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):

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.

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.

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.

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 the research project and immediately following its completion, in light of the actual findings. Investigators conducting a covered project shall, at the conclusion of the project, report on how the findings compare to the veteran impact forecast and propose any adjustments to the actions in the translation plan.

(2)

The Office of Research and Development, in conjunction with relevant clinical operations officials, shall evaluate these post-study reports to determine what implementation steps will be taken by the Department and shall track the outcomes of major research projects in terms of uptake into clinical practice or policy.

(g) Major research project defined

In this section, a major research project means—

(1)

a research study or program, including a clinical trial or multisite study, that meets criteria indicating substantial size, scope, or significance, as shall be defined by the Secretary; and

(2)

includes—

(A)

research projects with projected Department funding above a threshold amount set by the Secretary; and

(B)

any other research initiatives designated by the Office of Research and Development as having high potential impact on veterans health or health care systems.

7387. Department of Veterans Affairs regional research hubs

(a) Establishment

(1)

The Secretary shall establish a system of regional research hubs of the Department (in this section referred to as research hubs) within the Veterans Health Administration to support and coordinate the research activities of the Department across multiple medical centers and clinics. The number and locations of such research hubs shall be determined by the Secretary to ensure that all medical facilities of the Department with active research programs may access the services of a research hub. In establishing research hubs pursuant to this section, the Secretary may consider Veteran Integrated Services Networks, or other appropriate regional groupings of facilities.

(2)

Each research hub shall be organizationally established under the Office of Research and Development, and shall operate under the direction of a Regional Research Hub Director appointed by the Under Secretary for Health, or a designee of the Under Secretary. The Director of each research hub shall be an individual with experience in managing biomedical or health services research and knowledge of regulatory compliance, who shall report to the Office of Research and Development with respect to activities of the hub.

(b) Functions

Each research hub shall, in coordination with the Office of Research and Development, carry out the following functions in support of Department research within the applicable area of geographic responsibility:

(1)

Facilitating the efficient and timely review of research protocols by coordinating institutional review board approvals for multi-site studies, including—

(A)

establishing or utilizing regional or central institutional review boards to serve multiple facilities;

(B)

harmonizing institutional review board submission requirements; and

(C)

ensuring that a single institutional review board of record can be used for multi-site projects when feasible and in accordance with applicable regulations.

(2)

Providing technical assistance and support to investigators and research staff at facilities in the region. Such support shall include—

(A)

guidance on research proposal development;

(B)

study design and methodology consultation;

(C)

assistance with regulatory compliance, including human subjects protections, animal care, and safety regulations; and

(D)

training or education programs for new investigators and research coordinators to build research capacity.

(3)

Coordinating research efforts among the Department facilities in the region and with affiliated academic institutions or other partners. Such research efforts shall identify opportunities for multi-site research projects, promote sharing of resources (including research equipment, specialized laboratories, or data resources), and encourage collaboration on studies that address veteran health priorities. Pursuant to such research efforts, the research hub may organize regular regional research meetings or consortia to foster information exchange and partnership among investigators and clinicians.

(4)

Assisting investigators in developing strategies for recruitment and enrollment of veteran participants in research studies, especially for multi-site clinical trials or studies requiring large sample sizes. The hub shall facilitate outreach to veterans in the region who might be eligible for ongoing studies, in accordance with privacy rules, and coordinate with local clinical staff to improve awareness and engagement in research opportunities.

(5)

Offering centralized administrative support for research projects, such as budget and grant management assistance, data management and biostatistical support, and guidance on using Department data systems, including the VA Centralized Research Data System under section 7383 of this title and other information tools, for research purposes.

(6)

Performing such other research-supporting functions consistent with the goal of enhancing the productivity, efficiency, and effects of the research enterprise of the Department in service of veterans, as the Secretary or Under Secretary for Health determine appropriate.

(c) Evaluation and oversight

(1)

The Chief Research and Development Officer of the Office of Research and Development of the Department shall oversee the performance of the research hubs and ensure such research hubs are meeting the needs of the respective regions in which such research hubs are located.

(2)

The Under Secretary for Health shall establish metrics and goals for the hubs, including metrics related to institutional review board review times, number of multi-site studies supported, training activities conducted, and improvements in veteran research enrollment.

(3)

The Under Secretary shall—

(A)

require each research hub to submit periodic reports to the Under Secretary with respect to the activities carried out by the research hub and the outcomes of such activities; and

(B)

include such periodic reports into the annual report under section 7388 of this title.

(d) Consultation and partnerships

In establishing and operating the research hubs, the Secretary may collaborate with Federal partners, including the Department of Defense and the National Institutes of Health, and academic affiliates to co-locate or jointly support resources that benefit both Department and non-Department research endeavors. The Secretary may also seek input from investigators, veterans, and other stakeholders in each region in which a research hub is located with respect to the research priorities and support needs the research hubs should address.

7388. Research performance metrics; annual report

(a) Establishment of metrics; benchmarking program

The Secretary shall develop and implement a standardized program of metrics to assess the performance, productivity, and impact of research activities at each facility of the Veterans Health Administration (including Department medical centers and affiliated clinics) that conducts research. Such metrics shall be used to benchmark Veterans Health Administration facilities against each other and against Departmental goals to identify best practices and areas for improvement. At a minimum, such metrics shall include measures of the following:

(1)

The volume of research projects undertaken and completed, and the efficiency of research processes at the facility, including—

(A)

the number of research proposals submitted, approved, and initiated each year;

(B)

the average or median time from proposal submission to institutional review board approval and project start; and

(C)

the number of studies completed or publications produced per year, normalized to the research staff or funding level.

(2)

The extent of veteran engagement in research at the facility, including—

(A)

the total number of veteran participants enrolled in clinical trials or other research studies;

(B)

and the percentage of the facility’s patient population or eligible population involved in research.

(3)

The degree to which research findings are implemented into clinical care or inform improvements to health care delivery at the facility. This may include—

(A)

the number of evidence-based interventions or new clinical practices adopted by the facility that originated from research (whether Department-funded or external research);

(B)

the period of time between research discovery and implementation at the facility; and

(C)

qualitative examples of significant changes in patient care driven by research findings.

(4)

If determined relevant by the Secretary—

(A)

the level of collaboration and external support, including the number of partnerships with academic or industry researchers;

(B)

the amount of non-Department research funding (including grants from the National Institutes of Health or the Department of Defense) managed through the facility; and

(C)

the extent of participation in multi-site or nationwide studies.

(5)

Any other quantifiable measure that the Secretary considers appropriate to evaluate research program effectiveness, including—

(A)

compliance with research safety and ethics requirements;

(B)

training and career development of researchers; and

(C)

innovation in research operations.

(b) Annual report

(1)

Not later than 180 days after the end of each fiscal year, and on an annual basis thereafter, the Secretary shall submit to the Committees on Veterans’ Affairs of the House of Representatives and the Senate a report on the performance of the research program of the Department, with specific emphasis on the facility-level metrics described in subsection (a). The report shall include, for the fiscal year during which the report is submitted, the following:

(A)

A table or summary displaying each medical center of the Department, and any other major research site, and values of such research site for each of the performance metrics in subsection (a) for the fiscal year and, for context, for at least one prior year.

(B)

An analysis by the Secretary identifying which facilities represent the highest performers in various categories (including shortest research approval times, highest veteran participation rates, most implementations of findings, and which facilities are lagging behind benchmarks or averages). The analysis should discuss factors contributing to strong performance, as well as challenges faced by lower-performing sites.

(C)

A description of efforts of the Department to improve research performance and address any identified deficiencies. This should include any initiatives to share best practices from high-performing facilities, targeted support or corrective actions for under-performing facilities, and progress updates on any ongoing Department-wide research improvement efforts.

(D)

Highlights of significant research accomplishments from the year, especially instances where research conducted by the Department led to improvements in veteran care, new treatments or technologies, or notable scientific publications, as well as recognition of any researchers or teams for exceptional contributions.

(2)

The first annual report under this subsection shall be submitted not later than 18 months after the date of the enactment of this section.

(c) Public availability

(1)

The Secretary shall make each annual report under subsection (b) publicly available on an internet website of the Department, in a format that is readily accessible to veterans, researchers, and other stakeholders.

(2)

The publicly released version of the report may aggregate or anonymize data as the Secretary determines necessary to protect personal privacy and to safeguard confidential research project details.

(3)

The Secretary is encouraged to include on the website user-friendly visualizations or dashboards that illustrate the performance of the applicable research program on key metrics over time and by facility.

(d) Sunset or modification of metrics

(1)

The Secretary shall continuously evaluate the relevance and effectiveness of the performance metrics established under subsection (a). The Secretary may modify the metrics or benchmarking methods under subsection (a), as the Secretary determines appropriate, to better measure research impact and efficiency.

(2)

Any such modifications shall be described in the annual report under subsection (b).

7389. Integration of research data and interagency collaboration

(a) Improvement of data sharing for research

(1)

The Secretary may include, in the plan required under section 108(a)(1) of the Senator Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act (Public Law 118–210; 38 U.S.C. note prec. 5701), such actions as may be necessary to facilitate the secure integration and sharing of data for research purposes between the Department and key research partners, including other Federal agencies and academic institutions.

(2)

For purposes of this subsection, the Secretary shall ensure that any data in the custody, possession, or control of the Department, (without regard to the original ownership of such data), may be shared to the extent permitted under applicable privacy, security, and ethical standards.

(3)

The Secretary may include a description of any actions taken pursuant to this subsection in the reports required under subsection (c)(2) of such section.

(4)

In carrying out this subsection, the Secretary shall seek to improve interoperability of data systems and ease of collaboration with the following:

(A)

The Department of Defense, to—

(i)

facilitate research on—

(I)

members of the Armed Forces assigned to active duty; and

(II)

veterans across the continuum of military service and post-service life; and

(ii)

support joint research initiatives of the Department and the Department of Defense.

(B)

The Department of Health and Human Services, including the National Institutes of Health and other components engaged in biomedical and health services research, to facilitate—

(i)

mutually beneficial sharing of health data and research results; and

(ii)

participation of the Department in national research efforts, such as clinical trials networks and observational study consortia.

(C)

Affiliated universities and other academic research institutions that partner with the Department or receive research funding from the Department, to ensure that researchers can collaborate effectively while maintaining appropriate data security and patient privacy.

(D)

Other public or private research entities as determined appropriate by the Secretary, including nonprofit research organizations or industry partners, especially in contexts where cooperation can accelerate the development of treatments or technologies for the benefit of veterans.

(c) Privacy and security

(1)

All activities under this section shall be carried out in compliance with applicable Federal privacy laws, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA, Public Law 104–191; 110 Stat. 1936) and the Privacy Act of 1974 (5 U.S.C. 552a), and with regulations governing human subjects research confidentiality.

(2)

In carrying out this section, the Secretary shall ensure that robust safeguards are in place to protect personally identifiable information and personal health information of veterans. Such safeguards shall include user authentication, role-based access controls, encryption of data in transit and at rest, continuous monitoring for unauthorized access or anomalies, and regular cybersecurity audits.

(3)

When sharing data with the Department of Defense or other agencies, the Secretary shall, to the maximum extent practicable, use secure Federal health data exchange frameworks and reciprocal data access agreements that uphold the same or higher standards of privacy and security as those used within the Department.

(d) Consultation

In carrying out the provisions of this section, the Secretary shall consult with relevant Federal officials and outside experts, including the Chief Information Officer of the Department of Defense or designee, the Director of the National Institutes of Health or designee, and representatives of academic institutions with expertise in health information tools and data sharing.