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Grant Analysis

Purpose & Target

This grant, the Midcareer Investigator Award in Patient-Oriented Research (K24), aims to support mid-career health-professional doctorates by providing them with dedicated time to conduct patient-oriented research (POR). A key objective is for these senior researchers to act as mentors for junior clinical investigators entering POR. This is a sector-specific grant, focused on biomedical, behavioral, and clinical research needs. It targets individual investigators within eligible U.S. organizations (higher education, non-profits, government, and some for-profits). The program is recurring, reissuing a previous announcement, and falls under the broader NIH Research Career Development program.

Financial Structure

This grant provides financial support for your salary and other research-related expenses.

Salary: The grant covers salary for 3-6 person-months (25% to 50%) of your full-time professional effort. The actual salary amount is based on your institutional salary, up to a legislated maximum rate set by NIH.
Other Program-Related Expenses: Up to $50,000 per year is provided for these expenses. This can cover:
- Research expenses: Such as supplies, equipment, and technical personnel for your own research or for those you mentor.
- Travel and Training: Registration and travel costs for research-related courses and meetings.
- Statistical Services: Including personnel and computer time.
Ineligible Costs: Salary for mentors (your mentors), secretarial, and administrative assistants is not allowed.
Indirect Costs (F&A Costs): Reimbursed at 8% of modified total direct costs.
Cost Sharing: This grant does not require cost sharing.
Currency: All financial amounts are in U.S. Dollars (USD).

Eligibility Requirements

Who Can Apply (Organizations)

Higher Education Institutions: Public/State Controlled and Private.
Nonprofits: Both 501(c)(3) IRS Status and Non-501(c)(3).
For-Profit Organizations: Small Businesses and other For-Profit Organizations.
Governments: Local (State, County, City or Township, Special District) and Federally/Other Recognized Indian/Native American Tribal Governments.
Other: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations.
Geographic Restriction: Only U.S. organizations are eligible. Non-domestic entities or non-U.S. components of U.S. organizations are not eligible.

Who Can Apply (Individuals - Program Director/Principal Investigator)

Health-Professional Doctoral Degree: Must possess degrees such as MD, DO, DDS, DMD, OD, DC, PharmD, ND, or a PhD/other doctoral degree in clinical disciplines like clinical psychology, nursing, clinical genetics, speech-language pathology, audiology, or rehabilitation.
Citizenship: Must be a U.S. citizen, non-citizen national, or have been lawfully admitted for permanent residence by the time of award.
Career Stage: Typically at the Associate Professor level or equivalent in an academic or non-academic setting. This signifies a 'mid-career' stage.
Research and Mentoring Experience: Must have an established record of independent, peer-reviewed patient-oriented research grant funding (at the time of application) and a demonstrated record of supervising and mentoring patient-oriented researchers.
Protected Time Commitment: Must be able to commit 3-6 person-months (25-50% full-time professional effort) to the grant's activities, demonstrating a need for this protected time to augment their POR capabilities and mentoring ability.

Exclusions and Important Notes

Duplicate Applications: An individual cannot have two or more competing NIH career development applications pending review concurrently, nor can they submit duplicate or highly overlapping applications.
Cost Sharing: Not required for this funding opportunity.
Required Registrations: Applicant organizations must register and maintain active registrations with the System for Award Management (SAM), obtain a Unique Entity Identifier (UEI), register with eRA Commons, and Grants.gov. PD/PIs must have an eRA Commons account linked to a valid ORCID ID.
Institutional Environment: The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified in biomedical, behavioral, or clinical research to collaborate with the applicant.

Application Process

Key Dates and Deadlines

Posted Date: April 25, 2024
Open Date (Earliest Submission): May 10, 2024
Application Due Dates: This grant has multiple submission deadlines for new, renewal, resubmission, and revision applications. The latest possible deadline is February 12, 2027, for new applications, with subsequent deadlines on June 12, 2027, and October 12, 2027, for renewals/resubmissions/revisions.
Submission Time: All applications are due by 5:00 PM local time of the applicant organization.
Expiration Date: May 08, 2027 (This is when the funding opportunity itself expires).

Application Process

Submission Method: Applications must be submitted electronically through Grants.gov using either the NIH ASSIST system, an institutional system-to-system (S2S) solution, or the Grants.gov Workspace.
Pre-application Consultations: Strongly encouraged to consult with NIH staff (specifically IC-Specific Contacts) before submitting, as individual Institute and Center (IC) requirements vary.
Required Registrations: Ensure your organization and you (as PD/PI) complete all necessary registrations (SAM, UEI, eRA Commons, ORCID) well in advance, as this process can take six weeks or more.
Early Submission: Applicants are encouraged to submit early to allow time for correcting any errors before the deadline.

Required Documentation and Materials Applicants must follow instructions in the NIH 'How to Apply - Application Guide' and any program-specific instructions in this announcement. Key components include: * Standard grant forms: SF424(R&R) series (Cover, Project/Performance Site Locations, Senior/Key Person Profile Expanded, R&R Budget). * PHS forms: PHS 398 Cover Page Supplement, PHS 398 Career Development Award Supplemental Form. * Detailed Research Plan: Describe currently supported research and new research specific to this award. This section is critical for demonstrating the scientific merit of your work and opportunities for mentoring. * Candidate Section: Outline your research career background, ability to conduct and mentor POR, and how protected time will benefit your research and mentoring. * Career Goals and Objectives: Describe your goals under this award, including timelines and how it enhances your mentoring activities. * Mentoring Plan: A required component detailing available junior investigators, recruitment, selection, supervision, educational experiences, and how you will support their research. * Institutional Commitment: A statement from your institution confirming support for your development as an independent investigator, the protected time you'll receive, and how clinical/administrative duties will be covered. * Data Management and Sharing Plan: Required for all research generating scientific data. * Human Subjects and Clinical Trials Information: If applicable, this section must confirm the study is a basic experimental study with humans and meets NIH's clinical trial and basic research definitions. Project Implementation and Reporting

Project Period: The total project period cannot exceed 5 years.
Annual Reporting: Recipients must submit an annual Research Performance Progress Report (RPPR) and financial statements. For mentored awards, a Mentor's Report including an annual evaluation of the candidate's progress is required.
Final Reporting: A final RPPR, invention statement, and expenditure data are required for award closeout.
Data Management and Sharing: Recipients must implement their approved Data Management and Sharing Plan.

Evaluation Criteria

The evaluation focuses on the candidate's capacity for independent research and mentoring, and the scientific merit of the proposed work. Reviewers will assess the likelihood that the proposed career development and research plan will enhance the candidate's potential for a productive, independent scientific research career. Key Scored Criteria:

Candidate: Evaluation of your (the applicant's) ongoing high-quality patient-oriented research (POR), your ability and commitment to mentor new clinical investigators, how the protected time from this award will free you from non-research duties, and your track record of independent peer-reviewed POR funding. Your potential to manage clinical trials and your training in data management and statistics are also considered.
Plan to Provide Mentoring: The adequacy of your plans to mentor new clinical investigators in POR, how well you integrate relevant clinical research curricula, and if your proposed effort level for mentoring is appropriate.
Research Plan: How your proposed research and career development activities will advance your research career. The scientific and technical merit of your proposed research, its relevance to your career goals, and the availability of resources for the research are crucial. For clinical trials, ancillary trials, or feasibility studies, the scientific rationale, design, quality assurance, statistical analysis, and potential for advancing scientific understanding are reviewed.
Consultants/Collaborators: Adequacy of documented expertise for any consultants or collaborators.
Environment & Institutional Commitment: The suitability of research facilities, resources, and training opportunities, including faculty. The institution's intent to support you as an independent investigator, the quality and size of the pool of clinical investigators you will mentor, and the institution's commitment to your protected time and to developing new clinical investigators you mentor. For clinical trials, the appropriateness of administrative, data, enrollment, and laboratory centers, and plans for international sites if applicable.

Additional Review Considerations (Not Scored but Assessed):

Study Timeline for Clinical Trials: Feasibility and justification of the timeline, including efficiency measures and potential challenges/solutions.
Protections for Human Subjects: Justification for human subject involvement, adequacy of protection against risks, potential benefits, importance of knowledge gained, and data/safety monitoring.
Inclusion: Plans for inclusion (or justification for exclusion) of women, racial/ethnic minorities, and individuals across the lifespan in human subject research.
Vertebrate Animals: Justification for animal use, appropriate species, and measures to limit discomfort.
Biohazards: Assessment of potential hazards and proposed protections.
Resource Sharing Plans: Reasonableness of plans for sharing resources (e.g., model organisms) or rationale for not sharing.
Training in Responsible Conduct of Research (RCR): All applications must include an RCR training plan. This plan will be rated as 'Acceptable' or 'Unacceptable' based on format, subject matter, faculty participation, duration (at least 8 contact hours required), and frequency (at least once every four years).
Select Agent Research: Information on select agents, registration status, monitoring procedures, and biosafety/biocontainment/security plans.
Authentication of Key Resources: Brief plans for identifying and ensuring the validity of key biological and/or chemical resources.
Budget and Period of Support: Justification and reasonableness of the budget and requested project period.

Compliance & Special Requirements

Regulatory Compliance

Federal Regulations: Awards are made under the authority of Sections 301 and 405 of the Public Health Service Act and subject to Federal Regulations 42 CFR Part 52 and 2 CFR Part 75.
NIH Grants Policy Statement: All awards are subject to the terms and conditions outlined in the NIH Grants Policy Statement.
Required Registrations: Organizations must maintain active registrations with the System for Award Management (SAM) and eRA Commons. PD/PIs must have an eRA Commons account and an ORCID ID.
Nondiscrimination: Recipients must comply with all applicable nondiscrimination laws as agreed upon during SAM.gov registration.

Data, Ethics, and Research Standards

Data Management and Sharing: A Data Management and Sharing Plan is mandatory for all applications involving scientific data generation, regardless of requested direct costs. This plan must be implemented upon approval.
Responsible Conduct of Research (RCR): All applications must include a plan for instruction in RCR, adhering to NIH requirements (e.g., face-to-face instruction, minimum 8 contact hours, specific subject matter, faculty involvement).
Human Subjects Protections: Strict adherence to ethical guidelines for human subjects research, including IRB/IEC approval and data and safety monitoring requirements for clinical trials. Applications must involve basic science experimental studies with humans that meet both NIH's definition of a clinical trial and basic research.
Inclusion: Plans for inclusion of women, racial and ethnic minorities, and individuals across the lifespan must be addressed in human subjects research.

Unique Aspects and Strategic Considerations

Dual Role: This grant is unique in its dual emphasis: supporting the K24 recipient's own patient-oriented research while also requiring them to actively mentor junior clinical investigators.
Focus on Basic Experimental Studies: The grant specifically targets clinical trials that are also defined as basic research, focusing on understanding fundamental phenomena rather than direct product/process application (e.g., FDA Phase 0 or 1 studies, mechanistic clinical trials, safety/efficacy studies should apply to companion NOFOs). This is a very specific type of clinical trial.
Renewal Opportunity: Recipients may apply for a one-time renewal for an additional three to five years of support, provided they continue to hold independent peer-reviewed research support.
Career Progression: Intended for mid-career investigators (e.g., Associate Professors) to stabilize their careers, expand their research programs, and assume leadership roles in collaborative POR.
Risk Management: Progress reports require documentation of efforts to replace lost independent peer-reviewed funding during the award period.
Loan Repayment Programs (LRPs): Recipients are encouraged to consider applying for extramural NIH LRP awards, which help repay student loans for researchers.

Grant Details

Grant Analysis

Purpose & Target

Financial Structure

Eligibility Requirements

Application Process

Evaluation Criteria

Compliance & Special Requirements

Grant Details