Veterans TBI Breakthrough Exploration of Adaptive Care Opportunities Nationwide Act

supplements, and does not supplant, other clinical care and research of the Department of Veterans Affairs relating to mTBI; and

facilitates, as practicable, coordination with Veterans Health Administration facilities for referral, continuity of care, and dissemination of findings.

improve mental health outcomes among veterans;

reduce suicidality, and common risk factors for completing suicide, including depression and substance use disorders among veterans; and

mitigate long-term effects of mTBI and, to the extent outcomes are collected under the applicable clinical protocol, measure durability of outcomes at approximately six months following completion of treatment;

activities proposed to be conducted using the grant;

expected outcomes of such activities;

plans for evaluating the effectiveness of such activities;

how the eligible entity will coordinate, as practicable, with Veterans Health Administration facilities for referral and continuity of care for veterans who participate in activities carried out using grant funds, and for dissemination of aggregate findings;

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

assurances of compliance with applicable Federal laws and regulations relating to human subjects protections and patient safety.

a description of how the eligible entity used such grant;

a summary of the progress of activities funded with amounts from such grant;

measured outcomes relating to such activities;

a detailed accounting of expenditures of grant funds, including administrative or overhead costs;

to the extent collected under the applicable clinical protocol or in the ordinary course of care, a description of any adverse events and serious adverse events, including self-harm or suicide-related events; and

a description of actions taken pursuant to the coordination plan described in subparagraph (A)(iv).

ensure rigorous oversight of the grant program under this section, including by monitoring financial compliance and timely receipt of the reports required under subparagraph (B); and

on an annual basis until the termination date specified in paragraph (9)(A), evaluate the efficacy of activities carried out using grant funds based on the reports submitted under subparagraph (B) and other appropriate information.

subject to the requirement under subparagraph (B), award four grants for exploratory or pilot research and treatment projects, each of which shall be in an amount of not more than $625,000; and

award five grants for collaborative or multidisciplinary research and treatment initiatives, each of which shall be in an amount of not more than $1,500,000.

administer the research grant program under this subsection;

carry out studies and implement efforts that include—

submit to the Secretary not less frequently than annually a report describing activities carried out under this section, including outcome data and methodology; and

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.

the findings of the studies required under such agreement;

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; and

to the extent available from the reports and study materials of grant recipients, a summary of—