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

NIH launched the INCLUDE Project in 2018 as its own initiative. H.R. 3491, named for the late Down syndrome advocate DeOndra Dixon, would turn it into a program Congress requires by law.

Instead of existing because NIH chose to run it, the Down syndrome research program would exist because the law says it must.

The bill lists seven things the program has to cover. They range from high-risk basic science on how an extra copy of chromosome 21 shapes development, to long-term studies that follow people with Down syndrome over years, to research on quality of life for them and their families.

Clinical trials get specific attention. NIH would be directed to expand the number of trials that include people with Down syndrome or are built for them — covering new drugs, biomedical treatments, and therapies that help with everyday tasks.

The bill also names the conditions that show up more often in people with Down syndrome, including Alzheimer's disease and related dementias and autoimmunity. NIH would study both why they are more common and how to treat them alongside Down syndrome itself, including work on biomarkers for earlier diagnosis.

On the management side, the NIH Director's office would coordinate Down syndrome work across NIH's institutes and centers, favor projects that don't repeat existing studies, and consult patient advocates and other stakeholders where feasible.

Every 2 years, NIH would have to tell Congress which institutes did the work, whether they collaborated, and what real-world evidence came out of it that doctors can use. The bill sets no dollar amount, so how much research actually happens still depends on appropriations.