Working with NIH

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

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.

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

• August 20, 2018 letter reminded the research community of the requirement to disclose “support coming from foreign governments or other foreign entities”
• July 2019 NIH Notice NOT-OD-19-114 included Other Support guidance and reminded NIH applicants and recipients that “other support includes all resources made available to a researcher in support of and/or related to all of their research endeavors…”

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)

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

• Ohio State NIH DMS Policy Guide
• 2023 Data Management & Sharing Policy FAQs
• example budget form
• example budget narrative for detailed budget
• example budget narrative for modular budget

Beginning January 2, 2024, the National Institutes of Health will require 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.