US Codex
Bill
Notes

S. 1838 — what changed

DeOndra Dixon INCLUDE Project Act of 2026

From Introduced in Senate to Engrossed in Senate. 2 sections amended and 1 removed between Introduced in Senate and Engrossed in Senate.

Section 1 Short title

changed This Act may be cited as the “DeOndra Dixon INCLUDE Project Act of 2025”.2026”.

Sec. 2 DeOndra Dixon INCLUDE Project

changed Congress finds Part B of title IV of the Public Health Service Act (42 U.S.C. 284 et seq.) is amended by adding at the end the following:

added “409K. Down syndrome research

added “(a) In general—The Director of NIH shall carry out a program of research, training, and investigation related to Down syndrome to be known as the “INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE Project” or the “INCLUDE Project”.

added “(b) Program elements—The program under subsection (a) shall include—

added “(1) high-risk, high-reward research on the effects of trisomy 21 on human development and health;

added “(2) promoting research for participants with Down syndrome across the lifespan, including cohort studies to facilitate improved understanding of Down syndrome and co-occurring conditions and development of new interventions;

added “(3) expanding the number of clinical trials that are inclusive of, or expressly for, participants with Down syndrome, including novel biomedical and pharmacological interventions and other therapies designed to promote or enhance activities of daily living;

added “(4) research on the biological mechanisms in individuals with Down syndrome pertaining to structural, functional, and behavioral anomalies and dysfunction as well as stunted growth;

added “(5) supporting research to improve diagnosis and treatment of conditions co-occurring with Down syndrome, including the identification of biomarkers related to risk factors, diagnosis, and clinical research and therapeutics;

added “(6) research on the causes of increased prevalence, and concurrent treatment, of co-occurring conditions, such as Alzheimer’s disease and related dementias and autoimmunity, in individuals with Down syndrome; and

added “(7) research, training, and investigation on improving the quality of life of individuals with Down syndrome and their families.

added “(c) Coordination; prioritizing nonduplicative research—The Director of NIH shall ensure that—

added “(1) the programs and activities of the institutes and centers of the National Institutes of Health relating to Down syndrome and co-occurring conditions are coordinated, including through the Office of the Director of NIH and priority-setting reviews conducted pursuant to section 402(b)(3); and

added “(2) such institutes and centers, prioritize, as appropriate, Down syndrome research that does not duplicate existing research activities of the National Institutes of Health.

added “(d) Consultation with stakeholders—In carrying out activities under this section, the Director of NIH shall, as appropriate and to the maximum extent feasible, consult with relevant stakeholders, including patient advocates, to ensure that such activities take into consideration the needs of individuals with Down syndrome.

added “(e) Biennial reports to Congress

added “(1) In general—The Director of NIH shall submit, on a biennial basis, to the Committee on Energy and Commerce and the Subcommittee on Labor, Health and Human Services, Education, and Related Agencies of the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Subcommittee on Labor, Health and Human Services, Education, and Related Agencies of the Committee on Appropriations of the Senate, a report that catalogs the research conducted or supported under this section.

added “(2) Contents—Each report under paragraph (1) shall include—

added “(A) identification of the institute or center involved;

added “(B) a statement of whether the research is or was being carried out directly by such institute or center or by multiple institutes and centers; and

added “(C) identification of any resulting real-world evidence that is or may be used for clinical research and medical care for patients with Down syndrome.”

(1)
removed Down syndrome is the most common chromosomal disorder. Each year, about 6,000 babies born in the United States have Down syndrome, affecting about 1 in every 700 babies born.
(2)
removed Individuals with Down syndrome have a full or partial extra copy of chromosome 21 that leads to certain physical, intellectual, and developmental challenges.
(3)
removed Life expectancy of individuals with Down syndrome in the United States has increased dramatically in recent decades. In 1960, the average life expectancy was about 10 years. Today, the average life expectancy of an individual with Down syndrome is nearly 60 years.
(4)
removed Individuals with Down syndrome can attend school, work, make their own life decisions, have meaningful relationships, vote, and contribute to society.
(5)
removed Individuals with Down syndrome are at an increased risk for certain medical conditions, such as autoimmune disorders, leukemia, congenital heart disease, sleep dysfunction, and Alzheimer’s disease, but may be at a decreased risk for other conditions.
(6)
removed Research and medical care supporting individuals with Down syndrome and their unique disease profile will improve health outcomes and may potentially lead to treatments for individuals born with or without Down syndrome who suffer from diseases associated with that unique profile.

Sec. 3 Down syndrome research

removed

removed Part A of title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended by adding at the end the following:

removed “404P. Down syndrome research

removed “(a) In general—The Secretary, acting through the Office of the Director of NIH, and in consultation with other Federal agencies and partners, shall carry out, directly or through grants or contracts, a program of research, training, and investigation related to Down syndrome to be known as the INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE Project or the INCLUDE Project.

removed “(b) Program elements—The program under subsection (a) shall include research, training, and investigation related to—

removed “(1) high-risk, high reward basic science studies of the effects of chromosome 21 on human development and health;

removed “(2) assembling and maintaining a large study population of individuals with Down syndrome;

removed “(3) expanding the number of clinical trials that are inclusive of, or expressly for, individuals with Down syndrome, including novel biomedical and pharmacological interventions and other therapies designed to promote or enhance activities of daily living;

removed “(4) the biological mechanisms in individuals with Down syndrome responsible for structural and functional anomalies in cells, tissues, and organs, cognitive and behavioral dysfunction, and stunted growth;

removed “(5) the identification of biomarkers for the detection of risk factors, diagnosis, and customized interventions and treatments for conditions co-occurring with Down syndrome;

removed “(6) why several co-occurring conditions, such as Alzheimer’s disease and autoimmunity, are prevalent in individuals with Down syndrome and how such conditions can be treated concurrently with Down syndrome; and

removed “(7) improving the quality of life of individuals with Down syndrome and their families.

removed “(c) Coordination; prioritizing nonduplicative research—The Secretary shall ensure that—

removed “(1) the programs and activities of the institutes, centers, agencies, and offices of the National Institutes of Health relating to Down syndrome and co-occurring conditions are coordinated, including through the Division of Program Coordination, Planning, and Strategic Initiatives under sections 402(b)(7) and 402A(c); and

removed “(2) such institutes, centers, agencies, and offices prioritize, as appropriate, Down syndrome research that does not duplicate existing research activities of the National Institutes of Health.

removed “(d) Technical assistance—The Secretary shall provide technical assistance to grantees and other involved entities, as appropriate, for carrying out activities pursuant to this section.

removed “(e) Biennial reports to Congress

removed “(1) In general—The Secretary shall submit, on a biennial basis, to the Committee on Energy and Commerce and the Subcommittee on Labor, Health and Human Services, Education, and Related Agencies of the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Subcommittee on Labor, Health and Human Services, Education, and Related Agencies of the Committee on Appropriations of the Senate, a report that catalogs the research conducted or supported under this section.

removed “(2) Contents—Each report under paragraph (1) shall include—

removed “(A) identification of the institute, center, agency, office, or entity involved;

removed “(B) a statement of whether the research is or was being carried out directly by the institute, center, agency, office, or entity or by multiple institutes, centers, agencies, offices, or entities; and

removed “(C) identification of any resulting real world evidence that is or may be used for clinical research and medical care for patients with Down syndrome.”