I. Background

The Department of Veterans Affairs (VA), through the Veterans Health Administration (VHA) Office of Research and Development (ORD), provides this report to the Executive Office of the President, Office of Science and Technology Policy (OSTP) illustrating VA actions taken in accordance with the OSTP memorandum, Agency Guidance for Implementing Gold Standard Science in the Conduct and Management of Scientific Activities (Guidance), dated June 23, 2025.

II. Research at the U.S. Department of Veterans Affairs

Pursuant to 38 U.S.C. § 7303, VA carries out a program of medical research (VA research) in connection with the provision of Veteran medical care and treatment. VA research is exceptional in that it is the only Federal research program focused entirely upon Veterans’ needs. By law, VA research funding is available only to VA researchers, meaning that VA research is intramural; however, VA researchers often collaborate with industry, academic institutions, and other Federal agencies for which VA researchers may receive external funding, including through statutorily designated not-for-profit corporations as provided in 38 U.S.C. §§ 7361-7366.

ORD, which was established under 38 U.S.C. § 7381 and in P.L. 117-328 to support and conduct the full spectrum of VA research (including pre-clinical, clinical, and health systems investigations), technology transfer, and application, implements policy, administers funding, and provides administrative oversight to govern VA research activities. Despite being an intramural research program focused upon Veterans, ORD provides a publicly accessible website that includes information about ORD-funded and ORD-supported VA research activities. It also leverages systems hosted by the National Institutes of Health to provide information on studies it supports.

Collectively, VHA policies—including requirements applicable to the funding, management, and conduct of VA research, and specifically to ensuring the highest level of integrity in all aspects of VA’s generation, communication, and use of scientific findings and products (VA Directive 0005 , Scientific Integrity) — meet the Guidance requirements for Gold Standard Science (GSS) implementation, including the nine key tenets:

• Reproducible;
• Transparent;
• Communicative of Error and Uncertainty;
• Collaborative and Interdisciplinary;
• Skeptical of its Findings and Assumptions;
• Structured for Falsifiability of Hypotheses;
• Subject to Unbiased Peer Review;
• Accepting of Negative Results as Positive Outcomes; and
• Without Conflict of Interest.

For each of the listed key GSS tenets, the following are the steps that ORD took or plans to take to implement VA responsibilities, particularly for those activities ORD directly supports or funds. VA will take steps with OSTP and other Federal agencies to enable a consistent approach to upholding GSS tenets.

III. Reproducible

The Guidance requires that VA research be reproducible. To help ensure that others may reproduce or replicate VA research, ORD requires that VA funding applicants, as part of their applications, provide well-organized and detailed protocols to describe statistical methods, samples, methodologies, and controls that they will use in their research. The ORD Program Guides explain different VA research funding programs, specify that applicants must provide specific information and comprehensive documentation about their proposed research, including a description of how they will collect scientific data through the proposed research and how publications in which they describe their research activites and analyses will be available in publicly accessible repositories so that others may replicate or reproduce ORD research outcomes.

To communicate VA funding opportunities, ORD maintains a VA intranet page listing all announcements of current funding opportunities, including Notices of Special Interest (NOSIs) and Requests for Applications. To support VA funding applicants with their applications and VA-funded awardees with their awards, ORD funds Resource Centers and the Cooperative Studies Program (CSP) Coordinating Centers that provide subject matter expertise on, for example, study design using shared VA databases and specialized statistical methods and analytic techniques, and that provide broad, public dissemination of research results and scientific data. VA will develop a brief overview of this tenet directed towards VA funding applicants, VA funded awardees, VA Funding Program Managers, and others with roles and responsibilities related to review, management, and reporting of VA research, and will disseminate it through VA public-facing websites, VA intranet websites, and informational field calls. Although VA posts information for the general VA funding application and the submission process on the ORD Funding page, VA only provides links to more detailed VA funding information and most VA funding application forms through the VA intranet since VA research funding is available only to eligible VA researchers. ORD will provide this information and the forms to OSTP upon request.

ORD plans, in the forthcoming year, to review the criteria for VA research awards that consider funding applicants’ plans for prioritizing reproducibility and replicability of their VA research. This review may include updating guidance for VA funding applicants, VA funded awardees, and VA funding program staff and reviewers; developing related metrics (for example, ORD Program Guides and Requests for Applications (RFA) include the requirement that VA funding applicants describe how they will make their scientific data publicly accessible); evaluating adherence to developed guidance (for example, 100% of RFAs will include the requirement that VA funding applicants describe how they will make their scientific data publicly accessible); and determining how this tenet can be further implemented through the development and use of feasible and acceptable artificial intelligence (AI)-driven tools and other technology.

IV. Transparent

The Guidance requires that VA research be transparent. VA has for many years prioritized transparency in research, and transparency is considered a hallmark of scientific integrity, as stipulated in VA Directive 0005. VA research is transparent in that the peer and merit review process for funding includes providing clearly stated review criteria and communication to applicants of reviewers’ assessments and recommendations. Since 2016, ORD guidance for applications for VA research funding followed ORD Data Management and Access Plan (DMAP) Guidance, which alerts applicants and awardees to the requirement for making research publications and their underlying scientific data publicly available. VA requires VA research funding applicants to include a DMAP in their funding applications. VA expects VA funded awardees to implement their DMAP after publication of research results and upon collection of their final scientific data. To better ensure public access to VA research findings, ORD provides the public with information and instructions on how to locate full-text articles where VA is the funding agency on the website, Find VA Research Articles and Projects in PubMed Central and NIH RePORTER. VA also took an additional step to require registering ORD-funded clinical trials on the Government website, clinicaltrials.gov, since 2005. VA required the submission of results of these trials since 2013. For research funded by other Federal agencies, VA expects VA investigators to follow the respective Federal agency’s policies on data access and sharing as part of any conditions of award.

In addition, VA policy requires that research publications and presentations directly or indirectly supported by VA research funding, in the form of direct funding or the use of VA resources, or as a result of the investigator’s VA appointment, be appropriately acknowledged and made available to the public by, for example, depositing a copy of their publications through the National Library of Medicine PubMed Central portal (VHA Directive 1200.19, Presentation of Research Results.

VA-funded awardees, by accepting VA research support, agree to acknowledge their VA affiliation and VA support in all public reports and presentations. Failure to provide this acknowledgement may result in VA funding award termination. The DMAP submitted with VA funding applications requires VA funding applicants to acknowledge their obligation for making publications resulting from VA-funded research available through the National Library of Medicine PubMed Central portal; to state how they will make publicly available the final data sets underlying those publications (for example, through a website, databank, or repository); and to state how data sharing and preservation will enable validation of research results by data recipients.

As noted herein, although VA posts information for the general VA funding application and submission process on the ORD Funding public-page, VA only provides links to more detailed VA funding information and most VA funding application forms through the VA intranet since VA research funding is available only to eligible VA researchers. ORD will provide this information and the forms to OSTP upon request.

ORD plans, in the forthcoming year, to ensure the VA ORD DMAP guidance is consistent with the OSTP memorandum, Ensuring Free, Immediate, and Equitable Access to Federally Funded Research, dated August 25, 2022, or successor guidance. VA will develop a brief overview of this tenet directed towards VA funding applicants, VA-funded awardees, VA Funding Program Managers, and others with roles and responsibilities related to review, management, and reporting of VA research, and will disseminate it through VA public-facing websites, VA intranet websites, and informational field calls.
 
In addition, ORD plans, in the forthcoming year, to review its applicable documents that address transparency of VA research. As needed, this review may include:

• Updating or developing new VA policy and guidance for VA applications for funding, terms and conditions for VA funded awardees, and processes for VA funding application reviews;
• Reviewing metrics used by other Federal agencies and developing VA-specific ones (for example, number of VA funding applications include a DMAP;
•  Reviewing publications from ORD-funded research deposited in a repository;
• Evaluating adherence to developed guidance (for example, percentage of VA funding applications that include a DMAP; percentage of VA funding award close-outs that indicate depositing of publications resulting from the VA-funded research; and,
• Exploring how VA can support this tenet further by exploring available AI-driven tools and other technology that VA can implement feasibly while maintaining privacy and confidentiality of Veteran information and any intellectual property.

V. Communicative of Error and Uncertainty

The Guidance requires that VA research be communicative of error and uncertainty. ORD fosters VA researchers’ communication of error and uncertainty in their VA research by requiring broad dissemination of their VA research publications (VHA Directive 1200.19 and their sharing of scientific data underlying those VA research publications that are produced as the result of VA funding (see The ORD Program Guides). This imperative for wide dissemination of scientific findings, including data and results, is also stated in VA Directive 0005.

These VA requirements may reinforce VA researchers’ incentive to publish in higher quality (that is, peer-reviewed, double-blind) scientific journals. Publication in these scientific journals demonstrates that scientific journal peer reviewers accepted VA researchers’ statements about research error and uncertainty. In addition, ORD peer review of VA researchers’ funding applications is based in part upon the researchers’ demonstration of outstanding scientific achievement, which may include researchers’ past publications in higher quality scientific journals. These scientific journals include, as essential peer review criteria, evaluation of researchers’ representations about statistical uncertainties, sources of error, assumptions, methodological limitations, and potential biases.

ORD plans, in the forthcoming year, to develop guidance about standardized formats for VA researchers to provide reporting of error and uncertainty, to share guidance drafts with stakeholders for feedback and improvement, and to communicate the guidance. These steps also promote improved language that follows best practices in reporting errors and uncertainty.

VA will develop a brief overview of this tenet directed towards VA funding applicants, VA funded awardees, VA Funding Program Managers, and others with roles and responsibilities related to review, management, and reporting of VA research, and disseminate it through VA public-facing websites, VA intranet websites, and informational field calls.

In addition, ORD plans, in the forthcoming year, to review how mechanisms that are in place are used to determine that VA research is communicative of error and uncertainty. Subsequently, it may include updating VA policy and guidance for VA funding applicants (for example, Requests for Applications, with guidance to the effect that VA funding applicants should describe statistical uncertainties, sources of error, assumptions, methodological limitations, and potential biases; developing related metrics (for example, RFAs include guidance to the effect that VA funding applicants should describe statistical uncertainties, sources of error, assumptions, methodological limitations, and potential biases); and evaluating adherence to developed guidance (for example, percentage of RFAs that elicit descriptions of statistical uncertainties, sources of error, assumptions, methodological limitations, and potential biases; percentage of VA researchers’ publications that report study limitations such as potential errors and uncertainty); and examining if this tenet can be further achieved through the use of any feasible and acceptable AI-driven tools and other technology.

VI. Collaborative and Interdisciplinary

The Guidance requires that VA research be collaborative and interdisciplinary. ORD has long prioritized collaboration and interdisciplinary research. Several examples of such capabilities and their outcomes supported by ORD were publicized, particularly in areas related to clinical trials and genomic medicine research. Furthermore, ORD took an enterprise strategy for its research seeking to actively partner with clinical and operational offices to seek optimal approaches to translate VA research into clinical care.   

These efforts are complemented further by the establishment of a flexible funding mechanism under 38 U.S.C. §§ 7361-7366 whereby the Secretary of Veterans Affairs can establish VA medical center-affiliated nonprofit corporations (NPC) to facilitate extramurally funded research or education, or research and education at VA. ORD, through its Nonprofit Program Office (NPPO), ensures compliance with policies for this Federal statutory authority and provides oversight and guidance for VA-affiliated NPCs in accordance with VHA Handbook 1200.17, VA Nonprofit Research and Education Corporations, which is authorized by 38 U.S.C. 7361 through 7366.

NPCs now operate across the United States in over 43 states as well as Puerto Rico and the District of Columbia. VA personnel are actively engaged in the shared management of the NPCs, and NPCs may on behalf of VA medical centers administer funds related to research conducted at the VA medical centers. As another indicator of collaborative and interdisciplinary research conducted at VA and facilitated by VA-affiliated NPCs, NPCs cooperate with and obtain research funding from diverse sources, including the private sector, charitable foundations, private individuals, state and local governments, universities, and Federal entities such as the National Institutes of Health, Department of Defense, and Centers for Disease Control and Prevention. Through NPCs, funding from, and partnering with researchers from, a multitude of sponsors, including other Federal agencies, help to ensure interdisciplinary and collaborative research, including the sharing of valuable research talent, infrastructure, and resources. More about VA’s engagement with NPCs is available at the ORD Nonprofit Program Office (NPPO) website, including the latest NPPO Annual Report to Congress.

The VA CSP, referenced herein, is a long- and well-established research organization in the VHA ORD, through which VA conducts large scale, definitive clinical research on health issues vital to our Nations’ Veterans. For over 70 years, CSP has provided a national infrastructure that supports a broad and far-flung network of VA clinicians across many disciplines and over 80 VA medical centers. In addition to clinician-researchers, the CSP is staffed by expert statisticians, epidemiologists, pharmacists, regulatory professionals, and project managers. Through CSP, clinicians, researchers, and other experts from those many disciplines and VA medical centers collaborate to identify important medical and health services questions and perform scientific investigations to discover the answers to these questions. From this platform, VA established its Million Veteran Program that has enrolled over one million Veterans into one of the largest genomic medicine research cohorts in the world. 

In addition, the ORD Investigators, Scientific Review, and Management (ISRM) program, through which funding applicants are provided information and guidance about VA research funding opportunities, includes the Actively Managed Portfolios section, which makes available funding that is specifically intended to foster collaboration and coordination for particular VA research priority areas. 

Other examples of formal VA efforts to promote and strengthen VA collaborative and interdisciplinary research include the VA Office of Discovery, Education and Affiliate Networks (DEAN), under which ORD resides. The DEAN’s mission is to transform healthcare for Veterans and the Nation through innovation, training, research, and critically, robust, and formal partnerships with academia, healthcare institutions, and research organizations. The VA’s education and training programs, many of which include research components and activities, are affiliated with over 1,800 academic institutions, including most medical schools in the United States. Over 124,000 clinical trainees, including nurses, doctors, optometrists, podiatrists, pharmacists, and psychologists, among many disciplines, rotate through VA medical centers each year. These education and training programs include many opportunities for health professionals across every health profession discipline to conduct VA research team science as part of their educational programs, in close collaboration with VA and academic affiliate researchers at VA and academic affiliate medical facilities. Similar to VA’s NPC affiliates, DEAN’s academic affiliations programs help to ensure collaborative and interdisciplinary scholarship, including research, through the sharing of valuable research talent, infrastructure, and resources.

In addition, VA Directive 0005, an important element of VA policy, encourages VA researchers and other VA employees involved in the management and conduct of VA scientific activities to “interact with the broader scientific community,” in a manner that is consistent with applicable laws, ethics, and policies and “to the extent that is practicable given the availability of funding to support such interactions and any budgetary restraints.”

VA will develop a brief overview of this tenet directed towards VA funding applicants, VA funded awardees, VA Funding Program Managers, and others with roles and responsibilities related to review, management, and reporting of VA research, and disseminate it through VA public-facing websites, VA intranet websites, and informational field calls. ORD plans, in the forthcoming year, to ensure VA research remains collaborative and interdisciplinary, Improvements may include updating VA policy and guidance for VA funding applicants, VA-funded awardees, and VA funding program staff and reviewers; developing related metrics (for example, ORD Program Guides and RFAs include, when deemed appropriate to the funding opportunity, guidance about priority for collaborative and interdisciplinary projects); evaluating adherence to developed guidance (for example, percentage of RFAs that include, when deemed appropriate to the funding opportunity, prioritization of collaborative and interdisciplinary projects); and determining if VA can achieve this tenet further through the use of feasible and acceptable AI-driven tools and other technology. VA will further review how NPCs report collaborative and interdisciplinary activities as part of accountability reports to NPPO to determine what improvements VA could make to further improve implementation of this tenet.

VII. Skeptical of its Findings and Assumptions

The Guidance requires that VA research be skeptical of its findings and assumptions. VA fosters constructive skepticism of research findings and assumptions throughout VA research. VA funding opportunities and notices, which reflect VA and Congressional research priorities, require the VA funding applicants to address and satisfy criteria for validation or to use validated approaches or methods. Such approaches or methods may include, for example, validation of strategies to implement evidence-based practices; validation of data captured beyond healthcare; validation of biomarkers to advance diagnostics; drug validation; validation and application of data science, informatics or other systematic processes; and validation of predictive models using large language models, digital health, and other methods. The ORD Funding page provides links to the funding opportunities and notices that provide more specific information about requirements imposed upon funding applicants to describe how their research findings, methodologies, and underlying assumptions will help to ensure their study’s validity, robustness, and reliability. Note that the funding opportunities and notices are accessible only through the VA intranet, since only VA researchers may apply for and be provided VA funding. ORD will provide this information to OTSP upon request.

VA also fosters constructive skepticism by implementing stringent scientific peer and leadership review of funding applications. VA describes the VA scientific peer and leadership review process for making VA research funding decisions in different ORD Program Guides. Evaluation of funding applications involves review by subcommittees comprised of subject matter experts, such as the Scientific Review Group (SRG), with SRG reviewer assignments designated by VA research program staff. Reviewers’ recommendations are made to VA research program directors, with final funding decisions based upon the SRG recommendations and programmatic priorities. Priorities are themselves based upon thorough evaluation of the need for valid, robust, and reliable studies that will serve to support Veteran’s health-related needs. A unique element of the CSP mentioned herein is the requirement that funded researchers take part in an in-person defense of their studies aimed at providing definitive findings.

VA researchers also are required to deposit their research manuscripts in PubMed Central (VHA Directive 1200.19). Eligibility for depositing requires that the manuscript was based upon research funded by, for example, VA, whose funding review process includes stringent review as described herein, and that the manuscript itself was peer reviewed by a journal that is fully archived in PubMed Central. These scientific journals may include, as essential peer review criteria, evaluation that addresses skepticism of researchers’ representations about statistical uncertainties, sources of error, assumptions, methodological limitations, and potential biases. The review and publication requirements herein are also reflected in VA Directive 0005 to manifest these important attributes of VA policy in support of this tenet.

As stated herein, ORD plans, in the forthcoming year, to develop guidance about standardized formats for VA researchers’ reporting of error and uncertainty. ORD will share guidance drafts with stakeholders for feedback and improvement and will post the guidance. Also as stated herein, VA will develop a brief overview of this tenet directed towards VA funding applicants, VA funded awardees, VA Funding Program Managers, and others with roles and responsibilities related to review, management, and reporting of VA research, and will disseminate it through multiple mechanisms including VA public-facing websites, VA intranet websites, and informational field calls.

In addition, ORD plans to update VA policy and guidance for VA funding applicants, VA-funded awardees, and VA funding program staff and reviewers (for example, review and determine whether or how ORD Program Guides should include statements about evaluating funding applications for applicants’ descriptions of measuring and reporting error and uncertainty); develop related metrics and/or adopt other agency best practices (for example, the RFAs will require that funding applicants include descriptions or plans to validate or use of validated approaches or methods); and evaluate adherence to developed guidance (for example, percentage of RFAs that include, when deemed appropriate to the funding opportunity, the requirement that funding applicants describe their plans to validate or use of validated approaches or methods). ORD also will consider the feasibility of evaluating implementation of this tenet through the use of acceptable AI-driven tools and other technology. These steps will ensure that VA research is characterized by skepticism of findings and assumptions.

VIII. Structured for Falsifiability of Hypotheses

The Guidance requires that VA research be structured for falsifiability of hypotheses. VA requires that funding applicants’ proposed research study design specifically includes statements of hypotheses; addresses outcome variables or endpoints that are relevant to the hypotheses being tested; and be sufficiently powered to test hypotheses and provide interpretable results. These requirements may help to ensure that any stated hypothesis can be disproved through testing. There are, however, some VA research funding opportunities that do not focus upon hypothesis testing, such as, for example, the VA’s centers awards, which instead seek to establish research infrastructure at VA medical centers that are properly developed and conduct Veteran-focused research such as clinical trials, rehabilitation research or health systems research, and to improve patient, provider, and staff materials, educational opportunities, and tools. VA would expect the separately funded research through processes described herein that use these centers to include testable hypotheses, some of which may be disproved. As earlier mentioned, ORD’s Funding page provides links to the funding opportunities and notices, which provide more specific information about requirements imposed upon funding applicants to carefully describe testable hypotheses and how they will measure outcomes, and to use rigorous methodologies (for example, randomized, controlled trials) that are expected for the types of health-related research prioritized by VA and Congress. Note that the funding opportunities and notices are accessible only through the VA intranet website, since only VA researchers may apply for and be provided VA funding. ORD will provide this information to OTSP upon request.

In addition, and similar to the fostering of constructive criticism mentioned herein, the VA requirement for VA researchers’ obligation to report their research results may help to ensure that VA research is ultimately structured such that VA may test VA research hypotheses and potentially disprove them through empirical evidence. That is, VA researchers are required to deposit their research manuscripts in PubMed Central (VHA Directive 1200.19). Eligibility for depositing requires that the manuscript was based upon research funded by, for example, VA, whose review process for studies generally includes stringent review as described herein for funding applicants’ description of and justification for selecting outcome variables or endpoints that are relevant to the hypotheses being tested, as well as being sufficiently powered to test the proposed hypotheses and provide interpretable results. The PubMed Central requirement that the manuscript proposed for depositing has already undergone peer review by a journal which is itself fully archived in PubMed Central also may help to ensure that the researchers’ reporting of study results has been scrutinized through the journals’ peer review for academic rigor and accuracy, including designs and methods whose controls and outcomes are likely to uncover or disclose proven or disproven hypotheses. VA requires submission of ORD-funded clinical trials, study design, and any subsequent results to the Government website, clinicaltrials.gov, as a condition of the award.

To better ensure VA research is structured for falsifiability of hypotheses, ORD plans to update VA policy and guidance for VA funding applicants, VA funded awardees, and VA funding program staff and reviewers; develop related metrics and/or adopt other agency best practices (for example, ORD Program Guides and RFAs include, when deemed appropriate to the funding opportunity, guidance about research study designs specifically including statements of hypotheses, addressing outcome variables or endpoints that are relevant to the hypotheses being tested, and ensuring sufficient power to test hypotheses and provide interpretable results); evaluate adherence to developed guidance (for example, percentage of ORD Program Guides and RFAs include, when deemed appropriate to the funding opportunity, guidance about research study designs specifically including statements of hypotheses, addressing outcome variables or endpoints that are relevant to the hypotheses being tested, and ensuring sufficient power to test hypotheses and provide interpretable results); and determine if this tenet can be further achieved through the use of any feasible and acceptable AI-driven tools and other technology.

VA will develop a brief overview of this tenet directed towards VA funding applicants, VA funded awardees, VA Funding Program Managers, and others with roles and responsibilities related to review, management, and reporting of VA research, and will disseminate it through VA public-facing websites, VA intranet websites, and informational field calls.

IX. Subject to Unbiased Peer Review

The Guidance requires that VA research be subject to unbiased peer review. VA prioritizes unbiased peer review for all VA funded research. VA conducts the process of reviewing VA funding applications through a two-tiered system: the SRG, a subcommittee of ORD’s Scientific Merit Review Board that is composed of scientists performs one level of review. The SRG evaluates applications’ scientific and technical merit; however, the SRG does not make funding decisions. Program staff perform another, separate level of review, which is administrative in nature and based not only on considerations of scientific merit (as evaluated by the SRGs), but also on the feasibility of the protocol considering resource requirements, consistency with ORD requirements (which reflect statutory and legislative mandates, including Congressional appropriation requirements), the VA Secretary’s priorities (strategic drivers), and current strategic priorities, factors that are properly within program staff’s evaluation. Final funding decisions are then made by the respective ORD funding program Director and approved by the ISRM Leadership Council subject to budget availability. Thus, only applications deemed to have satisfied rigorous and unbiased scientific review proceed to program staff and program leadership review.

Each funding program opportunity, for example, RFAs, includes a detailed description of the review and award selection process, although NOSIs, which are very brief but which direct applicants with interests to specific RFAs, do not include this review and award selection description. As earlier mentioned, ORD’s Funding page provides links to the funding opportunities and notices, but these are accessible only through the VA intranet website, since only VA researchers may apply for and be provided VA funding. ORD will provide this information to OTSP upon request. For VA Cooperative Studies, VA follows similar processes involving scientific peer review and also performs an evaluation in context of clinical area needs to ensure results will meet goals for definitively informing Veteran healthcare.

VA prioritizes unbiased peer review by establishing criteria for the actual review of VA funding applications, which includes review of proposals by SRG and review of all funding applications by only subject matter experts. These experts must have expertise in scientific disciplines and current research areas that are relevant to the funding opportunity. SRG members are certified under the Federal Advisory Committee Act to include a group of highly qualified scientific experts covering a range of relevant areas of biomedical, rehabilitative, and health systems research. To maintain high ethical standards of the review process, reviewers undergo regular training and orientation that includes an overview of program and funding priorities, the scientific peer review process, and standards for ensuring high-quality review processes. Each funding application requires at least three assigned reviewers with expertise relevant to the application. A biostatistician should be included in the review of clinical trials. Applications are scored on a scale of 1.0 to 5.0, with lower scores indicating stronger scientific merit, based on the following factors: significance of the topic, innovation, investigators, approach (including methods/feasibility), research environment, engagement of affected groups (for example, Veterans and providers), and implementation plan.

VA funding applicants may request committee assignments based on written scientific or medical purview, but ORD makes final committee and reviewer assignments. For the VA CSP, proposed activities are similarly evaluated by a scientific evaluation committee, which is a chartered Federal advisory committee comprised of a group of experts and representatives from multiple medical specialties, including biostatistics and epidemiology. This committee, by design, is not intentionally focused on a particular disease area or condition; therefore, proposals must address a range of viewpoints relevant to medical practice. Each of ORD’s Program Guides, which establish procedures for review of proposed research, address the review process and review criteria for funding opportunities and awards.

Elements to help ensure the integrity of VA peer review include, for example, maintaining the confidentiality of scientific and administrative review; preventing improper influences on reviewers, and identifying and managing potential conflicts of interest during the review process; entering all proposal documents into the Federal eRA COMMONS grants management system, including ensuring that staff and reviewers maintain the confidentiality of the entered documents throughout the process; not sharing funding proposals; and not communicating with funding applicants regarding their proposals or the review process. Inappropriate contact with applicants as well as the failure to report such contact may lead to sanctions including the notification of other Federal agencies. Applicants who contact reviewers about their proposals or about the review process or otherwise attempt to influence the review process are subject to sanctioning up to and including permanent loss of eligibility to submit for VA research funding and notification to other Federal agencies. Reviewers declare potential conflicts of interest related to the proposals under their consideration including those in which there may be an appearance of a conflict of interest even if they believe that no actual conflict exists. The VA’s prioritization of unbiased peer review is an important element of VA policy, helping to ensure that VA scientific endeavors are characterized by objective, uncompromised, and independent peer review and other processes that are free of any inappropriate influence or interference (VA Directive 0005). VA will develop a brief overview of this tenet directed towards VA funding applicants, VA funded awardees, VA Funding Program Managers, and others with roles and responsibilities related to review, management, and reporting of VA research, and disseminate it through multiple mechanisms including VA public-facing websites, VA intranet websites, and informational field calls. ORD plans, in the forthcoming year, to evaluate existing VA funding-related information (such as internet and ORD Program Guides) to ensure that this information provides unambiguous statements about how VA prioritizes unbiased peer review for all VA funded research (for example, statements about the peer review process and peer review criteria), and updates will be made as necessary. In addition, ORD will develop related metrics and/or adopt other Federal agency best practices (for example, funding information includes statements or descriptions about VA funding peer review), evaluate adherence to developed guidance (for example, percentage of VA ORD funding information will include statements or descriptions about VA funding peer review), and determine if VA can achieve this tenet further through the use of feasible and acceptable AI-driven tools and other technology. These steps also may serve to ensure that VA research is characterized by unbiased peer review.

X. Accepting of Negative Results as Positive Outcomes

The Guidance requires that VA research be accepting of negative results as positive outcomes. VA’s recognizes the valuable contribution to scientific knowledge of reporting of negative or null research results, since any research result—positive, negative, or null—may have direct and profound impact on the delivery of healthcare to Veterans, who are at the core of the VA mission to care for those who have served in our Nation’s military and for their families, caregivers, and survivors, and the Federal statutory requirement that VA conduct research in support of that mission. Whether research results are positive, negative, or null, the VA requires that VA researchers, whether directly or indirectly funded by ORD, report their research results by depositing their research manuscripts in PubMed Central (VHA Directive 1200.19). In addition, ORD, since 2016, has provided its applicants and awardees with its ORD DMAP guidance to alert them to the requirement that they must make their publications and the publication’s underlying scientific data available in publicly accessible repositories such that others know about positive, negative, or null results, and also have the opportunity to replicate and reproduce ORD outcomes. This reporting responsibility of research results is integrated into VA policy, about which communication is deemed central to the free flow of scientific information, such as the requirement that VA-funded clinical trials be registered and that study results be reported through the National Library of Medicine’ portal, clinicaltrials.gov. The portal provides broad public access to details about planned, on-going, and completed clinical trials, including the findings and conclusions from those research endeavors. (VA Directive 0005).

VA will develop a brief overview of this tenet directed towards VA funding applicants, VA funded awardees, VA Funding Program Managers, and others with roles and responsibilities related to review, management, and reporting of VA research, and disseminate it through multiple mechanisms including VA public-facing websites, VA intranet websites, and informational field calls. ORD notes, however, the challenges that researchers may face to publish negative or null research results. For this reason, ORD will plan, in the forthcoming year, to develop related guidance for researchers, including identifying journals and repositories for negative and null reporting, as well as planning an update to VHA Directive 1200.19, to emphasize that null, negative, or inconclusive findings may well serve to inform VA clinical practices, including mitigating risk of preventable harms to VA patients, through a more balanced scientific literature that considers negative or null research results. In addition, ORD plans to update VA policy and guidance for VA funding applicants, VA funded awardees, and VA funding program staff and reviewers; develop related metrics; and evaluate adherence to developed guidance and determine if VA can achieve this tenet further achieved through the use of feasible and acceptable AI-driven tools and other technology.

XI. Without Conflicts of Interest

The Guidance requires that VA research be without conflicts of interest. Ensuring that VA research is designed, executed, reviewed, and reported free from financial, personal, or institutional influences that could bias outcomes or undermine objectivity will be or is addressed as follows:

• VA will develop a brief overview of this tenet directed towards VA funding applicants, VA funded awardees, VA Funding Program Managers, and others with roles and responsibilities related to review, management, and reporting of VA research, and will disseminate it through VA public-facing websites, VA intranet websites, and informational field calls.
• Financial Disclosures are Required. All VA research funding applicants are required to submit a Financial Disclosure Statement, in which applicants are obliged to provide a clear statement disclosing any financial conflict of interest that each investigator may have with the proposed research. VA researchers with outside consulting, employment, or royalty payment opportunities also are obligated to disclose those potential opportunities to their local VA medical facility to ensure compliance with the facility policy on financial conflict of interest.
• Managing Conflicts of Interest in Review of VA Funding Applications.
  • Several ORD Program Guides establish criteria for the review of funding applications, such as which criteria in part prohibit improper influences on reviewers and which require identification and management of potential conflicts of influence during the review process, such as not communicating with funding applicants regarding their proposals or the review process. Inappropriate contact with applicants as well as the failure to report such contact may lead to sanctions including the notification of other Federal agencies. Applicants who contact reviewers about their proposals or about the review process or otherwise attempt to influence the review process are subject to sanctioning up to and including permanent loss of eligibility to submit for VA research funding and notification to other Federal agencies. Reviewers declare potential conflicts of interest related to the proposals under their consideration including those in which there may be an appearance of a conflict of interest even if they believe that no actual conflict exists.
  • Managing Conflicts of Interest in the Funding Review Process. As described herein, VA conducts the review of applications for proposed VA-funded research through a two-tiered system to avoid possible conflicts of interest. SRG performs the first level of review. The SRG is made up of scientists who have expertise in the scientific disciplines and current research areas that are relevant to the funding opportunity and application, but the SRG does not make funding decisions. The ORD program staff perform the second level of review, which is administrative in nature and includes considerations of the SRG’s determination of funding applications’ scientific merit, but also reviews feasibility of the protocol considering resource requirements, consistency of the proposed study to the mission, programs and priorities of VA, VHA, and ORD, and factors that are properly within program staff’s purview to evaluate. Final funding decisions are then made at the discretion of the respective Portfolio Director and approved by the ISRM Leadership Council. Again, at no review level may an individual take part if they have a potential conflict of interest.
• Managing Conflicts in the Conduct of VA Research. VHA Directive 1200.13, Financial Conflicts of Interest and Outside Compensation for Performance in VA Research, includes top-down responsibilities for the reporting, review, and management of financial conflicts of interest in VA research, from the VA Under Secretary of Health through the VA medical facility study team member, from ensuring overall compliance with the Directive to not participating in VA research studies where they may have a conflict of interest, respectively. Among the interests that must be reported include income and compensation, business relationships, intellectual property, and non-publicly traded companies.

Conflicts of interest oversight approaches include independent review of financial disclosure reports, by, for example VA designated ethics officials, VA Office of the General Counsel, and VA medical facility Financial Conflicts of Interest Administrators. Review outcomes are reported to VA medical facilities’ Research and Development Committees, who oversee approval of research activities and who may require implementation of conflict-of-interest management before research may be undertaken. These approaches are consistent with conflicts of interest requirements in VA policy that apply to any VA researcher or others engaged in designing, conducting, or otherwise engaged in scientific activities (VA Directive 0005).

ORD plans, in the forthcoming year, to review and, as needed, update guidance about standardized disclosure of all financial, personal, or institutional interests across VA research activities (for example, VA funding applications and related review; VA research publications; and VA research data repositories). In addition, ORD plans to develop related metrics (for example, VA research funding applicants are required to submit a Financial Disclosure Statement; Financial Disclosure Statements review outcomes are reported to VA medical facilities’ Research and Development Committees); evaluate adherence to developed guidance (for example, percentage of VA research funding applicants submit a Financial Disclosure Statement; percentage of Financial Disclosure Statements review outcomes are reported to VA medical facilities’ Research and Development Committees); and determine if VA can achieve this tenet further through the use of feasible and acceptable AI-driven tools and other technology. These steps identify, mitigate, and manage potential biases in VA research.

XII. Conclusion

For each of the GSS tenets addressed herein, ORD plans, in the forthcoming year, to work across the VA research enterprise and other VA offices, and with other Federal agencies, academic affiliates, VA NPCs, and other partners to standardize compliance and reduce unnecessary administrative overhead. The intent of this report of VA actions taken in accordance with the Guidance is to illustrate how VA has implemented, and plans, in the forthcoming year, to implement, the GSS tenets throughout VA. GSS implementation at VA at this stage is a work in progress; however, VA will continue to find ways to further improve and strengthen the adoption of GSS tenets in VA research. VA has not experienced challenges in implementation. For future annual reports, VA will describe any challenges that may be encountered as things proceed for implementation of steps.

Department of Veterans Affairs
September 2025