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Grant Analysis

Purpose & Target

This grant, the 'NHLBI Career Transition Award (K22)', is designed for highly qualified postdoctoral fellows and doctoral-level researchers currently training within the National Heart, Lung, and Blood Institute's (NHLBI) Intramural Research Division. Its core objective is to help these individuals smoothly transition into independent research positions at extramural institutions (like universities or research organizations). It provides support for both a mentored research phase within NHLBI and a subsequent independent research phase at an external organization. This is a SECTOR-SPECIFIC grant, focused on biomedical, behavioral, and clinical research relevant to NHLBI's mission (heart, lung, blood, and sleep-related health). The geographic scope is U.S. organizations and individuals. A key filtering criterion is that the proposed research must not involve leading an independent clinical trial. This is a recurring grant opportunity with multiple application deadlines each year, and it's a reissue of a previous program (PAR-22-034), indicating an ongoing commitment to this career development pathway.

Financial Structure

This grant provides financial support structured across two phases: an intramural phase and an extramural phase. Funding Amounts & Duration:

The total project period is 5 years.
- Intramural Phase: Up to two years of mentored research within NHLBI.
- Extramural Phase: Three years of independent research support at an external institution.
Maximum Funding for Extramural Phase: The total cost for the three-year extramural phase may not exceed $747,000, which breaks down to $249,000 per year.

Eligible Costs:

Intramural Phase: Your salary will be provided by your NHLBI intramural laboratory, commensurate with NHLBI's salary structure based on your years of postdoctoral experience. Research expenses (personnel, consultants, equipment, supplies, travel) are negotiated with your NHLBI intramural laboratory chief.
Extramural Phase: The $249,000 per year cap includes your salary (up to the legislatively mandated NIH salary cap), fringe benefits, a research support allowance, and applicable Facilities & Administrative (F&A) costs.

Ineligible Costs:

Salaries for mentors, secretarial, or administrative assistants are generally not allowed.
K22 funds cannot be used to offset the typical startup package or usual institutional commitment (salary, resources) that the extramural institution would normally provide to a newly hired faculty member without grant support. The institution's commitment must be in addition to the K22 funds.

Indirect Costs (F&A Costs):

For the extramural phase, Indirect Costs are reimbursed at 8% of modified total direct costs.

Matching Fund Requirements:

There are no direct matching fund requirements for the grant itself.
However, the extramural institution must demonstrate a significant financial and resource commitment. This includes providing a startup package, protected research time, space, and supplemental funds, which should be sufficient to enable you to perform the proposed research and establish an independent research program. This institutional support is crucial for the transition to the extramural phase and is reviewed by NHLBI staff.

Eligibility Requirements

Who is Eligible to Apply? (The Individual) This award is specifically for individuals who are: * NHLBI postdoctoral fellows or other doctoral-level NHLBI researchers currently in training within the NHLBI Division of Intramural Research. * Have a terminal doctoral degree (e.g., PhD, MD, DO, DDS, DVM, ScD, PharmD). * Have demonstrated potential for highly productive research during their postdoctoral experience. * Have no more than 5 years of full-time research experience in the NHLBI Division of Intramural Research as of the application due date. * Must commit a minimum of 75% of their full-time professional effort (at least 9 person-months) to their career development program. * Not eligible if currently hired as a contractor, or if holding an independent, non-mentored position (e.g., staff scientist, tenure-track equivalent). * Not eligible if already a lead investigator on certain NIH research grants (R03, R21, R01, P01, DP2) or a subproject leader on large NIH grants. * Must be a U.S. citizen or non-citizen national, or have U.S. permanent residence by the time of the award. Who is Eligible to Receive Funds? (The Organization) While the individual applies, the award is granted to the institution where the independent phase of research will take place. This extramural institution must be located in the United States (U.S. Territory or Possession is also eligible). Eligible extramural organizations include a wide range, such as: * Higher Education Institutions (public or private universities and colleges) * Nonprofits (with or without 501(c)(3) IRS status) * For-Profit Organizations (small businesses or other for-profits) – eligibility depends on the nature of the tenure-track equivalent appointment and the individual's ability to conduct independent research. * Local Governments (State, County, City/Township, Special District, Indian/Native American Tribal Governments) * Federal Governments (Eligible Agencies of the Federal Government) * Other entities like Independent School Districts, Public Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, and Regional Organizations. Key Requirements for the Extramural Institution:

Must provide a full-time formal tenure-track (or equivalent) appointment offer to the candidate by the time of the award, and this offer must not be contingent on receiving this grant.
Must demonstrate a strong commitment to the candidate's development, including providing protected research time, space, and a startup package (comparable to what other newly hired faculty receive).
Must have appropriate infrastructure to support the proposed research and a history of external research funding.

Exclusions:

Foreign organizations (non-U.S. entities or non-U.S. components of U.S. organizations) are not eligible.
Research that involves leading an independent clinical trial is not permitted under this specific funding opportunity (a companion NOFO, PAR-24-211, exists for clinical trials).

Definition of a 'Postdoctoral Fellow': In the context of this grant, eligible individuals in the NHLBI Division of Intramural Research may have titles such as postdoctoral fellow, visiting fellow, research fellow, or clinical fellow. They are in mentored research positions, a necessary step toward independently leading a research group.

Application Process

Application Submission Process:

Intramural Phase Application: This initial application is submitted by the NHLBI intramural program on your behalf. You (the candidate) must work with your mentor to prepare it.
Extramural Phase Transition: If approved to transition, a separate 'application' (a set of required documents) will be submitted by the extramural institution where you've secured a position. This usually happens about three months before your proposed start date at the extramural institution.

How to Submit:

For the intramural phase application, you'll use either the NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Once submitted through Grants.gov, you'll track your application's status in the eRA Commons.
Reference letters are submitted directly by your referees through the eRA Commons, separate from your main application.

Key Dates & Deadlines:

Earliest Submission Date: September 12, 2024
Application Due Dates: This grant has multiple, recurring deadlines. The latest listed due date for applications is June 12, 2027, at 5:00 PM local time of your applicant organization. If a due date falls on a weekend or federal holiday, the deadline is extended to the next business day.
Expiration Date: July 13, 2027 (This is when the overall funding opportunity ends).

Required Documentation & Materials (for Intramural Phase Application):

Standard NIH forms (SF424(R&R) series, PHS 398 Cover Page Supplement).
PHS 398 Career Development Award Supplemental Form, which includes:
- Candidate Information and Goals for Career Development: Your background, how it relates to your long-term goals, evidence of your potential, and commitment to an NHLBI-relevant research career. It should detail a systematic career development plan and timeline.
- Research Plan: A narrative describing the research planned for both the mentored intramural phase and the independent extramural phase. Must clearly state significance, innovation, and approach.
- Training in Responsible Conduct of Research (RCR) Plan: How you will fulfill NIH's RCR training requirements (e.g., format, subject matter, faculty involvement, duration).
- Mentor/Co-Mentor/Consultant/Collaborator Information: Statements from your primary NHLBI intramural mentor (and any co-mentors) detailing their qualifications, supervision plan, and how they will promote your independence. Signed statements from collaborators/consultants are also needed.
- Environmental & Institutional Commitment: A statement from the NHLBI Scientific Director confirming the intramural program's strong research environment, resources, and commitment to your development.
Data Management and Sharing Plan: If your research generates scientific data, you must include a plan outlining how that data will be managed and shared.
Reference Letters: These are critically important and are submitted separately by your referees.

Types of Support Offered:

Funding: Direct financial support for salary and research expenses.
Mentorship: A structured mentorship phase with an NHLBI intramural investigator.
Career Development: Support and guidance to help you establish an independent research career.
Institutional Infrastructure: Access to the NHLBI's research environment during the intramural phase, and support from your extramural institution for the independent phase.

Project Implementation & Reporting:

Grant Duration: The total award is for 5 years (up to 2 years intramural, 3 years extramural).
Reporting: You will be required to submit annual Research Performance Progress Reports (RPPRs) and financial statements. Mentors also provide annual evaluations of your progress. A final RPPR and invention statement are required at the end of the award.
Transition to Extramural Phase: This is not automatic. It requires an NHLBI progress review, including an evaluation of your research plan for the extramural institution and a confirmed tenure-track (or equivalent) offer from an eligible extramural institution. The extramural institution will submit specific documentation to NHLBI to activate this phase.

Evaluation Criteria

Applications are rigorously evaluated for their scientific and technical merit, with a focus on the applicant's potential to become an independent research scientist. Reviewers provide an 'Overall Impact' score based on the likelihood of the proposed plan enhancing the candidate's potential for a productive, independent career. Scored Review Criteria:

Candidate: Assessment of the applicant's background, research potential (evident from publications, experience, references), and commitment to an NHLBI-relevant research career.
Career Development Plan/Career Goals and Objectives/Plan to Provide Mentoring: A systematic and logical plan showing progression from past training to independent status, justifying the need for further career development. This includes specific training activities, classes, seminars, and opportunities for interaction with other scientists, tailored to the individual's needs.
Research Plan: The proposed research must span both the intramural (mentored) and extramural (independent) phases. It should clearly describe what the candidate aims to achieve in the mentored phase to launch their independent program. Significance, innovation, and approach of the research are key, as is the relationship between the mentor's and candidate's research, and how the mentored phase leads to the independent phase.
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s): The primary mentor must be an accomplished NHLBI intramural investigator with a strong track record of training research scientists. The mentorship plan, including supervision, promotion of independence, and transition plans, is crucial.
Environment & Institutional Commitment to the Candidate: The NHLBI intramural environment must be strong and well-suited for the candidate's development. For the extramural phase, the institution's commitment (protected time, space, startup funds) must be clear and substantial, demonstrating a supportive environment for launching an independent career.

Additional Review Considerations (Not Scored, but Impact Funding Decisions):

Training in the Responsible Conduct of Research (RCR): The proposed RCR training plan (minimum 8 contact hours, specific format and subject matter) is reviewed for adequacy and rated as 'ACCEPTABLE' or 'UNACCEPTABLE'.
Data Management and Sharing Plan: For research generating scientific data, the plan for managing and sharing that data is reviewed for reasonableness and adherence to NIH policy.
Budget and Period of Support: Reviewers assess if the requested budget and duration are well-justified and reasonable for the proposed research and career development.
Human Subjects and Vertebrate Animals: If applicable, protocols for protection of human subjects and care of vertebrate animals are reviewed.
Inclusion of Women, Minorities, and Individuals Across the Lifespan: Compliance with NIH policies on diversity in research participants.

Overall Selection Priorities: Funding decisions are based on the scientific and technical merit of the proposed project (as determined by peer review), the availability of funds, and the relevance of the proposed project to NHLBI program priorities.

Compliance & Special Requirements

Regulatory Compliance:

All awards are subject to the NIH Grants Policy Statement and various federal regulations, including the Public Health Service Act and 45 CFR Part 75 (which covers uniform administrative requirements, cost principles, and audit requirements for federal awards).
Recipients must comply with nondiscrimination laws, confirmed through SAM.gov registration and submission of an HHS-690 Assurance of Compliance.
Compliance with Section 872 of the Duncan Hunter National Defense Authorization Act, which involves review of your organization's integrity and performance record in SAM.gov.

Data Protection and Privacy:

If your research generates scientific data, you must comply with the 2023 NIH Policy for Data Management and Sharing. This requires submitting a detailed Data Management and Sharing Plan as part of your application.

Ethical Standards:

You must adhere to ethical standards for research involving human subjects and vertebrate animals, if applicable.
A key requirement is completing training in the Responsible Conduct of Research (RCR). Your application must include a plan for this training, which needs to consist of at least 8 contact hours of instruction in a format that involves face-to-face discussion (online-only instruction is not acceptable). This training should cover topics like conflict of interest, data management, authorship, and research misconduct.

Unique Aspects & Challenges:

Two-Phase Structure: This grant has a distinct two-phase approach: an initial mentored phase within the NHLBI's intramural program, followed by an independent phase at an extramural institution. The transition between phases is not guaranteed and requires an NHLBI review.
No Independent Clinical Trials: A critical limitation is that this specific funding opportunity does not support projects where you lead an independent clinical trial, clinical trial feasibility study, or ancillary clinical trial. If your research involves leading such trials, you must apply to the companion NOFO (PAR-24-211).
Strong Institutional Commitment Required: For the extramural phase, your new institution must demonstrate a robust commitment beyond the grant funds. This includes providing a tenure-track (or equivalent) appointment, protected research time, laboratory space, and a startup package that is comparable to what other new faculty members receive, without using K22 funds to cover these typical institutional costs.
Highly Specific Target Audience: This grant is exclusively for researchers already training within the NHLBI's intramural program, aiming to help them establish independent careers outside of NIH.

Strategic Opportunities:

This grant provides a unique bridge for NHLBI intramural researchers to transition into independent academic or research roles, which is often a challenging career step. The structured mentorship and direct funding support this critical period.
The requirement for detailed career development and research plans, along with strong mentorship, helps ensure awardees are well-prepared for long-term independent research careers and future grant applications (e.g., R01).

Cross-Cutting Themes:

The grant encourages the inclusion of women, minorities, and individuals across the lifespan in research studies, aligning with broader NIH policies on diversity and inclusivity in research.
A strong emphasis is placed on innovation within the research plan, encouraging novel approaches to scientific problems relevant to NHLBI's mission.

Grant Details