Section 80. Informed consent required for human research (§ 32.1-162.18 of the Code of Virginia)  


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

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

    C. 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.

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

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

    F. A legally authorized representative may not consent to nontherapeutic research unless the Human Research Review Committee determines that such nontherapeutic research will present no more than a minimal risk to the human subject.

    G. No informed consent form shall include any language through which the human subject waives or appears to waive any legal right, including any release of any individual, institution, or agency or any agent thereof from liability for negligence (see § 32.1-162.18 of the Code of Virginia).

Historical Notes

Derived from Volume 21, Issue 09, eff. February 9, 2005; amended, Virginia Register Volume 33, Issue 05, eff. December 1, 2016.

Statutory Authority

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