Bill
SB 5388
SB 5388 shifts prison behavioral health oversight from DOH licensure to a joint DOC-DOH standards and annual inspections, with corrective actions and funding conditions.
Status: Enacted (Chapter 382, 2025 Laws). Governor signed May 20, 2025; effective date July 27, 2025.
Note: SB 5388 began as a 2023 bill addressing diversity in clinical trials but was later amended and used as the vehicle for 2025 legislation addressing Department of Corrections (DOC) behavioral health certification. This summary describes both the original clinical-trials provisions (as introduced/considered in 2023–24) and the final 2025 enacted provisions.
Intent
- Improve collection and use of demographic data in clinical trials and increase participation by groups underrepresented in trials (race, sex, sexual orientation, socioeconomic status, age, geographic location).
Key provisions (as introduced / substitute versions considered in 2023–24)
- Require the Washington State Institutional Review Board (the Washington State Review Board, housed at DSHS) to establish a “diversity in clinical trials” program to encourage participation by underrepresented groups.
- Program activities could include reviewing FDA guidance on race/ethnicity data, collaborating with investigators and community organizations, maintaining a website of FDA-recognized recruitment methods and local research links, applying for grants, and submitting biennial reports to the Legislature (beginning July 1, 2024, and every even-numbered year).
- Require any state entity (including UW, WSU, and state hospitals/agencies) that receives NIH funding for drug/device clinical trials to adopt policies to identify and recruit underrepresented persons; provide information in languages other than English; provide translation or bilingual screening staff; and offer culturally specific recruitment materials and electronic consent when allowed.
- Direct the Department of Health (DOH), in consultation with universities, community organizations and funders, to analyze current representation, recruitment methods, barriers (including transportation), and list community partners — and report findings and recommendations to the Legislature (deadline in earlier drafts: December 1, 2023).
- Create a new chapter in Title 69 RCW codifying the Review Board and definitions.
Who would be affected
- Washington State Institutional Review Board; UW and WSU; state agencies and hospitals receiving NIH funds; clinical trial investigators; community-based organizations; underrepresented communities and trial participants.
(As amended and passed in 2025, SB 5388 became legislation about DOC behavioral health oversight.)
Purpose
- Replace DOH licensure requirement for certain in‑prison behavioral health/substance use disorder services with a monitoring/standards model intended to reduce fiscal/operational burdens while maintaining oversight.
Key provisions (enacted)
- Amends RCW 9.94A.662 (Drug Offender Sentencing Alternative):
- During prison-based DOSA confinement, substance use disorder treatment services must be provided by individuals licensed by the state (rather than requiring the program itself to be licensed by DOH).
- New section added to chapter 72.09 RCW:
- By July 1, 2026, DOC and DOH must jointly establish/adopt standards for behavioral health services in correctional facilities.
- DOC must fully implement those standards by July 1, 2027.
- Beginning July 1, 2027, DOH must conduct annual inspections to determine DOC compliance, issue reports documenting noncompliance, and may provide technical assistance.
- DOC must submit corrective action plans within 45 days of DOH reports and reimburse DOH for inspection/technical assistance costs.
- DOC and DOH must enter a biennially renewed agreement (by July 1, 2027) specifying inspection processes and reimbursement.
- Standards must be jointly reviewed and updated by July 20, 2030, and every four years thereafter.
- Funding/nullification clause (in House amendments): the act is null and void unless funded in the omnibus appropriations act by June 30, 2025.
Who is affected
- Department of Corrections (primary implementer); Department of Health (oversight/inspections); incarcerated individuals serving prison-based DOSA sentences; service providers in DOC facilities; courts and sentencing processes tied to DOSA.
Procedural / timeline notes
- SB 5388 initially advanced through Health & Long Term Care and Appropriations committees (2023–24) on the clinical trials subject. In 2025, the bill was amended substantially and ultimately passed both chambers as the DOC behavioral health certification bill.
- Governor signed May 20, 2025; effective July 27, 2025 (subject to the enacted funding/null-and-void clause).
For readers seeking the original clinical-trials policy proposals: those provisions were included in earlier drafts and committee reports (2023) but were not retained in the final, enacted text of SB 5388 (2025).
Compiled from official sources — confirm details with the bill’s official record.
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