INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Predoctoral to Postdoctoral Fellow Transition Award (F99/K00 Clinical Trial Not Allowed) | RFA OD 23 016

INCLUDE Predoctoral to Postdoctoral Fellow Transition Award (F99/K00) - FAQ

What is the INCLUDE Predoctoral to Postdoctoral Fellow Transition Award (F99/K00)?

This is an NIH grant opportunity designed to help outstanding doctoral students transition from the final stage of their PhD training into a mentored postdoctoral position focused on Down syndrome research. It uses a two-part structure: an F99 phase (predoctoral) followed by a K00 phase (postdoctoral).

What is the main purpose of this award?

The goal is to grow the pipeline of scientists working on Down syndrome by supporting talented trainees, including those coming from many different research backgrounds, not only those already training in traditional Down syndrome labs.

How does the two-stage F99/K00 structure work?

The award supports a two-stage training path. The F99 phase supports the final part of the applicant's doctoral training. The K00 phase provides mentored postdoctoral support after the individual moves into a postdoctoral position and continues building expertise and research independence in Down syndrome related work.

What kinds of research areas or disciplines are encouraged to apply?

NIH explicitly invites applications from a broad range of fields that could be leveraged to answer important questions about Down syndrome. Examples mentioned include genetics, biochemistry, data science, imaging, engineering, and neurobiology, as well as other relevant areas.

Does my research have to be strictly within a Down syndrome lab or Down syndrome department?

No. A key feature of this opportunity is its broad disciplinary reach and its intention to attract strong candidates from many disciplines, including those whose prior training may not have been in a traditional Down syndrome research environment.

What does the FOA mean by focusing on "co-occurring conditions across the lifespan"?

The opportunity highlights interest in the many health and developmental issues that can accompany Down syndrome at different stages of life. This also signals interest in research approaches that can connect basic biology, translational research, and population-level or technology-driven methods when appropriate.

Are clinical trials allowed under this award?

No. The funding opportunity explicitly states "Clinical Trial Not Allowed." The supported work must not propose a clinical trial as defined by NIH policy.

If clinical trials are not allowed, can the work still be clinically relevant?

Yes. The information provided indicates that projects must remain on the non-clinical-trial side of NIH rules, even if the work is clinically relevant. The description also notes that human data may be used in an observational or secondary-analysis framework consistent with NIH guidance, as long as the project is not a clinical trial.

Who is this award intended for?

It is meant for exceptional PhD trainees (outstanding doctoral students) seeking a structured, mentored transition into a postdoctoral program specifically aimed at advancing Down syndrome related science.

Should prospective applicants contact NIH program staff before applying?

Yes. The announcement strongly encourages applicants to contact INCLUDE Program Staff before investing significant time in an application to confirm fit with program goals, clarify eligibility or scope questions, and ensure the proposed training and research plan aligns with the initiative's objectives.

What is the funding opportunity number for this NIH announcement?

The Funding Opportunity Number is RFA-OD-23-016.

Which federal agency runs this opportunity?

This is administered under the National Institutes of Health (NIH) as a discretionary grant opportunity in the health funding activity category.

What types of organizations are eligible to apply?

Eligible applicant organizations are broad and include public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with 501(c)(3) status (other than institutions of higher education), for-profit organizations (other than small businesses), small businesses, and other categories included in the NIH eligibility list.

Are minority-serving institutions and tribal institutions eligible?

Yes. The notice highlights several categories of institutions NIH calls out as eligible and relevant, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).

Does highlighting these institution types exclude other U.S. institutions?

No. The inclusion of these categories does not exclude other eligible U.S. institutions. It underscores interest in broadening participation and strengthening research training pathways across diverse organizations and communities.

Are foreign (non-U.S.) institutions eligible to apply as the main applicant?

No. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as the applicant organization.

Can a non-domestic component of a U.S. organization apply?

No. Non-domestic components of U.S. organizations are also not eligible to apply.

Are foreign components allowed at all?

Yes. Foreign components are allowed as defined in the NIH Grants Policy Statement, meaning certain parts of the research or collaboration may occur outside the U.S. as long as the primary applicant organization remains eligible and the arrangement is properly justified and compliant with NIH foreign component rules.

Is the award ceiling or expected number of awards provided?

Not in the provided listing. The award ceiling and expected number of awards are not specified, which can occur in NIH announcements where budgets and award counts may depend on appropriations, application quality, and program priorities.

What is the closing date listed for this opportunity?

The original closing date listed is 2023-07-01.

What assistance listing (CFDA) numbers are associated with this opportunity?

Multiple CFDA/assistance listing numbers are associated: 93.121, 93.233, 93.837, 93.838, 93.839, 93.840, 93.846, 93.866, and 93.867.

What is the bigger initiative connected to this award?

The opportunity is tied to the broader INCLUDE initiative, reflecting a wider interest in understanding Down syndrome and the many co-occurring conditions that may occur across the lifespan, and encouraging research approaches spanning basic, translational, and broader data- or technology-driven methods.

What is the core takeaway for applicants considering this mechanism?

It is a structured NIH-supported pathway for exceptional PhD trainees to move into a mentored postdoc centered on Down syndrome related research, with an emphasis on broad disciplinary entry points, early communication with INCLUDE program staff, and strict alignment with the "Clinical Trial Not Allowed" limitation.