[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6583 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 6583
To amend title 38, United States Code, to establish a centralized
research data system for the Department of Veterans Affairs and to make
certain improvements to processes applicable to major research projects
of the Department, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 10, 2025
Mr. Murphy introduced the following bill; which was referred to the
Committee on Veterans' Affairs
_______________________________________________________________________
A BILL
To amend title 38, United States Code, to establish a centralized
research data system for the Department of Veterans Affairs and to make
certain improvements to processes applicable to major research projects
of the Department, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``VA Research Reform Act of 2025''.
SEC. 2. ESTABLISHMENT OF CENTRALIZED VA RESEARCH DATA SYSTEM; STANDARDS
WITH RESPECT TO MAJOR RESEARCH PROGRAMS OF THE
DEPARTMENT.
Subchapter V of chapter 73 of title 38, United States Code, is
amended by adding at the end the following new sections (and conforming
the table of sections at the beginning of such chapter accordingly):
``Sec. 7383. VA Centralized Research Data System
``(a) Establishment.--The Secretary shall establish and maintain a
centralized research data system for the Department (to be known as the
`VA Centralized Research Data System'), to collect and manage
information on all research activities of the Department. Such system
shall include data with respect to all programs of medical research
conducted under section 7303 of this title, including biomedical
research, clinical research, mental health research, health services
and policy research, and any other category of research supported by
the Department.
``(b) Elements of System.--The VA Centralized Research Data System
shall include, for each research project conducted by or supported by
the Department the following information:
``(1) A summary of the objectives, scope, and study design
of the project.
``(2) An identification of Department funding, and any non-
Department funding, supporting the project, including amounts
and funding mechanisms.
``(3) The name and affiliation of the principal
investigator and key staff or collaborators involved in the
research.
``(4) The status and dates of all required approvals,
including institutional review board approvals or exemptions,
other regulatory approvals (including safety or ethical
reviews), and associated assurances of compliance.
``(5) Periodic updates on the progress of the project,
including--
``(A) the initiation date;
``(B) the completion of key milestones or phases;
and
``(C) the anticipated and actual completion dates
of the research.
``(6) The results and products of the research, including
any findings, publications in peer-reviewed journals,
presentations, patents or inventions, and noted impacts on
clinical care or policy arising from the project.
``(c) Use and Integration.--The Secretary shall ensure that the VA
Centralized Research Data System is--
``(1) used to facilitate oversight and coordination of
Department research;
``(2) designed to--
``(A) allow authorized personnel of the Department,
including the Office of Research and Development and
officials at Veterans Health Administration facilities,
to track research progress and outcomes, avoid
unnecessary duplication of research efforts, and
identify opportunities for translating research
findings into clinical practice; and
``(B) protect personally identifiable information,
in accordance with applicable laws and regulations; and
``(3) compatible with the electronic health record system
of the Department.
``(d) Regulations.--Not later than 180 days after the date of the
enactment of this section, the Secretary shall prescribe such
regulations or guidance as the Secretary determines necessary to
implement this section, including--
``(1) policies for the submission of information by
investigators into the Centralized Research Data System; and
``(2) protocols for maintaining the accuracy and security
of data in the system.
``Sec. 7384. Research proposal review and approval processes
``(a) Tiered Review Based on Risk and Impact.--The Secretary shall
develop and implement a tiered system for the ethical and scientific
review and approval of research proposals conducted by the Department
or using Department facilities, data, or resources. Under such system,
the level of review and applicable requirements shall be commensurate
with the projected risk to human subjects (or to animal subjects, as
applicable) and the expected effect or significance of the research.
``(b) Level of Review.--(1) Under the tiered system required by
subsection (a), the Secretary shall ensure that research proposals the
Secretary determines pose--
``(A) a minimal risk (as defined by Secretary in
regulations) to subjects or are of a small scope or short
duration are eligible for an expedited or abbreviated review
process that is consistent with the protection of human
subjects and sound research practice; and
``(B) a greater than minimal risk to subjects, involve
invasive procedures, or have broad potential impact (including
as large clinical trials or multi-site studies) undergo a full
review process.
``(2) The Secretary may establish intermediate levels of review
for--
``(A) categories of research the Secretary determines fall
between minimal risk and high risk; or
``(B) projects deemed of high scientific importance, to
ensure appropriate scrutiny without unnecessary delay.
``(c) Standardized National Timelines.--For each tier of research
review under subsection (b), the Secretary shall establish
standardized, Department-wide target timelines for completion of the
review and approval or disapproval of research proposals. Such
timelines shall be designed to expedite the initiation of valuable
research while maintaining standards for safety and ethics. The
Secretary shall ensure that these review processes and timelines are
applied uniformly across all facilities of the Veterans Health
Administration, notwithstanding any local policies.
``(d) Office of Research and Development Override Authority.--(1)
The Under Secretary for Health, acting through the Chief Research and
Development Officer of the Office of Research and Development
established under section 7381 of this title, shall monitor the
research proposal review process nationwide to identify any undue
delays or barriers to timely approval. If a research proposal subject
to Department review is not approved, conditionally approved, or
disapproved within the applicable timeline established under subsection
(c), the Under Secretary, through the Office of Research and
Development, may intervene to ensure a timely decision with respect to
the research proposal.
``(2)(A) In exercising the authority under paragraph (1), the Under
Secretary for Health may, as appropriate--
``(i) assume responsibility for or reassign the
review of the proposal to an alternative duly
constituted institutional review board or other
research review body that meets applicable standards;
or
``(ii) issue an approval or disapproval of the
proposal after such additional expedited review as the
Under Secretary determines necessary.
``(B) The Under Secretary shall notify the chief research
officer of the affected facility and the Office of Research
Oversight under section 7307 of this title of any intervention
under subparagraph (A) and the rationale for such intervention.
``(C) Any action by the Under Secretary under this
subsection shall ensure that all requisite ethical and safety
reviews are completed.
``(3) Nothing in this subsection shall be construed to waive or
override any law or regulation protecting human subjects, animal
welfare, or research integrity.
``(e) Guidance and Oversight.--The Secretary shall--
``(1) issue policies or guidance to implement the tiered
review system under this section, including--
``(A) definitions of risk and impact categories;
``(B) specific timeframes for review at each tier;
and
``(C) procedures for centralized monitoring of
compliance with these timelines;
``(2) oversee adherence to these processes through the
Office of Research and Development; and
``(3) provide training to members of institutional review
boards and other research review committees on the new
requirements to ensure consistent application.
``(f) Annual Review of Timeliness.--The Secretary shall track the
performance of the Department's research approval processes and include
in the annual report under section 7388 of this title an analysis of
the timeliness of research proposal reviews, identifying any systemic
bottlenecks and steps taken to improve the efficiency of research
approvals.
``Sec. 7385. Implementation of high-impact research findings
``(a) Funding Allocation Requirement.--Of the amounts appropriated
or otherwise made available to the Department each fiscal year for the
medical and prosthetic research program authorized under section 7303
of this title, the Secretary shall ensure that funds are allocated for
activities to implement the findings of such research program to
improve the delivery of care and services to veterans.
``(b) Use of Funds; `High-impact Research'.--(1) In carrying out
subsection (a), the Secretary, acting through the Chief Research and
Development Officer of the Office of Research and Development under
section 7381 of this title, shall identify completed or ongoing
research projects that have produced, or are likely to produce,
evidence or innovations with high potential to improve veteran health
care or quality of life (in this section referred to as `high-impact
research').
``(2) The Secretary shall utilize funds allocated pursuant to
subsection (a) to accelerate the transfer of such high-impact research
findings into clinical practice, systems of care, or programmatic
improvements.
``(3) Activities funded with such amounts may include--
``(A) implementation and dissemination studies;
``(B) the development or updating of clinical practice
guidelines;
``(C) training of health care providers in new evidence-
based practices;
``(D) modification of health information technology or
equipment to accommodate new treatments or diagnostic;
``(E) patient outreach and education regarding new
standards of care; and
``(F) other actions necessary to integrate research
discoveries into routine veterans care.
``(c) Coordination and Avoidance of Duplication.--(1) The Secretary
shall ensure that the allocation and use of funds for implementation
activities under this section are coordinated with other Department
initiatives in implementation science and quality improvement,
including the Quality Enhancement Research Initiative and other
translational research programs within the Department to leverage
existing expertise and avoid duplicative efforts.
``(2) The Office of Research and Development shall consult
regularly with Veterans Health Administration program offices
responsible for clinical operations to identify priority areas where
research findings are ready to be adopted on a wider scale within the
Department.
``(d) Accountability.--The Secretary shall include, in the annual
report required by section 7388 of this title--
``(1) the amount of research funding devoted to
implementation activities and the outcomes of such investments;
and
``(2) an analysis of compliance with the funding allocation
in subsection (a) and a description of major implementation
projects undertaken, the status of such projects, and the
effect of such projects on health care for veterans.
``Sec. 7386. Veteran impact forecast and translation plan for major
research projects required
``(a) Requirement for Major Research Projects.--The Secretary shall
ensure that any major research project of the Department includes, as
part of the research protocol and application for funding submitted to
the Secretary--
``(1) a veteran impact forecast described in subsection
(b); and
``(2) a translation plan described in subsection (c).
``(b) Veteran Impact Forecast.--A veteran impact forecast described
in this subsection is a written assessment, prepared by the
investigators or sponsors of a major research project at the time of
proposal, that describes the anticipated benefits and outcomes of the
research for veterans and the health care system of the Department. The
veteran impact forecast shall, to the maximum extent practicable,
quantify or describe the following:
``(1) How the findings or results of successful research is
successful are expected to improve health outcomes among
veterans, including--
``(A) reductions in morbidity or mortality;
``(B) improvements to functional status; and
``(C) enhancements to the quality of life for
veterans from the condition or conditions subject to
the research.
``(2) The ways in which the research results could--
``(A) be integrated into the clinical practice of
the Veterans Health Administration; or
``(B) lead to changes in health care policy or
programs for veterans (including adoption of new
treatments, diagnostics, preventive measures, or care
delivery models) and an estimate of the magnitude of
the veteran population likely to be affected by such
changes.
``(3) An explanation of the urgency of the research
question for veterans and an estimate of the time frame within
which positive findings could be implemented into clinical
practice, given the nature of the study design and any
necessary regulatory approvals.
``(c) Translation Plan.--A translation plan described in this
subsection is a proactive plan for how positive findings from the
research will be disseminated and implemented in the Department to
benefit veterans that includes the following:
``(1) An identification of steps and resources needed to
move any successful outcomes of the research into general
Department use.
``(2) A description of how and to whom the research results
will be communicated upon completion, including identification
of the relevant entities that should be informed of such
results, including--
``(A) program offices;
``(B) clinical practice leaders;
``(C) policymakers within the Department in a
position to act on such results;
``(D) external partners (including academic
affiliates); and
``(E) the heads of relevant Federal agencies.
``(3) Specific actions to be taken if the study yields
positive results, including--
``(A) the development or revision of clinical
protocols and guidelines;
``(B) pursuing regulatory approvals for new
therapies, if applicable;
``(C) training clinicians in new practices;
``(D) updating health information technology
systems or decision support tools; or
``(E) initiating pilot programs to implement the
findings in one or more medical centers of the
Department.
``(4) An identification of potential obstacles to
implementation, including resource needs, training gaps, or
interoperability issues.
``(5) A description of how the investigators or the
Department might address such obstacles to facilitate timely
translation of the research into practice.
``(6) As appropriate, to ensure that the translation of
findings is feasible and sustainable within the Department,
plans for engaging relevant stakeholders in the implementation
process, including--
``(A) the Under Secretary for Health;
``(B) veterans who would be affected by the change;
``(C) caregivers; or
``(D) external regulatory bodies.
``(d) Incorporation Into Approval and Funding.--(1) The Secretary
shall ensure that no major research project is approved or funded by
the Department unless the proposal includes a veteran impact forecast
and translation plan meeting the requirements of this section.
``(2) The Office of Research and Development shall review the
adequacy of the veteran impact forecast and translation plan during the
scientific review or funding decision process, and may provide feedback
or require modifications as necessary to strengthen the likelihood that
the research, if successful, can be readily applied to improve care for
veterans.
``(e) Guidance and Waiver.--(1) The Secretary, through the Office
of Research and Development, shall issue guidance defining the classes
of research projects subject to the requirements of this section and
detailing the format and content expectations for veteran impact
forecasts and translation plans.
``(2) The Secretary may exempt a particular project or class of
projects from one or both of these requirements only if the Secretary
determines that such project is of a nature for which these planning
documents would not be practicable or meaningful. Any such exemption
shall be documented in writing with a justification and submitted to
the Committees on Veterans' Affairs of the House of Representatives and
the Senate as part of the annual report under section 7388 of this
title.
``(f) Updates and Post-Study Review.--(1) The Secretary shall
establish a mechanism to revisit and update the translation plan as
necessary during the course of