NINDS Postdoctoral Mentored Career Development Award (K01 Clinical Trial Required) | PAR 23 142

FAQs: NINDS Postdoctoral Mentored Career Development Award (K01 Clinical Trial Required) - PAR-23-142

What is this funding opportunity?

This opportunity is the NINDS Postdoctoral Mentored Career Development Award (K01 Clinical Trial Required), Funding Opportunity Number PAR-23-142. It is a discretionary NIH grant in the health category (CFDA 93.853) focused on helping exceptional postdoctoral researchers transition into independent neuroscience research careers.

What is the main purpose of the NINDS K01 described here?

The central aim is to provide protected time, structured mentorship, and resources so a mentored postdoctoral researcher can complete a research project with clear potential for impact while also carrying out a robust, thoughtfully designed career development plan. The award is intended to function as a launchpad to independence, so that by the end of the project period the recipient is positioned to compete for and sustain independent funding and lead their own program.

What makes this K01 different from a K01 where a clinical trial is optional?

This FOA is "clinical trial required," not merely "clinical trial allowed." The proposed mentored research and training plan are expected to develop hands-on leadership capabilities in clinical trial design and execution, including scientific, operational, regulatory, and ethical responsibilities associated with serving as the lead investigator.

Does the proposed research have to include a clinical trial?

Yes. A key feature of this specific K01 is that the mentored research will include leading a clinical trial effort. The FOA is designed for candidates who will serve as lead investigator of an independent clinical trial, a clinical trial feasibility study, or an ancillary study that is separate but tied to an existing clinical trial.

What kinds of clinical trial-related studies are supported under this FOA?

Based on the description provided, supported trial-related efforts include: (1) an independent clinical trial led by the candidate, (2) a clinical trial feasibility study led by the candidate, or (3) an ancillary study that is distinct from but linked to an existing clinical trial, with the candidate serving as lead investigator for that ancillary effort.

What does "lead investigator" imply in this opportunity?

The FOA emphasizes that the candidate is expected to build real leadership experience in clinical trial design and execution. This includes taking on the scientific, operational, regulatory, and ethical responsibilities that come with leading the proposed clinical trial, feasibility study, or ancillary study.

Who is this award intended for (career stage)?

This award targets postdoctoral researchers in a specific window of mentored postdoctoral research experience. NINDS encourages candidates to apply between their second and fourth year of cumulative mentored postdoctoral research experience, and indicates that support can occur within the first six years of cumulative postdoctoral research experience.

Is it better to apply earlier or later in the eligibility window?

The FOA strongly nudges applicants to apply earlier within the eligibility window. The career development plan is treated as a critical component, and earlier support is presented as a way to allow sufficient time to build training, mentorship, and research momentum before transitioning to independence.

What are the main components NINDS expects in a competitive application?

Based on the information provided, NINDS places strong emphasis on two integrated components: (1) producing solid research outcomes through a mentored neuroscience research project with potential for impact, and (2) building the skills, training, and professional trajectory needed to lead an independent research program, supported by a structured mentorship arrangement and a robust career development plan.

What types of organizations are eligible to apply?

Eligibility is broad at the organizational level and includes many U.S.-based entities that can administer NIH grants. Eligible applicants include state, county, city/township, and special district governments; federally recognized tribal governments and certain tribal organizations; public housing authorities/Indian housing authorities; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (including both 501(c)(3) and non-501(c)(3), excluding higher education where specified); for-profit organizations (other than small businesses); small businesses; and other entities.

Are specific institution types (like HBCUs or HSIs) explicitly recognized as eligible?

Yes. The FOA explicitly calls out categories of institutions and organizations recognized as eligible applicants, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). It also includes faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

Can a foreign (non-U.S.) institution apply as the main applicant?

No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply under this opportunity.

Are non-U.S. components of U.S. organizations eligible to apply?

No. The FOA states that non-domestic components of U.S. organizations are not eligible to apply.

Are any foreign elements allowed at all?

Yes. While foreign institutions cannot apply as the main applicant and non-domestic components are not eligible to apply, foreign components are allowed as defined by the NIH Grants Policy Statement. This generally means a U.S. applicant organization may include certain foreign project elements or collaborations if they are justified and meet NIH policy requirements.

What is the Funding Opportunity Number (FOA number) for this grant?

The Funding Opportunity Number is PAR-23-142.

Which NIH institute is associated with this opportunity?

This opportunity is associated with the National Institute of Neurological Disorders and Stroke (NINDS).

What is the CFDA number listed for this opportunity?

The CFDA number provided is 93.853.

When was this opportunity created?

The opportunity was created on 2023-05-08.

What is the original closing date listed?

The original closing date listed is 2024-02-13.

Is the award ceiling (maximum funding amount) provided in the information above?

No. The source information provided does not specify an award ceiling.

Is the expected number of awards provided?

No. The source information provided does not specify the expected number of awards.

Where would an applicant look for budget limits, allowable costs, and project period details?

The information provided indicates applicants would typically need to consult the full FOA text and NIH budget guidance for the K01 mechanism, including any institute-specific budget policies, to understand allowable costs, project period, and related budget rules.

What outcome is NINDS expecting by the end of the K01 project period?

The award is framed as a launchpad. By the end of the K01 project period, the recipient is expected to be ready to compete for and sustain independent funding and operate as a leader in their field, with demonstrated progress in both research and career development.

Is this opportunity more focused on research results or career development?

It is explicitly both. NINDS emphasizes the candidate producing solid research outcomes and also building the skills, training, and trajectory needed for independence through a robust career development plan, protected time, and structured mentorship.

What is the overall "best fit" profile for this program based on the description?

Based on the information provided, the best fit is a mentored postdoctoral neuroscientist in the encouraged experience window who is ready to pair a clinically oriented research plan (with a required clinical trial leadership component) with deliberate training and mentorship, with the goal of emerging prepared to run an independent research program.