Revised Multiple Program Director(s)/Principal Investigator(s) Policy to Allow Change with Prior Approval

Notice Number: NOT-OD-11-118

Release Date: September 28, 2011

• October 20, 2011 - See Notice NOT-OD-12-003. Publication of the Revised NIH Grants Policy Statement (Rev. 10/1/2011): Policy Changes, Clarifications and Document Enhancements.
• November 20, 2006 - Notice (NOT-OD-07-017) Establishment of Multiple Principal Investigator Awards for the Support of Team Science Projects
• May 11, 2006 Notice (NOT-OD-06-069) Multiple PI Implementation Update

National Institutes of Health (NIH)

This Notice amends the NIH Multiple Program Director(s)/Principal Investigator(s) (PD/PI) policy to allow post award changes from or to a multiple-PD/PI award with the prior approval of the Grants Management Officer (GMO).

NIH began recognizing multiple-PD/PIs in 2007 to supplement the traditional single-PD/PI model and allow applicants and their institution to identify more than one PD/PI on a single grant application. The availability of the multiple-PD/PI option encourages team approaches to biomedical research, and multidisciplinary projects often benefit from an interdisciplinary team of scientists. The option of using a multiple-PD/PI model is open to most competing applications and requires that all the listed PD/PIs are recognized by their institution as PD/PIs; all PD/PIs assume responsibility and authority for the project; and the competing application must include a Leadership Plan that describes the roles, responsibilities, and working relationship of the PD/PIs. The multiple-PD/PI option was requested only in competing applications and was dependent on a favorable peer review of the Leadership Plan along with other components of the application.

After several years of experience with the multiple-PD/PI model, NIH has determined that there are legitimate circumstances under which it would be in the best interest of an active project to change either from a multiple-PD/PI model to a single-PD/PI model, or from a single-PD/PI model to a multiple-PD/PI model, and that peer review of the new leadership team and Leadership Plan may not be essential in these cases. The decision to apply for a single-PD/PI or a multiple-PD/PI competing award remains the responsibility of the investigators and the applicant organization, and those decisions should be determined by the scientific goals of the project. Accordingly, a request to change an active award from a single-PD/PI to a multiple-PD/PI model, or from a multiple-PD/PI model to a single-PD/PI model, must be made by the grantee organization and should be based on the scientific needs of the project. Justifications based on administrative convenience will not be considered. If the arrangements proposed by the grantee, including the qualifications of any proposed replacement or addition, are not acceptable to the NIH awarding IC the grant may be suspended or terminated.

This Notice amends the NIH policy to allow post award PD/PI changes with the prior approval of the Grants Management Officer (GMO), as detailed below. It is anticipated that such requests will be rare. Requested changes must be accompanied by a strong scientific justification related to the funded project. Prior Approval Requirements are described in the NIH Grants Policy Statement under Section 8.1.2. Changes may not be implemented by the grantee without the approval of the GMO and the receipt of a revised Notice of Award acknowledging the change.

Change from an active single-PD/PI to a multiple-PD/PI award, or changes in the number or makeup of multiple-PD/PIs. The Authorized Organization Representative (AOR) must submit a formal prior approval request to the GMO that includes the following:

• Scientific justification for the change to a multiple-PD/PI model, or change in the number or makeup of a multiple-PD/PI award.
• A Leadership Plan as detailed in the competing application instructions, including rationale for changing to a multiple-PD/PI approach or the number or makeup of multiple-PD/PIs. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PD/PIs and other collaborators.
• Designation of a contact PD/PI who is located at the grantee institution.
• Biographical sketches for PD/PIs to be added. The eRA Commons User Name is a required field on the biosketch for these individuals.
• Other support information for PD/PIs to be added.
• A description of how the loss of PD/PIs will affect the capacity to carry out the project.
• Any budgetary implications of the change.
• Any proposed changes in scope.

A grantee may only convert a single PD/PI award to a multiple-PD/PI award if the Funding Opportunity Announcement (FOA) explicitly allowed multiple-PD/PIs to be proposed at the time of the competing application. All listed PD/PIs must be registered in eRA Commons with a PD/PI Role; and the Commons User Name must be provided to the NIH as part of the prior approval request.

Change from an active multiple-PD/PI to a single-PD/PI award. The Authorized Organization Representative (AOR) must submit a formal prior approval request to the GMO that includes the following:

• Scientific justification for the change.
• A description of how the loss of PD/PIs will affect the capacity to carry out the project.
• Any budgetary implications of the change.
• Any proposed changes in scope.

Implications for New and Early Stage Investigator Status. The NIH definition of New Investigator is a PD/PI who has not previously successfully competed as a PD/PI for a substantial NIH independent research award. An Early Stage Investigator is a New Investigator who is within ten years of completing his or her terminal research degree or medical residency or equivalent. A New Investigator who is added as a PD/PI on a substantial NIH independent research award after initial peer review will not lose their New Investigator status. If a New Investigator is added prior to initial peer review and an award is issued the individual will lose their New Investigator status.

Note that adding a PD/PI prior to initial peer review is allowed in limited circumstances as detailed in the NIH Policy on Post-Submission Application Materials (NOT-OD-10-115).

The multiple-PD/PI web page and FAQs are updated to reflect this revised policy.

For additional information please visit the Multiple Principal Investigator website at https://grants.nih.gov/grants/multi_pi/.