DeOndra Dixon INCLUDE Project Act of 2026
Summary
What This Bill Does
The DeOndra Dixon INCLUDE Project Act of 2026 adds a permanent statutory directive for the NIH Director to carry out the INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE Project. The program covers high-risk, high-reward research on trisomy 21; lifespan and cohort studies; trials inclusive of or designed for participants with Down syndrome; biological mechanisms; biomarkers, diagnosis, treatment, and therapeutics for co-occurring conditions; Alzheimer’s disease and related dementias, autoimmunity, and concurrent treatment; and quality of life for individuals and families.
NIH institutes and centers must coordinate their Down syndrome work through the Office of the Director and priority-setting reviews and, where appropriate, prioritize projects that do not duplicate existing NIH research. The Director must consult relevant stakeholders, including patient advocates, as appropriate and to the maximum extent feasible so the program considers the needs of people with Down syndrome. Every two years, NIH must report to specified House and Senate health and appropriations panels, cataloging supported research, identifying involved institutes and centers, describing whether work is conducted singly or jointly, and identifying real-world evidence potentially useful for clinical research and care.
The Senate-passed version replaces the introduced bill's findings and proposed Public Health Service Act section 404P with section 409K in a different statutory part. It changes the short-title year from 2025 to 2026, refines the scientific agenda, replaces a technical-assistance provision with stakeholder consultation, and narrows organizational wording to NIH institutes and centers. The core research program and biennial reporting continue. The bill specifies no dollar appropriation or authorization in the passed text.
Who Benefits and How
People with Down syndrome and their families may benefit from more coordinated research, broader trial inclusion, better biomarkers and treatments, and attention to quality of life across the lifespan. Patient advocates gain an express consultation role in setting and implementing NIH activities. Down syndrome clinicians, academic researchers, trial sponsors, and research participants gain a durable federal program and clearer scientific priorities. Congressional committees receive recurring evidence about the work performed and its clinical relevance.
Who Bears the Burden and How
The NIH Director, institutes, and centers must plan and coordinate the program, avoid unnecessary duplication, conduct stakeholder consultation, and prepare biennial catalogs. NIH program and grants staff must support a wide research agenda using resources made available through ordinary funding channels. Researchers and clinical-trial teams must design work that includes participants with Down syndrome and generates usable evidence. Patient advocates and participants bear time and participation demands when consulted or enrolled, although their involvement is intended to improve relevance and representation.
Key Provisions
- Establishes the INCLUDE Project as an NIH Down syndrome research, training, and investigation program.
- Requires research on trisomy 21, lifespan cohorts, inclusive clinical trials, biological mechanisms, biomarkers, co-occurring conditions, and quality of life.
- Requires NIH institutes and centers to coordinate work and prioritize nonduplicative research when appropriate.
- Requires maximum-feasible consultation with relevant stakeholders, including patient advocates.
- Requires biennial reports identifying participating NIH units, collaborative work, and resulting real-world evidence.
- Modifies the introduced structure and title year without appropriating or authorizing a stated dollar amount.
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
Codifies the NIH INCLUDE Project as a coordinated, lifespan-wide Down syndrome research and training program, requires consultation with affected stakeholders, and mandates biennial reports to congressional health and appropriations panels.
Key Policy Areas
Biomedical Research, Down Syndrome, Public Health, Government Oversight
Primary Purpose
Codifies the NIH INCLUDE Project as a coordinated, lifespan-wide Down syndrome research and training program, requires consultation with affected stakeholders, and mandates biennial reports to congressional health and appropriations panels.
Policy Domains
NIH INCLUDE Project research program
Identified Gains
- People with Down syndrome
- Families of people with Down syndrome
- Down syndrome research participants
- Patient advocacy organizations
- Biomedical and clinical researchers
- Clinicians treating co-occurring conditions
Identified Costs
- NIH Director's Office
- NIH institutes and centers
- Down syndrome research teams
- Clinical-trial administrators
- Stakeholders participating in consultation
Biennial INCLUDE Project reporting
Identified Gains
- Congressional health committees
- Congressional appropriations subcommittees
- Down syndrome clinicians
- Patient advocates monitoring federal research
Identified Costs
- NIH reporting staff
- NIH institutes supplying project data
- Research administrators identifying real-world evidence
Sponsors
Legislative Progress
Passed SenateHeld at the desk.
Received in the House.
Message on Senate action sent to the House.
Passed Senate with an amendment by Voice Vote. (text of …
Passed/agreed to in Senate: Passed Senate with an amendment by …
Measure laid before Senate by unanimous consent. (consideration: CR S4495-4498)
Senate Committee on Health, Education, Labor, and Pensions discharged by …
Mr. Hickenlooper (for himself, Mr. Moran, Mr. Booker, and Mr. …
Read twice and referred to the Committee on Health, Education, …
Introduced in Senate
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
Congressional health and appropriations panels, Congressional health counsel, NIH Director, institutes, and centers
Down syndrome advocacy organizations, Down syndrome biomedical and clinical researchers, Down syndrome biomedical researchers
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "families"
- → Families of people with Down syndrome
- "advocates"
- → Patient advocates and other relevant stakeholders
- "nih_units"
- → NIH institutes and centers
- "researchers"
- → Down syndrome biomedical and clinical researchers
- "nih_director"
- → Director of the National Institutes of Health
- "participants"
- → Research participants with Down syndrome
- "clinicians"
- → Clinicians using real-world Down syndrome evidence
- "house_panels"
- → House health and Labor-HHS appropriations panels
- "nih_director"
- → Director of the National Institutes of Health
- "senate_panels"
- → Senate health and Labor-HHS appropriations panels
Note: {'scope_ids': ['include_program'], 'description': 'The Senate-passed substitute preserves the core program in a new statutory section but replaces express technical assistance and grants-or-contracts wording with stakeholder consultation and revised NIH organizational language.'}
Key Definitions
Terms defined in this bill
The NIH program formally named the INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE Project.
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology