The purpose of the NIH Midcareer Investigator Award in Patient-Oriented Research (K24) is to provide support to mid-career health-professional doctorates for protected time to devote to patient-oriented research (POR) and to act as research mentors primarily for clinical residents, clinical fellows and/or junior clinical faculty.

PA-24-187: Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Required)

Posted Date: April 25, 2024 Expiration Date: May 08, 2027

Participating Organization(s): National Institutes of Health (NIH)

Components of Participating Organizations:

• National Heart, Lung, and Blood Institute (NHLBI)
• National Institute on Aging (NIA)
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• National Institute of Allergy and Infectious Diseases (NIAID)
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• National Institute on Deafness and Other Communication Disorders (NIDCD)
• National Institute on Drug Abuse (NIDA)
• National Institute of Environmental Health Sciences (NIEHS)
• National Institute of Mental Health (NIMH)
• National Institute of Nursing Research (NINR)
• National Center for Complementary and Integrative Health (NCCIH)
• Office of Research on Women's Health (ORWH)
• Office of Data Science Strategy (ODSS)
• National Institute of Minority Health and Health Disparities (NIMHD)

Funding Opportunity Title: Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Required)

Activity Code: K24

Announcement Type: Reissue of PA-20-193

Related Notices:

• March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.
• April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084
• September 4, 2024 - Notice of Correction to the Eligible Individuals (PD/PI) Section for the NIH's Parent Mentored Patient-Oriented Research Career Development Award (Parent K23s) and the Midcareer Investigator Award in Patient-Oriented Research (Parent K24s). See Notice NOT-OD-24-168
• July 1, 2024 - Notice of Correction to Funding Opportunity Purpose Language and to Extend the Renewal/Resubmission/Revision Application Due Date for PA-24-187. See Notice NOT-OD-24-148.
• June 4, 2024 - Guidance Regarding Reduction of Effort for NIMHD Individual Mentored K Awards. See Notice NOT-MD-24-017
• May 20, 2024 - Notice of Participation of NIMHD in PA-24-187. See Notice NOT-MD-24-016
• May 7, 2025 - Notice of Change in the NIAID K24 Allowable Application Types and Eligibility Requirements. See Notice NOT-AI-24-043
• August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
• August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.

Funding Opportunity Number (FON): PA-24-187

Companion Funding Opportunity: PA-24-188, K24 Midcareer Investigator Awd in Patient-Oriented Res; PA-24-189, K24 Midcareer Investigator Awd in Patient-Oriented Res

Assistance Listing Number(s): 93.846, 93.273, 93.361, 93.213, 93.866, 93.279, 93.113, 93.242, 93.310, 93.233, 93.837, 93.838, 93.839, 93.840, 93.313, 93.173, 93.855, 93.307

Part 1. Overview Information

Funding Opportunity Purpose:

The purpose of the NIH Midcareer Investigator Award in Patient-Oriented Research (K24) is to provide support to mid-career health-professional doctorates for protected time to devote to patient-oriented research (POR) and to act as research mentors for junior clinical investigators pursuing POR research, such as clinical residents.

This Parent Announcement is for basic science experimental studies involving humans, referred to in NOT-OD-18-212 as “prospective basic science studies involving human participants.” These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should be submitted under this NOFO include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Applicants not planning an independent clinical trial or basic experimental study with humans, or proposing to gain research experience in a clinical trial or basic experimental study with humans led by another investigator, must apply to the 'Independent Clinical Trial Not Allowed' companion NOFO.

The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions.

This Notice of Funding Opportunity (NOFO) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary study to an existing trial, as part of their research and career development. Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion NOFO (PA-24-188).

Key Dates:

All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions:

It is critical that applicants follow the instructions in the Career Development (K) Instructions in the How to Apply - Application Guide except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

• Use the NIH ASSIST system to prepare, submit and track your application online.
• Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
• Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Table of Contents:

• Part 1. Overview Information
• Part 2. Full Text of Announcement
  • Section I. Funding Opportunity Description
  • Section II. Award Information
  • Section III. Eligibility Information
  • Section IV. Application and Submission Information
  • Section V. Application Review Information
  • Section VI. Award Administration Information
  • Section VII. Agency Contacts
  • Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall goal of the NIH Research Career Development program is to help ensure that a pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Research Training and Career Development website.

The NIH Midcareer Investigator Award in Patient-Oriented Research (K24) is designed to enable mid-career clinician-scientists to: (a) Devote more time to augment their capabilities in Patient-Oriented Research (POR); and (b) Provide mentoring to junior clinical investigators in the conduct of POR (see below for definition).

The K24 award is intended to provide protected time to mid-career clinical investigators who are typically at the Associate Professor level or the equivalent (see Section III, Eligible Individuals) and who have their own independent, peer-reviewed research support to provide mentoring to junior clinical investigators, particularly K23 grantees, in POR and to stabilize the careers of these investigators. The intent is to allow these investigators to continue to conduct POR and be available as mentors in POR. A K24 award recipient who continues to have an independent peer-reviewed patient-oriented research program and continues to provide mentoring to junior investigators can continue to contribute to the overall goals of the program after being promoted to Full Professor. It is expected that K24 recipients will obtain new or additional independent, peer-reviewed funding for POR as PD/PI and establish and assume leadership roles in collaborative POR programs. In addition, it is expected that there will be an increased effort and commitment to act as a mentor to beginning clinician investigators in POR to enhance the research productivity of both the K24 investigator and increase the pool of well-trained clinical researchers of the future.

For the purposes of the K24 award, Patient-Oriented Research is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. This area of research includes: (1) mechanisms of human disease; (2) therapeutic interventions; (3) clinical trials, and; (4) the development of new technologies. Excluded from this definition are in vitro studies that utilize human tissues but do not deal directly with patients. In other words, patient-oriented research is research in which it is necessary to know the identity of the patients from whom the cells or tissues under study are derived. Studies falling under Exemption 4 for human subjects research are not included in this definition. See also the NIH Directors Panel on Clinical Research Report.

NIH defines a clinical trial as "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." (NOT-OD-15-015).

NIH not only supports trials of safety and efficacy, it also supports mechanistic exploratory studies that meet the definition of a clinical trial and are designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. These studies may focus on basic and/or translational discovery research in healthy human subjects and in human subjects who are affected by the pathophysiology of diseases and disorders. By addressing basic questions and concepts in biology, behavior, and pathophysiology, these studies may provide insight into understanding human diseases and disorders along with potential treatments or preventive strategies. NIH also supports biomarker studies that meet the definition of a clinical trial and that may provide information about physiological function, target engagement of novel therapeutics, and/or the impact of therapeutics on treatment response. NIH thus supports studies that meet the definition of clinical trials (as noted above) but do not seek to establish safety, clinical efficacy, effectiveness, clinical management, and/or implementation of preventive, therapeutic, and services interventions.

Note: This Notice of Funding Opportunity (NOFO) is designed specifically for candidates proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial, as part of their research and career development. Those not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion NOFO (PA-24-188).

Special Note: Because of the differences in individual Institute and Center (IC) program requirements for this NOFO, prospective applicants are strongly encouraged to consult the Table of IC-Specific Information, Requirements and Staff Contacts, to make sure that their application is appropriate for the requirements of one of the participating NIH ICs.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument: Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed:

• New
• Renewal
• Resubmission
• Revision

The OER Glossary and the How to Apply - Application Guide provides details on these application types.

Clinical Trial? Required: Only accepting applications that propose an independent clinical trial(s).

Funds Available and Anticipated Number of Awards: The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget: Award budgets are composed of salary and other program-related expenses, as described below.

Award Project Period: The total project period may not exceed 5 years.

Other Award Budget Information:

• Salary: The NIH Midcareer Investigator Award in Patient-Oriented Research (K24) will provide salary for levels of effort between 3-6 person-months (or 25 and 50% full-time professional effort). The participating NIH Institutes and Centers will provide salary and fringe benefits for the award recipient (see Table of IC-Specific Information, Requirements and Staff Contacts). Further guidance on budgeting for career development salaries is provided in the How to Apply - Application Guide. In addition, the candidate may derive additional compensation for effort associated with other Federal sources or awards provided the total salary derived from all Federal sources does not exceed the maximum legislated salary rate (see http://grants.nih.gov/grants/policy/salcap_summary.html) and the total percent effort does not exceed 100%. See also NOT-OD-17-094.

• Other Program-Related Expenses: The NIH will provide up to $50,000 per year for the following expenses:

  • (a) research expenses, such as supplies, equipment and technical personnel for the PD/PI and/or those mentored by the PD/PI;
  • (b) registration and/or travel to research-related courses and meetings;
  • (c) statistical services including personnel and computer time. Salary for mentors, secretarial and administrative assistants, etc. is not allowed.

• Indirect Costs: Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants:

• Eligible Organizations:

  • Higher Education Institutions (Public/State Controlled, Private)
  • Nonprofits Other Than Institutions of Higher Education (with 501(c)(3) IRS Status, without 501(c)(3) IRS Status)
  • For-Profit Organizations (Small Businesses, Other than Small Businesses)
  • Local Governments (State, County, City or Township, Special District)
  • Indian/Native American Tribal Governments (Federally Recognized, Other than Federally Recognized)
  • Federal Governments
  • U.S. Territory or Possession
  • 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, Regional Organizations)

• Foreign Organizations: Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

• Non-domestic (non-U.S.) components of U.S. Organizations: are not eligible to apply.

• Foreign components: as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations:

• Applicant Organizations: Must complete and maintain registrations in:

  • System for Award Management (SAM): Requires renewal at least annually.
  • NATO Commercial and Government Entity (NCAGE) Code: For foreign organizations (in lieu of CAGE code).
  • Unique Entity Identifier (UEI): Issued via SAM.gov.
  • eRA Commons: Must have at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
  • Grants.gov: Requires active SAM registration.
  • Note: Registration can take 6 weeks or more. Failure to complete registrations in advance is not a valid reason for late submission.

• Program Directors/Principal Investigators (PD(s)/PI(s)):

  • Must have an eRA Commons account.
  • Must be registered with ORCID, and the eRA Commons profile must be linked to a valid ORCID ID.
  • Note: Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator):

• Must have the skills, knowledge, and resources necessary to carry out the proposed research.
• Multiple PDs/PIs are not allowed.
• By the time of award, must be a citizen or non-citizen national of the U.S. or have been lawfully admitted for permanent residence.
• Must have a health-professional doctoral degree (e.g., MD, DO, DDS, DMD, OD, DC, PharmD, ND, doctoral degree in nursing research or practice).
• Individuals with a PhD or other doctoral degree in clinical disciplines (e.g., clinical psychology, nursing, clinical genetics, speech-language pathology, audiology, rehabilitation) are also eligible.
• Candidates should typically be in midcareer (e.g., Associate Professor level or equivalent).
• Must have an established record of independent, peer-reviewed patient-oriented research grant funding and a record of publications.
• Must have a record of supervising and mentoring patient-oriented researchers.
• A K24 recipient who progresses to a more advanced career stage (e.g., promoted to Full Professor) may retain the award and remains eligible for renewal, provided they continue to maintain an independent, peer-reviewed patient-oriented research program and mentor new investigators.

2. Cost Sharing: This NOFO does not require cost sharing.

3. Additional Information on Eligibility:

• Number of Applications:

  • Applicant organizations may submit more than one application, provided each is scientifically distinct and from a different candidate.
  • NIH will not accept duplicate or highly overlapping applications under review concurrently.
  • An individual may not have two or more competing NIH career development applications pending review concurrently.
  • NIH will not accept:
    • A new (A0) application before the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application before the summary statement from the review of the previous new (A0) application.
    • An application with substantial overlap with another application pending appeal of initial peer review.

• Level of Effort:

  • Candidates must demonstrate the need for protected time: 3-6 person months ( 25-50% of full-time professional effort).
  • Candidates may not concurrently apply for or have another PHS career award pending review.
  • Candidates with VA appointments should contact the relevant Institute or Center staff prior to preparing an application to discuss eligibility.
  • Adjustments to the required level of effort may be made in certain circumstances (see NOT-OD-18-156).

• Renewals: Recipients may apply for a one-time renewal for an additional 3-5 years of support, depending on sponsoring NIH Institute/Center policies, if they continue to have independent peer-reviewed research support at the time of renewal application submission.

• Peer-Reviewed Research Support: Candidates are expected to continue to hold independent peer-reviewed research support for the period of the award.

• Institutional Environment: The applicant institution must have a strong, well-established record of research and career development activities and qualified faculty.

Section IV. Application and Submission Information

1. Requesting an Application Package: Application forms are available via the NIH ASSIST system or can be downloaded. Use institutional system-to-system solutions as instructed by your administrative office.

2. Content and Form of Application Submission:

• Follow instructions in the Career Development (K) Instructions in the How to Apply - Application Guide, except where superseded by this NOFO or a Notice.
• Applications out of compliance may be delayed or not accepted.
• Page limitations in the How to Apply - Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission:

• SF424(R&R) Cover: Follow How to Apply - Application Guide.
• SF424(R&R) Project/Performance Site Locations: Follow How to Apply - Application Guide.
• Other Project Information: Follow How to Apply - Application Guide.
• SF424(R&R) Senior/Key Person Profile Expanded: Follow How to Apply - Application Guide.
• R&R Budget: Follow How to Apply - Application Guide.
• PHS 398 Cover Page Supplement: Follow How to Apply - Application Guide.
• PHS 398 Career Development Award Supplemental Form:
  • Candidate Section:
    • Candidate Information and Goals for Career Development:
      • Candidate’s Background: Summarize research career, documenting ability to conduct high quality POR and commitment to POR. Document ability to mentor new clinician investigators (years of experience, role, number mentored, specialties, career stages, types of research conducted by mentees, proportion of mentees in academic medicine/POR).
      • Career Goals and Objectives: Provide details of immediate and long-term career objectives in POR and mentoring. Describe how protected time will contribute to POR program development/expansion and increased commitment to mentoring.
      • Candidate’s Plan for Career Development/Training Activities During Award Period: Describe professional responsibilities/activities beyond minimum effort commitment. Describe new or enhanced research skills and knowledge to be acquired and how they will enhance ability as an independent scientist.
      • Training: Candidate must demonstrate training or plans to participate in courses such as data management, epidemiology, study design (including statistics), hypothesis development, drug development, and legal/ethical issues associated with human subjects research and clinical trials.
    • Research Plan Section:
      • Research Strategy:
        • Currently supported research: Provide sufficient information on hypotheses, specific aims, background, significance, rationale, preliminary studies, and research design/methods to evaluate research activities and mentoring opportunities.
        • New research to be specifically supported by this award: Describe how the award will augment research skills or develop new directions in POR. Include hypothesis, specific aims, background, preliminary studies, significance, rationale, and research design/methods. Provide documentation of available resources and facilities.
        • Inclusion of Women, Minorities, and Children: Address inclusion in the design of all proposed patient-oriented research (see https://grants.nih.gov/policy/inclusion.htm).
        • Continuing Support: Provide plans for ensuring continuing support of POR programs, preferably with the candidate as PD/PI.
        • Clinical Trial/Feasibility/Ancillary Study: Describe planned analyses, statistical approach, and suitability for available resources, study design, scope, and methods. If proposing an ancillary trial, describe its relationship to the larger trial. If proposing a feasibility study, justify its necessity and contribution to overall goals. Describe proposed timelines, potential challenges, and solutions. Describe how the trial will test safety, efficacy, or effectiveness leading to a change in clinical practice, community behaviors, or health care policy (not applicable to feasibility studies).
      • Training in the Responsible Conduct of Research: Include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR).
    • Other Candidate Information Section:
      • Candidate’s Plan to Provide Mentoring: Describe availability of junior investigators, their training/specialization, recruitment/selection/supervision plans, types of educational/research experiences, and the candidate's role as a mentor. Describe integration with existing research curricula (e.g., CTSA). Describe plans for supporting mentees' research. Indicate proposed person months committed to mentoring.
    • Mentor, Co-Mentor, Consultant, Collaborators Section:
      • Plans and Statements of Mentor and Co-mentor(s): Not applicable.
      • Letters of Support from Collaborators, Contributors and Consultants: Signed statements confirming participation and describing specific roles. Biographical sketches are not required unless listed as senior/key personnel.
    • Environment & Institutional Commitment to the Candidate Section:
      • Description of Institutional Environment: Document a strong research and career development program, high-quality research environment, and capable faculty for collaboration. Describe how the environment is suited for the candidate's career development and proposed research. Describe available resources and facilities (including clinical trial support).
      • Institutional Commitment to the Candidate’s Research Career Development: Provide a statement of commitment to the candidate's development as an independent investigator and to meeting award requirements. Commitment should not be contingent upon award receipt. Letter should detail protected time, duties to be relieved, and institutional commitment to enhancing the candidate's productivity.
    • Other Plan(s):
      • Data Management and Sharing Plan: Required for all applications generating scientific data. Address the plan in the "Other Plan(s)" attachment in FORMS-H application forms packages.
    • Appendix: Follow How to Apply - Application Guide instructions. Limited items are allowed.
    • PHS Human Subjects and Clinical Trials Information: Follow How to Apply - Application Guide. Include at least one human subjects study record if "Yes" to "Are Human Subjects Involved?".
      • Study Record: PHS Human Subjects and Clinical Trials Information: Follow How to Apply - Application Guide.
      • Delayed Onset Study: Follow SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM): See Part 2. Section III.1 for information on required registrations.

4. Submission Dates and Times:

• Applications must be submitted electronically via Grants.gov using ASSIST or other electronic submission systems.
• Track application status in eRA Commons.
• Errors must be corrected and a changed/corrected application submitted by the due date and time. Late applications are subject to NIH Grants Policy Statement Section 2.3.9.2.
• Applicants are responsible for viewing their application in eRA Commons before the due date to ensure accurate submission.

5. Intergovernmental Review (E.O. 12372): This initiative is not subject to intergovernmental review.

6. Funding Restrictions: All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost. Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information:

• Paper applications will not be accepted.

• Complete all required registrations before the application due date (see Section III.1).

• For assistance with electronic applications, visit the How to Apply - Application Guide. Follow Dealing with System Issues guidance for system problems threatening on-time submission.

• Important reminders:

  • All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form.
  • The unique entity identifier must be consistent across SAM, eRA Commons, and the application.

• Upon receipt, applications will be evaluated for completeness and compliance. Incomplete or non-compliant applications will not be reviewed.

• Post Submission Materials: Follow instructions in the policy.

Section V. Application Review Information

1. Criteria:

Reviewers will evaluate applications based on the following criteria:

• Overall Impact: Likelihood that the proposed career development and research plan will enhance the candidate's potential for a productive, independent scientific research career and their ability to serve as a mentor.

• Scored Review Criteria:

  • Candidate:
    • Evidence of ongoing high-quality patient-oriented research and its relationship to the K24 application.
    • Capabilities and commitment to serve as a mentor for new clinical investigators in POR.
    • Demonstration that the proposed program and protected time will allow more time for POR and mentoring.
    • Record of independent peer-reviewed support for POR likely to continue.
    • Potential to organize, manage, and implement the proposed clinical trial, feasibility, or ancillary study.
    • Training (or plans for training) in data management and statistics relevant to clinical trials.
  • Plan to Provide Mentoring:
    • Adequacy of plans to mentor/supervise new clinical investigators in POR.
    • Adequacy of plans to integrate appropriate clinical research curricula.
    • Appropriate level of effort proposed for the mentoring component.
  • Research Plan:
    • Whether the research plan is an appropriate vehicle for demonstrating and developing the candidate's skills in POR.
    • Scientific and technical merit of the proposed research.
    • Relevance of the proposed research to the candidate's career objectives.
    • Adequacy of resources for the research program, including plans for continued support.
    • Scientific rationale and need for the clinical trial, ancillary trial, or feasibility study, supported by preliminary data or literature.
    • Justification and contribution of feasibility studies to future larger trials.
    • Necessity of the clinical trial or ancillary trial for testing safety, efficacy, or effectiveness.
    • Justification and relevance of the study design to hypotheses.
    • Appropriateness of plans for standardization, quality assurance, and protocol adherence.
    • Appropriateness of planned analyses and statistical approach.
    • Need for the trial to advance scientific understanding (for mechanistic/biomedical endpoints).
  • Consultant(s), Collaborator(s):
    • Adequate documentation of expertise in proposed areas.
  • Environment & Institutional Commitment to the Candidate:
    • Adequacy of research facilities, resources, and training opportunities.
    • Assurance that the institution intends the candidate to be an independent investigator.
    • Appropriate level of institutional commitment to the candidate's scientific development.
    • Adequacy of the pool of clinician investigators to be mentored.
    • Quality and relevance of the environment for continuing scientific and professional development.
    • Strong commitment from the institution to provide protected time.
    • Adequacy of institutional commitment to the career development of new clinical investigators mentored by the candidate.
    • Appropriateness of administrative, data coordinating, enrollment, and laboratory/testing centers.
    • Capability and ability to conduct the trial at proposed site(s).
    • Adequacy of plans for international sites, if applicable.

• Additional Review Criteria (Not Scored):

  • Study Timeline for Clinical Trials: Detailed, feasible, and justified timeline; incorporation of efficiencies; discussion of potential challenges and solutions.
  • Protections for Human Subjects: Justification for involvement, protection from risk, potential benefits, importance of knowledge gained, data and safety monitoring.
  • Inclusion of Women, Racial and Ethnic Minorities, and Individuals Across the Lifespan: Justified inclusion/exclusion based on scientific goals.
  • Vertebrate Animals: Description of procedures, justification for species, humane endpoints.
  • Biohazards: Assessment of potential hazards and proposed protections.
  • Resubmissions: Evaluation of responses to previous comments and changes made.
  • Renewals: Consideration of progress made in the last funding period.
  • Revisions: Appropriateness of proposed expansion of scope.

• Additional Review Considerations (Not Scored):

  • 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). Rated as ACCEPTABLE or UNACCEPTABLE.
  • Select Agent Research: Assessment of plans for handling select agents.
  • Authentication of Key Biological and/or Chemical Resources: Plans for ensuring validity.
  • Budget and Period of Support: Justification and reasonableness.

2. Review and Selection Process:

• Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group (SRG) in accordance with NIH peer review policies.
• Applications may undergo a selection process where only the highest merit applications are discussed and scored.
• Applications will receive a written critique.
• Applications will be assigned to the appropriate NIH Institute or Center (IC).
• Funding decisions will consider:
  • Scientific and technical merit.
  • Availability of funds.
  • Relevance to program priorities.

3. Anticipated Announcement and Award Dates: Refer to Part 1 for Key Dates, including peer review, advisory council review, and earliest start date. Summary Statements will be accessible via the eRA Commons.

Section VI. Award Administration Information

1. Award Notices:

• If an application is under consideration for funding, NIH will request "just-in-time" information.

• A formal Notice of Award (NoA) will be provided for successful applications.

• Recipients must comply with funding restrictions (Section IV.6). Costs incurred before receipt of the NoA are at the recipient's risk.

• Awards are subject to terms and conditions on the Award Conditions and Information for NIH Grants website.

• Specific to applications proposing clinical trials, ancillary or feasibility studies:

  • ICs may specify special reporting requirements in the NoA.
  • ClinicalTrials.gov: The "responsible party" must register and submit results for applicable clinical trials. NIH expects registration and results reporting for all trials.
  • Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure IRB/IEC review and provide NIH copies of major changes in protocol status.
  • Data and Safety Monitoring Requirements: NIH policy requires oversight and monitoring of human intervention studies (clinical trials).
  • Investigational New Drug or Investigational Device Exemption Requirements: Clinical research projects involving investigational therapeutics/devices must be performed under an FDA IND or IDE.

2. Administrative and National Policy Requirements:

• Awards are subject to the NIH Grants Policy Statement.
• Federal-wide Standard Terms and Conditions for Research Grants apply.
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment applies.
• Acknowledgment of Federal Funding is required.
• Recipients must comply with applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
• System for Award Management (SAM.gov) requirements apply, including review of integrity and performance information.
• Awards are subject to statutory provisions including Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009.

3. Data Management and Sharing: Recipients must adhere to the 2023 NIH Policy for Data Management and Sharing as outlined in the NIH Grants Policy Statement. Implementation of the approved Data Management and Sharing Plan is required.

4. Reporting:

• Recipients must submit the Research Performance Progress Report (RPPR) annually and financial statements as required.
• Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. Mentor's Report must include an annual evaluation statement.
• A final RPPR, invention statement, and expenditure data are required for closeout.
• Recipients must report information about first-tier subawards and executive compensation to the Federal Subaward Reporting System (FSRS) if applicable (FFATA).
• Recipients with cumulative Federal awards > $10,000,000 must report and maintain currency of information in SAM regarding civil, criminal, and administrative proceedings (2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200).

5. Evaluation: NIH may request information from databases and participants to assess program effectiveness. Participants may be contacted post-award for updates on employment history, publications, support, honors, professional activities, etc.

Section VII. Agency Contacts

Inquiries concerning this funding opportunity are encouraged. Prospective applicants MUST consult the Table of IC-Specific Information, Requirements, and Staff Contacts to ensure responsiveness to participating NIH ICs. Prior consultation with NIH staff is strongly encouraged.

Application Submission Contacts:

• eRA Service Desk:
  • Online: https://www.era.nih.gov/need-help (preferred)
  • Phone: 301-402-7469 or 866-504-9552 (Toll Free)
• General Grants Information:
  • Email: [email protected] (preferred)
  • Phone: 301-637-3015
• Grants.gov Customer Support:
  • Phone: 800-518-4726
  • Email: [email protected]

Scientific/Research Contact(s):

• See Table of IC-Specific Information, Requirements and Staff Contacts.

Peer Review Contact(s):

• Examine your eRA Commons account for review assignment and contact information (appears two weeks after submission due date).

Financial/Grants Management Contact(s):

• See Table of IC-Specific Information, Requirements and Staff Contacts.

Section VIII. Other Information

• Recently issued trans-NIH policy notices may affect application submission. A full list is provided in the NIH Guide for Grants and Contracts.
• All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
• Recipients of career development awards are encouraged to consider applying for an NIH Loan Repayment Program (LRP) award.

Authority and Regulations: Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 75.