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Grant Analysis

Purpose & Target

The Mentored Patient-Oriented Research Career Development Award (K23) aims to support the career development of individuals with clinical doctoral degrees who are committed to patient-oriented research. It provides salary and research support for 3-5 years of 'protected time' to help these individuals become independent investigators. - Target recipient type: Individuals with clinical doctoral degrees focused on patient-oriented research. - Target recipient size: Individual researchers; associated with organizations of various sizes. - SECTOR-SPECIFIC - Geographic scope: United States organizations only (foreign components of U.S. organizations are allowed, but foreign organizations are not eligible). - Key filtering criteria: Applicant must hold a clinical doctoral degree and commit to patient-oriented research; research must NOT involve leading an independent clinical trial. - Grant frequency: Recurring (Parent NOFO with multiple application due dates until May 2027). - Program context: Part of NIH's broader Research Career Development program to ensure a pool of highly trained scientists in biomedical, behavioral, and clinical research.

Financial Structure

Salary: Participating NIH Institutes and Centers provide salary and fringe benefits for the award recipient. The total salary from all Federal sources cannot exceed the maximum legislated salary rate.
Other Program-Related Expenses: These funds can be used for: (a) tuition and fees related to career development; (b) research-related expenses (supplies, equipment, technical personnel); (c) travel to research meetings or training; and (d) statistical services.
Ineligible Costs: Salary for mentors, secretarial, and administrative assistants is not allowed.
Indirect Costs: Reimbursed at 8% of modified total direct costs.
Cost-sharing: Not required by this funding opportunity.
Award Budget: The number of awards is contingent upon NIH appropriations and meritorious applications. No specific total budget or per-award budget is stated.
Project Period: Total project period may not exceed 5 years.
Financial reporting: Annual Research Performance Progress Report (RPPR) and financial statements are required. A final RPPR and expenditure data are required for closeout.

Eligibility Requirements

Eligible Individuals (Program Director/Principal Investigator)

Must hold a clinical doctoral degree (e.g., MD, DO, DDS, DMD, OD, DC, PharmD, ND, or doctoral degree in nursing research/practice). Individuals with PhDs in clinical disciplines like clinical psychology, nursing, clinical genetics, speech-language pathology, audiology, or rehabilitation are also eligible.
Must be a citizen or non-citizen national of the United States, or lawfully admitted for permanent residence (Green Card holder) by the time of award.
Must have completed clinical training, including specialty and subspecialty, prior to receiving the award (application can be submitted before completion).
Cannot be current or former PDs/PIs of NIH research project (R01, P01), center grants (P50), or other major individual career development awards (K01, K07, K08, K22, K23, K25, K76, K99/R00).
Must commit a minimum of 75% (9 person-months) of full-time professional effort to the career development program.
Must identify and secure a primary mentor (or mentoring team) who is an active investigator in the proposed research area and committed to the candidate's development.
Cannot have two or more competing NIH career development applications pending review concurrently.

Eligible Organizations (where the individual must be appointed)

Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (with or without 501(c)(3) IRS Status)
For-Profit Organizations (Small Businesses, Other than Small Businesses)
Local Governments (State, County, City/Township, Special District Governments, Indian/Native American Tribal Governments)
Federal Governments (U.S. Territory or Possession)
Other (Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations)
Must have an active registration with System for Award Management (SAM), Unique Entity Identifier (UEI), eRA Commons, and Grants.gov prior to submission.
Foreign Organizations: Not eligible to apply. Non-U.S. components of U.S. Organizations are not eligible. Foreign components are allowed if part of a U.S. organization's application.

Scope Limitations

The proposed research must NOT involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants are permitted to propose a research experience in a clinical trial led by a mentor or co-mentor.

Application Process

Application Submission and Deadlines

Application Due Dates: Multiple cycles available.
Latest Application Due Date: May 07, 2027 (for AIDS-related New/Renewal/Resubmission/Revision applications).
Submission Time: All applications are due by 5:00 PM local time of the applicant organization.
Application Expiration Date: May 08, 2027 (The NOFO is no longer valid after this date).
Submission Method: Electronically through Grants.gov using NIH ASSIST, institutional system-to-system (S2S) solution, or Grants.gov Workspace. Paper applications are not accepted.
Pre-application Requirement: Consultation with NIH staff before submitting is strongly encouraged.
Letter of Intent Due Date: Not Applicable.

Required Documentation and Materials

Follow instructions in the 'Career Development (K) Instructions' in the 'How to Apply - Application Guide' and specific NOFO instructions.
SF424(R&R) forms: Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile Expanded, R&R Budget.
PHS 398 Cover Page Supplement.
PHS 398 Career Development Award Supplemental Form: Includes Candidate Research Plan, Other Candidate Information, Mentor/Co-Mentor/Consultant/Collaborators, Environment & Institutional Commitment to the Candidate, Other Research Plan Sections, Appendix.
Candidate Section: Background, commitment to patient-oriented research, evidence of collaboration, prior training relevance, research efforts (publications, experience), potential for independence.
Career Goals and Objectives: Systematic plan showing logical progression to independence.
Candidate’s Plan for Career Development/Training Activities: Designed to develop necessary knowledge and research skills.
Research Plan Section: Sound research project consistent with candidate’s level, novelty, significance, creativity, approach, and relationship to mentor’s research. Must demonstrate ability to carry out research.
Training in the Responsible Conduct of Research (RCR) Plan.
Mentor, Co-Mentor, Consultant, Collaborators Section: Plans and statements from mentor(s) confirming supervision, research qualifications, previous experience, plan for supervision, career progression, monitoring progress. If applicable, statement from mentor/co-mentor for clinical trial experience guidance.
Letters of Support: Signed statements from collaborators/consultants confirming participation and roles. Signed statements from advisory committee members (if applicable).
Environmental and Institutional Commitment to the Candidate: Description of strong research and career development program, resources, facilities. Statement of commitment from sponsoring institution to candidate’s development, required effort, and access to resources.
Data Management and Sharing Plan.
PHS Human Subjects and Clinical Trials Information form (if applicable, without Section 4 & 5 for independent clinical trials).
PHS Assignment Request Form.
Reference Letters: Submitted directly through eRA Commons. Applications lacking reference letters will not be reviewed.

Post-Award Requirements

Progress Reports: Research Performance Progress Report (RPPR) annually, including Mentor’s Report with annual evaluation. Final RPPR, invention statement, and expenditure data for closeout.
Data Management and Sharing: Required to adhere to and implement the approved Data Management and Sharing Plan.
Compliance: Subject to NIH Grants Policy Statement terms and conditions, federal-wide standards, and other regulations.
Reporting: Recipients of federal grants must report subawards over threshold to FSRS.gov and maintain SAM.gov information on civil/criminal proceedings.

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: Potential to develop as an independent and productive researcher; appropriateness of prior training/research experience; quality of academic, clinical, and research record; commitment to program objectives; strength of reference letters.
Career Development Plan/Career Goals and Objectives: Likelihood of substantial contribution to candidate’s scientific development and independence; appropriateness of content, scope, phasing, and duration of the plan; adequacy of plans for monitoring and evaluating progress; contribution of clinical trial experience (if proposed).
Research Plan: Scientific and technical merit of proposed research question, design, and methodology; rigor of prior research; strategies for robust and unbiased approach; plans to address biological variables (e.g., sex); relevance to career objectives; appropriateness for candidate’s stage of development.
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s): Qualifications of mentor(s); adequacy of mentor’s description of role and elements of career development activities; evidence of mentor’s experience in fostering independent investigators; mentor’s current research productivity and peer-reviewed support; active/pending support for proposed research; plans for monitoring progress; appropriate expertise for clinical trial guidance (if applicable).
Environment & Institutional Commitment to the Candidate: Clear commitment from institution for required effort devoted to research; strength of institutional commitment to career development; adequacy and appropriateness of research facilities, resources, and training opportunities; quality of environment for scientific/professional development; assurance of candidate’s integral role as an independent investigator.

Additional Review Criteria (Not Separately Scored)

Protections for Human Subjects: Justification for involvement, adequacy of protection, potential benefits, importance of knowledge, data/safety monitoring.
Inclusion of Women, Racial and Ethnic Minorities, and Individuals Across the Lifespan: Evaluation of proposed plans for inclusion or justification for exclusion.
Vertebrate Animals: Description of procedures, justification of species, interventions to limit discomfort, euthanasia methods.
Biohazards: Assessment of potential hazards and proposed protections.
Resubmissions: Evaluation of responses to previous comments and changes made.
Revisions: Appropriateness of scope expansion and responses to previous comments.

Additional Review Considerations (Not Scored, but Commented On)

Resource Sharing Plans: Reasonableness of plans or rationale for not sharing.
Training in the Responsible Conduct of Research (RCR): Adequacy of proposed RCR training (format, subject matter, faculty participation, duration, frequency).
Select Agent Research: Information on select agents, registration, monitoring procedures, biosafety, biocontainment, security.
Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity of resources.
Budget and Period of Support: Justification and reasonableness in relation to proposed research.

Compliance & Special Requirements

Regulatory Compliance

Required Registrations: System for Award Management (SAM), Unique Entity Identifier (UEI), eRA Commons, and Grants.gov must be active before submission.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval: Required for all protocols involving human subjects. Grantee institutions must ensure all protocols are reviewed.
System for Award Management (SAM.gov): NIH awards are subject to SAM.gov requirements; applicants must review and comment on any information in their responsibility/qualification records.

Ethical and Research Standards

Responsible Conduct of Research (RCR): All applications must include a plan for RCR instruction. Plan must meet specific requirements regarding format (face-to-face, discussion), subject matter, faculty participation, duration (at least 8 contact hours), and frequency.
Human Subjects Research: Compliance with 45 CFR Part 46. Justification for involvement/exemption, adequacy of protection, benefits, knowledge importance, data/safety monitoring.
Inclusion: Plans for inclusion (or exclusion justification) of individuals based on sex, race, ethnicity, and age (children and older adults).
Vertebrate Animals: Detailed description, justification for species choice, interventions to limit discomfort, and euthanasia methods.
Biohazards: Assessment of potential hazards and proposed protections.
Select Agent Research: Details on select agents used, registration status, monitoring, biosafety, biocontainment, and security plans.
Authentication of Key Biological and/or Chemical Resources: Brief plans for identifying and ensuring validity of resources.

Intellectual Property Policies

Not explicitly detailed in the provided document beyond general NIH Grants Policy Statement adherence. Grant recipients typically retain IP rights, but specific reporting and access requirements apply for federally funded research.

Risk Management and Security

Data Management and Sharing: Required for research generating scientific data; plan must be implemented.
Security and Data Protection: Information regarding SAM.gov requirements for reporting civil/criminal proceedings and integrity/performance matters.

Unique Aspects and Considerations

Patient-Oriented Research (POR) Focus: Defined as research conducted with human subjects (or human origin material) where investigator directly interacts with subjects. Excludes in vitro studies without direct patient interaction.
No Independent Clinical Trials: This NOFO specifically excludes applications proposing to lead an independent clinical trial, clinical trial feasibility study, or ancillary clinical trial. Applicants can gain experience in a clinical trial led by a mentor.
Protected Time: The award aims to provide a sustained period of 'protected time' (3-5 years) for research career development.
Mentorship: Essential requirement; candidate must identify a qualified mentor(s) committed to their development and able to provide sufficient research support and facilities.
Intergovernmental Review (E.O. 12372): Not subject to this review.
Strategic Alignment: Supports the development of independent investigators in health-related fields, translating biomedical discoveries to clinical settings.

Grant Details