Analyst Brief July 20, 2026

H.R. 3491 — DeOndra Dixon INCLUDE Project Act of 2025

Current Status

Committed to the Committee of the Whole House

Executive Summary

H.R. 3491 formally authorizes the 'INCLUDE Project' at the National Institutes of Health (NIH) to conduct targeted research, training, and investigations related to Down syndrome and co-occurring conditions across the lifespan. The bill aims to expand clinical trials, investigate biological mechanisms of trisomy 21, and address the high prevalence of co-occurring conditions like Alzheimer's disease in this population. By codifying this initiative, Congress ensures sustained focus, inter-institute coordination, and regular reporting on Down syndrome research outcomes without duplicating existing efforts.

Bill Data

Primary Sponsor

Ms. DeGette

Bill Number

H.R. 3491

Session

119th

Co-Sponsors

Mr. HudsonMs. DeLauroMr. ColeMs. NortonMr. Stauber
View on Congress.gov ↗

Arguments For

  • Bipartisan win: Supports a highly sympathetic and historically under-researched population, offering members an easy, feel-good legislative victory.
  • Scientific spillover: Leveraging Down syndrome research to investigate co-occurring conditions like Alzheimer's and autoimmune diseases could unlock broader medical breakthroughs.
  • Efficiency: Explicitly requires the NIH to prioritize non-duplicative research, appealing to members focused on government efficiency and reducing waste.

Likely Supporters

Global Down Syndrome FoundationNational Down Syndrome SocietyAlzheimer's AssociationDisability rights advocates

Arguments Against

  • Precedent of statutory carve-outs: Fiscal conservatives and scientific purists often argue against disease-specific congressional mandates, preferring to let NIH set research priorities based purely on scientific merit.
  • Administrative burden: The requirement for detailed biennial reports across multiple congressional committees adds bureaucratic overhead to the NIH.

Likely Opponents

Groups generally opposed to disease-specific NIH mandates (though active opposition is highly unlikely due to optics)

📋 Key Provisions

  • Authorizes the NIH Director to establish the 'INCLUDE Project' focusing on Down syndrome research and co-occurring conditions.
  • Mandates research into high-risk/high-reward areas, biological mechanisms of trisomy 21, and the prevalence of co-occurring conditions like Alzheimer's and autoimmunity.
  • Requires the expansion of clinical trials to be inclusive of, or expressly for, participants with Down syndrome.
  • Directs the NIH to coordinate activities across its institutes and centers to prioritize non-duplicative research.
  • Requires biennial reports to Congress detailing the research conducted, institutes involved, and resulting real-world evidence.
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Claim Analysis Page 3, Line 15

Establishes the INCLUDE Project for Down syndrome research.

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"stand Down syndromE Project’ or the ‘INCLUDE"

Claim Analysis Page 4, Line 20

Requires research on co-occurring conditions like Alzheimer's.

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"ditions, such as Alzheimer’s disease and related de-"

Claim Analysis Page 5, Line 23

Mandates biennial reports to Congress.

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"submit, on a biennial basis, to the Committee on"