{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/32.1-162.18.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/32.1-162.18.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/32.1-162.18.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/32.1-162.18.html"}],"law_id":67598,"edition_id":1,"section_id":67598,"structure_id":16381,"section_number":"32.1-162.18","catch_line":"Informed consent","history":"1979, c. 38, \u00a7 37.1-235; 1986, c. 274; 1992, c. 603; 2002, c. 754; 2016, c. 84.","full_text":"A\n\nIn 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.\n\t\t\tNotwithstanding 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\n\nA 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\n\nExcept 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\n\nThe 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\n\nThe 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.","order_by":null,"text":{"0":{"id":244905,"text":"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.\n\t\t\tNotwithstanding 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.","type":"section","prefixes":["A"],"prefix":"A","entire_prefix":"A","prefix_anchor":"A","level":1,"next_prefix":"B"},"1":{"id":244906,"text":"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.","type":"section","prefixes":["B"],"prefix":"B","entire_prefix":"B","prefix_anchor":"B","level":1,"prior_prefix":"A","next_prefix":"C"},"2":{"id":244907,"text":"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.","type":"section","prefixes":["C"],"prefix":"C","entire_prefix":"C","prefix_anchor":"C","level":1,"prior_prefix":"B","next_prefix":"D"},"3":{"id":244908,"text":"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.","type":"section","prefixes":["D"],"prefix":"D","entire_prefix":"D","prefix_anchor":"D","level":1,"prior_prefix":"C","next_prefix":"E"},"4":{"id":244909,"text":"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.","type":"section","prefixes":["E"],"prefix":"E","entire_prefix":"E","prefix_anchor":"E","level":1,"prior_prefix":"D"}},"ancestry":[{"id":16381,"edition_id":1,"name":"Human Research","identifier":"5.1","label":"chapter","depth":2,"order_by":1,"parent_id":12727,"metadata":{},"date_created":"2026-06-26 04:15:51","date_modified":"2026-06-26 04:15:51","permalink":{"id":203483,"object_type":"structure","relational_id":16381,"identifier":"5.1","token":"32.1\/5.1","url":"\/32.1\/5.1\/","edition_id":1,"permalink":0,"preferred":1}},{"id":12727,"edition_id":1,"name":"Health","identifier":"32.1","label":"title","depth":1,"order_by":1,"parent_id":null,"metadata":{},"date_created":"2026-06-26 03:43:50","date_modified":"2026-06-26 03:43:50","permalink":{"id":201099,"object_type":"structure","relational_id":12727,"identifier":"32.1","token":"32.1","url":"\/32.1\/","edition_id":1,"permalink":0,"preferred":1}}],"structure_contents":[{"id":68456,"structure_id":16381,"section_number":"32.1-162.16","catch_line":"Definitions","url":"\/32.1-162.16\/","token":"32.1\/5.1\/32.1-162.16","metadata":false},{"id":86577,"structure_id":16381,"section_number":"32.1-162.17","catch_line":"Exemptions","url":"\/32.1-162.17\/","token":"32.1\/5.1\/32.1-162.17","metadata":false},{"id":67598,"structure_id":16381,"section_number":"32.1-162.18","catch_line":"Informed consent","url":"\/32.1-162.18\/","token":"32.1\/5.1\/32.1-162.18","metadata":false},{"id":80228,"structure_id":16381,"section_number":"32.1-162.19","catch_line":"Human research review committees","url":"\/32.1-162.19\/","token":"32.1\/5.1\/32.1-162.19","metadata":false},{"id":85369,"structure_id":16381,"section_number":"32.1-162.20","catch_line":"Applicability of federal policies","url":"\/32.1-162.20\/","token":"32.1\/5.1\/32.1-162.20","metadata":false}],"previous_section":{"id":86577,"structure_id":16381,"section_number":"32.1-162.17","catch_line":"Exemptions","url":"\/32.1-162.17\/","token":"32.1\/5.1\/32.1-162.17","metadata":false},"next_section":{"id":80228,"structure_id":16381,"section_number":"32.1-162.19","catch_line":"Human research review committees","url":"\/32.1-162.19\/","token":"32.1\/5.1\/32.1-162.19","metadata":false},"metadata":false,"official_url":"https:\/\/law.lis.virginia.gov\/vacode\/32.1-162.18\/","history_text":"

This law was first created in 1979. The record of its establishment is cataloged in chapter 38 of that year\u2019s edition of \u201cActs of Assembly,\u201d the annual state publication listing all changes made to the Code of Virginia in that year. Unfortunately, the 1979 \u201cActs\u201d aren\u2019t available online. It has been modified 4 times. Those modifications are cataloged by \u201cThe Acts of Assembly,\u201d a state publication, by year and chapter. Those modifications that can be read on the General Assembly\u2019s website will be linked accordingly. Those modifications are as follows: in 1986, chapter 274; in 1992, chapter 603; in 2002, chapter 754<\/a>; in 2016, chapter 84<\/a>.<\/p>","references":false,"refers_to":[{"id":56308,"section_number":"54.1-2982","catch_line":"Definitions","order_by":null,"url":"\/54.1-2982\/"}],"permalink":{"id":203493,"object_type":"law","relational_id":67598,"identifier":"32.1-162.18","token":"32.1\/5.1\/32.1-162.18","url":"\/32.1-162.18\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/32.1-162.18\/","token":"32.1\/5.1\/32.1-162.18","dublin_core":{"Title":"Informed consent","Type":"Text","Format":"text\/html","Identifier":"\u00a7 32.1-162.18","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t

A.<\/span> In order<\/span> to conduct human research<\/span> in this Commonwealth, informed consent<\/span> must be obtained if the person<\/span> 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<\/span> and witnessed; (ii) incapable of making an informed decision, as defined in § 54.1-2982<\/a>, at the time consent is required, then it shall be subscribed to in writing by the person<\/span>’s legally authorized representative<\/span> and witnessed; or (iii) a minor<\/span> otherwise capable of rendering informed consent<\/span>, then it shall be subscribed to in writing by both the minor<\/span> and his legally authorized representative<\/span>. The giving of consent by a legally authorized representative<\/span> shall be subject to the provisions of subsection B of this section. If two or more persons<\/span> who qualify as legally authorized representatives<\/span> 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<\/span>, the subject shall not be enrolled in the human research<\/span> that is the subject of the consent. No informed consent<\/span> form shall include any language through which the person<\/span> who is to be the human subject waives<\/span> or appears to waive<\/span> any of his legal rights, including any release of any individual, institution<\/span>, or agency<\/span> or any agents thereof from liability for negligence<\/span>.\n\t\t\tNotwithstanding consent by a legally authorized representative<\/span>, no person<\/span> shall be forced to participate in any human research<\/span> if the investigator conducting the human research<\/span> knows that participation in the research is protested by the prospective subject. In the case of persons<\/span> 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<\/span> has given informed consent<\/span> shall not constitute the use of force. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

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

C.<\/span> 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<\/span> of the subject or the subject’s legally authorized representative<\/span>. An investigator shall seek such consent only under circumstances that provide the prospective subject or the legally authorized representative<\/span> sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

D.<\/span> The human research<\/span> review committee may approve a consent procedure which omits or alters some or all of the basic elements of informed consent<\/span>, or waives<\/span> the requirement to obtain informed consent<\/span>, if the committee finds and documents that (i) the research involves no more than minimal risk<\/span> to the subjects; (ii) the omission, alteration or waiver<\/span> 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<\/span>; and (iv) after participation, the subjects are to be provided with additional pertinent information, whenever appropriate. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

E.<\/span> The human research<\/span> review committee may waive<\/span> the requirement that the investigator obtain written informed consent<\/span> 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. <\/i><\/a><\/p><\/section>","plain_text":" CODE OF VIRGINIA\n\nINFORMED CONSENT (\u00a7 32.1-162.18)\n\nA. In order to conduct human research in this Commonwealth, informed consent\nmust be obtained if the person who is to be the human subject is as follows: (i)\ncapable of making an informed decision, then it shall be subscribed to in\nwriting by the person and witnessed; (ii) incapable of making an informed\ndecision, as defined in § 54.1-2982, at the time consent is required, then\nit shall be subscribed to in writing by the person’s legally authorized\nrepresentative and witnessed; or (iii) a minor otherwise capable of rendering\ninformed consent, then it shall be subscribed to in writing by both the minor\nand his legally authorized representative. The giving of consent by a legally\nauthorized representative shall be subject to the provisions of subsection B of\nthis section. If two or more persons who qualify as legally authorized\nrepresentatives and have equal decision-making priority under this chapter\ninform the principal investigator or attending physician that they disagree as\nto participation of the prospective subject in human research, the subject shall\nnot be enrolled in the human research that is the subject of the consent. No\ninformed consent form shall include any language through which the person who is\nto be the human subject waives or appears to waive any of his legal rights,\nincluding any release of any individual, institution, or agency or any agents\nthereof from liability for negligence.\n\t\t\tNotwithstanding consent by a legally authorized representative, no person\nshall be forced to participate in any human research if the investigator\nconducting the human research knows that participation in the research is\nprotested by the prospective subject. In the case of persons suffering from\nneurodegenerative diseases causing progressive deterioration of cognition for\nwhich there is no known cure, the implementation of experimental courses of\ntherapeutic treatment, including non-pharmacological treatment, to which a\nlegally authorized representative has given informed consent shall not\nconstitute the use of force.\n\nB. A legally authorized representative may not consent to nontherapeutic\nresearch unless it is determined by the human research committee that such\nnontherapeutic research will present no more than a minor increase over minimal\nrisk to the human subject. A legally authorized representative may not consent\nto participation in human research on behalf of a prospective subject if the\nlegally authorized representative knows, or upon reasonable inquiry ought to\nknow, that any aspect of the human research protocol is contrary to the\nreligious beliefs or basic values of the prospective subject, whether expressed\norally or in writing. A legally authorized representative may not consent to\nparticipation in human research involving nontherapeutic sterilization,\nabortion, psychosurgery or admission for research purposes to a facility or\nhospital as defined in § 37.2-100.\n\nC. Except as provided elsewhere in this chapter, no investigator may involve a\nhuman being as a subject in research covered by this chapter unless the\ninvestigator has obtained the legally effective informed consent of the subject\nor the subject’s legally authorized representative. An investigator shall\nseek such consent only under circumstances that provide the prospective subject\nor the legally authorized representative sufficient opportunity to consider\nwhether or not to participate and that minimize the possibility of coercion or\nundue influence.\n\nD. The human research review committee may approve a consent procedure which\nomits or alters some or all of the basic elements of informed consent, or waives\nthe requirement to obtain informed consent, if the committee finds and documents\nthat (i) the research involves no more than minimal risk to the subjects; (ii)\nthe omission, alteration or waiver will not adversely affect the rights and\nwelfare of the subjects; (iii) the research could not practicably be performed\nwithout the omission, alteration or waiver; and (iv) after participation, the\nsubjects are to be provided with additional pertinent information, whenever\nappropriate.\n\nE. The human research review committee may waive the requirement that the\ninvestigator obtain written informed consent for some or all subjects, if the\ncommittee finds that the only record linking the subject and the research would\nbe the consent document and the principal risk would be potential harm resulting\nfrom a breach of confidentiality. The committee may require the investigator to\nprovide the subjects with a written statement explaining the research. Further,\neach subject shall be asked whether he wants documentation linking him to the\nresearch and the subject’s wishes shall govern.\n\nHISTORY: 1979, c. 38, \u00a7 37.1-235; 1986, c. 274; 1992, c. 603; 2002, c. 754;\n2016, c. 84.","edition":{"id":1,"name":"2025","slug":"2025","date_created":"2026-06-21 22:39:22","date_modified":"2026-06-21 22:39:22","current":1,"order_by":1,"last_import":null}}