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Grant Analysis

Purpose & Target

This grant, the NIH Pathway to Independence Award (K99/R00), aims to help outstanding postdoctoral researchers successfully transition from mentored positions to independent, tenure-track or equivalent faculty roles. Its core objective is to provide independent NIH research support to facilitate the launch of competitive, self-sufficient research careers for these individuals. The grant specifically targets postdoctoral researchers with a research and/or clinical doctorate degree who are ready to undertake basic science experimental studies involving human participants, aligning with NIH's definition of both a clinical trial and basic research. This is a SECTOR-SPECIFIC grant, focusing exclusively on biomedical, behavioral, and clinical research, particularly studies involving basic experimental research with humans. The geographic scope is limited to the United States; foreign organizations cannot apply, though foreign components of projects within U.S. institutions are allowed. Key filtering criteria include the applicant's career stage (postdoctoral, no more than 4 years of experience), their doctoral degree, and the nature of their proposed research (basic experimental studies with humans). This is a recurring funding opportunity with multiple application deadlines each year until its expiration.

Financial Structure

This grant does not specify a total funding amount for the program; awards are contingent on NIH appropriations and the submission of meritorious applications. Budget Range and Limitations

K99 Phase (Mentored): Salary and other research costs may be requested up to the level provided by the specific NIH Institute or Center (IC). Intramural NIH candidates are supported by intramural funds, with salary consistent with similar NIH positions. Extramural candidates' salaries must align with institutional salary structures and actual institutional provisions for comparable staff. Total salary from all federal sources cannot exceed the maximum legislated salary rate, and total effort cannot exceed 100%.
R00 Phase (Independent): The total cost for this phase may not exceed $249,000 per year. This amount is comprehensive, covering salary, fringe benefits, research costs, and applicable indirect costs.

Eligible and Ineligible Costs

Eligible Expenses: Funds can be used for tuition and fees related to career development, research-related expenses (such as supplies, equipment, and technical personnel), travel to research meetings or training, and statistical services (including personnel and computer time).
Ineligible Expenses: Salary for mentors, secretarial, and administrative assistants is not allowed.

Matching Fund Requirements

This funding opportunity does not require cost sharing.

Indirect Cost Policies

K99 Phase (Extramural): Indirect Costs (Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.
R00 Phase: Indirect costs will be reimbursed at the extramural sponsoring institution’s full indirect cost rate.

Financial Reporting and Sustainability

Recipients must submit annual financial statements and a final expenditure data report. Annual Research Performance Progress Reports (RPPR) are also required. The R00 phase aims to support the development of a research program that will be competitive for subsequent independent funding (e.g., R01 grants), indicating an expectation for future financial independence. The R00 sponsoring institution must provide a startup and salary package comparable to that given to other newly hired faculty members who do not have grant support, as R00 funds cannot be used to offset typical institutional commitments.

Eligibility Requirements

Organizational Eligibility This grant is open to a wide range of U.S. organizations that can serve as the sponsoring institution for the postdoctoral candidate, including: * Higher Education Institutions: Public/State Controlled and Private Institutions of Higher Education. * Nonprofit Organizations: Both 501(c)(3) and other nonprofits. * For-Profit Organizations: Including Small Businesses and other For-Profit Organizations. * Government Entities: Local (County, City/Township, Special District), State, Indian/Native American Tribal Governments (Federally Recognized and Other), and Eligible Agencies of the Federal Government. * Other: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations (other than Federally recognized tribal governments), Faith-based or Community-based Organizations, and Regional Organizations. Important Note for Organizations: While many organization types are eligible for the K99 (mentored) phase, Federal government agencies (like NIH intramural programs) are only eligible for the mentored phase. For the R00 (independent) phase, the eligibility of organizations other than higher education institutions depends on the candidate's appointment and their ability to conduct independent research and apply for NIH R01-equivalent grants. Foreign Organizations are explicitly not eligible to apply. Non-domestic components of U.S. Organizations are also not eligible to apply. However, foreign components within a project (e.g., research activities conducted abroad by a U.S. recipient) are allowed as defined by NIH policy. Individual Eligibility (Program Director/Principal Investigator) Candidates for this award must meet strict criteria: * Possess a research or clinical doctorate degree, such as PhD, MD, DO, DC, ND, DDS, DMD, DVM, ScD, DNS, PharmD, or equivalent. * Have no more than 4 years of postdoctoral research experience at the time of application (initial or resubmission). * Must be in a mentored, postdoctoral training position when applying. If a candidate achieves an independent faculty or non-mentored research position before a K99 award is made, they become ineligible for both the K99 and R00 phases. * There is no citizenship requirement; applicants can be U.S. citizens, lawful permanent residents, or non-U.S. citizens with appropriate visa status that allows them to conduct research in the U.S. for the duration of the award. Exclusion Criteria: Individuals are NOT eligible if they have: * Currently or previously held an independent research faculty or tenure-track faculty position (or its equivalent) in academia, industry, or elsewhere. * More than 4 years of related postdoctoral research training. * Been an independent Program Director/Principal Investigator (PD/PI) on significant research grants, specifically: * NIH research grants (e.g., R01, R03, R21). * NIH career development awards (e.g., K01, K07, K08, K23, K25). * Other peer-reviewed NIH or non-NIH research grants exceeding $100,000 direct costs per year. * Project Leaders on sub-projects of program project (P01) or center (P50) grants or equivalent. Special Considerations:

Postdoctoral Experience Calculation: The 4-year limit may be extended for childbirth (1 year) or other well-justified leaves (e.g., parental, medical, military) of less than 12 months. Only time dedicated to research activities counts toward the limit. Clinical training without research involvement is generally excluded.
Mentorship: The candidate must identify a primary mentor (or a mentoring team) who is an active investigator in the proposed research area, committed to the candidate's career development, and can provide direct supervision and sufficient research support. The mentor should have a successful track record of mentoring individuals at this career stage.
Institutional Environment: The sponsoring institution must demonstrate a strong record of research and career development and possess faculty qualified to serve as mentors. They must also commit to providing the necessary resources and facilities for the candidate's research and development.

Application Process

Application Deadlines and Submission Applications must be submitted electronically via NIH ASSIST, an institutional system-to-system (S2S) solution, or Grants.gov Workspace. All applications are due by 5:00 PM local time of the applicant organization. Applicants are strongly encouraged to submit early to allow for error correction. Key Application Due Dates (Latest is February 12, 2027): * June 12, 2024 * October 12, 2024 * February 12, 2025 * June 12, 2025 * October 12, 2025 * February 12, 2026 * June 12, 2026 * October 12, 2026 * February 12, 2027 (Latest New/Resubmission/Revision Due Date) Project Duration The total project period, encompassing both the mentored (K99) and independent (R00) phases, may not exceed 5 years (up to 2 years for K99 and up to 3 years for R00). Required Documentation and Materials Applicants must follow the instructions in the Career Development (K) Instructions in the NIH 'How to Apply - Application Guide', supplemented by this specific funding opportunity's instructions. Key components include: * Standard Forms (SF424(R&R)): Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile Expanded, and R&R Budget. * PHS 398 Forms: Cover Page Supplement and Career Development Award Supplemental Form. * Career Development Award Supplemental Form Sections: * Candidate Section: Includes candidate's background, commitment to research, potential as an independent investigator, career goals and objectives, and a systematic plan for career development and training activities. * Research Plan Section: Must span both K99 and R00 phases, detailing the research strategy, significance, innovation, and approach. For clinical trials, detailed analyses, statistical approaches, and timelines are required. * Mentor, Co-Mentor, Consultant, Collaborators Section: Requires statements from the primary mentor (and co-mentors) detailing their qualifications, supervision plan, how scientific independence will be promoted, and commitment of resources. Signed statements from collaborators/consultants are also needed. * Environment & Institutional Commitment to the Candidate Section: Describes the institutional research environment, available resources and facilities, and the institution's commitment to the candidate's development into an independent investigator, including assurance of required effort commitment. * PHS Human Subjects and Clinical Trials Information: Required for all proposed basic experimental studies involving humans. * PHS Assignment Request Form. * Reference Letters: Submitted directly by referees through the eRA Commons (a separate process from the application submission). * Data Management and Sharing Plan: Required for all research generating scientific data. Types of Support Offered The grant primarily provides funding to cover salary, research costs, travel, and tuition related to career development. Beyond financial support, it inherently offers significant mentorship, research development, and capacity building opportunities for the awardee to transition to an independent research career. Post-Award Requirements and Compliance

Reporting: Recipients must submit annual Research Performance Progress Reports (RPPRs) and financial statements. A final RPPR, invention statement, and expenditure data are required for closeout. Mentored awards require an annual evaluation statement from the mentor.
Transition to R00: The R00 phase is activated upon securing an independent, tenure-track (or equivalent) faculty position. The R00 institution submits an application (including updated budget, research plan, progress report for K99) to the awarding IC. Strong institutional commitment for the R00 phase is vital.
Data Management and Sharing: Recipients must adhere to their approved Data Management and Sharing Plan.
Federal Reporting: Compliance with the Federal Funding Accountability and Transparency Act (FFATA) and reporting to the Federal Subaward Reporting System (FSRS) for subawards over specific thresholds. Semiannual disclosures on integrity matters in SAM.gov are also required.

Evaluation Criteria

Applications are reviewed for scientific and technical merit with a focus on the candidate's potential to achieve an independent, productive scientific research career. Overall Impact Reviewers assess the likelihood that the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career. This includes evaluating the value of the K99 (mentored) phase in facilitating transition to independence and the feasibility of the proposed R00 (independent) project as a vehicle for a successful independent research program. Scored Review Criteria Each of the following categories receives a separate score: * Candidate: Evaluation focuses on the candidate's potential to become a highly successful independent investigator. This includes their prior research and training experience, publication record, referee evaluations, and ability to organize and implement the proposed clinical trial. Reviewers also assess their training (or plans for training) in data management and statistics relevant to clinical trials. * Career Development Plan/Career Goals and Objectives: Reviewers assess the appropriateness and justification of the proposed career development activities (content and duration) for the candidate's stage. The plan should significantly enhance their research training and skills, facilitating a successful transition to independence. The evaluation includes the adequacy of plans for monitoring progress and the timeline for transitioning to the independent phase. * Research Plan: This section is evaluated for both the K99 and R00 phases. * K99 Phase: Assessed for scientific significance, soundness, and rigor (addressing weaknesses in prior research, ensuring robust/unbiased approach, considering biological variables like sex). The K99 research must be appropriate for developing the candidate's research skills and preparing them for a strong R00 program. * R00 Phase: Evaluated for scientific significance, soundness, logical extension from the K99 phase, and long-term viability. Innovation (novel hypotheses, concepts, methodologies) is also considered. * Clinical Trial Focus: For proposed basic experimental studies with humans (which meet the NIH clinical trial definition), reviewers check if the scientific rationale is well-supported, the study design is justified, and plans for quality assurance, protocol adherence, and statistical analysis are appropriate. The necessity of the trial for advancing scientific understanding is also evaluated. * Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s): Evaluated based on the mentor's track record in training independent researchers, their qualifications, scientific stature, and commitment to the applicant's career development. The mentorship plan should clearly address training needs and promote the candidate's scientific separation and independence. Expertise in guiding clinical trials is also a key consideration. * Environment & Institutional Commitment to the Candidate: Assessment of the sponsoring institution's research environment, facilities, and educational opportunities for the candidate's development during the K99 phase. A strong institutional commitment to fostering the candidate's transition to independence is critical, including assurance of the required 75% professional effort dedicated to research and career development. For clinical trials, the adequacy of administrative, data coordinating, enrollment, and laboratory resources is reviewed. Additional Review Criteria (Not Scored)

Study Timeline for Clinical Trials: Feasibility, efficiency, and discussion of potential challenges and solutions.
Protections for Human Subjects: Justification for involvement, adequacy of protection against risks, potential benefits, importance of knowledge gained, and data and safety monitoring.
Inclusion: Plans for inclusion (or exclusion) of individuals based on sex, race, ethnicity, and age (lifespan) are evaluated for scientific justification.
Vertebrate Animals: Justification of species, methods to limit discomfort, and euthanasia protocols.
Biohazards: Assessment of potential hazards and proposed protection measures.
Resubmissions/Revisions: Evaluation of responses to previous review comments and changes made to the project or scope.

Other Review Considerations (Not Scored)

Resource Sharing Plans: Reasonableness of plans or rationale for not sharing resources.
Training in Responsible Conduct of Research (RCR): Adequacy of the proposed RCR training plan, including format (face-to-face required), subject matter, faculty participation, duration (at least 8 contact hours), and frequency (at least every four years). Rated as 'ACCEPTABLE' or 'UNACCEPTABLE'.
Select Agent Research: Assessment of safety, containment, and security measures.
Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity of resources.
Budget and Period of Support: Reasonableness and justification of the budget and requested period of support in relation to the proposed research.

Compliance & Special Requirements

Regulatory Compliance Requirements Awardees must comply with a broad range of federal and NIH-specific regulations: * NIH Grants Policy Statement: All awards are subject to the terms and conditions outlined here. * Federal Regulations: Including 42 CFR Part 52 and 2 CFR Part 75. * Nondiscrimination Laws: Recipients agree to abide by these laws upon SAM.gov registration. * SAM.gov Requirements: Federal agencies review integrity and performance information for applicants in SAM.gov prior to making awards. * Data Protection and Privacy: Compliance with the 2023 NIH Policy for Data Management and Sharing is mandatory for research generating scientific data. Required Permits and Authorizations

IRB or IEC Approval: Recipient institutions must ensure all human subjects protocols are reviewed and approved by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Data and Safety Monitoring: Required for all NIH-funded human biomedical and behavioral intervention studies (clinical trials).

Ethical Standards

A plan for instruction in the Responsible Conduct of Research (RCR) is required for all applications. This plan must cover specific formats (face-to-face discussion), subject matter (e.g., conflict of interest, data management, human subjects, research misconduct), faculty involvement, duration (at least 8 contact hours), and frequency (at least every four years).

Unique Aspects and Strategic Opportunities

Dual-Phase Structure: This grant uniquely supports a career transition, with an initial mentored (K99) phase (up to 2 years) followed by an independent (R00) phase (up to 3 years). The R00 phase is contingent on securing a suitable independent faculty position.
Specific Research Focus: This funding opportunity is specifically for basic science experimental studies involving human participants that meet both the NIH definition of a clinical trial and basic research. Applicants proposing other types of clinical trials or observational studies must apply to different NIH funding opportunities (e.g., PA-24-193 or PA-24-194).
Career Independence Emphasis: A core goal is to foster the candidate's transition to scientific independence. The application must clearly articulate how the K99 phase will enable the candidate to launch an independent research program and how they will scientifically separate from their mentor.
Strict Eligibility on Prior Experience: Candidates must not have previously held independent research faculty positions or significant prior independent grant funding.
Institutional Commitment for R00 Phase: The institution where the R00 phase will be conducted must demonstrate a strong commitment, including providing a start-up package and salary comparable to those offered to new faculty members without grant support. The R00 appointment must be a tenure-track assistant professor (or equivalent) position.
Mentorship Quality: The mentor's commitment, expertise, and track record in successfully training independent researchers are critical evaluation factors.

Cross-Cutting Considerations

Inclusion: Projects involving human subjects must detail plans for the inclusion (or justified exclusion) of individuals across sex, race, ethnicity, and lifespan. These plans are subject to review.
Risk Management: Applications must address protections for human subjects, biohazards, and, if applicable, the safe handling of select agents.
Data Management & Sharing: Required for all data-generating research.

Grant Details