FOR-DA-26-003
Limited Competition for the HEAL Initiative: HEALthy Brain and Child Development (HBCD) Study – Coordinating Administrative Core and Data Coordinating Center (U24 Clinical Trial Not Allowed)
Summary
HEALthy Brain and Child Development Study: Coordinating and Data Centers
NIDA and partner NIH institutes (including the NIH HEAL Initiative) are establishing coordinating and data infrastructure for a large longitudinal cohort study examining prenatal opioid and polysubstance exposure and its effects on fetal and pediatric neurodevelopment. The HEALthy Brain and Child Development (HBCD) study follows approximately 7,200 pregnant women and their children from the second or third trimester through childhood, with assessments spanning growth, medical history, sleep and activity patterns, biospecimen collection, cognitive and emotional function, and brain imaging via structural MRI and electroencephalography (EEG). This is a 5-year renewal funding the second phase of the consortium's operations. The coordinating and data centers will manage protocol standardization, data integration and quality control, analytic workflows, and facilitate data sharing to the broader research community—roles requiring substantial organizational capacity and expertise in consortium management, budget oversight, and performance metrics.
Note: This is a limited competition restricted to pre-identified eligible organizations; applications are not currently being solicited. Interested organizations should begin developing collaborations now in preparation for the formal NOFO release.
- Who can apply: Limited competition restricted to eligible organizations only (not open to all applicants; see formal NOFO for eligibility criteria)
- Funding & project length: 5 years (renewal phase); exact funding amount not stated
- Award mechanism: U24 (Cooperative Agreement)
- Key dates: Applications not yet being solicited; NOFO forthcoming
- Best fit for: Organizations with expertise in longitudinal cohort management, data coordination, and substance use epidemiology spanning clinical, neurodevelopmental, and computational domains
Insights (5)
Limited Competition Restricts Applicant Pool to Pre-Identified Organizations
This is explicitly a Limited Competition NOFO—applications are not open to all institutions. Only pre-identified or specifically eligible organizations will be invited to apply when the NOFO is released. Researchers at institutions not pre-selected by NIDA cannot submit, regardless of qualifications. Verify your institution's eligibility status directly with NIDA before investing planning effort.
Coordinating Center Roles Demand Substantial Organizational Infrastructure and Expertise
The HCAC and HDCC positions require demonstrated capacity in consortium leadership, budget management, protocol standardization, data coordination, and multi-site integration across ~7,200 dyads. These are not research-focused roles but operational leadership positions. Applicants must have prior experience managing large, multi-site longitudinal studies, robust data management systems, and the administrative bandwidth to coordinate a complex consortium—this is a hidden prerequisite beyond typical grant qualifications.
Consortium Coordination Role Requires Institutional Commitment Beyond Single PI
The HCAC and HDCC are consortium-wide leadership and data infrastructure roles, not individual research projects. Success depends on institutional buy-in, dedicated staff, and the ability to standardize protocols and manage performance metrics across multiple sites. This is fundamentally a team and institutional commitment, not a traditional PI-driven research award.
Renewal Funding Favors Continuity; Incumbent Advantage Likely
This is a 5-year renewal of an existing HBCD study infrastructure. Incumbent coordinating centers have established relationships, proven operational track records, and integrated systems. New applicants would need to demonstrate equivalent or superior capacity and a compelling case for transition. Competitive advantage strongly favors organizations already embedded in the HBCD consortium.
Coordinating Center Roles Suit Established Research Administrators, Not Early-Career Researchers
U24 mechanism awards for coordinating centers are infrastructure and management positions, not independent research opportunities. These roles are best suited to experienced research administrators, data scientists, or established investigators with prior consortium management experience. Early-stage investigators should not view this as a pathway to independent research funding.
Key Facts
Deadline
—
Posted
Fri, May 9, 2025
Max Duration
5 years
Keywords
Research Areas
Gotchas (3)
The HCAC and HDCC are described as having specific leadership, management, and coordination responsibilities (budget, performance metrics, protocol standardization, data coordination, etc.). Applicant
90%
Source Text
“The HDCC coordinates, standardizes, and integrates all core data collection, processing, storage, and analytic activities of the consortium, and facilitates data sharing to the broader scientific community... The HCAC is responsible for leadership and management of the HBCD consortium; including, budget, performance metrics, protocol standardization, policies, outreach and dissemination plans across the consortium”
This is a Limited Competition NOFO restricted to eligible organizations only—not open to all applicants. The forecast explicitly states 'This is a Forecast for a Limited Competition that will invite a
95%
Source Text
“This is a Forecast for a Limited Competition that will invite application(s) from eligible organization(s) to apply. Please see Eligibility Section for additional information... Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This limited competition NOFO will utilize the U24 activity code.”
This is explicitly a renewal of an existing HBCD study for a second 5-year funding period. Applicants must understand whether they are applying to continue an existing award, take over management of a
85%
Source Text
“This is a renewal that will continue the funding for the second 5-year period. The HBCD cohort includes babies exposed pre- or perinatally to prescription and illicit opioids, marijuana, stimulants, alcohol and/or nicotine, and the study protocol includes assessments that span multiple domains of child and caregiver outcomes... The HDCC coordinates, standardizes, and integrates all core data collection, processing, storage, and analytic activities of the consortium, and facilitates data sharing ”