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Leveraging Network Infrastructure to Conduct Innovative Research for Women, Children, Pregnant and Lactating Individuals, and Persons with Disabilities (UG3/UH3 - Clinical Trial Optional)

ID: PAR-25-311 • Type: Posted

Description

The purpose of this Notice of Funding Opportunity (NOFO) is to leverage NICHD clinical research Network infrastructure relevant to infants, children, women, pregnant and lactating individuals, and persons with disabilities to conduct innovative, multisite, investigator-initiated clinical trials and observational studies. This NOFO will utilize a bi-phasic (UG3/UH3), milestone-driven mechanism consisting of a start-up phase (UG3) and a full enrollment and clinical trial implementation phase (UH3). Applications submitted in response to this NOFO must address specific aims and milestones for both the UG3 and UH3 phases. A UG3 project (phase I) that meets its milestones will be administratively considered by NICHD and prioritized for transition to the UH3 award (phase II). This NOFO provides an opportunity to leverage NICHD clinical research Network infrastructure as a platform for investigator-initiated innovative hypotheses by any investigator in the extramural community. 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), or equivalent as determined by the NICHD.
Background
The National Institutes of Health (NIH), specifically the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), is issuing this Notice of Funding Opportunity (NOFO) to leverage its clinical research network infrastructure. The goal is to conduct innovative, multisite, investigator-initiated clinical trials and observational studies focusing on women, children, pregnant and lactating individuals, and persons with disabilities.

This NOFO employs a bi-phasic (UG3/UH3) mechanism that includes a start-up phase (UG3) and a full enrollment and clinical trial implementation phase (UH3). Applications must address specific aims and milestones for both phases.

Grant Details
The UG3 phase allows for up to two years for project initiation, while the UH3 phase can extend up to five years for full implementation. Applications must demonstrate clear project deliverables, timelines, and milestones that align with NICHD's goals.

The NICHD expects projects to utilize innovative study designs such as complex adaptive designs or machine learning approaches. Strong preference will be given to studies optimizing diverse participant enrollment and integrating into real-world clinical care. The application process requires collaboration with NICHD-supported Network Data Coordinating Centers (DCC) or equivalent entities. Projects must also include a Plan for Enhancing Diverse Perspectives (PEDP).

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local governments, state governments, tribal governments, and other entities as specified in the NOFO. Special encouragement is given to institutions serving underrepresented groups such as Historically Black Colleges and Universities (HBCUs) and Hispanic-serving Institutions.

Individuals from diverse backgrounds are also encouraged to apply.

Period of Performance
The maximum project period for the UG3/UH3 award is seven years total: up to two years for the UG3 phase and up to five years for the UH3 phase.

Grant Value
Application budgets are limited to direct costs of $6,250,000 for the entire project period across both phases. Projects requiring more than this amount may be proposed but will need additional NICHD approval.

Place of Performance
The grant activities will be performed within NICHD-supported Clinical Research Networks across various geographic locations relevant to the populations being studied.

Overview

Category of Funding
Health
Income Security and Social Services
Funding Instruments
Cooperative Agreement
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
On 12/16/24 the National Institutes of Health posted grant opportunity PAR-25-311 for Leveraging Network Infrastructure to Conduct Innovative Research for Women, Children, Pregnant and Lactating Individuals, and Persons with Disabilities (UG3/UH3 - Clinical Trial Optional). The grant will be issued under grant program 93.313 NIH Office of Research on Women's Health.

Timing

Posted Date
Dec. 16, 2024, 12:00 a.m. EST
Closing Date
Nov. 15, 2027, 12:00 a.m. EST Due in 1011 Days
Last Updated
Dec. 16, 2024, 9:52 a.m. EST
Version
1
Archive Date
Dec. 21, 2027

Eligibility

Eligible Applicants
State governments
Public and State controlled institutions of higher education
Special district governments
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Small businesses
Independent school districts
City or township governments
Private institutions of higher education
For profit organizations other than small businesses
County governments
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Additional Info
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Award Sizing

Ceiling
$6,250,000
Floor
Not Listed
Estimated Program Funding
Not Provided
Estimated Number of Grants
Not Listed

Contacts

Contact
National Institutes of Health
Contact Email
Email Description
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
Contact Phone
(301) 402-2541
Additional Information
https://grants.nih.gov/grants/guide/pa-files/PAR-25-311.html

Documents

Posted documents for PAR-25-311

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