Key Dates

Related Announcements

NOT-OD-22-129 - Updated Requirements for NIH Notification of Removal or Disciplinary Action Involving Program Directors/Principal Investigators or other Senior/Key Personnel

NOT-OD-18-172 - Clarification of NIH's Policy Regarding a Change in Program Director's/Principal Investigator's Status

Issued by

NATIONAL INSTITUTES OF HEALTH (NIH)

Purpose

The purpose of this notice is to clarify NIH expectations regarding change in status, including absence of Program Director / Principal Investigator (PD/PI) and other Key Personnel named in the Notice of Award (NoA) of NIH grants, as well as change in recipient institution. NIH expects that funded biomedical and behavioral research occurs within an environment that is safe, healthful, and conducive to high-quality work.

Background

The NIH Grants Policy Statement Section 4 states that NIH recipients are expected to provide safe and healthful working conditions for their employees and foster work environments conducive to high-quality research, regardless of the recipient institution.

NIH appreciates that changes in status and changes in recipient institution may occur because of concerns about the safety of working conditions and about the ability of work environments to be conducive to high-quality research.

These updates apply to both requests for a change in status as outlined in the NIH GPS 8.1.2.6, Change in Status, Including Absence of PD/PI and Other Senior/Key Personnel Named in the NoA, and 8.1.2.7, Change of Recipient Organization.

Guidance

NIH is clarifying expectations regarding requests for change in status of the PD/PI and other Senior/Key Personnel and Change in Recipient Institution.

Change in PD/PI and Other Senior/Key Personnel

NIH is modifying section 8.1.2.6 for clarification. The requirements for obtaining prior approval are not changing. See changes to particular sentences in italics:

The recipient is required to submit a prior approval request to the Grants Management Official (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 theNoA, 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.

Change in Recipient Institution

NIH also expects that requests for change in recipient institution, as outlined in 8.1.2.7, should include mention as to whether the change in recipient institution is related to concerns about safety and/or work environments (e.g. due to concerns about harassment, bullying, retaliation, or hostile working conditions) involving the PD/PI. 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. The NIH expects both the relinquishing and applicant organizations to disclose whether a Change of Recipient Organization is occurring within the context of an ongoing or recent investigation of misconduct of any kind, including but not limited to professional misconduct or research misconduct.

Therefore, for awards (competing, non-competing and supplements) issued after the publication date of this notice, NIH expects recipients requesting prior approval for change in PI or Senior/Key Personnel named in the NoA, or changes in recipient institution to include mention as to whether these requests are related to concerns about the safety and/or work environments as noted above.

Inquiries

Please direct all inquiries to:

Division of Grants Policy
Office of Policy for Extramural Research Administration
Office of Extramural Research
Telephone: 301-435-0949
[email protected]