HEAL Initiative: HEAL KIDS (Knowledge, Innovation and Discovery Studies) Pain: Acute Pain Clinical Trials Program (U01 Clinical Trial Required) | RFA HD 24 011

Opportunity Information: Apply for RFA HD 24 011

The HEAL Initiative: HEAL KIDS Pain: Acute Pain Clinical Trials Program (RFA-HD-24-011) is an NIH funding opportunity that supports large, multi-site, investigator-initiated clinical trials focused on acute pain in pediatric populations. It sits under the NIH Helping to End Addiction Long-term (HEAL) Initiative and is led by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) along with other participating NIH Institutes and Centers. The main goal is to fund rigorous clinical studies that move the field forward on how acute pain in infants, children, and adolescents is understood, assessed, measured, treated, and prevented, with an explicit interest in including children with disabilities and children affected by health disparities.

This opportunity uses a U01 Cooperative Agreement mechanism, which means it is not a typical investigator-driven grant with minimal federal involvement. Instead, NIH expects substantial collaboration during the project, often including coordinated planning, shared expectations for milestones, and adherence to common program requirements. The trials are expected to be innovative and scalable, and the language of the NOFO emphasizes large-scale and multi-site designs, signaling that NIH is looking for studies capable of generating strong, generalizable evidence rather than small single-center pilots.

A key scientific boundary in this announcement is priority: while many approaches to pain care can include behavioral elements, clinical trials in which behavioral interventions are being tested specifically to manage pain as the primary outcome are not considered high priority for this program. In other words, applicants proposing behavioral pain-management trials as the central focus should expect to be less competitive under this particular NOFO, even though the broader HEAL portfolio may support behavioral work elsewhere. The emphasis here is on advancing pediatric acute pain research in ways that may include, but are not centered on, behavioral pain-management as the primary endpoint.

The NOFO is designed to operate alongside a companion funding announcement (RFA-HD-24-012) that will fund a single HEAL KIDS Pain Resource and Data Center (RDC). The RDC is intended to serve as shared infrastructure for the entire HEAL KIDS Pain effort, providing leadership and practical support for data management, data curation, data harmonization, and the development of data standards. It also provides administrative and logistical coordination, including oversight of HEAL-related NIH requirements and coordination of shared research resources across the funded clinical trials. For applicants to RFA-HD-24-011, this parallel structure implies that funded trial sites and coordinating teams will likely be expected to align their data collection and reporting practices with RDC-developed standards and to contribute data in harmonized formats to enable cross-study comparisons and broader reuse.

Eligibility for applicants is broad and includes many domestic organization types that commonly apply to NIH programs: state, county, and city/township governments; special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; Native American tribal organizations (other than federally recognized tribal governments); nonprofits with or without 501(c)(3) status (outside of higher education); for-profit organizations (other than small businesses); and small businesses. The NOFO also explicitly highlights categories of “other eligible applicants,” including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, the funding opportunity is clear about restrictions related to foreign involvement: non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed.

Administratively, this is an NIH discretionary funding opportunity with a cooperative agreement instrument, and it spans multiple CFDA listings (a sign of multi-Institute participation). The original closing date listed for the opportunity was November 20, 2023, and the opportunity was created on August 18, 2023. While the summary information provided does not list an award ceiling or expected number of awards, the framing suggests NIH is seeking a coordinated set of substantial clinical trials that can work in concert with the RDC and comply with HEAL program requirements for data sharing and standardization.

In practical terms, a competitive application under this NOFO would be expected to propose a well-justified, ethically and methodologically strong, multi-site pediatric acute pain trial; demonstrate the ability to recruit and retain infants, children, and/or adolescents (including those with disabilities and those experiencing health disparities); and show readiness to operate within a coordinated HEAL KIDS Pain ecosystem where data standards, harmonization, and cross-project consistency are central expectations.

• The National Institutes of Health in the education, food and nutrition, health, income security and social services sector is offering a public funding opportunity titled "HEAL Initiative: HEAL KIDS (Knowledge, Innovation and Discovery Studies) Pain: Acute Pain Clinical Trials Program (U01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.213, 93.233, 93.361, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.865, 93.866.
• This funding opportunity was created on 2023-08-18.
• Applicants must submit their applications by 2023-11-20. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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