CODE OF VIRGINIA

INFORMED CONSENT (§ 32.1-162.18)

A. In order to conduct human research in this Commonwealth, informed consent
must be obtained if the person who is to be the human subject is as follows: (i)
capable of making an informed decision, then it shall be subscribed to in
writing by the person and witnessed; (ii) incapable of making an informed
decision, as defined in § 54.1-2982, at the time consent is required, then it
shall be subscribed to in writing by the person’s legally authorized
representative and witnessed; or (iii) a minor otherwise capable of rendering
informed consent, then it shall be subscribed to in writing by both the minor
and his legally authorized representative. The giving of consent by a legally
authorized representative shall be subject to the provisions of subsection B of
this section. If two or more persons who qualify as legally authorized
representatives and have equal decision-making priority under this chapter
inform the principal investigator or attending physician 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. No
informed consent form shall include any language through which the person who is
to be the human subject waives or appears to waive any of his legal rights,
including any release of any individual, institution, or agency or any agents
thereof from liability for negligence.Notwithstanding consent by a legally
authorized representative, no person shall be forced to participate in any human
research if the investigator conducting the human research knows that
participation in the research is protested by the prospective subject. In the
case of persons suffering from neurodegenerative diseases causing progressive
deterioration of cognition for which there is no known cure, the implementation
of experimental courses of therapeutic treatment, including non-pharmacological
treatment, to which a legally authorized representative has given informed
consent shall not constitute the use of force.

B. A legally authorized representative may not consent to nontherapeutic
research unless it is determined by the human research committee that such
nontherapeutic research will present no more than a minor increase over minimal
risk to the human subject. A legally authorized representative may not consent
to participation in human research on behalf of a prospective subject if the
legally authorized representative knows, or upon reasonable inquiry ought to
know, that any aspect of the human research protocol is contrary to the
religious beliefs or basic values of the prospective subject, whether expressed
orally or in writing. A legally authorized representative may not consent to
participation in human research involving nontherapeutic sterilization,
abortion, psychosurgery or admission for research purposes to a facility or
hospital as defined in § 37.2-100.

C. Except as provided elsewhere in this chapter, no investigator may involve a
human being as a subject in research covered by this chapter unless the
investigator has obtained the legally effective informed consent of the subject
or the subject’s legally authorized representative. An investigator shall
seek such consent only under circumstances that provide the prospective subject
or the legally authorized representative sufficient opportunity to consider
whether or not to participate and that minimize the possibility of coercion or
undue influence.

D. The human research review committee may approve a consent procedure which
omits or alters some or all of the basic elements of informed consent, or waives
the requirement to obtain informed consent, if the committee finds and documents
that (i) the research involves no more than minimal risk to the subjects; (ii)
the omission, alteration or waiver will not adversely affect the rights and
welfare of the subjects; (iii) the research could not practicably be performed
without the omission, alteration or waiver; and (iv) after participation, the
subjects are to be provided with additional pertinent information, whenever
appropriate.

E. The human research review committee may waive the requirement that the
investigator obtain written informed consent for some or all subjects, if the
committee finds that the only record linking the subject and the research would
be the consent document and the principal risk would be potential harm resulting
from a breach of confidentiality. The committee may require the investigator to
provide the subjects with a written statement explaining the research. Further,
each subject shall be asked whether he wants documentation linking him to the
research and the subject’s wishes shall govern.

HISTORY: 1979, c. 38, § 37.1-235; 1986, c. 274; 1992, c. 603; 2002, c. 754;
2016, c. 84.