What changed between these versions
A substantive revision to the DeOndra Dixon INCLUDE Project Act, v2 updates the short title year and streamlines the program's authority by shifting it from the Secretary of Health and Human Services to the Director of NIH. It also removes the findings section and technical assistance provision, while adding a new requirement for stakeholder consultation.
Overview
A moderate number of changes are present, including one major deletion, one major addition, and several modifications to existing provisions. · v2 refines the program's implementation by centralizing authority and updating coordination mechanisms, while also broadening the scope of certain research elements and adding a new consultation requirement.
The most significant change in v2 is the removal of the entire 'Findings' section, which provided the legislative rationale for the bill. Additionally, the authority for carrying out the INCLUDE Project shifts from the Secretary of Health and Human Services to the Director of NIH, streamlining oversight. A new provision for stakeholder consultation has been added, while the technical assistance provision was removed. Minor refinements to research program elements and reporting details are also present.
Major additions
This new subsection mandates that the Director of NIH, in carrying out activities under this section, shall consult with relevant stakeholders, including patient advocates, to ensure that such activities consider the needs of individuals with Down syndrome.
This addition introduces a formal requirement for stakeholder engagement, ensuring that the research program's direction and activities are informed by the perspectives and needs of the Down syndrome community and their advocates. This could lead to more relevant and impactful research outcomes.
Deletions
This section contained six legislative findings detailing the prevalence of Down syndrome, its characteristics, increased life expectancy, capabilities of individuals with Down syndrome, associated medical risks and benefits, and the potential for research to improve health outcomes.
The deletion of the findings section removes the explicit legislative rationale and background information that prefaced the bill's operative provisions. While the core purpose of the bill remains, the detailed context and justification for the INCLUDE Project are no longer present in the statutory text, potentially streamlining the bill's presentation and focusing solely on the operative language.
Modifications
This is a minor, technical update reflecting the likely year of enactment or a re-introduction, with no substantive policy impact on the program itself.
Before
The Act was cited as the 'DeOndra Dixon INCLUDE Project Act of 2025'.
After
The Act is cited as the 'DeOndra Dixon INCLUDE Project Act of 2026'.
This change alters the statutory placement of the INCLUDE Project within the Public Health Service Act, moving it from Part A (General Provisions) to Part B (National Research Institutes). This may reflect a more appropriate organizational fit within the existing statutory framework for research institutes, but does not change the program's core function.
Before
The bill amended Part A of title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) by adding SEC. 404P.
After
The bill amends Part B of title IV of the Public Health Service Act (42 U.S.C. 284 et seq.) by adding SEC. 409K.
This modification centralizes the direct responsibility and authority for the INCLUDE Project under the Director of NIH, potentially streamlining decision-making and implementation. The removal of the explicit 'consultation with other Federal agencies and partners' from the general authorization may reduce a formal procedural step, though coordination is still addressed in subsection (c).
Before
The Secretary, acting through the Office of the Director of NIH, and in consultation with other Federal agencies and partners, was authorized to carry out the program.
After
The Director of NIH shall carry out the program.
This change slightly broadens the type of research beyond just 'basic science studies' to 'research' generally, and uses the more precise genetic term 'trisomy 21' instead of the broader 'chromosome 21', enhancing scientific accuracy without altering the core intent.
Before
Program elements included 'high-risk, high reward basic science studies of the effects of chromosome 21 on human development and health'.
After
Program elements include 'high-risk, high-reward research on the effects of trisomy 21 on human development and health'.
This modification expands the scope of this program element from a passive data collection role to an active research promotion role, emphasizing longitudinal studies and the development of new interventions. This could lead to more dynamic and comprehensive research efforts over time.
Before
Program elements included 'assembling and maintaining a large study population of individuals with Down syndrome'.
After
Program elements include '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'.
This is a minor semantic change, likely to align with common terminology in clinical research, with no substantive impact on the eligibility or scope of clinical trials.
Before
Program elements included expanding clinical trials inclusive of, or expressly for, 'individuals with Down syndrome'.
After
Program elements include expanding clinical trials inclusive of, or expressly for, 'participants with Down syndrome'.
This modification slightly streamlines the description of biological mechanisms, making it less prescriptive about specific areas like 'cells, tissues, and organs' and 'cognitive' dysfunction, while retaining the overall focus on structural, functional, and behavioral anomalies. The change from 'responsible for' to 'pertaining to' offers a slightly broader connection.
Before
Program elements included research on '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'.
After
Program elements include research on 'biological mechanisms in individuals with Down syndrome pertaining to structural, functional, and behavioral anomalies and dysfunction as well as stunted growth'.
This modification expands the scope of this program element to encompass broader research efforts aimed at improving diagnosis and treatment, rather than just biomarker identification. The inclusion of 'clinical research and therapeutics' suggests a more direct pathway to practical applications and interventions.
Before
Program elements included 'the identification of biomarkers for the detection of risk factors, diagnosis, and customized interventions and treatments for conditions co-occurring with Down syndrome'.
After
Program elements include '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'.
This modification refines the language to focus on 'causes of increased prevalence' rather than 'why' and explicitly includes 'related dementias' alongside Alzheimer's disease, broadening the scope of neurological conditions to be researched. The emphasis on 'concurrent treatment' remains.
Before
Program elements included research on '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'.
After
Program elements include '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'.
This modification clarifies that the efforts to improve quality of life are to be achieved through the core activities of the INCLUDE Project (research, training, and investigation), rather than being a standalone goal, thus better integrating it into the program's mandate.
Before
Program elements included 'improving the quality of life of individuals with Down syndrome and their families'.
After
Program elements include 'research, training, and investigation on improving the quality of life of individuals with Down syndrome and their families'.
This modification aligns the coordination authority with the overall shift of program responsibility to the Director of NIH. The updated statutory references for coordination mechanisms reflect a different internal NIH process for ensuring non-duplicative research, potentially streamlining coordination efforts within the NIH structure.
Before
The Secretary was to ensure coordination through the Division of Program Coordination, Planning, and Strategic Initiatives under sections 402(b)(7) and 402A(c).
After
The Director of NIH shall ensure coordination through the Office of the Director of NIH and priority-setting reviews conducted pursuant to section 402(b)(3).
The deletion of the technical assistance provision removes a specific support mechanism for grantees and involved entities. While other forms of support might still exist, this explicit mandate for technical assistance is no longer present, which could affect the direct support provided to research implementers.
Before
The Secretary was to provide technical assistance to grantees and other involved entities.
After
This provision was deleted.
This modification aligns the reporting responsibility with the Director of NIH, consistent with the overall shift in authority. The narrowing of identified entities in the report suggests a more focused reporting on core NIH institutes and centers, potentially simplifying the reporting process but also providing less detail on broader agency or office involvement.
Before
The Secretary was to submit biennial reports, identifying the institute, center, agency, office, or entity involved.
After
The Director of NIH shall submit biennial reports, identifying the institute or center involved.
Scope
Meaningful expansion or narrowing — Changes are concentrated within the core operative section establishing the Down syndrome research program (Section 2/3) and the introductory elements (short title and findings). — While the core policy direction of establishing and funding Down syndrome research remains consistent, v2 represents a refinement in the administrative structure and specific programmatic emphasis. The addition of stakeholder consultation and the removal of the findings section represent meaningful shifts in the bill's approach and presentation. — The changes primarily affect the newly added section of the Public Health Service Act and its internal structure. The shift in authority and coordination mechanisms interacts with existing NIH administrative provisions by specifying which parts of the PHS Act govern the INCLUDE Project's coordination.
Impact analysis
Researchers and institutions conducting Down syndrome research
Procedural change with potential for slightly expanded research opportunities.
The authority for the INCLUDE Project is now directly under the Director of NIH, potentially streamlining administrative processes. The scope of certain research elements has been slightly broadened (e.g., 'research' instead of 'basic science studies', 'cohort studies', 'clinical research and therapeutics').
Individuals with Down syndrome and their families/advocates
Gain of formal influence and participation.
A new provision explicitly mandates consultation with stakeholders, including patient advocates, in carrying out the program.
Federal agencies and partners (other than NIH institutes/centers)
Loss of explicit formal consultation and reporting requirements.
The explicit requirement for the Secretary to consult with 'other Federal agencies and partners' in the general authorization for the program was removed. Also, these entities are no longer explicitly listed for identification in biennial reports.