Virginia Administrative Code
Title 12 - HEALTH
Agency 35 - DEPARTMENT OF BEHAVIORAL HEALTH AND DEVELOPMENTAL SERVICES
Chapter 115 - REGULATIONS TO ASSURE THE RIGHTS OF INDIVIDUALS RECEIVING SERVICES FROM PROVIDERS LICENSED, FUNDED, OR OPERATED BY THE DEPARTMENT OF BEHAVIORAL
Part III - Explanation of Individual Rights and Provider Duties
Section 12VAC35-115-130 - Research
Universal Citation: 2 VA Admin Code 35-115-130
Current through Register Vol. 41, No. 3, September 23, 2024
A. Each individual has a right to choose to participate or not participate in human research.
B. The provider's duties.
1. Providers shall obtain prior, written,
informed consent of the individual or his authorized representative before any
individual begins to participate in human research unless the research is
exempt under § 32.1-162.17 of the Code of Virginia.
2. Providers shall comply with all other
applicable state and federal laws and regulations regarding human research,
including the provisions under Chapter 5.1 (§ 32.1-162.16 et seq.) of
Title 32.1 of the Code of Virginia and the regulations adopted under §
37.2-402 of the Code of Virginia.
3. Providers shall obtain review and approval
from an institutional review board or research review committee prior to
performing or participating in a human research protocol. Documentation of this
review and approval shall be maintained and made available on request by the
individual or his authorized representative.
4. Prior to participation by individuals in
any human research project, the provider shall inform and provide a copy of the
institutional review board or research review committee approval to the LHRC.
Once the research has been initiated, the provider shall update the LHRC
periodically on the status of the individual's participation.
Statutory Authority
§§ 37.2-203 and 37.2-400 of the Code of Virginia.
Disclaimer: These regulations may not be the most recent version. Virginia may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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