Grants8 | The most comprehensive grants search on the web

Grant Analysis

Purpose & Target

The core objective of this grant is to support and advance an existing Human Tissue and Organ Research Resource program. This resource aims to facilitate the continued availability of a wide variety of human tissues and organs (both diseased and normal) to qualified biomedical researchers for laboratory studies.

Target recipients: Established organizations with a proven track record in managing human tissue and organ research resources.
SECTOR-SPECIFIC: This grant is highly sector-specific, focusing exclusively on biomedical research related to human tissues and organs.
Geographic scope: Applicants must be located within the United States, its states, or its territories and possessions. Foreign organizations and foreign components of U.S. organizations are not eligible.
Key filtering criteria: Your organization must have a demonstrated history of successfully operating a human tissue and organ research resource. Proposals involving clinical trials are explicitly not allowed.
Grant frequency: This is a reissue of a previous funding opportunity, indicating that this type of support may recur, although specific deadlines are tied to this current announcement.

Financial Structure

Maximum direct costs: The grant has a maximum direct cost limit of $720,000 per year.
Award Project Period: The scope of the project should determine the period, with a maximum of 5 years.
Cost Sharing: This funding opportunity does not require cost sharing.
Pre-award costs: Allowable as described in the NIH Grants Policy Statement.
Program Income: Applicants are expected to describe how Program Income will contribute to reductions in procurement, distribution, and other service costs, supporting the resource's sustainability.
Financial Reporting: Recipients are required to submit an annual Research Performance Progress Report (RPPR) and financial statements as required by the NIH Grants Policy Statement.
Audit Requirements: All NIH awards are subject to the terms and conditions, cost principles, and audit requirements described in the NIH Grants Policy Statement and 2 CFR Part 200.

Eligibility Requirements

To be eligible for this grant, your organization must meet the following hard requirements: Organization Type

Any Higher Education Institution (Public/State Controlled or Private).
Nonprofit Organizations (with or without 501(c)(3) IRS status, other than institutions of higher education).
For-Profit Organizations (including Small Businesses and other For-Profit Organizations).
Local Governments (State Governments, County Governments, City or Township Governments, Special District Governments, Indian/Native American Tribal Governments).
Eligible Agencies of the Federal Government.

Geographic Location

Must be a domestic (U.S.) entity. Foreign Organizations are explicitly not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are also not eligible to apply.
Foreign components as defined by NIH Grants Policy Statement are not allowed.

Organizational Capacity & Track Record

Must have a demonstrated track record of running an established human tissue and organ research resource.
Possess recognized relevant expertise in managing such a resource.
Demonstrate adequate implementation of quality control protocols.
Prove effective customer service in this domain.

Technical & Infrastructure

Must have the capacity to facilitate the procurement and preservation of human tissues and organs.
Must have the capacity for the distribution of these materials to qualified biomedical researchers.
Ability to manage a multi-component application (Overall, Management, and Resource sections).

Registrations

Must complete and maintain active registrations prior to application submission in:
System for Award Management (SAM) (requires annual renewal).
Unique Entity Identifier (UEI) (issued as part of SAM.gov registration).
eRA Commons (organization must register, identify Signing Official and at least one Program Director/Principal Investigator).
Grants.gov (requires active SAM registration).
All Program Directors/Principal Investigators (PD/PIs) must have an eRA Commons account affiliated with the applicant organization.

Application Process

Application Deadlines & Submission

Application Due Dates: There are two main application due dates:
January 24, 2025, by 5:00 PM local time of applicant organization.
September 26, 2025, by 5:00 PM local time of applicant organization.
Applicants are strongly encouraged to submit early to allow time for corrections.
Applications must be submitted electronically via Grants.gov using either the NIH ASSIST system or an institutional system-to-system (S2S) solution.
After submission, applicants must track their application status in eRA Commons.

Required Registrations Prior to Application

Your organization must have active registrations with System for Award Management (SAM), Unique Entity Identifier (UEI), eRA Commons, and Grants.gov.
All Program Directors/Principal Investigators (PD/PIs) must have an active eRA Commons account affiliated with your organization.

Required Documentation & Materials Applications are multi-component and must follow the Multi-Project (M) Instructions from the How to Apply - Application Guide, with specific supplements from this NOFO: - Overall Component (required): - SF424(R&R) Cover & PHS 398 Cover Page Supplement. - Research & Related Other Project Information & Project/Performance Site Locations. - Research and Related Senior/Key Person Profile (for PD/PIs only). - Budget (Estimated Project Funding only). - PHS 398 Research Plan (Specific Aims, Research Strategy, Letters of Support, Resource Sharing Plan, Other Plan(s) - including a detailed Data Management and Sharing Plan). - PHS Human Subjects and Clinical Trials Information (if applicable). - Management Section Component (required, max 1): - SF424(R&R) Cover, PHS 398 Cover Page Supplement. - Research & Related Other Project Information (limited questions). - Project/Performance Site Location(s). - Research & Related Senior/Key Person Profile (for component leads). - Budget. - PHS 398 Research Plan (Specific Aims, Research Strategy detailing administrative structure, communication, quality control, advisory board, capacity enhancement, adherence to regulations like HIPAA, evaluation of processes, pathologic review, and quality control). - Resource Section Component (required, max 1): - SF424(R&R) Cover, PHS 398 Cover Page Supplement. - Research & Related Other Project Information (limited questions). - Project/Performance Site Location(s). - Research & Related Senior/Key Person Profile (for component leads). - Budget. - PHS 398 Research Plan (Specific Aims, Research Strategy detailing resource design/plan, customer service, milestones, integration plan, sustainability plan, evaluation procedures, and optionally a Pilot Award Program). Project Implementation Timeline

Earliest Start Date:
For Jan 24, 2025 submission: December 2025.
For Sep 26, 2025 submission: July 2026.
Project Period: Maximum of 5 years.

Reporting Obligations

Annual Reporting: Submit Research Performance Progress Reports (RPPR) annually.
Financial Statements: Submit as required.
Final Reports: A final RPPR, invention statement, and expenditure data are required for closeout.

Evaluation Criteria

Applications for this grant will be evaluated based on the following criteria, with an overall impact score reflecting the likelihood of the project's sustained influence on the research field: Overall Impact Factors

Significance: How well the proposed Center addresses the needs of the research resource, if its scope is appropriate, and if it brings unique advantages or will improve scientific knowledge, technical capability, or clinical practice.
Investigator(s): Assessment of the PD(s)/PI(s) and other personnel's suitability, experience, training, and track record in managing biomedical research. For multi-PD/PIs, evaluation of their complementary expertise, leadership, and conflict resolution plans.
Innovation: Whether the application proposes novel organizational concepts, management strategies, or instrumentation, and their potential broad applicability or refinement.
Approach: Evaluation of the overall strategy, operational plan, and organizational structure for accomplishing goals, promotion of robust and unbiased science, identification of problems and alternative strategies, and appropriate consideration of biological variables (like sex).
Environment: How the institutional environment supports the project's success, adequacy of institutional support, equipment, and physical resources, and availability of resources for electronic information handling.

Management Section Specific Criteria

Effectiveness of the goals and administrative structure in facilitating resource operation and meeting research community needs.
Ability of the proposed administrative structure to maintain communication across all stakeholders (tissue/organ banks, hospitals, research facilities, federal agencies, biomedical community).
Demonstrated scientific and administrative leadership of the PD/PI(s).
Applicant's proven track record in managing an established human tissue/organ resource, including customer service functions.
Adequacy of structures for overseeing procurement, collection/storage protocols, distribution procedures, and quality control of specimens.
Appropriateness of the advisory board/committee structure.
Capacity to engage biomedical researchers and address tissue/organ requests.
Strength of shared commitment and linkages with affiliated tissue/organ banks and procurement organizations.
Utilization of technologies to improve access, procurement, preservation, storage, and distribution of specimens.
Consideration and adherence to the HIPAA Privacy Rule implications.
Effectiveness of evaluation mechanisms for continuous program improvement.
Adequacy of pathologic review of specimens and quality control protocols.

Resource Section Specific Criteria

Detailed plans for design and development of the resource, including current capacities, procurement, shipping, preservation, confidentiality, informed consent, biohazards, pathogen screening, request fulfillment, redundancy, and disaster recovery.
Adequacy of pathologic review, quality control, data collection/analysis, and diagnostic verification systems.
Quality of the proposed database for user-friendly accounting, data integrity, accuracy, and security.
Maintenance of a core of remote-site collection centers.
Quality of customer service and public relations plans.
Presence of specific milestones and proposed metrics for tracking program success over five years.
Effectiveness of the integration plan for proposed goals and milestones, including personnel recruitment and training.
Adequacy of the Sustainability Plan, particularly how Program Income contributes to cost reductions and resource operations.
Effectiveness of procedures for evaluating core functioning and implementing recommendations.
If an optional Pilot Award Program is proposed, its alignment with resource goals, appropriateness of support provided, and design quality (promotion, application, review, tracking, funding).

Additional Review Criteria (not scored separately but considered)

Protections for Human Subjects: Evaluation of justification for human subject involvement and proposed protections.
Inclusion: Plans for inclusion/exclusion of individuals based on sex, race, ethnicity, and age.
Vertebrate Animals: If applicable, assessment of animal use justification, alternatives, and welfare interventions.
Biohazards: Assessment of proposed procedures for potential hazards and adequate protection.
Resource Sharing Plans: Reasonableness of sharing plans (e.g., for model organisms) or rationale for not sharing.
Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity.

Compliance & Special Requirements

Regulatory Compliance

All awards are subject to the terms and conditions outlined in the NIH Grants Policy Statement.
Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) is mandatory.
Awards are authorized under Sections 301 and 405 of the Public Health Service Act (42 USC 241 and 284) and Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.
Recipients must comply with all applicable nondiscrimination laws, as agreed upon during SAM.gov registration.
Mandatory disclosure of violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award (2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35).

Data Protection & Privacy

Adherence to Health Insurance Portability and Accountability Act (HIPAA) regulations, specifically the Privacy Rule, is required for resource operations.
Compliance with the 2023 NIH Policy for Data Management and Sharing is required. Applicants must submit a detailed Data Management and Sharing Plan for any research generating scientific data, especially from the Pilot Research Program component. Genomic data sharing for any component generating genome-wide genetic data must also be addressed.

Ethical Standards & Human Subjects

Compliance with NIH guidelines and regulations on informed consent and research resources is essential.
Strict adherence to protections for human subjects from research risks, including adequacy of protection against risks, potential benefits, importance of knowledge gained, and data/safety monitoring for clinical trials (if applicable).
Grantee institutions must ensure protocols are reviewed by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Prior NIH approval is required for recipient-selected projects involving human subjects with greater than minimal risk.

Intellectual Property & Technology Specifications

While specific IP policies are not detailed, the expectation is for the resource to enhance capacity to utilize technologies and improve approaches/protocols for specimen access, procurement, preservation, storage, and distribution.

Risk Management & Security

Evaluation and continual maintenance of biohazard safety.
Discussion of redundancy and disaster recovery plans for the human organ and tissue resource.

Special Considerations & Unique Aspects

This funding is structured as a Cooperative Agreement (U42), meaning there will be substantial Federal scientific or programmatic involvement from NIH staff. This is not a typical grant where the funder has minimal involvement after award.
The primary responsibility for the project rests with the recipient, but NIH staff will act as partners, facilitating collaborations and providing expert advice.
The opportunity allows for an optional Pilot Award Program to solicit applications from investigators for limited human biospecimens at no cost, with priority for early-stage or preclinical investigators.
Strong emphasis on sustainability, with expectations for Program Income to contribute to the resource's ongoing operations and cost reduction.

Grant Details