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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 Health and Developmental Services
11/21/2024

12VAC35-115-130. Research.

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 and § 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.

Historical Notes

Derived from Virginia Register Volume 18, Issue 3, eff. November 21, 2001; amended, Virginia Register Volume 23, Issue 25, eff. September 19, 2007; Volume 33, Issue 10, eff. February 9, 2017.

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