Administrative Code

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Virginia Administrative Code
Title 6. Criminal Justice And Corrections
Agency 35. Department (Board) of Juvenile Justice
Chapter 170. Regulation Governing Juvenile Data Requests and Research Involving Human Subjects

6VAC35-170-80. Informed consent required for human research.

A. Except as provided elsewhere in this chapter, no researcher may involve a human subject in human research without first obtaining the informed consent of the human subject or his legally authorized representative. A researcher shall seek such consent only under circumstances that provide the human subject or the legally authorized representative sufficient opportunity to consider whether to participate and that minimize the possibility of coercion or undue influence.

B. If a human subject is competent, informed consent shall be given in writing by the subject and witnessed.

C. If a human subject is not competent, informed consent shall be given in writing by the subject's legally authorized representative and witnessed.

D. If a human subject is a minor who is otherwise capable of giving informed consent, informed consent shall be given in writing by both the minor and his legally authorized representative.

E. If two or more persons who qualify as legally authorized representatives with decision-making authority inform the researcher that they disagree as to the participation of the human subject, the subject shall not be enrolled in the human research that is the subject of the consent.

F. Notwithstanding consent by a legally authorized representative, no person who is otherwise capable of giving informed consent shall be forced to participate in human research.

G. A legally authorized representative may not consent to nontherapeutic research unless the HRRC determines that the research will present no more than a minimal risk to the human subject.

H. The informed consent form shall not include any language through which the human subject waives or appears to waive any legal right, including the release of an individual, institution, or agency or any agent thereof from liability for negligence .

Statutory Authority

§§ 66-10 and 66-10.1 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 9, eff. February 9, 2005; amended, Virginia Register Volume 33, Issue 5, eff. December 1, 2016; Volume 37, Issue 14, eff. April 15, 2021.

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