HR-3491 : Still Just a Bill

The DeOndra Dixon INCLUDE Project Act of 2025, also known as H.R. 3491, amends the Public Health Service Act to authorize the Secretary of Health and Human Services, through the National Institutes of Health (NIH), to carry out a program of research, training, and investigation related to Down syndrome. Key provisions of the bill include:

• Directing the NIH to establish and conduct the INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project.
• Outlining specific program elements, including:
  • High-risk, high-reward research on the effects of trisomy 21.
  • Promoting research for participants with Down syndrome across their lifespan.
  • Expanding the number of clinical trials inclusive of participants with Down syndrome.
  • Research on biological mechanisms related to structural, functional, and behavioral anomalies.
  • Supporting research to improve diagnosis and treatment of conditions co-occurring with Down syndrome.
  • Research on the causes and treatment of co-occurring conditions such as Alzheimer's disease and autoimmunity.
  • Research, training, and investigation on improving the quality of life for individuals with Down syndrome and their families.
• Ensuring coordination among NIH institutes and centers regarding Down syndrome research and prioritizing non-duplicative research efforts.
• Requiring consultation with stakeholders, including patient advocates, to ensure activities address the needs of individuals with Down syndrome.
• Mandating biennial reports to Congress on research conducted or supported under this section, including information on the involved institute or center, whether the research is carried out directly or by multiple entities, and identification of resulting real-world evidence for clinical research and medical care.