Grants8 | The most comprehensive grants search on the web

Grant Analysis

Purpose & Target

The IDeA Clinical & Translational Research Development (CTR-D) Award aims to build clinical and translational research capacity by enhancing workforce development and infrastructure at health research organizations in IDeA-eligible U.S. states. - Target recipient type and size: Health research organizations. Implied to be institutions with established research infrastructure capable of managing multi-component projects. - SECTOR-SPECIFIC (Health Research, Biomedical Research, Clinical Research) - Geographic scope and any location requirements: IDeA-eligible states in the U.S. (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). - Key filtering criteria: Must be a health research organization in an IDeA-eligible state, with existing external C&T research grants, and not already participating in certain other NIH IDeA awards. - Grant frequency and program context: Recurring opportunity with annual application cycles. Part of the broader NIH Institutional Development Award (IDeA) program to enhance research capacity in states with historically low NIH funding.

Financial Structure

Annual direct costs for the overall award must not exceed $1.5 million, excluding consortium facilities and administrative (F&A) costs.
Cost sharing is not required.
Health Research (HR) Core research projects budget: Up to $500,000 annually in direct costs.
Individual Pilot Projects within the HR Core: $50,000-$100,000 in annual direct costs, 1-year duration.
Individual Developmental Projects within the HR Core: Up to $100,000 in annual direct costs, up to 2-year duration.
Administrative Core (AC) funds: Up to $200,000 in annual direct costs for recruitment of faculty, staff, and/or clinical fellows (salary, supplies, equipment).
Eligible costs include: salaries for PD/PIs (up to 6.0 person-months collectively, min 3.0 person-months each for multi-PI), Core Leads (min 1 person-month each), staff; consultant fees; travel to the National IDeA Symposium of Biomedical Research Excellence (NISBRE); acquisition/modernization of equipment; professional development activities; costs to establish/strengthen community clinic connections; data curation/integration; data platforms.
Ineligible costs include: graduate student or postdoctoral stipends (salary as research staff is allowed); funds for collaborators in non-IDeA states or foreign sites (unless for fee-for-service activities like learning techniques, sample/data analysis, workshops); procurement of access to commercially available EHR data.
PD/PIs cannot use CTR-D funds to supplement their own research projects.

Eligibility Requirements

Organizational Eligibility

Lead organization must be located in one of the IDeA-eligible U.S. states: 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.
Lead organization must hold externally funded Clinical and Translational (C&T) research grants.
Lead or partner organization cannot be a lead or partner organization of an active CTR-D, CTR-N, IDeA-CTR, or Clinical and Translational Science Award (CTSA) Hub award at the time of submission (includes no-cost extension awards).
Lead organization cannot be located in a state with an active CTR-D, CTR-N, or IDeA-CTR award.
Only one application allowed per organization (identified by Unique Entity Identifier (UEI) or NIH IPF number).
Eligible types of organizations:
- Higher Education Institutions (Public/State Controlled, Private)
- Nonprofits with or without 501(c)(3) IRS Status
- For-Profit Organizations (Small Businesses, Other than Small Businesses)
- Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal Governments - Federally Recognized and Other than Federally Recognized)

Individual Eligibility

Program Director/Principal Investigator (PD/PI) must have a track record of external funding in C&T research, leadership experience, and mentoring experience.
PD/PI's primary appointment must be at the applicant institution.
A CTR-D PD/PI may not simultaneously lead an IDeA COBRE or INBRE award.
Postdoctoral scholars and others holding non-independent positions are not eligible to lead HR Core projects, except clinician fellows (for Pilot Projects only).

Registration Requirements

Applicant organizations must complete and maintain active registrations in:
- System for Award Management (SAM), renewed annually.
- Unique Entity Identifier (UEI).
- eRA Commons (organization must identify at least one Signing Official (SO) and at least one PD/PI account).
- Grants.gov.
All PD/PIs must have an eRA Commons account affiliated with the applicant organization.

Exclusions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Applications with a narrow disease or population focus will not be accepted.

Application Process

Application Timeline and Deadlines

Latest application due date: October 9, 2025, by 5:00 PM local time of applicant organization. (Earlier dates for this cycle were November 9, 2023, and October 9, 2024).
Grant expiration date: October 10, 2025.
Earliest project start date for an application submitted on October 9, 2025, is July 2026.
Application submission is electronic via the NIH ASSIST system or an institutional system-to-system (S2S) solution, through Grants.gov.

Required Documentation and Materials

Multi-Project (M) Instructions must be followed.
SF424 (R&R) Application Guide and Table of Page Limits must be followed for all components.
Application must include an Overall Plan and 5 distinct cores: Administrative Core (AC), Professional Development (PD) Core, Community Engagement and Outreach (CEO) Core, Research Design, Compliance, and Data Management (RDCD) Core, and Health Research (HR) Core.
Key components requiring detailed plans: Specific Aims, Research Strategy (Overall Plan including goals, organizational structure, governance model, management plan).
Letters of Support: Required from a senior official of the applicant organization and each partner organization, demonstrating institutional commitment and resource commitments. Letters from PD/PIs of other NIH IDeA awards are allowed.
Resource Sharing Plan and Data Management and Sharing (DMS) Plan (required for all research generating scientific data, effective Jan 25, 2023).
Biographical sketches for all Senior/Key personnel.
If human subjects involved: PHS Human Subjects and Clinical Trials Information form.
Budget forms for each component.

Post-Award Requirements and Obligations

HR Core Project Approval: All recipient-selected HR Core projects require prior approval by NIH before initiation. This involves submitting specific documentation (Face page, Biosketches, Other Support, Project Summary, Budget, Specific Aims, Research Strategy, EAC approval, Checklist Format Page, Human Subjects/Clinical Trials forms if applicable).
Annual Reporting: Research Performance Progress Report (RPPR).
Financial Reporting: Final RPPR, invention statement, expenditure data (Federal Financial Report).
Federal Funding Accountability and Transparency Act (FFATA): Reporting of first-tier subawards over the threshold in the Federal Subaward Reporting System (FSRS).
Federal Awardee Performance and Integrity Information System (FAPIIS): Reporting on civil, criminal, and administrative proceedings for active Federal awards over $10,000,000.
Data Management and Sharing Plan: Must be implemented as described in the approved plan.
Regulatory Compliance: Adherence to NIH Grants Policy Statement, institutional policies, and federal regulations regarding human subjects, clinical trials (ClinicalTrials.gov registration/reporting), data and safety monitoring, IND/IDE requirements.
Civil Rights Compliance: Compliance with federal civil rights laws prohibiting discrimination based on race, color, national origin, age, sex, disability, and conscience laws (HHS Assurance of Compliance form HHS 690 required).
Site Visits/Evaluation: NIGMS may evaluate the program periodically using metrics including investigator capacity building, scientific productivity, and collaborations.

Evaluation Criteria

Overall Impact Reviewers will assess the likelihood for the program to exert a sustained, powerful influence on the research field(s) involved, based on the following scored criteria: - Significance: - Identified important problems or barriers to conducting C&T research. - How plans will strengthen C&T research at the CTR-D organization(s). - How the organization(s) will contribute to the CTR-D program's goals. - Investigator(s): - Suitability of PD(s)/PI(s) to lead the CTR-D program (prior scientific/administrative leadership, ability to integrate components, cross-departmental work, mentoring experience). - Appropriateness of leadership approach and shared responsibility for multi-PI applications. - Innovation: - Innovativeness of plans to build C&T research capacity within the organization(s). - Innovativeness of approaches for engaging more investigators in C&T research. - Ways proposed plans enhance communication, coordination, and/or collaboration within and across organizations, community clinics, and other community groups. - Approach: - Effectiveness of the Overall Plan in strengthening C&T research activities. - How well community input and engagement are incorporated. - Extent of leveraging resources from other NIH-supported programs (COBREs, INBREs). - Feasibility of collaboration with other IDeA state organizations. - Clarity and appropriateness of roles for Steering Committee (SC), Executive Committee (EC), and External Advisory Committee (EAC). - Appropriateness of expertise of SC, EC, and EAC members. - Extent to which organizational structure, governance, and communication enable synergistic collaboration. - Soundness of rationale and plans if a phased approach for cores is proposed. - Environment: - Suitability of research and clinical infrastructures. - Appropriateness of lead organization's research administration infrastructure. - Adequacy of institutional commitments. - Presence of C&T research investigators/workforce who can benefit. Core-Specific Review Criteria Each of the five required cores (Administrative, Professional Development, Community Engagement and Outreach, Research Design, Compliance, and Data Management, Health Research) will be assessed and scored based on: - Administrative Core (AC): Effectiveness of management, coordination, integration, communication plans; suitability of financial management; plans for assessing needs and capacity building; effectiveness of evaluation strategies and benchmarks. - Professional Development (PD) Core: Appropriateness of interface with other cores for topics; plans for enhancing knowledge/competency of investigators, staff, mentors, and clinical fellows. - Community Engagement and Outreach (CEO) Core: Strength of communication strategies for engaging communities; plans for engaging advisory boards; assistance to investigators in developing culturally appropriate community-engaged research. - Research Design, Compliance, and Data Management (RDCD) Core: Appropriateness of core design to assist investigators with protocol development, risk assessment, regulatory compliance; strength of plans for EHR database curation, management, and privacy protection. - Health Research (HR) Core: Strength of communication strategies to engage diverse investigators; well-developed plans for soliciting, reviewing, and selecting Pilot and Developmental Projects; suitability of support distribution; likelihood of increasing externally supported C&T research; integration with other CTR-D cores; plans for mentoring clinical trial leads; adequacy of resources; plans for study participant safety and regulatory compliance. Additional Review Criteria (Not Scored Separately)

Protections for Human Subjects (justification, protection against risks, benefits, knowledge gained, data/safety monitoring).
Inclusion of Women, Racial and Ethnic Minorities, and Individuals Across the Lifespan (justification for inclusion/exclusion).
Vertebrate Animals (proposed procedures, justifications, minimization of discomfort, euthanasia).
Biohazards (assessment of hazardous materials/procedures and proposed protections).
Resubmissions: Evaluation considers responses to previous comments and changes.
Select Agent Research (if applicable): Use, registration, monitoring, biosafety/biocontainment.
Resource Sharing Plans: Reasonableness of sharing plans or rationale for not sharing.
Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity.
Budget and Period of Support: Justification and reasonableness in relation to proposed research.

Funding Decisions Beyond scientific/technical merit, funding decisions consider: - Availability of funds. - Relevance to program priorities. - Geographic distribution of awards among IDeA states. - Potential to serve the CTR-D population and address their most urgent health concerns.

Compliance & Special Requirements

Regulatory Compliance

Strict adherence to the NIH Grants Policy Statement.
Compliance with federal regulations 45 CFR Part 46 for research involving human subjects (IRB/IEC approval required, human subjects education certification).
Compliance with FDA investigational new drug (IND) or investigational device exemption (IDE) requirements for clinical research involving unapproved therapeutics/devices.
Compliance with NIH policy for data and safety monitoring for human biomedical and behavioral intervention studies.
Compliance with regulations for vertebrate animals (IACUC approval, Vertebrate Animal Section).
Compliance with federal civil rights laws (Title VI of the Civil Rights Act, Section 504 of the Rehabilitation Act, Age Discrimination Act, Section 1557 of the Affordable Care Act, and federal conscience protection laws).
Adherence to federal laws regarding select agent research (if applicable).

Data and Intellectual Property

Data Management and Sharing Policy: Required for all research generating scientific data (effective for due dates on or after January 25, 2023); a detailed plan must be provided and implemented.
Resource Sharing Plans: Required; reviewers will comment on reasonableness.
Safeguarding protected health information is mandatory, including processes for patient consent, de-identification, and IRB approval for EHR use.

Ethical and Safety Standards

Emphasis on ethical standards for human subjects research, including risk assessment, safety protocols, and robust data monitoring.
Commitment to a safe and respectful work environment, addressing harassment.
Development of cultural respect and knowledge for community engagement in research.

Unique Programmatic Requirements

The program must include an Overall Plan and five specific Cores: Administrative, Professional Development, Community Engagement and Outreach, Research Design, Compliance, and Data Management, and Health Research.
Three required committees: Steering Committee (SC), Executive Committee (EC), and External Advisory Committee (EAC), with specific roles and operating plans. The EAC must provide advice from 3-5 experts outside the state.
Funds for the Health Research (HR) Core cannot be used for direct research activities until prior NIH approval is obtained for individual Pilot or Developmental Projects.
Applications with a narrow disease or population focus will not be accepted.
Lead PD/PI cannot be simultaneously leading an IDeA COBRE or INBRE award.

Strategic Considerations

Opportunity to build C&T research capacity at an institutional level in underserved states.
Encourages partnerships with other health research organizations and community clinics (e.g., Practice-Based Research Networks - PBRN).
Encourages collaboration with and leveraging resources from other IDeA programs (INBRE, COBRE) and other NIH-funded C&T programs (CTR-N, CTR-D, CTSA, I-CRRC).
A phased approach for establishing and ramping up core activities is permissible with a clear rationale.

Grant Details