include project for down syndrome

Full Title:
DeOndra Dixon INCLUDE Project Act of 2026

Summary#

This bill adds a new federal program at the National Institutes of Health (NIH) called the INCLUDE Project. The program would fund and coordinate research, training, and investigation about Down syndrome and conditions that occur with it. The stated broad goal is to improve health outcomes and quality of life for people with Down syndrome and their families.

  • Main change: Authorizes the Secretary of Health and Human Services, through the NIH director, to run the INCLUDE Project (research, training, and investigations related to Down syndrome).
  • Research priorities: Supports basic science on chromosome 21, building a large study population, more clinical trials that include or focus on people with Down syndrome, biomarker research, and study of co-occurring conditions such as Alzheimer’s and autoimmune disease.
  • Coordination: Requires NIH institutes and offices to coordinate efforts and avoid duplicating research.
  • Support functions: Directs technical assistance to grantees and entities involved.
  • Reporting: Requires a report to Congress every two years cataloging what research was done, who did it, whether it was done by single or multiple NIH entities, and any real-world evidence useful for clinical care.

What it means for you#

  • Individuals with Down syndrome and families: Could see more research focused on health issues common in Down syndrome, more clinical trials that include or are designed for people with Down syndrome, and research aimed at improving daily living and long-term health.
  • Researchers and clinicians: May have new grant and training opportunities and must coordinate with NIH efforts under the INCLUDE Project.
  • Hospitals and clinical trial sites: Could be asked to recruit and enroll more people with Down syndrome in trials or to help build and maintain the large study population the bill describes.
  • Federal health agencies (NIH and partners): Must coordinate programs across institutes and provide technical help to grantees. They must also prepare biennial reports to Congress.
  • Pharmaceutical and biotech companies: May see expanded opportunities to test therapies in populations that include people with Down syndrome, if they choose to participate.
  • General public and taxpayers: The bill aims to improve care and knowledge about Down syndrome, but the bill text does not state specific funding amounts or new taxes.

Expenses#

No publicly available information.

  • The bill text does not include an authorization of specific funding amounts or a fiscal note.
  • This would likely require NIH spending on grants, cohort development, clinical trials, staff time for coordination, and the biennial reporting process, but the bill does not state how those costs will be paid.
  • The requirement to maintain a large study population and expand clinical trials suggests ongoing program costs, though the bill gives no dollar estimates.

Proponents' View#

  • The bill appears intended to increase research focused on the unique health needs of people with Down syndrome.
  • A possible argument for the bill is that coordinated, targeted research can improve diagnosis, treatments, and quality of life for people with Down syndrome and may also generate medical insights useful for others.
  • The bill appears designed to expand clinical trial access for people with Down syndrome, including trials of novel treatments and therapies to support daily living.
  • The coordination requirement could be seen as a way to reduce wasted effort and avoid duplicate research across NIH.
  • Biennial reporting could improve transparency about what research is being done and by whom.

Opponents' View#

  • No clear argument against the bill is provided in the bill text or accompanying material.
  • One concern is that the bill does not specify funding levels or how the program will be financed. This makes it hard to judge the bill’s likely scale or the trade-offs with other NIH priorities.
  • The bill does not explain how the large study population will be recruited, how privacy and data protection will be handled, or how informed consent will be managed for people with intellectual disabilities. These implementation details are important for ethics and practicality.
  • Although the bill requires coordination to avoid duplication, it does not set timelines, measurable targets, or oversight details for how coordination will work in practice.
  • Expanding clinical trials “inclusive of, or expressly for” people with Down syndrome raises practical questions about trial design, safety monitoring, and how results will be applied; the bill does not give specifics on these issues.