Sponsors (19)
The bill directs more coordinated federal research and clinical trial activity toward Down syndrome—likely improving treatments and access for affected individuals—while raising federal costs and creating a risk of shifting resources and limiting stakeholder input unless paired with additional funding and stronger engagement requirements.
People with Down syndrome and their families will gain substantially more targeted research, biomarkers, clinical trials, and quality‑of‑life interventions, improving access to novel therapies and evidence-based care.
Researchers, hospitals, and taxpayers benefit from coordinated NIH priority‑setting and reporting that can reduce duplication and improve the efficiency and impact of federal research funding.
Scientists and patients could see faster discovery of underlying mechanisms and long‑term outcomes because the bill supports lifespan cohort studies and high‑risk/high‑reward research.
Federal taxpayers face higher NIH spending to support the expanded research activities, which could increase budgetary pressures.
Patients and researchers in other disease areas risk having NIH resources diverted to Down syndrome research if the bill's priorities are not matched with new funding.
Patients, families, and advocates may get limited meaningful input because stakeholder consultation is only required 'to the maximum extent feasible,' weakening guaranteed participation.
Based on analysis of 2 sections of legislative text.
Creates an NIH INCLUDE Project to coordinate and support prioritized Down syndrome research, training, stakeholder consultation, and biennial reporting to Congress.
Official title: To amend the Public Health Service Act to authorize the Secretary of Health and Human Services to carry out a program of research, training, and investigation related to Down syndrome, and for other purposes.
Introduced May 19, 2025 by Diana DeGette · Last progress July 20, 2026
Creates a new NIH program called the INCLUDE Project to fund, coordinate, and report on research, training, and investigations related to Down syndrome. The law lists seven research priorities (from high‑risk trisomy 21 projects to quality‑of‑life studies), requires cross‑NIH coordination and stakeholder consultation, and mandates biennial reports to Congress cataloging funded projects and any real‑world evidence generated.