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Grant Analysis

Purpose & Target

This grant, PAR-25-090, is a planning cooperative agreement (U34) from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) designed to support the initial administrative and preparatory phases of investigator-initiated, high-risk multi-center clinical studies. The primary objective is to facilitate the rigorous planning and documentation required before participant recruitment can begin for complex clinical studies, ultimately leading to a full-scale clinical study (U01). This grant is SECTOR-SPECIFIC, focusing exclusively on diseases within the mission of NIDDK (e.g., diabetes, digestive, and kidney diseases). It targets research institutions, non-profits, and for-profit organizations (including small businesses) based in the United States. Foreign organizations are not eligible to apply, but foreign components (e.g., for specific data analyses) of US-based organizations are allowed. Key filtering criteria: The proposed clinical study must be high-risk, as defined by NIDDK, and multi-center (more than one clinical research center). It's a planning grant, not for conducting preliminary data collection, pilot studies, or the clinical study itself. Consultation with NIDDK staff is strongly encouraged prior to application. This is a recurring grant opportunity, reissued from PAR-24-094, indicating an ongoing program context for supporting high-risk clinical study planning.

Financial Structure

This grant provides financial support for the planning phase of high-risk multi-center clinical studies.

Award Budget: Budgets for direct costs are allowed up to $225,000 per year.
Budget Variation: The funds requested are expected to vary based on the number of clinical centers involved and the complexity of the study.
Grant Duration: The maximum project period for this U34 planning award is 2 years.
Eligible Costs: This grant supports administrative study group activities required to prepare for participant recruitment. Activities include, but are not limited to, finalizing study protocols, developing consent forms and investigators' brochures, creating manuals of operations, establishing data monitoring plans, obtaining regulatory approvals (e.g., FDA IND/IDE), identifying clinical sites, developing training materials, and initiating IRB approvals. Support may also cover engagement activities with patients/communities.
Ineligible Costs: The U34 grant is not designed for:
- Collection of preliminary data.
- Conduct of pilot studies to support the rationale for a clinical study.
- Design of the study (the study design and full protocol must be included in the application, not developed under the U34).
Matching Fund Requirements: This Funding Opportunity does not require cost sharing.
Financial Reporting: Recipients are required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required by NIH Grants Policy Statement Section 8.4.1 Reporting. A final RPPR and expenditure data are required for closeout.

Eligibility Requirements

To be eligible for the NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreement (U34), applicants must meet the following hard, non-negotiable criteria: Eligible Organization Types and Legal Structure Organizations must be based in the United States. Foreign organizations are not eligible to apply, nor are non-domestic components of U.S. organizations (though foreign components for scientific input are allowed). Eligible types include: - Higher Education Institutions: Public/State Controlled Institutions of Higher Education, Private Institutions of Higher Education. - Nonprofits: With or without 501(c)(3) IRS status (other than Higher Education Institutions). - For-Profit Organizations: Small Businesses, and For-Profit Organizations (other than Small Businesses). - Governments: Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal Governments - Federally Recognized and Other than Federally Recognized), and Federal Governments (Eligible Agencies, U.S. Territory or Possession). - Other: 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. Specific Qualifications and Certifications

The proposed clinical study must be hypothesis-driven and focus on a disease within the mission of NIDDK.
The clinical study must be classified as 'high-risk', involving either a high-risk intervention (e.g., unknown safety profile, substantial side effects, complex/invasive, vulnerable populations) or high operational risk (e.g., inexperienced investigator in clinical trials/coordination, complex study design across multiple centers, reliance on third-party agreements for regulatory filings).
Applications for low-risk clinical studies or those primarily within the mission of other NIH Institutes and Centers are explicitly not responsive and will not be reviewed.
Applications involving animal or in vitro studies are not responsive.
Recruitment of participants exclusively from foreign sites is not allowed.

Required Registrations All applicant organizations must complete and maintain active registrations prior to submission: - System for Award Management (SAM): Requires annual renewal. - Unique Entity Identifier (UEI): Issued through SAM.gov registration. - eRA Commons: Organizations need at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account. Obtaining an account can take up to 2 weeks. - Grants.gov: Requires active SAM registration. Principal Investigator (PD/PI) Requirements

Any individual with the necessary skills, knowledge, and resources may serve as PD/PI.
All PD/PIs must have an eRA Commons account affiliated with the applicant organization.

Application Process

Application Process Timeline and Deadlines Applications for PAR-25-090 follow a tiered submission schedule. The latest application due date is: - June 10, 2027, by 5:00 PM local time of the applicant organization. Other due dates include: June 10, 2025; February 11, 2026; October 08, 2026. The grant expires on June 11, 2027. If a submission date falls on a weekend or Federal holiday, the deadline is automatically extended to the next business day. Submission Mechanisms Applications must be submitted electronically through one of the following systems: - NIH ASSIST system: For online preparation, submission, and tracking. - Institutional System-to-System (S2S) solution: Check with your institutional officials for availability. - Grants.gov Workspace: For preparing and submitting your application. Required Documentation and Materials Applicants must follow instructions in the NIH 'How to Apply - Application Guide' and any program-specific instructions in this NOFO. Key required documents (if lacking, applications will be considered incomplete and not reviewed): - Milestone Plan (PDF): Detailed interim performance measures and timelines for key objectives and administrative functions. Must include specific anticipated dates for regulatory approvals, finalizing protocols, consent forms, training manuals, data entry systems, ClinicalTrials.gov registration, and recruitment milestones (e.g., enrollment percentages). - Organization Plan (PDF): Describes how the study will be organized and managed for both the planning period and the full study, including leadership, proposed clinical sites, network building, and succession plans. - Study Protocol (in Appendix): A full protocol for the proposed clinical study must be submitted as part of the Appendix. - Research Plan: Must address both the U34 planning period and the full proposed clinical study. - Specific Aims: Delineate aims for both U34 planning and the full study, specifying primary and major secondary endpoints. - Research Strategy: Articulate significance, evidence gap, public health impact, and discussion of preliminary/supporting data. - Letters of Support: Must be provided from all clinical centers, reading centers, central laboratories, or other required study components. If non-NIH co-funding or in-kind support is planned, letters from business officials outlining commitment details are required. Letters should also come from individuals/organizations involved in engagement efforts. - Data Management and Sharing Plan: All applications generating scientific data must address this plan, regardless of direct costs requested. - PHS Human Subjects and Clinical Trials Information form: Required if human subjects are involved. Pre-Application Requirements

Registrations: All required organizational registrations (SAM, UEI, eRA Commons, Grants.gov) must be active before submission (can take 6+ weeks).
PD/PI eRA Commons Account: All PD/PIs must have an eRA Commons account.
Letter of Intent (Optional but Encouraged): Although not required or binding, applicants are asked to submit a letter of intent to NIDDK (via email to John Connaughton, Ph.D. at [email protected]) by the date listed in Part 1. Overview Information. This helps NIDDK estimate review workload.
Consultation with NIDDK Staff: Strongly encouraged at least 12 weeks prior to submission to determine if the proposed study fits NIDDK's mission and this NOFO.

Post-Award Requirements

Reporting: Annual Research Performance Progress Reports (RPPR) and financial statements are required.
Milestone Achievement: Future year support is contingent on satisfactory achievement of performance milestones agreed upon at award. Failure to meet milestones may lead to remedial actions.
Data Management and Sharing Plan Implementation: The approved plan becomes a term of the award and is routinely monitored.
ClinicalTrials.gov Registration/Reporting: Required for clinical trials.
IRB/IEC Approval: Recipient institutions must ensure all protocols are reviewed by their IRB/IEC.

Evaluation Criteria

Applications for this U34 Cooperative Agreement will be evaluated for scientific and technical merit through the NIH peer review system, based on the following criteria: Scored Review Criteria Reviewers will assign separate scores for these three factors, which contribute to the overall impact score:

Factor 1. Importance of the Research (Significance and Innovation):
- Assesses the likelihood of the project exerting a sustained, powerful influence on the research field.
- Evaluation of the significance of the proposed full clinical study, including why it's needed and what evidence gap it will address.
- Discussion of how results will impact clinical care or public health.
- Consideration of preliminary data supporting the study's need and feasibility.
- Adequacy and quality of previous studies supporting the design.
- For clinical trials: study design, methods, and intervention may not be innovative but must address important questions or unmet needs.
Factor 2. Rigor and Feasibility (Approach):
- Evaluation of how the U34 planning period will be used and the activities that will be conducted during this phase.
- Detailed description of the proposed full study design, including scientific rationale, target population, outcomes assessed, and feasibility.
- Critical elements such as overall design, primary objective, inclusion/exclusion criteria, proposed study population, and sample size.
- Delineation of primary endpoint and key secondary outcomes.
- Proposed timeline for recruitment, follow-up, and study close-out.
- Statistical methods, assumptions for power calculations, and sample size calculations (with enough detail for duplication).
- Discussion of anticipated adherence and follow-up rates.
- Description of all completed, ongoing, and planned engagement efforts with patients, community members, and stakeholders.
Factor 3. Expertise and Resources (Investigator(s) and Environment):
- Assessment of the PD/PI's and key team members' experience in conducting and administering complex studies, including success in recruitment, retention, and publications.
- Evaluation of the study organization and management plan (for both planning period and full study), including leadership, proposed clinical sites, and network building.
- Description of committee structures (e.g., Steering Committee), internal/external advisory committees, and oversight plans.
- Inclusion of a succession plan for key personnel.

Additional Review Criteria (Not Scored, but considered for Overall Impact)

Protections for Human Subjects
Vertebrate Animals (if applicable)
Biohazards (if applicable)
Resubmissions: Evaluation of the full application as now presented.

Additional Review Considerations (Not Scored, not considered for Overall Impact Score)

Authentication of Key Biological and/or Chemical Resources
Budget and Period of Support: Evaluation of whether the budget and requested period are justified and reasonable.

Compliance & Special Requirements

Regulatory Compliance Requirements

NIH Grants Policy Statement: All awards are subject to the terms and conditions, cost principles, and considerations described in this policy.
Federal Regulations: Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) and 45 CFR Part 75 is mandatory.
Nondiscrimination Laws: Recipients must comply with all applicable nondiscrimination laws, agreed upon during SAM.gov registration.
Institutional Review Board (IRB) / Independent Ethics Committee (IEC) Approval: All protocols must be reviewed by the recipient's IRB/IEC. NIH must receive copies of documents for major changes in ongoing protocols.
Investigational New Drug (IND) or Investigational Device Exemption (IDE): Clinical research involving investigational therapeutics, vaccines, or medical interventions must be performed under an FDA IND or IDE, if applicable.
ClinicalTrials.gov Registration and Reporting: Required for certain 'applicable clinical trials' by law, and NIH expects registration and results reporting for all trials.
Single IRB Policy: Applicants are reminded of the NIH policy on the use of a single Institutional Review Board for multi-site research.

Data Protection and Privacy Regulations

Data Management and Sharing Plan: A detailed plan is required for all applications generating scientific data. This plan, once approved, becomes a term and condition of the award and will be routinely monitored. It dictates how data, samples, and other project-generated resources will be archived and stored (e.g., in the NIDDK Central Repository).
Confidentiality: Recipients must maintain confidentiality of information developed by investigators and proprietary information of collaborators.

Ethical Standards and Requirements

Mandatory Disclosure: Recipients must report any violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award.
Data and Safety Monitoring: All NIH-supported human biomedical and behavioral intervention studies require oversight and monitoring to ensure participant safety and data integrity.

Intellectual Property Policies

Recipients retain custody and primary rights to data and software developed, subject to Government rights of access. Study Publication and Presentation Policy must be adhered to.

Unique Aspects and Strategic Opportunities

Cooperative Agreement (U34): This is a cooperative agreement mechanism, meaning there will be substantial Federal scientific or programmatic involvement from NIH staff. NIH staff act as partners, assisting, guiding, and coordinating project activities. The Principal Investigator retains primary responsibility for the project, but specific tasks and activities are shared.
Two-Part Process: This U34 planning grant is the first part of a two-part process for high-risk multi-center clinical studies. Successful completion is expected to lead to the submission of a U01 application for the full-scale study. However, award of a U34 does not guarantee acceptance or funding of a U01 application.
NIDDK Involvement: NIDDK Program Officials and Project Scientists/Coordinators will be substantially involved, including:
- Serving as contact points for scientific interaction.
- Participating as voting members on the Steering Committee (the main governing body of the study).
- Assisting in research activity design, coordination of regulatory clearances, and potentially co-authoring publications.
- Monitoring study progress, reviewing and approving protocols, and making recommendations for continued funding.
- Appointing independent Data and Safety Monitoring Boards (DSMB) or Observational Study Monitoring Boards (OSMB) for high-risk studies.
Patient and Community Engagement: NIDDK is committed to studies developed in partnership with patients, community members, and other stakeholders. Active and meaningful engagement, beyond mere participation, is expected, aiming for bidirectional communication and integration into the research team.

Potential Challenges or Limitations

Strict adherence to NIH 'How to Apply - Application Guide' and NOFO instructions is critical; non-compliance leads to delays or rejection.
The application process involves multiple registrations that can take significant time (6+ weeks).
Applications failing to include a Milestone Plan or Organization Plan are considered incomplete and will not be peer-reviewed.
The grant specifically excludes low-risk studies, animal/in vitro studies, and preliminary data collection.

Grant Details