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Grant Analysis

Purpose & Target

The core objective of the Midcareer Investigator Award in Patient-Oriented Research (K24) is to provide protected time for mid-career health-professional doctorates to focus on patient-oriented research (POR) and to serve as research mentors for junior clinical investigators pursuing POR.
Target recipients are mid-career clinician-scientists, typically at the Associate Professor level or equivalent, who have their own independent, peer-reviewed research support.
This grant is SECTOR-SPECIFIC to healthcare, biomedical, behavioral, and clinical research fields.
Geographic scope is limited to the United States; foreign organizations are not eligible to apply.
Key filtering criteria for initial screening include: candidate's mid-career stage, health-professional doctoral degree, existing independent peer-reviewed POR funding, and a commitment to mentoring junior clinical investigators.
This is a recurring grant opportunity, reissued from a previous announcement (PA-20-186), with multiple application due dates extending through February 2027.

Financial Structure

Funding Instrument: Grant, a financial assistance mechanism.
Award Project Period: The total project period may not exceed 5 years. Renewals for an additional 3-5 years are possible.
Salary: The K24 award provides salary for levels of effort between 3-6 person-months (25% and 50% full-time professional effort). The actual salary is based on a full-time, 12-month appointment at the sponsoring institution, the PD/PI's institutional salary, and requested effort, up to the maximum legislated NIH salary rate.
Other Program-Related Expenses: Up to $50,000 per year is provided for:
Research expenses (e.g., supplies, equipment, technical personnel for the PD/PI and/or those mentored).
Registration and/or travel to research-related courses and meetings.
Statistical services (including personnel and computer time).
Ineligible Costs: Salary for mentors, secretarial, and administrative assistants is not allowed as part of the K24 award budget.
Indirect Costs: Reimbursed at 8% of modified total direct costs.
Cost Sharing/Matching Funds: This funding opportunity does not require cost sharing.

Eligibility Requirements

Organizational Eligibility

Eligible organizations include:
Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (501(c)(3) IRS Status, and other Nonprofits)
For-Profit Organizations (Small Businesses, and other For-Profit Organizations)
Local, State, County, City, Special District, and Indian/Native American Tribal Governments (Federally Recognized and other)
Other entity types: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations.
Geographic: Must be a U.S. organization. Non-domestic (non-U.S.) Entities are not eligible to apply, nor are non-domestic components of U.S. Organizations. However, foreign components (e.g., collaborators, specific sites) are allowed.
Registrations: Applicant organizations must complete and maintain active registrations in the System for Award Management (SAM), obtain a Unique Entity Identifier (UEI), register with eRA Commons, and Grants.gov prior to application submission. These registrations can take 6+ weeks.

Individual (PD/PI) Eligibility

Citizenship: By the time of award, the individual must be a U.S. citizen, non-citizen national, or a lawful permanent resident (possess a valid Permanent Resident Card USCIS Form I-551, or other legal verification).
Degree: Must hold a health-professional doctoral degree, including but not limited to MD, DO, DDS, DMD, OD, DC, PharmD, ND (Doctor of Naturopathy), or PhD/other doctoral degree in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology, or rehabilitation.
Career Stage: Candidates should typically be in the mid-career stage (e.g., at the Associate Professor level or functioning at that rank in an academic or equivalent non-academic setting).
Research Track Record: Must have an established record of independent, peer-reviewed patient-oriented research grant funding at the time of application and a record of publications.
Mentoring Track Record: Must have a record of supervising and mentoring patient-oriented researchers.
Concurrent Awards: May not concurrently apply for any other PHS career award or have another PHS career award pending review.
Effort Commitment: Must commit 3-6 person-months (equivalent to 25-50% full-time professional effort) for intensive research focus and mentoring activities.
Clinical Trial Focus: This specific funding opportunity (PA-24-188) is designed for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. However, candidates are permitted to propose a research experience in a clinical trial led by a mentor or co-mentor.

Institutional Environment

The applicant institution must demonstrate a strong, well-established record of research and career development activities.
The institution must have faculty qualified in biomedical, behavioral, or clinical research who can collaborate with the candidate.
The institution must provide a written statement of commitment to the candidate's development, including providing the required protected time and clearly describing how the candidate will be relieved from patient care or administrative duties.

Application Process

Application Submission

Submission Method: Applications must be submitted electronically through Grants.gov. Applicants can use the NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Instructions: It is critical to follow the instructions in the 'Career Development (K) Instructions in the How to Apply - Application Guide' as well as any specific instructions provided in this NOFO. Non-compliance may lead to delayed processing or non-acceptance for review.
Deadlines: Applications are due by 5:00 PM local time of the applicant organization. The latest due date provided is 2027-02-12. Multiple recurring due dates are available throughout the year (e.g., June, October, February).
Early Submission: Applicants are strongly encouraged to submit early to allow time for correction of any errors identified during the submission process.
Post-Submission Materials: Follow the NIH policy for submitting post-submission materials.

Required Registrations

Organizations: Must complete and maintain active registrations in the System for Award Management (SAM), obtain a Unique Entity Identifier (UEI), register with eRA Commons, and Grants.gov. These processes can take 6 weeks or more.
Individuals (PD/PIs): Must have an eRA Commons account, which must be linked to a valid ORCID ID.

Required Documentation and Materials

Standard Forms: SF424(R&R) forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile Expanded, R&R Budget).
Supplemental Forms: PHS 398 Cover Page Supplement and PHS 398 Career Development Award Supplemental Form, which includes:
Candidate Section: Details on career goals, background, commitment to POR and mentoring, and plan for career development/training activities.
Research Plan Section: Information on currently supported research, proposed new research (not requiring R01-level detail but sufficient for scientific merit evaluation), and a plan for training in the Responsible Conduct of Research (RCR).
Other Candidate Information Section: A detailed plan for providing mentoring to junior investigators, including availability of mentees, recruitment, selection, supervision, and educational experiences.
Mentor, Co-Mentor, Consultant, Collaborators Section: Signed statements from collaborators/consultants confirming participation and specific roles.
Environmental and Institutional Commitment to the Candidate: Description of institutional environment and a statement of institutional commitment.
Data Management and Sharing Plan: Required for all applications planning research that generates scientific data (for due dates on or after January 25, 2023).
Appendix: Limited items are allowed.
PHS Human Subjects and Clinical Trials Information: Required if human subjects are involved; note that for this NOFO, sections for independent clinical trial protocol synopsis are not completed.

Evaluation Process

Peer Review: Applications are evaluated for scientific and technical merit by Scientific Review Groups according to NIH peer review policies.
Scoring: Only applications deemed to have the highest scientific and technical merit (typically the top half) will be discussed and assigned an overall impact score.
Feedback: All applicants will receive a written critique (Summary Statement).
Second Level Review: Recommended applications undergo a second level of review by an appropriate National Advisory Council or Board.
Funding Decisions: Based on scientific/technical merit, availability of funds, and relevance to program priorities.

Project Implementation and Reporting

Project Duration: The total project period for an award may not exceed 5 years. A one-time renewal for an additional 3 to 5 years is possible under certain conditions.
Annual Reporting: Recipients must submit an annual Research Performance Progress Report (RPPR) and financial statements. Mentored awards require a Mentor's Report including an annual evaluation of the candidate's progress.
Closeout Reporting: A final RPPR, invention statement, and expenditure data are required for award closeout.
Data Management and Sharing: Approved Data Management and Sharing Plans must be implemented as described.

Support Types

Funding: Provides salary support for the mid-career investigator's protected time and annual funds (up to $50,000) for research expenses, travel, and statistical services.
Mentorship: Supports the candidate in acting as a research mentor for junior clinical investigators.
Research & Career Development: Provides protected time to enhance the candidate's capabilities in Patient-Oriented Research and foster their independent research career.

Evaluation Criteria

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 in a health-related field.

Scored Review Criteria

Candidate:
Evidence of ongoing high-quality patient-oriented research and its relevance to the K24 application.
Demonstration that the protected time provided by the award will effectively relieve non-research patient care and administrative duties, thereby augmenting capabilities in patient-oriented research.
Record of independent peer-reviewed patient-oriented research (POR) support, indicating likelihood of continuation during the K24 award.
Demonstrated capabilities and commitment to serve as a mentor for new clinical investigators in POR.
Plan to Provide Mentoring:
Adequacy of plans for providing mentoring or supervising new clinical investigators in POR.
Adequacy of plans to integrate appropriate clinical research curricula into the mentoring approach.
Appropriateness of the proposed level of effort dedicated to the mentoring component.
Research Plan:
Evaluation of how the research and career development plans together advance the candidate's research career.
Appropriateness of the research plan as a vehicle for demonstrating and developing the prospective mentee's skills and capabilities in POR.
Scientific and technical merit of the proposed research.
Relevance of the proposed research to the candidate's overall career objectives.
Availability of adequate resources to conduct the research program, including plans for continued support during the funding period.
If clinical trial experience is proposed (led by a mentor), its contribution to the overall research project.
Consultant(s), Collaborator(s):
Adequacy of information provided to clearly document expertise in the proposed area(s) of consulting/collaboration.
Environment & Institutional Commitment to the Candidate:
Adequacy and appropriateness of research facilities, resources, and training opportunities, including faculty capable of productive collaboration.
Assurance that the institution intends the candidate to be an integral part of its research program as an independent investigator.
Appropriateness of the applicant institution’s commitment to the scientific development of the candidate.
Adequacy of the size and quality of the pool of clinician investigators available for mentoring by the PD/PI.
Appropriateness and adequacy of the environment for continuing the scientific and professional development of the candidate and others pursuing POR.
Adequacy of commitment from the sponsoring institution to provide protected time for the candidate's research and mentoring program.
Adequacy of the institution's commitment to the career development of new clinical investigators mentored by the candidate.

Additional Review Criteria (Not Scored)

Protections for Human Subjects: Evaluation of justification for involvement, proposed protections, potential benefits, importance of knowledge, and data/safety monitoring for clinical trials (if applicable).
Inclusion of Women, Racial and Ethnic Minorities, and Individuals Across the Lifespan: Evaluation of plans for inclusion/exclusion based on sex, race, ethnicity, and age to ensure scientific justification.
Vertebrate Animals: Assessment of procedures, justification for species, and interventions to limit discomfort (if applicable).
Biohazards: Assessment of potential hazards from materials/procedures and adequacy of proposed protections.
Resubmissions/Renewals/Revisions: Progress made, responses to previous review comments, and appropriateness of scope expansion.

Additional Review Considerations (Not Scored)

Resource Sharing Plans: Reasonableness of sharing plans or rationale for not sharing.
Training in the Responsible Conduct of Research (RCR): Evaluation of the RCR training plan's adequacy based on five required components: Format (must include face-to-face, not solely online), Subject Matter (breadth of topics), Faculty Participation, Duration of Instruction (at least 8 contact hours), and Frequency (at least once every four years). Rated as 'ACCEPTABLE' or 'UNACCEPTABLE'.
Select Agent Research: Information on agents used, registration status, monitoring procedures, and biosafety/biocontainment plans.
Authentication of Key Biological and/or Chemical Resources: Brief plans for identifying and ensuring validity.

Compliance & Special Requirements

Regulatory Compliance

General: All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Required Registrations: Strict compliance with organizational (SAM, UEI, eRA Commons, Grants.gov) and individual (eRA Commons, ORCID) registration requirements is mandatory. Failure to register can prevent submission or award.
Human Subjects Research: Compliance with 45 CFR Part 46 and NIH Inclusion Policies for Research Involving Human Subjects (covering women, racial/ethnic minorities, and individuals across the lifespan) is required if applicable.
Animal Research: Compliance with ethical standards for the involvement of live vertebrate animals is required if applicable.
Biohazards: Projects involving potentially hazardous materials or procedures must propose adequate protections for research personnel and the environment.
Responsible Conduct of Research (RCR): All applications must include a plan for RCR instruction that meets NIH requirements, including specific format (not solely online), subject matter, faculty participation, duration (at least 8 contact hours), and frequency (at least once every four years).
Data Management and Sharing Policy: Compliance is required for research that generates scientific data, effective for applications with due dates on or after January 25, 2023.
Institutional Review Board (IRB) / Independent Ethics Committee (IEC) Approval: Grantee institutions must ensure all research protocols involving human subjects are reviewed and approved by their IRB or IEC.
Non-discrimination Laws: Recipients must comply with all applicable nondiscrimination laws, as agreed upon during SAM.gov registration, and submit an Assurance of Compliance (HHS-690).
Federal Reporting: Includes reporting of first-tier subawards (over threshold) to the Federal Subaward Reporting System (FSRS) and, for large awards (>$10M cumulative value), reporting civil/criminal/administrative proceedings in SAM.gov.

Intellectual Property

No specific intellectual property policies are detailed within this NOFO beyond general NIH policies, implying adherence to standard federal regulations such as the Bayh-Dole Act for inventions arising from federally funded research.

Risk Management

Reviewers assess proposed risk mitigation strategies related to biohazards and ensure adequate protections are in place.
Applicants are responsible for ensuring applications are complete and compliant by the deadline; incomplete or non-compliant applications will not be reviewed.

Unique Aspects / Special Considerations

Clinical Trial Restriction: A critical aspect of this specific K24 (PA-24-188) is that it explicitly excludes applicants proposing to lead an independent clinical trial, clinical trial feasibility study, or ancillary clinical trial. However, proposing to gain experience in a clinical trial led by a mentor or co-mentor is permitted.
Dual Focus: The grant serves two primary purposes for the mid-career investigator: augmenting their own patient-oriented research capabilities and providing dedicated time for mentoring junior clinical investigators.
Mid-Career Stablization: Intended to stabilize the careers of established clinician-scientists who already possess independent research funding.
Protected Time: A key benefit is the provision of protected time to reduce clinical and administrative responsibilities, allowing increased focus on research and mentoring.
IC-Specific Requirements: Applicants are strongly advised to consult the 'Table of IC-Specific Information, Requirements, and Staff Contacts' as individual NIH Institutes and Centers (ICs) participating in this program may have specific requirements and areas of interest.
Renewal Opportunity: The award may be renewed one time for an additional 3-5 years, subject to IC policies, continued independent research support, and demonstration of continued need for protected time.
NIH Loan Repayment Programs (LRPs): Recipients are encouraged to explore and apply for extramural LRP awards, which can help repay student loans for researchers.

Grant Details