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Virginia Regulatory Town Hall
Department of Behavioral Health and Developmental Services
State Board of Behavioral Health and Developmental Services

Regulations to Assure the Protection of Participants in Human Research [12 VAC 35 ‑ 180]
Guidance Documents   Periodic Reviews
Chapter Information
Description This regulation defines policy and review requirements to protect individuals with mental illness, mental retardation, and substance abuse or dependence problems who are participants in human research performed by facilities or programs operated, funded, or licensed by the Department of Mental Health, Mental Retardation and Substance Abuse Services.
State Authority Sections 37.2-203 and 37.2-402 of Va . Code
Federal Authority None entered
Exempt from APA No, changes to this chapter are subject to the Administrative Process Act and the standard executive branch review process.
Text of Regulation Link to Virginia Administrative Code
Goals of Regulation To protect the rights and health of the participants in human research conducted in the public mental health system.
To ensure that participation in human research is voluntary and entered into with adequate knowledge of the research procedures, risks, and benefits.
To minimize the costs and intrusiveness of the administrative procedures to research organizations and the citizens of Virginia.

Contact Information
Name / Title: Ruth Anne Walker  / Regulatory Coordinator
Address: Jefferson Bldg.
1220 Bank St., 11th Floor
Richmond, VA 23219
Email Address:
Telephone: (804)225-2252    FAX: (804)786-8623    TDD: (804)371-8977
Current Actions
Action Title Latest Stage Status

Past Actions
Action Title Latest Stage Status
Minor revisions to update language and eliminate unneccessary regulatory provisions Fast-Track Stage complete. This regulation became effective on 11/12/2009.
Update provisions to be consistent with current Virginia Code and applicable federal requirements. Final Stage complete. This regulation became effective on 2/11/2004.