NIH Director’s New Innovator Award Program (DP2 Clinical Trial Optional)

For the purpose of this NOFO, multiple PD(s)/PI(s) are not allowed.

Applicants must meet the definition of an Early Stage Investigator (ESI) at the time of application submission. An ESI is a PD/PI who has completed their terminal research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years and who has not previously competed successfully as PD/PI for a substantial NIH independent research award. See the Office of Extramural Research website for a complete list of NIH awards that do not disqualify a PD/PI as a new investigator and for frequently asked questions about the NIH ESI Policy.

An extension to the 10-year period may be granted under certain circumstances (e.g., childbirth, family care responsibilities, clinical loan repayment requirements, disability or illness, natural or other disaster, etc.). It may take several weeks for the review process for the request, so applicants should plan accordingly. Note: If an applicant is not identified as an ESI in the eRA Commons, it may result in the application not being reviewed. Applicants are responsible for reviewing and/or updating their degree information in their eRA Commons account in a timely fashion.

Applicants must hold an independent research position at a domestic (U.S.) institution by September 1, 2026. For this NOFO, an “independent research position” is a position that automatically confers eligibility to the investigator (based on institutional policy) to apply for R01 grants with appropriate institutional commitment of facilities for the conduct of the proposed research. Investigators still in training or mentored status (such as postdoctoral fellows) are not eligible to apply unless they have a written commitment from the institution stating they will be in an independent faculty position by September 1, 2026. The commitment is certified by the institution's submission of the application.

Applicants may submit or have an NIH R01 or other grant application (including an ESI MIRA R35 application) pending concurrently with their NIH Director’s New Innovator Award application, but scientific overlap is not allowed per NIH policy. If a pending grant becomes active prior to the New Innovator Award, and the grant mechanism is not on the list of smaller NIH grants and awards that maintain ESI status, the applicant is no longer eligible to receive the New Innovator Award.

Award recipients are required to commit at least three person-months (25%) of their research effort each year to activities supported by the New Innovator Award.

For more details regarding eligibility requirements, see FAQs on the New Innovator website.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct. Only one application per PD/PI is permitted in response to this NOFO.