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

This bill, known as the DeOndra Dixon INCLUDE Project Act of 2025, aims to enhance research, training, and investigations concerning Down syndrome. It amends the Public Health Service Act to establish a specific program managed by the Director of the National Institutes of Health (NIH). Below are the key components of the bill:

Establishment of the INCLUDE Project

The bill creates a new program called the "INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE Project," or INCLUDE Project. The main goal of this program is to conduct research focused on various aspects of Down syndrome throughout an individual's life.

Research Areas Included in the Program

The INCLUDE Project will emphasize several areas of research, including:

• High-risk, high-reward research: This focus is on studying the effects of trisomy 21 (the genetic condition that causes Down syndrome) on human development and health.
• Lifespan research: Promoting studies that involve participants with Down syndrome at different life stages to understand the condition better and to develop new interventions.
• Clinical trials: Expanding the number of clinical trials that include or specifically target participants with Down syndrome, particularly in biomedical, pharmacological, and therapeutic methods that enhance daily living activities.
• Biological mechanism research: Investigating the biological mechanisms related to structural and functional abnormalities, growth issues, and behavioral challenges faced by individuals with Down syndrome.
• Co-occurring conditions: Research focused on diagnosing and treating conditions that often occur alongside Down syndrome, including identifying biomarkers related to these conditions.
• Prevalence studies: Examining reasons for the higher occurrence of co-occurring conditions, such as Alzheimer's disease and autoimmune disorders, in those with Down syndrome, as well as ways to concurrently treat these issues.
• Quality of life improvement: Research, training, and investigations aimed at enhancing the quality of life for individuals with Down syndrome and their families.

Coordination and Stakeholder Engagement

The bill mandates that the NIH Director ensure coordination of programs related to Down syndrome among various NIH institutes and centers. It also requires that activities avoid duplicating existing research. To optimize the relevant programs, the Director must consult with stakeholders, including patient advocates, to ensure their needs are considered.

Reporting to Congress

The NIH Director is required to submit reports to Congress every two years that summarize the research conducted under the INCLUDE Project. These reports must include:

• The specific institutes or centers involved in the research.
• Information on whether the research was conducted directly by these institutes or through collaborative efforts.
• Details on any real-world evidence that may aid in clinical research and medical care for individuals with Down syndrome.

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