Dean for Research Pablo Debenedetti released an email to all NIH-funded Principal Investigators and Senior/Key Personnel regarding the recent NIH document changes.  The email is below:

Dear colleagues,

I write to bring to your attention two recent notices issued by the National Institutes of Health--NOT-OD-21-073 (issued 3/12/21) and NOT-OD-21-110 (issued 4/28/21), which are particularly relevant to researchers who propose or manage NIH-funded projects. As we have communicated to you in email messages and in meetings over the last couple of years, federal research sponsors are increasingly requiring and enforcing disclosure and transparency standards regarding researchers’ activities outside the University.

The above notices represent significant changes to guidance regarding the Biographical Sketch and Other Support forms, which are key components of NIH proposals, Just-In-Time (JIT) requests, and Research Performance Progress Reports (RPPRs). These changes are required as of January 25, 2022. Note that NIH encouraged adoption of the new guidance starting on May 25, 2021 and has reserved the option to follow-up on materials already submitted to enforce the changes. The Office of Research and Project Administration (ORPA) will work with researchers and staff respond to any NIH post-submission requests for additional information received prior to January 25, 2022.

A current summary of the changes is provided below, but I encourage you to carefully read these NIH notices, as well as the Biosketch and Other Support FAQs referenced within the notices. Note that the FAQs are periodically updated. The Princeton research administration community has been made aware of these changes over the last few months. ORPA is currently planning additional training on these changes for the research administration community this fall.

NIH has promised further clarifications and FAQs over the next few months. We will continue to be in touch with you on these changes as NIH and federal guidance becomes clearer, and as we refine our plan to implement the guidance.

Princeton continues to work with its peers and the national research community to clarify and implement the changes, as well as to advocate for its interests, which include continuing support for researchers’ outside academic activities and collaborations, and an unwavering commitment to global engagement.

Should you have any questions regarding this guidance, or the preparation of grant proposals, JIT materials or progress reports, please contact your department grant management staff or your Grant and Contract Administrator in the Office of Research and Project Administration. Of course, should you have any other questions or concerns, please feel free to contact Elizabeth Adams, Director of ORPA ([email protected] ; 8-3090) or me — we will be happy to help.

With all good wishes,

Pablo

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Summary of NIH guidance changes (effective January 25, 2022)

• More comprehensive Biographical Sketch information is required for all senior/key personnel. This information includes all current positions and scientific appointments, both domestic and foreign, including affiliations with foreign entities or governments. This also 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)
• In connection with Other Support submissions that reflect “foreign activities and resources,” a requirement to include translated copies of contracts, grants or other documents “specific to senior/key personnel appointments or employment with a foreign institution”. Note that all senior/key personnel on an award are subject to these new requirements, not just the PI, co-PIs or co-Is; therefore, it is important for all researchers proposing or managing NIH funding to retain and have readily available copies (in English) of their contracts, MOUs, agreements, or appointment/affiliation documents with any foreign company or institution, including foreign universities
• Unique, high-value materials and data received within the past three years and that are still in use must be included as in-kind contributions in Other Support
• To the extent that consulting entails “conducting research”, it must be reported in Other Support; estimates for the amount paid must be included (rather than effort reflected in calendar months) for consulting that is disclosed in Other Support
• A specific requirement that individual researchers personally certify the accuracy of their Other Support information (beyond the general assurance signoff in Princeton ERA prior to proposal submission)
• A mandatory disclosure obligation to immediately correct any failure to disclose; this underscores the need for PIs to submit relevant administrative documents to ORPA in time for meaningful institutional reviews of submissions to NIH, which will help limit risk to researchers and the University