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Grant Analysis

Purpose & Target

The core objective of this grant is to facilitate short-term, interventional clinical trials focused on arthritis, musculoskeletal, and skin diseases. It specifically aims to support early-stage studies, such as proof-of-concept, first-in-human, Phase I, and Phase II clinical trials, to translate promising research into clinical practice. - Target recipient type: Research organizations including universities, nonprofits, for-profit entities, and various government agencies. - Target recipient size: Not explicitly defined by employee count, but implies organizations with research capacity. - This grant is SECTOR-SPECIFIC to healthcare and medical research. - Geographic scope: Applicant organizations must be based in the U.S.; foreign entities are not eligible to apply. - Key filtering criteria: Requires an NIH-defined clinical trial, must align with NIAMS mission areas, and the applicant organization must be U.S.-based. - Grant frequency: Recurring, with multiple application deadlines available until late 2026. - Program context: This is an R61 Phase 1 Exploratory/Developmental Grant, part of the broader NIH clinical trial program.

Financial Structure

Maximum direct costs for the entire three-year project period may not exceed $600,000.
No more than $300,000 in direct costs may be requested in any single year.
The currency for funding is USD.
Cost sharing is not required.
Eligible costs are subject to the terms and conditions described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1.
Financial reporting requirements include submission of annual financial statements and expenditure data (Federal Financial Report) for project closeout.

Eligibility Requirements

Eligible Organizations

Eligible types include:
- Higher Education Institutions (Public/State Controlled, Private)
- Nonprofits (with or without 501(c)(3) IRS Status)
- For-Profit Organizations (Small Businesses, or other For-Profit Organizations)
- Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal Governments - Federally Recognized and Other)
- Federal Governments (Eligible Agencies of the Federal Government, U.S. Territory or Possession)
- Other organizational types include: 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.

Geographic Eligibility

The applicant organization must be a U.S. entity.
Non-domestic (non-U.S.) Entities are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components (specific research activities or collaborations conducted outside the U.S. as part of a U.S. organization's project) are allowed.

Principal Investigator (PD/PI) Requirements

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application.

Technical/Programmatic Requirements

The proposed project must meet the NIH definition of a clinical trial.
The project must address research questions related to the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) mission and goals.
The project must involve evaluating interventions.
The study must be feasible within the specified time and budget limits of this funding opportunity.

Registration Requirements

Applicant organizations must complete and maintain active registrations prior to application submission. This process can take 6 weeks or more:
- System for Award Management (SAM) with an active annual renewal.
- Unique Entity Identifier (UEI) (obtained through SAM.gov registration).
- eRA Commons (organization registration, and both Signing Official (SO) and Program Director/Principal Investigator (PD/PI) accounts must be in place).
- Grants.gov (requires an active SAM registration).
All PD(s)/PI(s) must have an eRA Commons account affiliated with the applicant organization.

Application Process

Application Timeline

Earliest Submission Date: February 04, 2025.
Application Due Dates: Multiple rounds, including March 04, 2025; July 02, 2025; November 04, 2025; March 04, 2026; July 02, 2026; and November 02, 2026.
The latest application due date is November 02, 2026, by 5:00 PM local time of the applicant organization.
The overall funding opportunity expires on November 03, 2026.
Maximum Project Period: three years.

Submission Process

Applications must be submitted electronically through one of the following platforms:
- NIH ASSIST system.
- An institutional system-to-system (S2S) solution.
- Grants.gov Workspace.
Applicants are strongly encouraged to submit applications before the due date to allow time for corrections.
It is critical to view the application in eRA Commons before the due date to ensure accurate and successful submission.

Required Documentation and Materials

Standard application forms (SF424(R&R) series), including Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, and Budget/Subaward Budget forms.
PHS 398 Cover Page Supplement.
PHS 398 Research Plan, with specific sections:
- Specific Aims: Must clearly present aims and state primary/secondary hypotheses.
- Research Strategy: Requires detailed discussion of clinical significance, biological relevance, scientific rationale, prior studies, and rationale for development.
- Resource Sharing Plan: Compliance with instructions is required.
- Other Plan(s): A Data Management and Sharing Plan is mandatory for all applications, regardless of direct costs requested.
PHS Human Subjects and Clinical Trials Information Form: Includes study records for human subjects research, and specifies required attachments.
- Clinical Monitoring and Data Management Plan: A required attachment (filename: 'Clinical Monitoring and Data Management Plan.pdf'), detailing monitoring activities and data management controls.
- Intervention Documents: A required attachment (filename: 'Intervention Documents.pdf'), including either an Investigator's Brochure/Product Label (for device/drug/biologic trials) or Intervention Monitoring Manuals (for behavioral/social interventions).
PHS Assignment Request Form.

Pre-Application Requirements

Applicants are encouraged to consult with NIAMS staff while developing their application plans. This contact can help clarify NIAMS policies and guidelines, and discuss project timelines, milestone plans, and strategies for recruitment and inclusion.

Post-Award Requirements

Recipients are required to submit a Research Performance Progress Report (RPPR) annually.
A final RPPR, an invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of the award.
Registration and results reporting for all clinical trials on ClinicalTrials.gov is legally required for certain trials and expected for all NIH-funded trials.
Recipient institutions must ensure all protocols are reviewed and approved by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Implementation of the approved Data Management and Sharing Plan is required.

Evaluation Criteria

Overall Impact Score

Reviewers will assign an overall impact score reflecting the likelihood of the project to exert a sustained, powerful influence on the relevant research field(s). An application does not need to be strong in all categories to receive a high impact score.

Scored Review Criteria

Factor 1: Importance of the Research (Significance and Innovation):
- Clarity and conciseness of the specific aims of the exploratory clinical trial.
- Clear statement of the primary and major secondary hypotheses.
- Clinical significance and biological relevance of the proposed clinical trial.
- Discussion of how the trial will test the primary hypothesis and advance the field.
- Explanation of why the proposed trial is necessary for planning subsequent studies.
Factor 2: Rigor and Feasibility (Approach):
- Discussion of the scientific rationale for the trial, supported by preliminary data, literature, and/or biological mechanisms.
- Description of major findings from preclinical and/or clinical studies that led to the proposed clinical trial.
- Discussion of pilot studies demonstrating the need for and feasibility of the trial.
- Assessment of whether study conceptualization and planning are sufficient to assess the likelihood of trial success.
- Consideration of the intervention, including toxicology data, medicinal chemistry/pharmacology data, regulatory considerations (e.g., FDA, EMA evaluations), public health impact, ethical dimensions, and patient perspectives on acceptability.
- Description of characteristics of any preliminary research results provided to allow evaluation of supporting evidence strength.
- Discussion of limitations if preclinical data are not conclusive.
- Outline of specific plans for future development, if applicable, in the event of promising results.
- Discussion of potential biases in the study and how they will be addressed.
- Inclusion of evaluation of early signals of activity utilizing biomarkers or surrogate endpoints.
- Proposed study cohort should match the diversity of the population affected by the disease; otherwise, the application may be considered low priority.
Factor 3: Expertise and Resources (Investigator(s) and Environment):
- Assessment of the skills, knowledge, and resources of the Program Director(s)/Principal Investigator(s).
- Evaluation of the appropriateness of the research environment to conduct the proposed project.

Additional Review Criteria (not scored, but considered for overall impact)

Protections for Human Subjects (if applicable).
Vertebrate Animals (if applicable).
Biohazards (if applicable).
Review of Resubmissions, Renewals, or Revisions (if applicable).

Additional Review Considerations (not scored, do not influence overall impact directly)

Budget and Period of Support: Evaluation of whether the requested budget and project period are fully justified and reasonable in relation to the proposed research.
Authentication of Key Biological and/or Chemical Resources: Evaluation of brief plans for identifying and ensuring the validity of these resources (if applicable).

Compliance & Special Requirements

Regulatory and Policy Compliance

All awards are subject to the terms and conditions outlined in the NIH Grants Policy Statement.
Compliance with federal-wide and HHS-specific policy requirements, including 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
Awards are made under the authority of Sections 301 and 405 of the Public Health Service Act and Federal Regulations 42 CFR Part 52.
Recipients must comply with all applicable nondiscrimination laws, affirmed by SAM.gov registration, and submit an Assurance of Compliance (HHS-690).

Data Management and Privacy

A comprehensive Data Management and Sharing Plan is a mandatory requirement for all applicants.
The Clinical Monitoring and Data Management Plan must include methods and systems to ensure data confidentiality and subject privacy.

Ethical Standards and Oversight

All human subjects research must adhere to stringent protections and monitoring plans.
NIAMS will appoint an independent monitoring body (such as a Data and Safety Monitoring Board - DSMB, or Safety Officer(s) - SOs) based on the risks and complexity of the trial.
Protocols must receive approval from an Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Clinical research projects involving investigational therapeutics, vaccines, or medical interventions must comply with Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements, if applicable.

Reporting and Disclosure

Recipients are required to disclose any information related to violations of federal criminal law (fraud, bribery, gratuity) potentially affecting the federal award.
Registration and results reporting on ClinicalTrials.gov is required for all NIH-defined clinical trials.

Special Programmatic Requirements

This funding opportunity specifically targets exploratory clinical trials and is not intended to support large-scale clinical trials (e.g., Phase 3) where the primary aim is to establish or confirm robust efficacy or effectiveness.
Preliminary data is not required for R61 applications; however, if provided, it will be evaluated during the review process.
A strong scientific rationale for the trial is crucial, based on unmet medical needs, plausible biological mechanisms, and/or compelling preclinical data.
Applications should prioritize inclusion of a proposed study cohort that matches the diversity of the population affected by the disease; failure to do so may lead to the application being considered low priority.
Applicants are encouraged to demonstrate patient involvement as partners in the concept development and design of the trial, supported by letters from stakeholders (e.g., patient groups).
Exploratory IND studies with very limited human exposure, as defined by the FDA, may be proposed.

Grant Details