Administrative Code

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Virginia Administrative Code
Title 12. Health
Agency 35. Department of Behavioral Health And Developmental Services
Chapter 180. Regulations to Ensure the Protection of Subjects in Human Research
5/20/2024

12VAC35-180-40. Policy.

A. No human research may be conducted without obtaining the informed consent of the individual or his legally authorized representative. This informed consent shall be documented in writing and supported by the signature of a witness. Adequate and appropriate arrangements shall be made for those who need special assistance in understanding the consequences of participating in the human research.

B. No official or employee of the institution or agency conducting or authorizing the human research shall be qualified to act as a legally authorized representative for an individual participating in the particular human research.

C. Each human research activity shall be approved by a research review committee composed of representatives of varied backgrounds who shall assure the competent, complete, and professional review of human research activities.

D. Institutions or agencies, as defined by this chapter, may participate in human research activity when such activity has been considered and approved by a university institutional review board (IRB) that complies with the relevant requirements of § 32.1-162.19 of the Code of Virginia.

E. Nontherapeutic human research using individuals receiving services in a residential or hospital setting is prohibited unless it is determined by the research review committee that such nontherapeutic human research will present no more than a minor increase over minimal risk to the individual.

F. The person, institution, or agency conducting the human research shall be required to notify all individuals who are subjects of the human research of risks caused by the human research that are discovered after the human research has concluded.

Statutory Authority

§§ 37.2-203 and 37.2-402 of the Code of Virginia.

Historical Notes

Derived from VR470-06-01:1 § 4, eff. May 15, 1993; amended, Virginia Register Volume 20, Issue 9, eff. February 11, 2004; Volume 26, Issue 2, eff. November 12, 2009.

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