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Grant Analysis

Purpose & Target

The Innovations to Optimize HIV Prevention and Care Continuum Outcomes (R21) grant aims to fund innovative, exploratory research projects that advance understanding and intervention approaches across the HIV prevention and care continuum. This includes novel basic or applied behavioral and social science to identify gaps and advance innovative interventions. - Target Recipient Type: Research-focused organizations including higher education institutions, nonprofits, for-profit organizations (including small businesses), and various government entities. - Target Size: Not explicitly restricted by organizational size or employee count, open to a wide range of research entities. - This grant is SECTOR-SPECIFIC, focusing on HIV prevention and care within the health and social science research sectors. - Geographic Scope: Domestic and non-domestic (non-U.S.) entities are eligible to apply, including foreign institutions. - Key Filtering Criteria: Focus on HIV prevention/care, innovative/exploratory research, and adherence to specific NIH application and data sharing requirements. - Grant Frequency: Recurring opportunity with multiple application due dates annually until its expiration date.

Financial Structure

Budget Range and Limitations: The combined budget for direct costs for the two-year project period may not exceed $275,000.
Annual Limitation: No more than $200,000 may be requested in any single year.
Eligible Costs: Costs related to carrying out approved research projects, subject to NIH Grants Policy Statement guidelines.
Ineligible Costs: Not explicitly detailed, but generally, costs not directly related to the approved project activities.
Matching Fund Requirements: This funding opportunity does not require cost sharing.
Co-financing Requirements: Not required.
Payment Schedule and Mechanisms: Awards are typically provided as grants. Specific payment schedules would be detailed in the Notice of Award (NoA).
Financial Reporting Requirements: Recipients are required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required by NIH Grants Policy Statement. A final RPPR and expenditure data are required for closeout.
Audit Requirements: Not explicitly detailed here, but subject to federal audit requirements for recipients of federal financial assistance.
Financial Sustainability Expectations: Not directly addressed as an explicit requirement for the grant itself, but project teams are encouraged to collaborate with relevant organizations to optimize public health impact.
Indirect Cost Policies: Not explicitly stated, but NIH grants generally adhere to federal indirect cost policies.
Budget Flexibility Parameters: Not explicitly stated, but subject to NIH Grants Policy Statement.
Financial Guarantees Required: None explicitly stated.

Eligibility Requirements

Eligible Organizations

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

Required Registrations

System for Award Management (SAM): Must complete and maintain active registration, renewed annually. Includes CAGE Code for domestic organizations; NCAGE code for foreign organizations.
Unique Entity Identifier (UEI): Issued as part of SAM.gov registration; must be used for all registrations and applications.
eRA Commons: Organizations must register and identify at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI).
Grants.gov: Applicants must have an active SAM registration to complete Grants.gov registration.

Eligible Individuals (Program Director/Principal Investigator)

Any individual with the skills, knowledge, and resources to carry out the proposed research.
Must have an eRA Commons account, affiliated with the applicant organization.

Application Process

Application Package Request

Access application forms through NIH ASSIST system, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.

Application Submission Dates

Open Date (Earliest Submission Date): April 09, 2023.
Application Due Dates: Multiple deadlines throughout the year. The latest application due date (for AIDS-related applications) is January 09, 2026 by 5:00 PM local time of applicant organization.
Expiration Date: January 10, 2026.
Submission Deadline (Latest): 2026-01-09 17:00:00 (Local Time of Applicant Organization).
Applicants are encouraged to apply early to allow time for corrections.
If a due date falls on a weekend or Federal holiday, the deadline is automatically extended to the next business day.

Content and Form of Application Submission

Applicants must follow instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, with specific program-specific instructions in the FOA taking precedence.
Page Limitations: Adhere to SF424 Application Guide and Table of Page Limits.
Required Forms/Sections: SF424(R&R) 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, PHS 398 Research Plan.
Other Plan(s): Data Management and Sharing Plan (for due dates on or after January 25, 2023) must be attached and comply with NIH policy. This includes sharing data via the National Institute of Mental Health Data Archive (NDA) semi-annually.
Appendix: Only limited materials allowed (e.g., blank questionnaires/surveys). No publications or other material.
PHS Human Subjects and Clinical Trials Information: Required if human subjects are involved, following SF424 (R&R) Application Guide instructions.
PHS Assignment Request Form: Must be completed.

Submission Process and Tracking

Applications must be submitted electronically through Grants.gov.
Applicants must track the status of their application in eRA Commons.
Applications are checked for completeness and compliance upon receipt. Incomplete/non-compliant applications will not be reviewed.
Applicants are responsible for viewing their application in eRA Commons before the due date to ensure accurate submission.
Post-submission materials rules must be followed.

Types of Support Offered

Funding: Grant mechanism provides financial support for approved projects.
Research & Development: Supports exploratory/developmental research into HIV prevention and care.
Networking/Collaboration: Encourages multidisciplinary research teams and collaborations with community members, health service providers, public health agencies, etc.

Project Implementation Timeline and Reporting Obligations

Project Period: The total project period may not exceed 2 years.
Reporting: Research Performance Progress Report (RPPR) is required annually.
Data Submission: Semi-annual submission of descriptive/raw data to NDA (January 15 and July 15). All other data submitted at publication or prior to grant end.

Post-Award Requirements and Compliance Obligations

Awardees must comply with terms and conditions described in the NIH Grants Policy Statement.
For clinical trials, timely registration to ClinicalTrials.gov, submission of review determinations, and timely reporting of events are required.
Adherence to HHS Assurance of Compliance (HHS 690) regarding civil rights, accessibility, and non-discrimination.
Compliance with Federal Funding Accountability and Transparency Act (FFATA) for subaward reporting.
Compliance with Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.

Evaluation Criteria

Overall Impact Reviewers will assess the likelihood of the project to have a sustained, powerful influence on the research field(s), considering the following criteria. Scored Review Criteria

Significance: Does the project address an important problem or critical barrier in HIV prevention/care? Will it improve scientific knowledge, technical capability, or clinical practice? Is the prior research rigorous?
Investigator(s): Are the PD(s)/PI(s), collaborators, and other researchers well-suited with appropriate experience and training? For collaborative projects, is leadership, governance, and organizational structure appropriate?
Innovation: Does the application challenge existing paradigms using novel concepts, approaches, methodologies, instrumentation, or interventions? Is it novel to the field or in a broad sense?
Approach: Are the strategy, methodology, and analyses well-reasoned and appropriate? Are plans to address prior research weaknesses robust and unbiased? Are potential problems and alternative strategies presented? For human subjects/clinical research, are plans for protection of human subjects and inclusion/exclusion criteria justified?
Environment: Will the scientific environment contribute to success? Are institutional support, equipment, and resources adequate? Will the project benefit from unique features or collaborative arrangements?

Additional Review Criteria (Not Scored, but Considered)

Study Timeline: For clinical trials, is the timeline detailed, feasible, and justified? Does it incorporate efficiencies and existing resources?
Protections for Human Subjects: Evaluation of risks, adequacy of protection, potential benefits, importance of knowledge, and data/safety monitoring for clinical trials (if applicable).
Inclusion of Women, Minorities, and Individuals Across the Lifespan: Evaluation of proposed plans for inclusion/exclusion based on sex, race, ethnicity, and age.
Vertebrate Animals: Evaluation of procedures, justifications, interventions to minimize discomfort, and euthanasia methods (if applicable).
Biohazards: Assessment of potential hazards and proposed protection measures.
Resubmissions: Consideration of responses to previous comments and changes made.
Renewals: Consideration of progress made in the last funding period.
Revisions: Consideration of appropriateness of scope expansion and responses to prior comments (if applicable).

Additional Review Considerations

Applications from Foreign Organizations: Assessment of unique talent, resources, populations, or environmental conditions not readily available in the U.S.
Select Agent Research: Review of proposed select agents, registration status, monitoring procedures, and biosafety/biocontainment plans.
Resource Sharing Plans: Reviewers comment on the reasonableness of Data Sharing Plan, Sharing Model Organisms, and Genomic Data Sharing Plan (GDS) or rationale for not sharing (Note: Data Sharing Plan and GDS not evaluated for scoring for due dates on or after January 25, 2023).
Authentication of Key Biological and/or Chemical Resources: Comment on plans for identifying and ensuring validity.
Budget and Period of Support: Review of justification and reasonableness in relation to the proposed research.

Compliance & Special Requirements

Regulatory Compliance Requirements

Adherence to federal regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.
Compliance with Federalwide Research Terms and Conditions.
Compliance with terms of the NIH Grants Policy Statement.
Human Research Protection: Adherence to NIH policies and guidance regarding human research protection and clinical research data and safety monitoring (e.g., NOT-MH-19-027). This includes IRB/IEC approval and data/safety monitoring for clinical trials.
Investigational New Drug (IND)/Investigational Device Exemption (IDE): Clinical research involving investigational products must be performed under FDA IND/IDE.

Data Protection and Privacy Regulations

NIH Data Management and Sharing Policy: Effective for due dates on or after January 25, 2023. Requires a Data Management and Sharing Plan.
NIMH Data Archive (NDA): Investigators funded under this FOA are expected to share human subjects data via NDA. This includes formulating enrollment and budget strategies for data submission.
Common Data Elements (CDEs): Expectation to collect CDEs for HIV-related human subjects research unless strong justification is provided.

Ethical Standards and Requirements

Protection of Human Subjects: Applications must address protection from research risks and inclusion/exclusion criteria.
Clinical Trial Registration: NIH expects registration and results reporting of all clinical trials on ClinicalTrials.gov.
Non-discrimination: Compliance with federal civil rights laws prohibiting discrimination based on race, color, national origin, age, sex, disability, and conscience laws. Ensuring meaningful access for individuals with limited English proficiency and persons with disabilities.
Safe and Respectful Work Environment: Adherence to NIH's commitment to supporting a safe and respectful work environment, free of sexual harassment.

Unique Aspects / Strategic Opportunities

Exploratory/Developmental (R21) mechanism: Supports novel scientific ideas or new model systems/tools/technologies with potential for significant impact. Preliminary data are not required but can be included.
Community and Partnership Involvement: Strong encouragement for inclusion of individuals from relevant communities, community-based or HIV service organizations as research team members or advisory groups. Academic/Department of Health partnerships and collaboration with service providers, government agencies (housing, transportation, criminal justice, schools, faith-based) are recommended.
Multidisciplinary Research: Encourages approaches drawing from multiple disciplines for novel understandings of complex problems.
Consultation with NIH Staff: Potential applicants are strongly encouraged to consult with NIH staff early to ensure alignment with program priorities.

Risk Management and Security Requirements

Risk Management: Implicitly covered by overall NIH grant policies and review criteria on approach (e.g., managing risky aspects of the project).
Security: For projects involving Select Agents, plans for biosafety, biocontainment, and security are reviewed.
Telecommunications and Video Surveillance: Prohibition on certain telecommunications and video surveillance services or equipment.

Grant Details