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Grant Analysis

Purpose & Target

Primary objective: Stimulate basic, translational, and clinical HIV/AIDS research within the specific mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), aligning with NIH HIV/AIDS research priorities. - Target recipient type: Primarily research institutions, non-profit organizations, for-profit entities (including small businesses), and various government bodies. - Target size: Open to diverse organizational sizes, from small businesses to large higher education institutions; size not defined by specific employee counts. - SECTOR-SPECIFIC - Geographic scope: Open to entities located in the U.S. and non-U.S. (foreign) organizations. - Key filtering criteria: Research must specifically focus on HIV/AIDS topics within NIDDK's mission areas (e.g., diabetes, GI, liver, kidney, hematologic diseases) and align with current NIH HIV/AIDS research priorities. Clinical trials are optional. - Grant frequency: This is a recurring funding opportunity, a reissue of a previous call, with multiple application submission windows spanning several years until January 2028. - Program context: This grant is part of a broader federal initiative by the National Institutes of Health (NIH) to address HIV/AIDS through targeted scientific inquiry, leveraging NIDDK's specialized research focus.

Financial Structure

Total funding available: $2,000,000 for fiscal year 2026.
Estimated number of awards: 3 to 5.
Application budgets: Not subject to specific dollar limitations per award, but must be appropriate and reflect the actual needs of the proposed project.
Maximum project period: 5 years.
Cost sharing/matching funds: Not required.
Pre-award costs: Allowable only as outlined in the NIH Grants Policy Statement.
Currency: USD.
Funding rate: Not specified as a percentage; grants provide direct financial assistance for approved project costs.
Financial reporting: Recipients are required to submit financial statements as per NIH Grants Policy Statement and a Federal Financial Report for closeout.

Eligibility Requirements

Eligible Organizations

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

Geographic Requirements

Applicants can be from the U.S. or any non-U.S. (foreign) entity. There are no specific country restrictions for foreign organizations beyond being non-U.S.

Registration and Certification

Applicant organizations must complete and maintain active registrations prior to application submission in:
- System for Award Management (SAM) (requires annual renewal).
- NATO Commercial and Government Entity (NCAGE) Code (for foreign organizations, in lieu of a CAGE code for SAM).
- Unique Entity Identifier (UEI) (issued via SAM.gov, must be used for all registrations and the grant application).
- eRA Commons (requires at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account).
- Grants.gov (requires active SAM registration).
Program Directors/Principal Investigators (PD/PIs) must have an eRA Commons account affiliated with the applicant organization.

Cost Sharing

No cost sharing is required for this funding opportunity.

Application Limits

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
Duplicate or highly overlapping applications are not accepted if under simultaneous review by NIH.

Application Process

Application Deadlines

Multiple application due dates are available annually until the funding opportunity's expiration date of January 08, 2028.
The latest application due date is January 07, 2028, by 5:00 PM local time of the applicant organization.
Applicants are strongly encouraged to submit applications early to allow for any necessary corrections before the due date.
If a submission date falls on a weekend or Federal holiday, the deadline is automatically extended to the next business day.

Submission Process

Applications must be submitted electronically via Grants.gov.
Application forms are accessed through one of three primary options: the NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
After submission to Grants.gov, applicants must track the status of their application in the eRA Commons system.
Applications are initially evaluated for completeness and compliance with instructions; incomplete or non-compliant applications will not be reviewed.
Applicants are responsible for viewing their application in eRA Commons prior to the due date to ensure successful and accurate submission.

Required Documentation and Materials

All applicants must adhere to the instructions provided in the Research (R) Instructions in the How to Apply - Application Guide, with any program-specific instructions in this NOFO taking precedence.
Key required forms/sections include: SF424(R&R) forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile), R&R or Modular Budget, R&R Subaward Budget, PHS 398 Cover Page Supplement, and PHS 398 Research Plan.
Resource Sharing Plan: Required for all applications.
Data Management and Sharing Plan: Required for all applications that will generate scientific data, irrespective of the direct costs requested.
Appendix: Only limited materials are permitted (e.g., blank questionnaires or surveys).
PHS Human Subjects and Clinical Trials Information form: Required if the proposed research involves human subjects or NIH-defined clinical trials.

Pre-Application Requirements

For applications requesting $500,000 or more in direct costs in any single year (excluding consortium F&A), applicants must contact a Scientific/Research Contact at least 6 weeks before the intended submission date.

Post-Award Reporting Obligations

Research Performance Progress Report (RPPR): Required annually for multi-year awards.
Financial statements: Required periodically as specified.
Final RPPR, invention statement, and expenditure data (Federal Financial Report): Required for the closeout of an award.
ClinicalTrials.gov Registration and Results Reporting: Required for certain 'applicable clinical trials' (per law) and expected by NIH for all clinical trials.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval: Required for all protocols involving human subjects.
Data and Safety Monitoring Requirements: Required for all NIH-funded human biomedical and behavioral intervention studies to ensure participant safety and data integrity.

Evaluation Criteria

Reviewers will assign an overall impact score reflecting the project's likelihood of exerting a sustained, powerful influence on the research field(s), based on the following criteria: Scored Review Criteria These three factors will determine the scientific merit and contribute to the overall impact score, with Factors 1 and 2 also receiving separate criterion scores: - Factor 1. Importance of the Research (Significance and Innovation): Evaluates the project's potential to advance scientific knowledge and its originality. - Factor 2. Rigor and Feasibility (Approach): Assesses the soundness, design, methods, and analyses of the proposed research, as well as the feasibility of execution. - Factor 3. Expertise and Resources (Investigator(s) and Environment): Considers the qualifications and experience of the research team and the suitability of the research environment and resources. Additional Review Criteria (Considered, but not scored separately)

Protections for Human Subjects: Evaluation of the proposed measures to protect human research participants.
Vertebrate Animals: Assessment of procedures, justification for animal use, and efforts to minimize discomfort, distress, pain, and injury if live vertebrate animals are involved.
Biohazards: Review of significant hazardous materials or procedures and the adequacy of proposed protection measures.
Resubmissions: Comprehensive re-evaluation of the entire application as presented.
Renewals: Evaluation of the progress achieved during the previous funding period.
Revisions: Assessment of the appropriateness and justification for the proposed expansion of the project's scope.

Additional Review Considerations (Considered, but not scored or for overall impact)

Authentication of Key Biological and/or Chemical Resources: Review of brief plans for identifying and ensuring the validity of essential biological and/or chemical resources.
Budget and Period of Support: Evaluation of whether the requested budget and project duration are fully justified and reasonable in relation to the proposed research scope and objectives.

Compliance & Special Requirements

Regulatory Compliance

Awards are subject to federal regulations 42 CFR Part 52 and 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
All activities must comply with the NIH Grants Policy Statement and all applicable nondiscrimination laws (agreed to upon SAM.gov registration).
Compliance with all federal statutes and regulations relevant to federal financial assistance, including NIH Grants Policy Statement Section 4 Public Policy Requirements, is mandatory.

Data Management and Sharing

Recipients are required to adhere to the 2023 NIH Policy for Data Management and Sharing.
The approved Data Management and Sharing Plan must be implemented as described.

Ethical and Safety Standards

Human Subjects Research: Requires appropriate protections for participants. Clinical research involving investigational therapeutics, vaccines, or medical interventions must comply with FDA investigational new drug (IND) or investigational device exemption (IDE) requirements.
Vertebrate Animals: Projects involving live vertebrate animals must justify their use and describe interventions to minimize discomfort, distress, pain, and injury, adhering to AVMA Guidelines for the Euthanasia of Animals.
Biohazards: Adequate protection measures must be proposed if the research involves significantly hazardous materials or procedures.

Intellectual Property and Data Use

Common Data Elements (CDEs): Investigators are encouraged to utilize NIH-supported CDEs to facilitate data sharing and standardization across studies, consulting the NIH CDE Resource Portal.
Invention Statement: Required as part of the award closeout process.

Risk Management and Security

NIH reviews an applicant's federal award history in SAM.gov to assess sound business practices and risk, in accordance with 2 CFR Part 200.206.
Mandatory Disclosure: Recipients are required to disclose any information related to violations of federal criminal law involving fraud, bribery, or gratuity that could potentially affect the federal award (as per 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35).

Special Considerations and Exclusions

Projects must align specifically with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'s mission, covering areas such as:
- Diabetes and other endocrine and metabolic diseases.
- Gastrointestinal, liver, and pancreatic diseases.
- Nutritional disorders and obesity.
- Kidney, urologic, and hematologic diseases.
All proposed research must align with the NIH HIV/AIDS research priorities, as most recently described in NOT-OD-20-018.
Non-responsive applications that will be administratively withdrawn without review include those with a primary focus on:
- HIV reservoirs in tissues outside NIDDK's mission.
- HIV-related comorbidities, co-infections, or complications (CCCs) affecting organs, tissues, or processes outside NIDDK's mission.
- The virus itself in viral hepatitis co-infection, rather than its pathogenic consequences.
- The effects of social determinants of health (SDoH) on CCCs primarily affecting organs, tissues, or processes outside NIDDK's mission.
- Research not aligned with NIH HIV/AIDS research priorities.

Unique Aspects

The grant encourages mechanistic interrogation of how HIV or its treatment interacts with NIDDK-relevant physiological processes.
A specific focus is placed on characterizing HIV reservoirs within NIDDK-relevant tissues (e.g., gastrointestinal mucosa, male genital tract, kidney, adipose tissue).
Research exploring the impact of health-impeding social determinants of health (SDoH) on HIV-related CCCs within NIDDK's scope and on reservoir dynamics is specifically encouraged.

Grant Details