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Grant Analysis

Purpose & Target

The core objective of this grant is to attract productive professionals with quantitative science and engineering backgrounds (e.g., mathematics, statistics, computer science, physics) to NIH-relevant biomedical, behavioral, bioimaging, or bioengineering research. It specifically targets individual investigators who propose to serve as the lead researcher for an independent clinical trial, a clinical trial feasibility study, or a separate ancillary study to an existing trial. This is a SECTOR-SPECIFIC grant, focused on health and biomedical research. Geographic scope requires the applicant organization to be U.S.-based. However, foreign components and international sites are permitted for the actual conduct of clinical trials. Key filtering criteria: Individuals must possess an advanced quantitative degree, intend to lead an independent clinical trial, and secure strong institutional and mentorship support within NIH's mission areas. This is a recurring grant opportunity, part of the broader NIH Research Career Development program.

Financial Structure

Funding Type: Grant, providing financial assistance.
Cost Sharing: Not required.
Project Period: The total project period may not exceed 5 years.
Individual Salary Support: Participating NIH Institutes/Centers will provide salary and fringe benefits for the award recipient, up to the maximum legislated salary rate. Total salary from all federal sources cannot exceed this rate.
Other Program-Related Expenses: Provided by participating NIH Institutes/Centers. These funds can be used for:
- Tuition and fees related to career development.
- Research-related expenses (e.g., supplies, equipment, technical personnel).
- Travel to research meetings or training.
- Statistical services (including personnel and computer time).
Ineligible Costs: Salary for mentors, secretarial, and administrative assistants is not allowed.
Indirect Costs: Reimbursed at 8% of modified total direct costs.

Eligibility Requirements

Organizational Eligibility

Eligible Types: Higher Education Institutions (Public/State Controlled, Private), Nonprofits (501(c)(3) IRS Status, Non-501(c)(3)), For-Profit Organizations (Small Businesses, Other For-Profit), Local Governments (State, County, City, Special District, Indian/Native American Tribal Governments), and Other (Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based/Community-based Organizations, Regional Organizations).
Geographic Location: Must be a U.S. organization. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components (e.g., international sites for clinical trials) are permitted for research activities.
Institutional Commitment: The applicant institution must demonstrate a strong, well-established record of research and career development activities, and provide assurance of committing at least 75% of the candidate's full-time effort to the award and ensuring access to sufficient resources/facilities.
Registration: Organizations must complete and maintain active registrations in SAM.gov, eRA Commons, and Grants.gov prior to application submission. This process can take 6 weeks or more.

Individual Eligibility (Candidate)

Citizenship: By the time of the award, the individual must be a U.S. citizen, non-citizen national, or lawfully admitted for permanent residence (i.e., possess a valid Permanent Resident Card).
Degree: Must hold an advanced degree in a quantitative area of science or engineering (e.g., MSEE, PhD, DSc).
Experience: Must have demonstrated research interests and professional accomplishments in their primary quantitative discipline, including research outside of biomedicine/health.
Prior Funding: Individuals who are current or former Program Directors/Principal Investigators (PD/PIs) on NIH research project (R01, P01, P50) or major individual career development awards (K01, K07, K08, K22, K23, K25, K76, K99/R00) are not eligible. PD/PIs of NIH Small Grants (R03), Exploratory/Developmental Grants (R21/R33), Planning Grants (R34/U34), Dissertation Awards (R36), SBIR/STTR (R41, R42, R43, R44), Transition Scholar (K38) awards, or those appointed to institutional K programs (K12, KL2) remain eligible.
Level of Effort: Must commit a minimum of 75% of full-time professional effort (equivalent to 9 person-months) to the career development program.
Research Focus: This specific funding opportunity (PA-24-190) is only for candidates 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. Candidates not planning an independent clinical trial must apply to companion NOFO (PA-24-191).

Mentorship Requirements

Mentor Identification: Candidates must identify a primary mentor (or mentoring team) who is an active investigator in the proposed research area and committed to the candidate's career development and research supervision.
Mentor Qualifications: The mentor must have a successful track record of mentoring individuals at the candidate's career stage and demonstrate appropriate expertise in guiding the organization, management, and implementation of clinical trials.
Mentor Resources: The mentor must document the availability of sufficient research support and facilities to cover costs beyond the grant's allowable expenses.

Application Process

Application Deadlines and Submission

Application Due Dates: Multiple standard due dates are available. The latest listed due date for new applications is February 12, 2027.
Submission Time: All applications are due by 5:00 PM local time of the applicant organization.
Deadline Extension: If a due date falls on a weekend or a Federal holiday, the deadline is automatically extended to the next business day.
Submission Method: Applications must be submitted electronically via the NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Pre-submission Registrations: Applicant organizations must register and maintain active status with SAM.gov, eRA Commons, and Grants.gov. The registration process can take 6 weeks or more, so early initiation is crucial.
PD/PI Accounts: All Program Directors/Principal Investigators (PD/PIs) must have an eRA Commons account and their personal profile linked to a valid ORCID ID.

Required Documentation

Standard Forms: SF424(R&R) forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile Expanded, R&R Budget).
Supplements: PHS 398 Cover Page Supplement.
Career Development Form: PHS 398 Career Development Award Supplemental Form, which includes:
- Candidate Information and Goals for Career Development (Candidate's Background, Career Goals and Objectives, Plan for Career Development/Training Activities).
- Research Plan Section (Research Strategy, Training in the Responsible Conduct of Research).
- Mentor, Co-Mentor, Consultant, Collaborator Section (Plans and Statements of Mentor and Co-mentor(s), Letters of Support from Collaborators, Contributors, and Consultants, including Advisory Committee members if applicable).
- Environmental and Institutional Commitment to the Candidate (Description of Institutional Environment, Institutional Commitment).
- Other Plan(s), specifically the Data Management and Sharing Plan (if applicable, for applications due on/after January 25, 2023).
- Appendix (limited items allowed).
Human Subjects: PHS Human Subjects and Clinical Trials Information form (if involving human subjects research).
Assignment Request: PHS Assignment Request Form.
Reference Letters: These are submitted directly through the eRA Commons 'Submit Referee Information' link and not as part of the electronic application package.

Post-Award Requirements

Annual Reporting: Recipients are required to submit the Research Performance Progress Report (RPPR) annually, along with annual financial statements. For mentored awards, an annual Mentor's Report evaluating the candidate's progress is also required.
Closeout: A final RPPR, invention statement, and expenditure data portion of the Federal Financial Report are required for award closeout.
Clinical Trial Reporting: If the award involves a clinical trial, the 'responsible party' must register and submit results information on ClinicalTrials.gov.
Ethical Approvals: Recipient institutions must ensure all protocols are reviewed and approved by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Safety Monitoring: Adherence to NIH policy for data and safety monitoring for all human biomedical and behavioral intervention studies.
FDA Compliance: Compliance with Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements if applicable.
Subaward Reporting: Recipients must report information about first-tier subawards over the threshold to the Federal Subaward Reporting System (FSRS).
Integrity Reporting: For active federal grants with a cumulative total value greater than $10,000,000, semiannual disclosures are required regarding civil, criminal, and administrative proceedings.

Evaluation Criteria

Overall Impact

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 in a health-related field.

Scored Review Criteria

Candidate: This criterion evaluates the candidate's potential to become an independent and productive researcher, the appropriateness of their prior training and research experience, the quality of their academic and research record, their commitment to the program's objectives, and the supportive evidence from reference letters. It also considers the candidate's ability and training (or plans for training) in organizing, managing, and implementing clinical trials and related data/statistics.
Career Development Plan/Goals & Objectives: This section assesses the likelihood that the proposed plan will significantly contribute to the candidate's scientific development and lead to research independence. It examines the appropriateness of the plan's content, scope, phasing, and duration given the candidate's prior experience and stated objectives. The adequacy of plans for monitoring and evaluating the candidate's progress is also considered.
Research Plan: The evaluation focuses on the rigor of prior research supporting the project and the strategies proposed to ensure a robust and unbiased approach, including addressing relevant biological variables (e.g., sex). Key considerations include the relevance of the research plan to the candidate’s career objectives, its suitability as a vehicle for developing research skills, and its potential to establish an independent line of research for the candidate. For clinical trials, the scientific rationale, necessity for testing intervention safety/efficacy/effectiveness (or feasibility), justification of study design, plans for standardization, quality assurance, data monitoring, and appropriate statistical approaches are critical.
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s): This criterion evaluates the qualifications of the mentor(s), the quality and extent of their proposed guidance, their previous success in fostering independent investigators, their current research productivity and peer-reviewed support, and the adequacy of their active/pending research support for the proposed project. The mentor's expertise in guiding clinical trial organization, management, and adherence to timelines is also assessed.
Environment & Institutional Commitment to the Candidate: This assesses the institutional commitment to ensuring the required 75% effort for the candidate's career development, the strength of its commitment to the candidate's development into an independent investigator, and the adequacy of research facilities, resources, and training opportunities (including clinical trial-related resources). The suitability of the environment for scientific and professional development and the institution's capability to conduct the proposed trial are also evaluated.

Additional Review Criteria (Not Separately Scored)

Study Timeline for Clinical Trials: Detailed, feasible, and justified timeline for the clinical trial, including start-up, enrollment, and follow-up, with consideration for efficiencies and potential challenges.
Protections for Human Subjects: Evaluation of justification for human subjects involvement, adequacy of protections against risks, potential benefits, importance of knowledge, and data/safety monitoring.
Inclusion: Assessment of plans for inclusion (or exclusion) of women, racial/ethnic minorities, and individuals across the lifespan in the research.
Responsible Conduct of Research (RCR) Training: Evaluation of the RCR training plan's adequacy regarding format (must include face-to-face instruction), subject matter breadth, faculty participation, duration (minimum 8 contact hours), and frequency. The plan will be rated as 'ACCEPTABLE' or 'UNACCEPTABLE'.
Budget and Period of Support: Review of whether the requested budget and project period are fully justified and reasonable.

Compliance & Special Requirements

Regulatory Compliance

NIH Policy: Adherence to the comprehensive NIH Grants Policy Statement.
Federal Regulations: Compliance with 42 CFR Part 52 and 2 CFR Part 75.
Human Subjects Protection: Strict compliance with 45 CFR Part 46 for human subjects research, including justifying involvement, protecting against risks, ensuring benefits, and implementing data and safety monitoring.
Clinical Trials: Registration and results reporting for all applicable clinical trials on ClinicalTrials.gov. Required Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval.
FDA Requirements: Compliance with Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements for clinical research involving investigational therapeutics or devices.
Transparency: Adherence to System for Award Management (SAM.gov) requirements, including integrity and performance reporting. Compliance with the Federal Funding Accountability and Transparency Act (FFATA) for subaward reporting.
Nondiscrimination: Compliance with all applicable nondiscrimination laws and submission of an Assurance of Compliance (HHS-690).

Responsible Conduct of Research (RCR) Training

All applications must include a detailed plan for RCR instruction.
Format: Instruction must include face-to-face components (lectures, coursework, real-time discussion groups); online-only instruction is not acceptable.
Subject Matter: Broad coverage including conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, and research ethics.
Faculty Participation: Mentors and other faculty must be involved in the instruction.
Duration: A minimum of 8 contact hours of instruction is required.
Frequency: Instruction must occur during each career stage and at least once every four years.

Data Management and Sharing

For applications due on or after January 25, 2023, a Data Management and Sharing Plan is required for all research generating scientific data, regardless of the direct costs requested.
Approved plans must be implemented by the recipients.

Unique Program Focus

This specific funding opportunity (PA-24-190) is highly specialized, exclusively targeting candidates who will serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary study to an existing trial.
It aims to integrate quantitative science and engineering expertise directly into NIH-relevant health research, offering a structured path to independence.
The program allows for a phased developmental period, which can include initial didactic training (e.g., 1-2 years) followed by intensive supervised research, tailored to the candidate's prior experience.

Institutional Requirements

The sponsoring institution must ensure that the candidate has access to all necessary resources and facilities, including specialized administrative, data coordinating, enrollment, and laboratory/testing support specifically for clinical trials.
If international sites are proposed for clinical trial execution, the application must thoroughly address the complexities involved in such collaborations.

Pre-award Costs

Pre-award costs are only allowable as specified in the NIH Grants Policy Statement.

Grant Details