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Grant Analysis

Purpose & Target

The core objective of this grant is to leverage existing NICHD clinical research network infrastructure to conduct innovative, multisite, investigator-initiated clinical trials and observational studies. It specifically targets research relevant to infants, children, women (including pregnant and lactating), and persons with disabilities. This grant is SECTOR-SPECIFIC. - Target recipient type: Research institutions, universities, non-profits, for-profits, and government entities that can conduct clinical research. - Target size: Not specified, but organizations must have the capacity and infrastructure for multisite clinical research. - Geographic scope: Organizations must be US-based. Non-domestic components of US organizations are eligible. Research may involve international sites if affiliated with specific NICHD Networks (e.g., Global Network). - Key filtering criteria: Must propose to utilize a NICHD Network infrastructure; require approval of a concept proposal prior to full application; focus on clinical trials or observational studies; relate to the health of women, children, pregnant/lactating women, or persons with disabilities. - Grant frequency: Recurring, as it is a reissue of a previous funding opportunity (PAR-23-037).

Financial Structure

Award budget is limited to $6,250,000 in direct costs for the entire project period (both UG3 and UH3 phases combined).
Projects exceeding $6,250,000 in direct costs may be proposed but require additional NICHD approval via the pre-application process.
No cost sharing (matching funds) is required.
Eligible costs include: study-related costs not covered by Network infrastructure awards, detailed annual budgets, subcontracts for non-Network sites, salaries for non-Network investigators/personnel, travel funds for meetings (up to $1500 per person per trip for PD/PIs, $3000 per year per site for junior faculty travel), Single IRB costs, Data Management and Sharing Plan (DMS Plan) costs (including data/biospecimen submission to DASH/NICHD Biorepository), capitation (participant enrollment reimbursement), biospecimen collection/storage, and secondary analyses of study data.
Ineligible costs: Services provided by the Network DCC and/or other Network components, as these are supported by existing infrastructure awards.
Funding mechanism is a Cooperative Agreement, implying substantial NIH programmatic involvement.

Eligibility Requirements

Eligible Organizations

Any type of U.S.-based organization, including:
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/Township, Special District, Federally Recognized Indian/Native American Tribal, Other Indian/Native American Tribal)
Federal Governments (Eligible Agencies, U.S. Territory or Possession)
Other (Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based/Community-based Organizations, Regional Organizations)
Non-domestic (non-U.S.) entities are not eligible to apply directly.
Non-domestic components of U.S. organizations are eligible.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Technical & Collaborative Requirements

Applications must propose to utilize the infrastructure of at least one NICHD Network (e.g., CPCCRN, Global Network, MFMU, NRN, PFDN).
Applications must be submitted as investigator-initiated, multi-Project Director/Principal Investigator (PD/PI) grant applications in conjunction with the respective NICHD-supported Network Data Coordinating Center (DCC).
All proposals must undergo a rigorous pre-application process and receive NICHD approval of a 'Concept Proposal' prior to formal application submission. Applications without this approval will be considered non-responsive.
The PD/PI will have primary responsibility for scientific leadership, coordination, and adherence to policies.

Exclusion Criteria

Single-center studies are not eligible.
Animal studies are not eligible.
Basic science studies are not eligible.
Basic experimental studies involving humans are not eligible.
Projects seeking infrastructure support for a Network other than a NICHD Network are not eligible.

Application Process

Pre-Application Process

All proposals must undergo a rigorous pre-application process to assess scientific scope and feasibility, including NICHD concept proposal approval.
Potential applicants should start this process early.
Instructions and timelines for the pre-application process are on the NICHD Pre-Application Process for NICHD Network Multisite Clinical Research website.

Application Submission Dates

Open Date (Earliest Submission Date): February 15, 2025
Application Due Dates (by 5:00 PM local time of applicant organization):
March 14, 2025
July 15, 2025
November 14, 2025
March 15, 2026
July 15, 2026
November 13, 2026
March 15, 2027
July 15, 2027
November 15, 2027 (Latest deadline)
If a due date falls on a weekend or Federal holiday, the deadline is extended to the next business day.
Expiration Date: November 16, 2027

Submission Method & Required Documentation

Applications must be submitted electronically via NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
Required forms: SF424(R&R) suite, PHS 398 Research Plan, PHS Human Subjects and Clinical Trials Information form.
Detailed annual budgets are required, excluding costs covered by Network infrastructure awards.
A Data Management and Sharing Plan (DMS Plan) is mandatory.
Resource Sharing Plan is required, specifically addressing biospecimen sharing.
Multiple PD/PI Leadership Plan (if applicable, which it is for this grant) is required, outlining roles, communication, and dispute resolution.
Letters of Support:
Network Steering Committee Chairperson must provide a letter committing all Network Clinical Research Centers.
Each non-Network institution participating must provide a separate letter signed by their Institutional Signing Official.
Limited Appendix materials allowed (blank questionnaires/surveys only).

Project Implementation & Reporting

Project period: Maximum of 7 years.
UG3 (start-up) phase: Up to 2 years.
UH3 (implementation) phase: Up to 5 years.
Funding for the UH3 phase is contingent on meeting milestones in the UG3 phase and subsequent NICHD approval (not guaranteed).
Milestones: Must be well-defined, scheduled events signifying completion of major stages/activities. Quarterly milestone updates (including enrollment tables) are expected.
Reporting: Annual Research Performance Progress Report (RPPR) and financial statements are required.
Monitoring: NIH will monitor progress through reports, site visits, and participation in study activities (due to cooperative agreement).
ClinicalTrials.gov registration and results reporting are required for applicable clinical trials.

Evaluation Criteria

Applications are evaluated for scientific and technical merit through NIH's peer review system, considering the likelihood for the project to exert a sustained, powerful influence on the research field(s). Scored Review Criteria (receive a separate factor score and contribute to overall impact score)

Importance of the Research (Significance and Innovation):
Potential impact of the research on clinical care and/or public health.
Rationale, timeliness, and scientific relevance of the proposed study.
Evidence that the intervention is ready for clinical development.
For drug/biologic trials, rationale for mechanism of action and dose selection.
Innovative aspects (novel concepts, methods, technologies, study design, intervention, assessment tools, statistical analyses) and their potential to enhance quality, facilitate enrollment, augment participant variety, foster efficient completion, and benefit the target population.
Rigor and Feasibility (Approach):
Concise summary of the planned clinical study, including study population, sample size, and socio-demographic information.
Detailed description of milestones for both UG3 and UH3 phases.
Rationale for study design and its effectiveness/efficiency, especially for innovative designs (e.g., adaptive, pragmatic trials, Bayesian analysis, machine learning, real-world data).
Justification if a traditional design is proposed over innovative designs.
Use of existing common data elements (CDEs) or development of new ones.
Plan for timely completion and dissemination of findings.
Discussion of potential biases/challenges and mitigation strategies.
Evidence of 'equipoise' among investigators and medical/patient communities for clinical trials.
Processes to monitor study progress and safety.
Efficient and cost-effective follow-up methods, including innovative techniques like EHR use or non-traditional data collection.
Plans for timely dissemination to various stakeholders.
Description of methods to identify barriers/facilitators for implementing findings into clinical care.
Plans for practical implementation of findings into clinical care.
Expertise and Resources (Investigator(s) and Environment):
Justification for conducting research in the proposed NICHD Network(s) and how Network resources will be used to accomplish milestones.
Role of Network Community Engagement Board or patient input.
Defined roles, responsibilities, and expertise of investigators and key personnel.
Inclusion and clearly defined role of a junior investigator (Fellows, Assistant Professors, NIH-defined early-stage investigators) at each Clinical Research Center (high priority given to projects including junior investigators).
Organizational structure and integration of non-Network sites (if applicable).
Rationale for adding non-Network sites and their capabilities (recruitment, retention, follow-up).
Assessment plan for non-Network site progress.
Detailed Multiple PD/PI Leadership Plan, including dispute resolution.
Letters of support from Network Steering Committee Chairperson and non-Network institutions.

Additional Review Criteria (considered, but not scored)

Protections for Human Subjects
Vertebrate Animals (if applicable)
Biohazards (if applicable)
Resubmissions: Evaluation of the full application as presented.
Renewals: Evaluation of progress made in the previous funding period.

Additional Review Considerations (considered, but not scored)

Authentication of Key Biological and/or Chemical Resources.
Budget and Period of Support: Justification and reasonableness relative to proposed research.

Compliance & Special Requirements

Regulatory Compliance

Adherence to NIH Grants Policy Statement.
Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
Compliance with all applicable non-discrimination laws (requiring HHS-690 Assurance of Compliance).
Compliance with federal statutes and regulations relevant to federal financial assistance.
Mandatory disclosure of any federal criminal law violations (fraud, bribery, gratuity) potentially affecting the award (2 CFR 200.113 and NIH GPS 4.1.35).

Ethical and Data Standards

Research involving human subjects must have Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval.
Data and Safety Monitoring Requirements: Oversight and monitoring of all human biomedical and behavioral intervention studies.
Data Management and Sharing Plan (DMS Plan) is mandatory; data sharing is expected to be maximized and accessible no later than publication or end of award.
Human clinical trial data should use the NICHD Data and Specimen Hub (DASH).
Large-scale human genetic data should be shared via NIH-approved repositories (e.g., dbGaP, Sequence Read Archive).
Biospecimen sharing is expected, preferably through the NICHD Biorepository integrated with DASH.
Tools, workflows, and pipelines created/used with grant support should be shared following open-source practices.

Technical and Security Standards

Health IT used must meet standards in 45 CFR part 170, Subpart B, if applicable.
Health IT for eligible clinicians in ambulatory settings/hospitals must be certified under ONC Health IT Certification Program, if applicable.
If handling HHS-owned/operated information or PII/PHI, recipients must develop plans and procedures modeled after the NIST Cybersecurity framework.

Specific Project Requirements

Interventional studies involving investigational agents/devices must be performed under an FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE).
Cooperative Agreement: Substantial NIH programmatic involvement is expected. NIH staff will assist, guide, coordinate, or participate in project activities. The recipient retains primary responsibility, but joint responsibilities with NIH exist.
Dispute Resolution: A formal dispute resolution procedure is outlined for scientific or programmatic disagreements between recipients and NIH.
The grant encourages flexibility, cost-effectiveness, and integration into clinical care.

Grant Details