Virginia Regulatory Town Hall
Agency
Department of Behavioral Health and Developmental Services
Board
State Board of Behavioral Health and Developmental Services
 
chapter
Regulations to Assure the Protection of Participants in Human Research [12 VAC 35 ‑ 180]
Guidance Documents
Chapter Information
Description This regulation defines policy and review requirements to protect individuals with mental illness, developmental disabilities, or substance use disorders who are participants in human research performed by facilities or programs operated, funded, or licensed by the Department of Behavioral Health and Developmental 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.
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 behavioral health and developmental services 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.
Meetings See all meetings (4) relating to this chapter.

Contact Information
Name / Title: Ruth Anne Walker  / Director of Regulatory Affairs
Address: Jefferson Bldg.
1220 Bank St., 4th Floor
Richmond, VA 23219
Email Address: ruthanne.walker@dbhds.virginia.gov
Telephone: (804)225-2252    FAX: (804)371-4609    TDD: (804)371-8977
Current Actions
Action Title Latest Stage Status
None

Past Actions
Action Title Latest Stage Status
Amend Regulations Following Periodic Review Fast-Track Stage complete. This regulation became effective on 03/15/2020.
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 02/11/2004.

Periodic Reviews
Last Activity Status
2/17/2023 Agency Completed Retain As Is
10/10/2018 Agency Completed Amend
5/3/2013 Agency Completed Retain As Is
4/10/2008 Agency Completed Amend