Reminder

Compliance protocols MUST be approved and linked in SeRA to a SPO project record prior to award acceptance. 

See ORA's Award Acceptance Resources for additional information.
Stanford
Office of Research Administration

NIH Grants and Contracts – General

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Award Management Keys to Success

1.  Read all Notices of Award (NOAs) issued for the NIH projects you have and/or manage.  Pay special attention to Project and Budget Period Dates, funded amounts, named individuals on the NOA, and the listed terms and conditions in sections III and IV of NIH NOAs. 

NOTE: NIH NOAs are stored in SeRA as project attachments and viewable to anyone who has SeRA access to the given project.

2.  Always refer to the most recent sponsor approved budget and budget justification to inform you what was proposed and approved by the sponsor to charge to the project.  This may require you to refer back to the budget and budget justification that was submitted at the time of proposal.

NOTE: Budget and budget justifications that were submitted to sponsors and/or were attached to sponsor award documents are stored in SeRA as project attachments and viewable to anyone who has SeRA access to the given project.

3.  Familiarize yourself with what project changes require NIH's prior approval

4.  Ensure expenses charged to NIH projects are always...

  • Allowable - Refer to the NOAs, sponsor approved budgets, and budget justifications for the NIH projects you have and/or manage, the specific program guidelines, the NIH Grants Policy Statement, and Stanford fiscal policies.  The most restrictive policy, typically the individual award terms, will always take precedent.
  • Allocable - That is to say, the expense directly benefits the project(s) to which it is being charged in the proportion it is being charged.  If an expense benefited multiple projects, the expense should be allocated to the benefiting projects in proportion to the benefit each project received using an allocation methodology that is appropriate for the given expense, can be documented, and can be reasonably retro-engineered.
  • Reasonable - Expenses must reflect what a prudent person would pay.

  • Consistent - Expenses must be handled consistently across the university by following Stanford policy.

5. Note when technical reports [interim progress and final] are due, and help remind your investigators to submit those timely. 

NIH Prior Approval Requirement for Change in Status, Including Absence of PD/PI and Other Senior/Key Personnel Named in the NIH Notice of Award (NOA)

The NIH requires NIH's prior approval for a variety of project changes.  A key to NIH award management success is to familiarize yourself with what project changes require NIH's prior approval as defined in the Notices of Award for the NIH projects you manage, the specific program guidelines, and the NIH Grants Policy Statement.  One particularly frequently asked about prior approval requirement we would like to highlight is the NIH Prior Approval Requirement for Change in Status, Including Absence of PD/PI and Other Senior/Key Personnel Named in the NIH Notice of Award (NOA).

From NIH Grants Policy Statement Chapter 8.1.2.6

The recipient is required to submit a prior approval request to the GMO if:

  • There is a significant change in the status of the PD/PI or other Senior/Key Personnel specifically named in the NoA including but not limited to withdrawing from the project entirely, being absent from the project during any continuous period of 3 months or more, or reducing time devoted to the project by 25 percent or more from the level that was approved at the time of initial competing year award (for example, a proposed change from 40 percent effort to 30 percent or less effort or in calendar months a change from 4.8 to 3.6 calendar months). Reductions are cumulative, i.e., the 25% threshold may be reached by two or more successive reductions that total 25% or more. Once agency approval has been given for a significant change in the level of effort, then all subsequent reductions are measured against the approved adjusted level. Selecting Yes in the RPPR constitutes a prior approval request to the agency and the issuance of a subsequent year of funding constitutes agency approval of the request.
  • There is a change from a multiple PD/PI model to a single PD/PI model.
  • There is a change from a single PD/PI model to a multiple PD/PI model.
  • There is a change in the number or makeup of the PD/PIs on a multiple PD/PI award.

NIH must approve any alternate arrangement proposed by the recipient, including any replacement of the PD/PI or senior/key personnel named in the NoA, and the addition of any new PD/PIs.

The request for prior approval of any additional or substitute PD/PIs or Senior/Key Personnel named in the NoA, or change from a multiple PD/PI model to a single PD/PI model, must be submitted promptly, and must be accompanied by a strong scientific justification related to the scientific project, including any proposed changes in scope, the biographical sketch of any new individuals proposed and other sources of support, and any budget changes resulting from the proposed change. A new or revised Leadership Plan is required if the request is to change from a single PD/PI model to a multiple PD/PI model, or to change the number or makeup of the PD/PIs on a multiple PD/PI award. The Commons ID must be provided for any new PD/PIs. In addition, because NIH recipients are expected to provide safe and healthful working conditions for their employees and foster work environments conducive to high-quality research, the request for approval should include mention as to whether change(s) in PD/PI or Senior/Key Personnel is related to concerns about safety and/or work environments (e.g. due to concerns about harassment, bullying, retaliation, or hostile working conditions). NIH will in turn be better positioned to enable informed grant-stewardship decisions regarding matters including, but not limited to, substitute personnel and institutional management and oversight.

If the arrangements proposed by the recipient, including the qualifications of any proposed replacement, are not acceptable to the NIH awarding IC, the grant may be suspended or terminated. If the recipient wishes to terminate the project because it cannot make suitable alternate arrangements, it must notify the GMO, in writing, of its wish to terminate, and NIH will forward closeout instructions.

The requirement to obtain NIH prior approval for a change in status pertains only to those personnel NIH designates in the NoA regardless of whether the applicant organization designates others as senior/key personnel for its own purposes.

Need further NIH award assistance? Have questions, feedback, or are experiencing other issues? Please reach out to your OSR Post Award Research Accountant