This bill would add a new section to the Public Health Service Act directing the National Institutes of Health (NIH) to run a program called the INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE Project (INCLUDE Project). The program would fund research, training, and investigations specifically related to Down syndrome. It lists program elements such as high-risk, high-reward research on trisomy 21; lifespan cohort studies; expanding clinical trials that include or focus on participants with Down syndrome; study of biological mechanisms and co-occurring conditions; biomarker research; and work to improve quality of life for people with Down syndrome and their families. The bill also requires NIH to coordinate related work across its institutes, consult stakeholders including patient advocates, and send biennial reports to specified congressional committees cataloging the supported research and any resulting real-world evidence.
If enacted, NIH would formally run and coordinate the INCLUDE Project to support research and training about Down syndrome. The program could lead to more studies and clinical trials that include people with Down syndrome, efforts to find biomarkers or treatments for co-occurring conditions (such as Alzheimer’s disease and autoimmune conditions), and projects aimed at improving daily life for people with Down syndrome and their families. NIH would consult stakeholders and provide Congress with reports every two years about the research supported.
No publicly available information.
The bill directs NIH to pursue research goals described in the text: better understanding of how trisomy 21 affects development and health; more inclusive clinical trials and new interventions; study of biological mechanisms and co-occurring conditions; improved diagnosis, biomarkers, and treatments; and research and training to improve quality of life for individuals with Down syndrome and their families.
No publicly available information.