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NIH Post-Award Management — Post Award Personnel Changes
Change in Status, Including Absence, of Principal Investigator and Other Key Personnel
Overview
The status of the Principal Investigator (PI) and Key Personnel (KP) may change over the course of an NIH award performance period. NIH requires certain changes regarding the PI and KP named on the Notice of Grants Award be approved prior to their implementation. Waiting to report these changes on the annual progress report does not constitute a prior approval for the previous year. What changes require a prior approval are defined in the NIH Grants Policy Manual (12/1/2003, as amended).
Significant Change in Effort, PI Absence Greater than 3 months or Withdrawing from the Project:
The PI is required to submit a request (either a Memo or email originating from the PIs email address) for “NIH Prior Approval” to the Sponsored Projects Office (SPO) for institutional review and endorsement. The SPO Contracts Officer will, upon receipt, review the package (see sample). If additional information is required, the SPO CO will request this information from the PI with a copy to the appropriate divisional administrative staff. Once a complete package has been received by SPO, the SPO CO will endorse the request and forward it to the NIH Program Manager and Grants Management Specialist specified on the Notice of Grant Award. A copy of the endorsed request will be distributed to the PI, Division Administration Staff, and the SPO file.
Termination of Award due to PI Absence:
If LBNL wishes to terminate a project due to a PI’s absence and it cannot make suitable alternate arrangements, a request (memo or email originating from the PIs email address) to the SPO CO. The SPO CO will review, request additional internal approvals (i.e. Division Director or Business Manager) and endorse the letter to NIH. Upon receipt, the NIH will forward closeout instructions. NOTE: If the alternative arrangements proposed by LBNL are not acceptable to the NIH awarding office, the grant may be suspended or terminated.
Process
The following is to be included in the LBNL Proposal Package to SPO based on NIH’s specific requirements. The request is due to the SPO Contracts Officer 10 working days prior to the submission of the request to the Sponsor.
- NIH Prior Approval request letter (original) addressed to the NIH Program Manager and the NIH Grants Management Specialist (as noted on the Notice of Grant Award or the NIH eRA Grant Award Record) and forwarded to the SPO CO for review and endorsement. The letter should provide sufficient justification to allow NIH to review and approve the request. If this is a request for a substitute PI or KP, the qualifications of the replacement PI and/or KP should be included. A sample letter can be found here.
- If this is for a substitute PI or KP, a copy of the Biosketch, Current and Pending (Other) Support, and Detailed Budget Page (if the Budget is impacted), must be included in the request package.
- If this is a substitute PI or KP that is not currently on the project, the NIH/NSF Conflict of Interest form is required to be included in the request package (original forms if negative disclosure/copy if positive disclosure). Please consult the Conflict of Interest policy for complete guidance and COI forms.
- If this is substitute PI or KP that is not currently on the project and the project includes Human Subjects, a copy of the LBNL personnel training profile indicating that the LBNL Human Subjects Education requirement has been fulfilled must be included with the request package. SPO will complete the appropriate documentation letter and include with the request to NIH.
Missing or incomplete items will delay the endorsement and submission of the NIH Prior Approval request package to NIH.
If SPO has no questions or revisions regarding the package, the SPO CO will:
- Send the request to the Sponsor within 5 working days of receipt of a viable package
- Return a copy of the endorsed request package to the PI and the division
Negotiating and Receiving NIH Prior Approval
If there are any questions from NIH regard the request package, typically the SPO CO will receive either a phone call or an e-mail from the Grants Management Specialist. SPO will work with the PI and division staff to provide any additional information requested.
NIH approval of a request may come in the form of a letter (change in effort) or a revision of the Notice of Grant Award (substitute PI and KP). SPO will issue a SPAA to distribute the NIH approval.
