32.1-162.18 - Informed consent.
§ 32.1-162.18. Informed consent.
A. In order to conduct human research in this Commonwealth, informed consentmust 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 inwriting by the person and witnessed; (ii) incapable of making an informeddecision, as defined in § 54.1-2982, at the time consent is required, then itshall be subscribed to in writing by the person's legally authorizedrepresentative and witnessed; or (iii) a minor otherwise capable of renderinginformed consent, then it shall be subscribed to in writing by both the minorand his legally authorized representative. The giving of consent by a legallyauthorized representative shall be subject to the provisions of subsection Bof this section. If two or more persons who qualify as legally authorizedrepresentatives and have equal decision-making priority under this chapterinform the principal investigator or attending physician that they disagreeas to participation of the prospective subject in human research, the subjectshall not be enrolled in the human research that is the subject of theconsent. No informed consent form shall include any language through whichthe person who is to be the human subject waives or appears to waive any ofhis legal rights, including any release of any individual, institution, oragency or any agents thereof from liability for negligence.
Notwithstanding consent by a legally authorized representative, no personshall be forced to participate in any human research if the investigatorconducting the human research knows that participation in the research isprotested by the prospective subject. In the case of persons suffering fromorganic brain diseases causing progressive deterioration of cognition forwhich there is no known cure or medically accepted treatment, theimplementation of experimental courses of therapeutic treatment to which alegally authorized representative has given informed consent shall notconstitute the use of force.
B. A legally authorized representative may not consent to nontherapeuticresearch unless it is determined by the human research committee that suchnontherapeutic research will present no more than a minor increase overminimal risk to the human subject. A legally authorized representative maynot consent to participation in human research on behalf of a prospectivesubject if the legally authorized representative knows, or upon reasonableinquiry ought to know, that any aspect of the human research protocol iscontrary to the religious beliefs or basic values of the prospective subject,whether expressed orally or in writing. A legally authorized representativemay not consent to participation in human research involving nontherapeuticsterilization, abortion, psychosurgery or admission for research purposes toa facility or hospital as defined in § 37.2-100.
C. Except as provided elsewhere in this chapter, no investigator may involvea human being as a subject in research covered by this chapter unless theinvestigator has obtained the legally effective informed consent of thesubject or the subject's legally authorized representative. An investigatorshall seek such consent only under circumstances that provide the prospectivesubject or the legally authorized representative sufficient opportunity toconsider whether or not to participate and that minimize the possibility ofcoercion or undue influence.
D. The human research review committee may approve a consent procedure whichomits or alters some or all of the basic elements of informed consent, orwaives the requirement to obtain informed consent, if the committee finds anddocuments that (i) the research involves no more than minimal risk to thesubjects; (ii) the omission, alteration or waiver will not adversely affectthe rights and welfare of the subjects; (iii) the research could notpracticably be performed without the omission, alteration or waiver; and (iv)after participation, the subjects are to be provided with additionalpertinent information, whenever appropriate.
E. The human research review committee may waive the requirement that theinvestigator obtain written informed consent for some or all subjects, if thecommittee finds that the only record linking the subject and the researchwould be the consent document and the principal risk would be potential harmresulting from a breach of confidentiality. The committee may require theinvestigator to provide the subjects with a written statement explaining theresearch. Further, each subject shall be asked whether he wants documentationlinking him to the research and the subject's wishes shall govern.
(1979, c. 38, § 37.1-235; 1986, c. 274; 1992, c. 603; 2002, c. 754.)