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Grant Analysis

Purpose & Target

Core objective: To support and enhance biomedical research capacity, clinical and translational (C&T) research infrastructure, and workforce development within health organizations across specific IDeA-eligible states.
Target recipient: Health research organizations and associated community clinics within IDeA states.
Size: Organizations with established research administration infrastructure and a track record of externally funded C&T research grants.
Designation: SECTOR-SPECIFIC
Geographic scope: IDeA-eligible U.S. states and Puerto Rico, forming statewide or multi-state regional networks.
Key filtering criteria: Location in an IDeA state, existing C&T research grants, ability to form/lead a robust network, and focus on broad health challenges rather than narrow disease/population.
Grant frequency: Recurring (this is a reissue of a previous funding opportunity).

Financial Structure

Maximum annual direct costs for the overall award: $3,300,000, excluding consortium facilities and administrative (F&A) costs.
Cost sharing: Not required.
Eligible costs for cores:
- Salaries for core staff.
- Acquisition and/or modernization of new equipment.
- Preparation and maintenance of large clinical datasets (e.g., Electronic Health Records - EHR, medical images, biospecimens) for research use.
- Establishment or strengthening of Practice-Based Research Networks (PBRNs) and development of communication mechanisms.
- Travel costs and compensation for External Advisory Committee (EAC) members (as consultants).
- Compensation for Executive Committee (EC) members.
- Travel for PD(s)/PI(s) and other key personnel to the National IDeA Symposium of Biomedical Research Excellence (NISBRE) biennial meetings.
- Consulting services that assist the CTR-N's strategic planning.
Eligible costs for Health Research (HR) Core's research projects (require prior NIH approval):
- Direct costs up to $1,000,000 annually to support the HR Core's research projects.
- Pilot Projects: Individual project budget of $50,000-$100,000 in annual direct costs (1-year duration).
- Developmental Projects: Individual project budget up to $100,000 in annual direct costs (up to 2 years duration).
- Multi-Site Collaborative Projects: Individual project budget up to $400,000 in annual direct costs (at least one expected).
Ineligible costs:
- Funds for collaborators at organizations in non-IDeA states or foreign sites, except for specific fee-for-service activities (e.g., learning new techniques, sample/data analysis, workshops).
- Graduate student or postdoctoral stipends (salary support for research staff from an awarded project is allowed).
- PD/PIs may not use CTR-N funds to supplement their own research projects or teams.
- HR project leads may not receive simultaneous research support as project leads from this or another IDeA parent award (e.g., COBRE, INBRE, IDeA-CTR, CTR-N, or CTR-D).
- Funds cannot be used to procure access to commercially available EHR data.
Financial reporting: Annual financial statements are required as per NIH Grants Policy Statement.
Indirect cost policies: Consortium F&A costs are excluded from the annual direct cost cap, indicating they are allowed in addition to the direct costs.

Eligibility Requirements

Lead Organization Requirements

Must be located in one of the following IDeA-eligible states, commonwealth, or jurisdictions: Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Puerto Rico, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia, Wyoming.
Must hold externally funded Clinical and Translational (C&T) research grants.
Must have a well-established research administration infrastructure capable of effectively managing C&T research projects and sub-awards.
For new applications:
- Must NOT be a partner organization of an active IDeA-CTR award.
- Must NOT be a lead or partner organization of an active CTR-N award, CTR-D award, or Clinical and Translational Science Award (CTSA) Hub.
- Must NOT be located in a state or multi-state region that already has an active CTR-N, CTR-D, or CTSA Hub award.
For renewal applications:
- Must hold an active IDeA-CTR award (including those in no-cost extension).
An organization may only be the lead of one IDeA-CTR, CTR-N, or CTR-D award or application at a time.
A state may hold only one active IDeA-CTR, CTR-N, or CTR-D award.

Partner Organization Requirements

Must be located in the same state or multi-state region as the lead organization of the CTR-N application.
Must NOT be a lead or partner organization of an active CTR-N, CTR-D, or CTSA Hub award.
Must NOT be located in a state or multi-state region that has an active CTR-N award.
An organization may only be a partner of one IDeA-CTR, CTR-N, or CTR-D award or application at a time.

Consortium Requirement

Applications must assemble a statewide or multi-state network of health research organizations, including a nexus of community clinics interested in health research (e.g., clinics of a Practice-Based Research Network - PBRN).

Individual/Program Director/Principal Investigator (PD/PI) Requirements

PD/PI must be an established clinical investigator with a track record of leading externally funded C&T research projects or programs.
PD/PI should have leadership experience and skills to work across institutional boundaries to coalesce the network.
The primary appointment of the contact PD/PI must be at the applicant organization.
A CTR-N PD/PI may not simultaneously lead an IDeA COBRE or INBRE award.

Eligible Organization Types

Higher Education Institutions (Public/State Controlled, Private)
Nonprofits Other Than Institutions of Higher Education (501(c)(3) IRS Status and others)
For-Profit Organizations (Small Businesses, Other For-Profit Organizations)
Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal - Federally Recognized and Other)
U.S. Territory or Possession

Ineligible Organizations

Foreign institutions (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 (as defined by NIH Grants Policy Statement) are NOT allowed.

General Eligibility Restrictions

Applications that focus on a narrow disease or population are NOT responsive and will not be accepted for review.
Only one application is allowed per applicant organization (identified by unique entity identifier - UEI or NIH IPF number).

Registration Requirements

Applicant organizations must complete and maintain active registrations in:
- System for Award Management (SAM) - requires renewal at least annually.
- Unique Entity Identifier (UEI) - obtained via SAM.gov.
- eRA Commons - organization must register and identify at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
- Grants.gov - requires active SAM registration.
All PD/PIs must have an eRA Commons account, affiliated with the applicant organization.
Registrations can take 6 weeks or more and must be completed prior to application submission.

Application Process

Application Deadlines and Submission

Applications are due by 5:00 PM local time of the applicant organization on the following dates:
- October 09, 2024
- October 09, 2025
Applicants are strongly encouraged to submit early to allow time for any necessary corrections.
If a submission date falls on a weekend or federal holiday, the deadline is automatically extended to the next business day.

Submission Method

Electronic submission is mandatory via the NIH ASSIST system or an institutional system-to-system (S2S) solution to Grants.gov.
Paper applications will NOT be accepted.
Applicants must track their application status in eRA Commons.

Required Documentation and Materials

Applications must follow the Multi-Project (M) Instructions in the 'How to Apply - Application Guide' and program-specific instructions in this NOFO.
The application must include an 'Overall' component and five required 'Core' components: Administrative Core (AC), Research Design, Compliance, and Data Management (RDCD) Core, Community Engagement and Outreach (CEO) Core, Professional Development (PD) Core, and Health Research (HR) Core. Optional 'Other Cores' may be proposed.
Overall Component includes:
- Standard forms: SF424(R&R) Cover, PHS 398 Cover Page Supplement, Research & Related Other Project Information (including Facilities and Other Resources), Project/Performance Site Locations.
- Research and Related Senior/Key Person Profile (for PD/PIs only, with biographical sketches).
- Budget (Estimated Project Funding section).
- PHS 398 Research Plan: Introduction (for Resubmission applications), Specific Aims for the CTR-N, and a comprehensive Research Strategy (Overall Plan) detailing Goals, Capacity for C&T Research, and Organizational Structure/Governance Model.
- Letters of Support: Required from a senior official of each network organization to demonstrate institutional commitment and resource allocation. Letters from other NIH IDeA award PD(s)/PI(s) may also be included.
- Resource Sharing Plan.
- Data Management and Sharing (DMS) Plan (required for research generating scientific data).
- PHS Human Subjects and Clinical Trials Information (if applicable).
Each Core Component includes:
- Specific SF424(R&R) fields, PHS 398 Cover Page Supplement, Research & Related Other Project Information.
- Project/Performance Site Location(s).
- Research & Related Senior/Key Person Profile (for the Core Lead and other Senior/Key persons, with biographical sketches).
- Specific budget forms for the core.
- PHS 398 Research Plan: Introduction (for Resubmissions), Specific Aims for the Core, and a Research Strategy for the Core.
- Letters of Support: Only letters specific to the individual core are allowed here; institutional support should be included in the Overall Component.
- Resource Sharing Plan.
- PHS Human Subjects and Clinical Trials Information (if applicable).

Support Offered

The primary support type is direct funding in the form of a grant (P50 Specialized Center).
This funding supports capacity building, workforce development, infrastructure enhancement, and clinical/translational research activities within the established network.

Project Implementation Timeline and Reporting

Maximum project period is 5 years.
Award recipients are required to submit an annual Research Performance Progress Report (RPPR) and financial statements.
Progress reports should include the status of pilot projects, data and safety monitoring, and notification of serious adverse events.
A final RPPR, invention statement, and expenditure data are required for award closeout.

Post-Award Requirements

All recipient-selected HR Core projects require prior approval by NIH before initiation.
Compliance with ClinicalTrials.gov registration and results reporting for applicable clinical trials is mandatory.
Protocols involving human subjects must receive Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval.
Data and Safety Monitoring is required for human biomedical and behavioral intervention studies.
Compliance with Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements is necessary for relevant clinical research projects.

Evaluation Criteria

Overall Impact (Scored)

Reviewers will provide an overall impact score reflecting the likelihood for the network to exert a sustained, powerful influence on the research field(s) involved.

Scored Review Criteria - Overall Application

Significance: Evaluation of existing C&T research capacity and collaborations, importance of identified barriers, effectiveness of plans to strengthen C&T research, contributions of network organizations, and potential to advance research on health concerns in IDeA states. For renewals, progress from the previous funding period will be assessed.
Investigator(s): Assessment of PD(s)/PI(s) suitability to lead, prior scientific and administrative leadership experience, and ability to integrate components and work across organizational boundaries. For multi-PI applications, leadership approach and responsibility sharing are considered.
Innovation: How innovative are the approaches to enhancing C&T research capacity, engaging investigators, and improving communication, coordination, and collaboration within the network.
Approach: Likelihood of the Overall Plan to significantly strengthen C&T research, effective leveraging of other NIH-supported programs (e.g., COBREs, INBREs), feasibility and impact of external collaborations, and clarity/appropriateness of the roles of required committees (SC, EC, EAC).
Environment: Strength of the lead organization's C&T research base, breadth of faculty expertise, adequacy of research administration infrastructure, sufficiency of institutional commitments, and the potential for network organizations to contribute to and benefit from the C&T infrastructure. For renewals, the success of previous IDeA-CTR as a foundation for further capacity building.

Scored Review Criteria - Cores

Each required core (Administrative, Research Design, Compliance, and Data Management (RDCD), Community Engagement and Outreach (CEO), Professional Development (PD), Health Research (HR)) and any proposed optional cores will be individually assessed and scored based on their specific aims, plans, roles, responsibilities, and expected outcomes.

Additional Review Criteria (Not Scored, but Considered)

Protections for Human Subjects: Justification for involvement, adequacy of protection against risks, potential benefits, importance of knowledge to be gained, and data and safety monitoring plans for clinical trials.
Inclusion of Women, Racial and Ethnic Minorities, and Individuals Across the Lifespan: Evaluation of plans for inclusion/exclusion based on scientific goals.
Vertebrate Animals: Justification for use, appropriateness of species, interventions to minimize discomfort, and justification for euthanasia methods.
Biohazards: Assessment of potential hazards and proposed protection measures.
Resubmissions: Consideration of responses to comments from previous scientific reviews and changes made to the project.
Renewals: Evaluation of progress made in the last funding period.
Resource Sharing Plans: Assessment of the reasonableness of sharing plans or rationale for not sharing resources.
Authentication of Key Biological and/or Chemical Resources: Review of plans for identifying and ensuring the validity of these resources.
Budget and Period of Support: Consideration of whether the budget and requested period are fully justified and reasonable in relation to the proposed research.

Funding Decision Factors (Beyond Peer Review)

Scientific and technical merit of the proposed project (as determined by peer review).
Availability of funds.
Relevance of the proposed project to program priorities.
Geographic distribution among IDeA-eligible states.
Potential to serve the population of the state(s) and address their most urgent health concerns.

Compliance & Special Requirements

Regulatory Compliance

Human Subjects Research: Must comply with 45 CFR Part 46. Protocols must be reviewed and approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Clinical Trials: Registration and results reporting on ClinicalTrials.gov is required for applicable trials. Compliance with Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) regulations is necessary for relevant interventions. Data and safety monitoring requirements apply to all NIH-supported human intervention studies.
Vertebrate Animals: Compliance with regulations and guidelines for the care and use of vertebrate animals if involved in research.
Biohazards: Assessment of potential hazards and proposed protection measures are required if materials or procedures are hazardous.
Data Management and Sharing (DMS): A Data Management and Sharing Plan is required for research that generates scientific data (effective for due dates on or after January 25, 2023). The plan must be implemented as described.
Federal Civil Rights Laws: Recipients must comply with non-discrimination laws based on race, color, national origin, age, sex, and disability. This includes ensuring meaningful access for persons with limited English proficiency, effective communication with persons with disabilities, and administering programs free of sexual harassment.
Federal Awardee Performance and Integrity Information System (FAPIIS): Recipients with active federal awards exceeding $10,000,000 cumulative value must report information about civil, criminal, and administrative proceedings related to federal awards.
Electronic Submission: All applications must be submitted electronically; paper applications are not accepted.

Organizational Structure and Governance

The grant requires a formal network structure with a lead organization and multiple partner organizations across one or more IDeA states.
Mandatory Committees: The network must establish and operate with a Steering Committee (SC), an Executive Committee (EC), and an External Advisory Committee (EAC). Each committee has defined roles and responsibilities to assist the PD(s)/PI(s) in administering the award.
Interactions between the PD(s)/PI(s) and Core Leads must be clearly described.
For renewal applications, a succession plan for PD(s)/PIs who have led a CTR program for more than 10 years is required.

Data and Information Security

The Research Design, Compliance, and Data Management (RDCD) Core is responsible for managing Electronic Health Records (EHR) and other large clinical datasets, including ensuring compliance with NIH and institutional data management policies to safeguard protected health information.

Intellectual Property

Resource Sharing Plans are required, and reviewers will comment on their reasonableness.

Unique Aspects / Strategic Opportunities

This grant is specifically designed to build biomedical research capacity in IDeA states, which are historically underserved by NIH grant funding.
A strong emphasis is placed on forming and strengthening statewide or multi-state regional networks for clinical and translational research.
Applicants are encouraged to leverage and collaborate with resources and infrastructure supported by other IDeA programs (e.g., INBRE, COBRE) within their networks.
Engagement with community clinics and Practice-Based Research Networks (PBRNs) is a critical component, with a dedicated Community Engagement and Outreach (CEO) Core.
The Health Research (HR) Core supports a pipeline of investigators through different project types: Pilot Projects (feasibility), Developmental Projects (leading to larger grants), and Multi-Site Collaborative Projects (advancing C&T research outcomes).
Applications with a narrow disease or population focus are explicitly stated as not being responsive to this funding opportunity.
The grant supports projects that are 'Clinical Trial Optional', meaning applications may or may not propose clinical trial(s).

Grant Details