Administrative Code

Creating a Report: Check the sections you'd like to appear in the report, then use the "Create Report" button at the bottom of the page to generate your report. Once the report is generated you'll then have the option to download it as a pdf, print or email the report.

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

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.

Website addresses provided in the Virginia Administrative Code to documents incorporated by reference are for the reader's convenience only, may not necessarily be active or current, and should not be relied upon. To ensure the information incorporated by reference is accurate, the reader is encouraged to use the source document described in the regulation.

As a service to the public, the Virginia Administrative Code is provided online by the Virginia General Assembly. We are unable to answer legal questions or respond to requests for legal advice, including application of law to specific fact. To understand and protect your legal rights, you should consult an attorney.