Committee on the Research Environment.

NIH has updated its application forms and instructions to support the need for applicants and recipients to provide full transparency and disclosure of all research activities, foreign and domestic.

SIGNIFICANT CHANGES TO OTHER SUPPORT:

Certification statement and signature block added for Program Director/Principal Investigator and Other Senior/Key Personnel to certify the accuracy of the information submitted. Each PD/PI and senior/key personnel must electronically sign their respective Other Support form as a PDF prior to submission.

The updated forms and instructions and updated format pages will be required for use for applications and Research Performance Progress Reports (RPPR) submitted for due dates on or after May 25, 2021.

During the transition to the new Biosketch format, NIH will not withdraw applications that include the previous Biosketch format. Beginning with applications submitted on or after January 25, 2022, failure to follow the appropriate Biosketch format may cause NIH to withdraw your application from consideration.

Updated Biosketch resources, including FAQs and sample Biosketch format pages can be found here.

Updated Other Support resources, including FAQs and sample Other Support format pages can be found here.

Complete details can be found here.

Please share this with all faculty and staff who may need this information.

If you have any questions, please contact the conflictofinterest@uc.edu.