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Proposal Development and Submission

Working with NIH

Grants Policy Statement

Visit NIH Grants Policy Statement (NIHGPS) for the latest version.

Other Support Reporting for NIH

Other Support is sometimes referred to as current and pending support or active and pending support. It is each investigator’s responsibility to ensure true, complete and accurate reporting of all sources of support for their research activities. While reporting other support has always been expected, a number of federal agencies have published expanded guidance.

Concerns Regarding International Activities

Review recent announcements by NIH regarding undue foreign influence at U.S. institutions:

RCR Training Requirements

The National Institutes of Health (NIH) NIH requires that all trainees, postdocs, fellows, participants and scholars receiving support through any NIH training, career development award, research education grant and dissertation research grant must receive in-person instruction in the responsible conduct of research (see NIH RCR NOT-OD-10-019 and NOT-OD-22-055).

Training requirements apply to the following grant programs: D43, D71, F05, F30, F31, F32, F33, F34, F37, F38, K01, K02, K05, K07, K08, K12, K18, K22, K23, K24, K25, K26, K30, K99/R00, KL1, KL2, R25, R36, T15, T32, T34, T35, T36, T37, T90/R90, TL1, TU2, and U2R or any other NIH-funded programs supporting research training, career development or research education that require instruction in responsible conduct of research as stated in the relevant funding opportunity announcements.

Depending on the grant type, additional courses may be required for researchers working with human subjects or in clinical research.

For the specified award categories, the Principal Investigator (PI) must develop a discipline-specific, tailored plan for RCR training that meets NIH requirements with significant face-to-face interaction and participation by research faculty members. The instructional plan is evaluated as a component of the funding proposal and applications lacking an RCR instructional plan may be delayed in the review process or not reviewed.

The PI is responsible for ensuring that course attendance is monitored, and training records are maintained to document that all NIH-supported individuals received the required instruction. The PI must also comply with the specific reporting requirements in continuation applications. The RCR training should occur within one year of assignment to an applicable NIH Grant. NIH training records are subject to audit.

Ohio State's Office of Research Compliance offers an in-person RCR course - Responsible and Ethical Conduct of Research (GRDSCH 8000 RCR) - designed to fulfill the in-person NIH required training.

Additional courses that meet the in-person NIH requirement for RCR instruction include:

  • BIOPHRM 5510 - Responsible Conduct in Biomedical Research
  • MEDCOLL 5000 - Responsible Conduct of Research & Research Ethics
  • ANIMSCI 7789 - Nutrition Research Ethics
  • BIOMEDE 6983 - Research Ethics
  • BIOPHRM 5510 - Responsible Conduct in Biomedical Research
  • BIOPHRM 7510 - Professional and Ethical Issues in Biomedical Sciences
  • BIOPHYS 7600 - First-Year Student Orientation
  • MCDBIO 7600 - First-Year Student Orientation
  • MICRBIO 7600 - First-Year Student Orientation
  • MOLGEN 7600 - First-Year Student Orientation
  • OSBP 7600 - First-Year Student Orientation
  • PHR 8520 - Research Ethics
  • VISSCI 7960 - Ethics in Biomedical Research
  • Center for Ethics and Human Values: CARE Training Program (open to graduate and professional students, postdocs, university staff, and faculty)

Data Management and Sharing Policy

Many new funding applications submitted to NIH on or after January 25, 2023, must comply with the National Institutes of Health (NIH) Data Management and Sharing (DMS) Policy. Under the policy, investigators and institutions are expected to:

  • plan and budget for the managing and sharing of data
  • submit a DMS plan for review when applying for funding
  • comply with the approved DMS plan.

Unless specifically noted in the funding opportunity announcement, plans are not part of the scored peer review criteria and are reviewed only by program staff. However, peer reviewers will see and may comment on the related budget items.

Resources

Public Access Policy

Since 2008, publications resulting from NIH-sponsored research must be made publicly available in PubMed Central. A 2024 NIH Public Access Policy went into effect on July 1, 2025, based on guidance released in 2022 from the White House Office of Science and Technology Policy (OSTP) to make federally-funded research freely available without a delay. Under the policy, investigators are expected to:

  • provide immediate access in PubMed Central upon the official date of publication
  • include an acknowledgement statement of federal funding in all publications
  • agree to a standard Government Use License for all publications

These requirements no longer allow for a 12-month embargo of publications. All manuscripts accepted for publication on or after July 1, 2025 must be made available in PubMed Central immediately upon publication in a journal. The policy applies to all publications resulting from NIH-sponsored research, regardless of when the grant was initiated.

Resources

Foreign Subaward Records Access

The National Institutes of Health requires that foreign subrecipients of NIH awards provide the primary recipient access to copies of all lab notebooks, data and documentation that supports the research outcomes described in the progress report.

This was outlined in NOT-OD-23-182 NIH Final Updated Policy Guidance for Subaward/Consortium Written Agreements. Access, which can be electronic, must be provided at least once per year, in alignment with the timing requirements for Research Performance Progress Reports (RPPR).

Two important issues to be aware of:

  1. The access requirement applies to all foreign subawards, both new and active.
  2. For all proposals submitted on or after January 2, 2024, NIH expects applicants to ask potential subrecipients to submit language in their letters of support indicating their awareness of these requirements and their willingness to abide by all requirements should an award be issued.

In addition to the Ohio State Subrecipient Letter of Intent distributed by Sponsored Programs to all potential subrecipients during the proposal stage, Sponsored Programs will also dispatch the "Additional Requirements for Foreign Subawards under NIH Prime Awards" to prospective foreign subrecipients of NIH grants.

Contact Laurie Rosenberg, Sponsored Programs Subaward Lead, with questions at rosenberg.1045@osu.edu.

Foreign Subaward Award Structure Policy

On May 1, 2025, NIH announced an updated policy on foreign subawards.  NIH will establish a new award structure that will prohibit foreign subawards from being nested under the parent grant. Under the new structure, which is expected to be implemented by no later than September 30, 2025, NIH will fund foreign components that are structured as independent subprojects directly linked to the prime award.

Until the details of the new foreign collaboration award structure are released, NIH will not issue awards (new, renewal or non-competing continuation) that include a subaward to a foreign institution to domestic (U.S.) or foreign (non-U.S.) institutions. This applies to all foreign monetary collaborations. In addition, NIH will no longer accept prior approval requests to add a new foreign component or subaward to an ongoing project.

Impact on Ohio State Awards and Collaborations

  • New, renewal, and non-competing continuations awards to Ohio State cannot fund subawards to foreign institutions.
  • Awards to foreign Institutions can include subawards to Ohio State investigators.
  • Ohio State awards can pay for foreign consultants or purchase unique equipment or supplies from foreign vendors where subaward agreements are not required.  

Options for Awards with Existing Foreign Subawards

  • NIH will not retroactively revise ongoing (active awarded) grants to remove foreign subawards at this time, so the impact will come with your next new, renewal or non-competing continuation (including annual progress reports/RPPR) action.
  • NIH will allow Ohio State to renegotiate awards (competing, renewal, and non-competing) to remove foreign subawards and rebudget the subaward funds for use by you at Ohio State or by issuing a domestic subaward  
  • If your project is no longer viable without the foreign subaward NIH will work with Ohio State to negotiate a bilateral termination, taking into consideration any need to support participant safety and/or animal welfare.

NIH is beginning to contact impacted Ohio State awardees with award-specific instructions. Please share such communications with your SPO.

Guidance for New Proposals with Foreign Collaborations

NIH has not yet issued instructions for submitting proposals using the new subaward structure.  NIH has advised that current proposals should not include foreign subawards, applications that propose foreign subawards will be withdrawn by CSR and will not be reviewed, and institutions should delay submitting proposals that include what would have been a subaward to a foreign entity until revised instructions or additional guidance become available.