Department of Veterans Affairs grant program for independent third-party research studies and treatment with respect to supplemental neurorehabilitation treatments for mTBI

(a) Establishment The Secretary of Veterans Affairs shall establish and carry out a research grant program to award grants to eligible entities described in subsection (b) for to be used to carry out studies and applied programs on approaches and methodologies for the treatment of TBI mTBI in veterans. (b) Eligible entities described An eligible entity described in this subsection is any of the following: (1) A nonprofit organization that has demonstrated the capability to conduct clinical trials and to evaluate traumatic brain injury treatments through patient care delivery. (2) An academic institution that conducts significant research on TBI. (2) A nonprofit organization with— (A) expertise in TBI research traumatic brain injury and neurorehabilitation; and (B) has demonstrated capabilities in the capability to conduct clinical trials relating to neurorehabilitation treatments (3) A partnership or consortium of two or more entities described in paragraphs (1) and TBI treatment evaluation and patient care delivery. (3) An entity, or a partnership among entities, that the Secretary determines appropriate to receive a grant under this section. (2). (c) Applications An eligible entity desiring a grant under this section shall submit to the Secretary an application in such form, at such time, and containing such information and assurances as the Secretary determines appropriate, including a summary of— (1) proposed the research and treatment activities proposed to be carried out using grant funds; (2) the methodology to be used for such activities; (2) methodology; (3) the expected outcomes of such activities; (4) how the eligible entity will coordinate, as practicable, with Veterans Health Administration facilities for referral and (3) expected outcomes. continuity of care for veterans who participate in activities carried out using grant funds, and for dissemination of aggregate findings; (5) the budget of the entity for the use of the grant, including a narrative justification and an identification of the estimated amount of grant funds to be used for administrative or overhead costs; and (6) assurances of compliance with applicable Federal laws and regulations relating to human subjects protections and patient safety. (d) Administration (1) Grant categories (1) In general Pursuant to carrying out the research grant program under this section, each fiscal year the Secretary shall, each fiscal year— shall— (A) subject to the requirement under paragraph (2), award four grants in amounts of not more than $625,000 for exploratory or pilot research and treatment projects; projects, each of which shall be in an amount of not more than $625,000; and (B) award five grants in amounts of not more than $1,500,000 for collaborative or multidisciplinary research and treatment initiatives. initiatives, each of which shall be in an amount of not more than $1,500,000. (2) Priority The Of the grants awarded under paragraph (1)(A), the Secretary shall award not fewer than three grants described in paragraph (1)(A) to nonprofit organizations. (e) Responsibilities (3) Enforcement authority The Secretary may suspend, modify, or terminate a grant awarded under this section, if the Secretary determines that the recipient of such grant has failed to comply with the applicable terms and conditions of the third-Party grant. (e) Agreement with independent organization (1) In general The Secretary shall seek to enter into an agreement with an independent third-party organization comparable to the National Center for Posttraumatic Stress Disorder that is not a component of the Department of Veterans Affairs and that has demonstrated expertise in randomized controlled trials, neurorehabilitation outcomes evaluation, and research integrity, under which the organization agrees to— (A) administer the research grant program; and program under this section; (B) carry out studies and implement efforts that include— (i) analyzing data from TBI mTBI treatment methodologies developed pursuant to the research grant program to assess the effect, among veterans, of such methodologies on enhanced brain health outcomes, mental health outcomes health, and long-term recovery; recovery, including, to the extent outcomes are collected under the applicable clinical protocol, durability of outcomes at approximately six months following completion of treatment; (ii) identifying evidence-based data-driven best practices and providing recommendations for further research or clinical application; application, including recommendations for dissemination to Veterans Health Administration clinicians and facilities (as appropriate); and (iii) randomized, controlled clinical trials to— (I) validate and deliver treatments; (II) establish a standard of care; and (III) improve access to such treatments for veterans. (2) Report The independent third-party organization with which veterans; (C) submit to the Secretary not less frequently than annually a report describing activities carried out under this section, including outcome data and methodology; and (D) make available to the Secretary all data and findings from the grants made under this section, consistent with applicable Federal law, regulation, and Department policies relating to patient protections, data security, and privacy. (2) Rule of construction Nothing in this section shall be construed to authorize the Secretary, or an independent organization that enters into an agreement with the Secretary under paragraph (1), to require prior approval of, or changes to, any clinical protocol, study design, outcome measures, or follow-up schedule established by an eligible entity that receives a grant under this section, except as necessary to ensure compliance with applicable Federal laws and regulations relating to human subjects protections and patient safety. (3) Report An agreement under paragraph (1) shall submit include a requirement that the independent organization submits to Congress and the Secretary a comprehensive report that includes— (A) the findings of the studies required under such agreement; and (B) recommendations with respect to the expansion of successful TBI treatment methodologies and standard of care recommendations, if any, developed pursuant to the research grant program. program; and (C) to the extent available from the reports and study materials of grant recipients, a summary of— (i) the durability of outcomes at approximately six months following completion of treatment, if collected under the applicable clinical protocol; (ii) adverse events and serious adverse events, including self-harm or suicide-related events, if collected under the applicable clinical protocol or in the ordinary course of care; and (iii) aggregate expenditures of grant funds, including administrative or overhead costs. (4) Surveys The Secretary may conduct surveys of any independent organization that enters into an agreement with the Secretary under paragraph (1) in order to assess the effectiveness of such organization in administering the research grant program under this section. (f) Available amounts; authorization of appropriations (1) Available amounts The Secretary may use amounts available to the Secretary for the operating budget of the National Center for Posttraumatic Stress Disorder to carry out the research grant program under this section. section, if the use of such amounts supplements, and does not supplant, amounts otherwise available for Department programs and services. (2) Authorization of appropriations There are is authorized to be appropriated to the Secretary $10,000,000 for each of fiscal years 2026 through 2028 to carry out this section. (g) Reports to Congress Not later than two years after the date on which the Secretary commences the research grant program under this section, and on an annual basis thereafter during the period the authority of the Secretary to carry out such research grant program is effective, the Secretary shall submit to Congress a report that includes— (1) the findings of the studies under— (A) section 2(f)(2); and (B) the agreement required by section 3(e); and (2) recommendations of the Secretary with respect to policy and programmatic improvements to services of the Department to treat TBI among veterans. (h) Termination date The authority of the Secretary to carry out the research grant program under this section shall terminate on the date that is three years after the date of the enactment of this Act.