{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/32.1-162.16.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/32.1-162.16.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/32.1-162.16.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/32.1-162.16.html"}],"law_id":68456,"edition_id":1,"section_id":68456,"structure_id":16381,"section_number":"32.1-162.16","catch_line":"Definitions","history":"1979, c. 38, \u00a7 37.1-234; 1986, c. 274; 1992, c. 603; 2002, c. 754.","full_text":"As used in this chapter, unless the context requires a different meaning:\n\t\t“Human research” means any systematic investigation, including research development, testing and evaluation, utilizing human subjects, that is designed to develop or contribute to generalized knowledge. Human research shall not be deemed to include research exempt from federal research regulation pursuant to 45 C.F.R. \u00a7 46.101(b).\n\t\t“Informed consent” means the knowing and voluntary agreement, without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion, of a person who is capable of exercising free power of choice. For the purposes of human research, the basic elements of information necessary to such consent shall include:\n\n1\n\nA reasonable and comprehensible explanation to the person of the proposed procedures or protocols to be followed, their purposes, including descriptions of any attendant discomforts, and risks and benefits reasonably to be expected;2\n\nA disclosure of any appropriate alternative procedures or therapies that might be advantageous for the person;3\n\nAn instruction that the person may withdraw his consent and discontinue participation in the human research at any time without prejudice to him;4\n\nAn explanation of any costs or compensation which may accrue to the person and, if applicable, the availability of third party reimbursement for the proposed procedures or protocols; and5\n\nAn offer to answer and answers to any inquiries by the person concerning the procedures and protocols.\n\t\t\t“Institution” or “agency” means any facility, program, or organization owned or operated by the Commonwealth, by any political subdivision, or by any person, firm, corporation, association, or other legal entity.\n\t\t\t“Legally authorized representative” means, in the following specified order of priority, (i) the parent or parents having custody of a prospective subject who is a minor, (ii) the agent appointed under an advance directive, as defined in § 54.1-2982, executed by the prospective subject, provided the advance directive authorizes the agent to make decisions regarding the prospective subject’s participation in human research, (iii) the legal guardian of a prospective subject, (iv) the spouse of the prospective subject, except where a suit for divorce has been filed and the divorce decree is not yet final, (v) an adult child of the prospective subject, (vi) a parent of the prospective subject when the subject is an adult, (vii) an adult brother or sister of the prospective subject or (viii) any person or judicial or other body authorized by law or regulation to consent on behalf of a prospective subject to such subject’s participation in the particular human research. For the purposes of this chapter, any person authorized by law or regulation to consent on behalf of a prospective subject to such subject’s participation in the particular human research shall include an attorney in fact appointed under a durable power of attorney, to the extent the power grants the authority to make such a decision. The attorney in fact shall not be employed by the person, institution, or agency conducting the human research. No official or employee of the institution or agency conducting or authorizing the research shall be qualified to act as a legally authorized representative.\n\t\t\t“Minimal risk” means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.\n\t\t\t“Nontherapeutic research” means human research in which there is no reasonable expectation of direct benefit to the physical or mental condition of the human subject.","order_by":null,"text":{"0":{"id":247864,"text":"As used in this chapter, unless the context requires a different meaning:\n\t\t“Human research” means any systematic investigation, including research development, testing and evaluation, utilizing human subjects, that is designed to develop or contribute to generalized knowledge. Human research shall not be deemed to include research exempt from federal research regulation pursuant to 45 C.F.R. \u00a7 46.101(b).\n\t\t“Informed consent” means the knowing and voluntary agreement, without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion, of a person who is capable of exercising free power of choice. For the purposes of human research, the basic elements of information necessary to such consent shall include:","type":"section","prefixes":[""],"prefix":"","entire_prefix":"","prefix_anchor":"","level":1,"next_prefix":"1"},"1":{"id":247865,"text":"A reasonable and comprehensible explanation to the person of the proposed procedures or protocols to be followed, their purposes, including descriptions of any attendant discomforts, and risks and benefits reasonably to be expected;","type":"section","prefixes":["1"],"prefix":"1","entire_prefix":"1","prefix_anchor":"1","level":1,"prior_prefix":"","next_prefix":"2"},"2":{"id":247866,"text":"A disclosure of any appropriate alternative procedures or therapies that might be advantageous for the person;","type":"section","prefixes":["2"],"prefix":"2","entire_prefix":"2","prefix_anchor":"2","level":1,"prior_prefix":"1","next_prefix":"3"},"3":{"id":247867,"text":"An instruction that the person may withdraw his consent and discontinue participation in the human research at any time without prejudice to him;","type":"section","prefixes":["3"],"prefix":"3","entire_prefix":"3","prefix_anchor":"3","level":1,"prior_prefix":"2","next_prefix":"4"},"4":{"id":247868,"text":"An explanation of any costs or compensation which may accrue to the person and, if applicable, the availability of third party reimbursement for the proposed procedures or protocols; and","type":"section","prefixes":["4"],"prefix":"4","entire_prefix":"4","prefix_anchor":"4","level":1,"prior_prefix":"3","next_prefix":"5"},"5":{"id":247869,"text":"An offer to answer and answers to any inquiries by the person concerning the procedures and protocols.\n\t\t\t“Institution” or “agency” means any facility, program, or organization owned or operated by the Commonwealth, by any political subdivision, or by any person, firm, corporation, association, or other legal entity.\n\t\t\t“Legally authorized representative” means, in the following specified order of priority, (i) the parent or parents having custody of a prospective subject who is a minor, (ii) the agent appointed under an advance directive, as defined in § 54.1-2982, executed by the prospective subject, provided the advance directive authorizes the agent to make decisions regarding the prospective subject’s participation in human research, (iii) the legal guardian of a prospective subject, (iv) the spouse of the prospective subject, except where a suit for divorce has been filed and the divorce decree is not yet final, (v) an adult child of the prospective subject, (vi) a parent of the prospective subject when the subject is an adult, (vii) an adult brother or sister of the prospective subject or (viii) any person or judicial or other body authorized by law or regulation to consent on behalf of a prospective subject to such subject’s participation in the particular human research. For the purposes of this chapter, any person authorized by law or regulation to consent on behalf of a prospective subject to such subject’s participation in the particular human research shall include an attorney in fact appointed under a durable power of attorney, to the extent the power grants the authority to make such a decision. The attorney in fact shall not be employed by the person, institution, or agency conducting the human research. No official or employee of the institution or agency conducting or authorizing the research shall be qualified to act as a legally authorized representative.\n\t\t\t“Minimal risk” means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.\n\t\t\t“Nontherapeutic research” means human research in which there is no reasonable expectation of direct benefit to the physical or mental condition of the human subject.","type":"section","prefixes":["5"],"prefix":"5","entire_prefix":"5","prefix_anchor":"5","level":1,"prior_prefix":"4"}},"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}],"next_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},"metadata":false,"official_url":"https:\/\/law.lis.virginia.gov\/vacode\/32.1-162.16\/","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 3 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>.<\/p>","references":[{"id":84277,"section_number":"18.2-371.2:1","catch_line":"Prohibiting possession of retail tobacco products and hemp products intended for smoking by a person younger than 21 years of age; seizure","order_by":null,"url":"\/18.2-371.2_1\/"},{"id":73577,"section_number":"22.1-16.1","catch_line":"Board to establish regulations regarding human research","order_by":null,"url":"\/22.1-16.1\/"},{"id":68499,"section_number":"23.1-107","catch_line":"Private institutions of higher education; human research review committees","order_by":null,"url":"\/23.1-107\/"},{"id":79716,"section_number":"23.1-1303","catch_line":"Governing boards; duties","order_by":null,"url":"\/23.1-1303\/"},{"id":84908,"section_number":"32.1-12.1","catch_line":"Board to establish regulations regarding human research","order_by":null,"url":"\/32.1-12.1\/"},{"id":57839,"section_number":"37.2-402","catch_line":"Board to establish regulations regarding human research","order_by":null,"url":"\/37.2-402\/"},{"id":69032,"section_number":"51.5-132","catch_line":"Commissioner to establish regulations regarding human research","order_by":null,"url":"\/51.5-132\/"},{"id":83752,"section_number":"53.1-10","catch_line":"Powers and duties of Director","order_by":null,"url":"\/53.1-10\/"},{"id":60917,"section_number":"53.1-36","catch_line":"Prisoners may assist in medical research programs","order_by":null,"url":"\/53.1-36\/"},{"id":73269,"section_number":"54.1-2407","catch_line":"Requirements for human research","order_by":null,"url":"\/54.1-2407\/"},{"id":61815,"section_number":"54.1-2983.1","catch_line":"Participation in health care research","order_by":null,"url":"\/54.1-2983.1\/"},{"id":75661,"section_number":"63.2-218","catch_line":"Board to adopt regulations regarding human research","order_by":null,"url":"\/63.2-218\/"},{"id":57776,"section_number":"66-10.1","catch_line":"Board to establish regulations regarding human research","order_by":null,"url":"\/66-10.1\/"},{"id":73464,"section_number":"8.01-44.1","catch_line":"Immunity from civil liability of members of certain committees, etc","order_by":null,"url":"\/8.01-44.1\/"}],"refers_to":[{"id":56308,"section_number":"54.1-2982","catch_line":"Definitions","order_by":null,"url":"\/54.1-2982\/"}],"permalink":{"id":203485,"object_type":"law","relational_id":68456,"identifier":"32.1-162.16","token":"32.1\/5.1\/32.1-162.16","url":"\/32.1-162.16\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/32.1-162.16\/","token":"32.1\/5.1\/32.1-162.16","dublin_core":{"Title":"Definitions","Type":"Text","Format":"text\/html","Identifier":"\u00a7 32.1-162.16","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t

As used in this chapter, unless the context requires a different meaning:\n\t\t“Human research<\/span>” means any systematic investigation, including research development, testing and evaluation, utilizing human subjects, that is designed to develop or contribute to generalized knowledge. Human research<\/span> shall not be deemed to include research exempt from federal research regulation pursuant to 45 C.F.R. \u00a7 46.101(b).\n\t\t“Informed consent<\/span>” means the knowing and voluntary agreement, without undue inducement or any element of force, fraud<\/span>, deceit, duress, or other form of constraint or coercion, of a person<\/span> who is capable of exercising free power of choice. For the purposes of human research<\/span>, the basic elements of information necessary to such consent shall include:<\/p><\/section>\n\t\t\t\t\t\t

1.<\/span> A reasonable and comprehensible explanation to the person<\/span> of the proposed procedures or protocols to be followed, their purposes, including descriptions of any attendant discomforts, and risks and benefits reasonably to be expected; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

2.<\/span> A disclosure of any appropriate alternative procedures or therapies that might be advantageous for the person<\/span>; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

3.<\/span> An instruction that the person<\/span> may withdraw his consent and discontinue participation in the human research<\/span> at any time without prejudice to him; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

4.<\/span> An explanation of any costs or compensation which may accrue to the person<\/span> and, if applicable, the availability of third party<\/span> reimbursement for the proposed procedures or protocols; and <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

5.<\/span> An offer to answer and answers to any inquiries by the person<\/span> concerning the procedures and protocols.\n\t\t\t“Institution<\/span>” or “agency<\/span>” means any facility, program, or organization owned or operated by the Commonwealth, by any political subdivision, or by any person<\/span>, firm, corporation, association, or other legal entity.\n\t\t\t“Legally authorized representative<\/span>” means, in the following specified order<\/span> of priority, (i) the parent or parents having custody<\/span> of a prospective subject who is a minor<\/span>, (ii) the agent appointed under an advance directive, as defined in § 54.1-2982<\/a>, executed by the prospective subject, provided the advance directive authorizes the agent to make decisions regarding the prospective subject’s participation in human research<\/span>, (iii) the legal guardian of a prospective subject, (iv) the spouse of the prospective subject, except where a suit for divorce has been filed and the divorce decree<\/span> is not yet final, (v) an adult child of the prospective subject, (vi) a parent of the prospective subject when the subject is an adult, (vii) an adult brother or sister of the prospective subject or (viii) any person<\/span> or judicial or other body authorized by law<\/span> or regulation to consent on behalf of a prospective subject to such subject’s participation in the particular human research<\/span>. For the purposes of this chapter, any person<\/span> authorized by law<\/span> or regulation to consent on behalf of a prospective subject to such subject’s participation in the particular human research<\/span> shall include an attorney in fact<\/span> appointed under a durable power of attorney<\/span>, to the extent the power grants the authority to make such a decision. The attorney in fact<\/span> shall not be employed by the person<\/span>, institution<\/span>, or agency<\/span> conducting the human research<\/span>. No official or employee of the institution<\/span> or agency<\/span> conducting or authorizing the research shall be qualified to act as a legally authorized representative<\/span>.\n\t\t\t“Minimal risk<\/span>” means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.\n\t\t\t“Nontherapeutic research<\/span>” means human research<\/span> in which there is no reasonable expectation of direct benefit to the physical or mental condition of the human subject. <\/i><\/a><\/p><\/section>","plain_text":" CODE OF VIRGINIA\n\nDEFINITIONS (\u00a7 32.1-162.16)\n\nAs used in this chapter, unless the context requires a different meaning:\n\t\t“Human research” means any systematic investigation, including\nresearch development, testing and evaluation, utilizing human subjects, that is\ndesigned to develop or contribute to generalized knowledge. Human research shall\nnot be deemed to include research exempt from federal research regulation\npursuant to 45 C.F.R. \u00a7 46.101(b).\n\t\t“Informed consent” means the knowing and voluntary agreement,\nwithout undue inducement or any element of force, fraud, deceit, duress, or\nother form of constraint or coercion, of a person who is capable of exercising\nfree power of choice. For the purposes of human research, the basic elements of\ninformation necessary to such consent shall include:\n\n1. A reasonable and comprehensible explanation to the person of the proposed\nprocedures or protocols to be followed, their purposes, including descriptions\nof any attendant discomforts, and risks and benefits reasonably to be expected;\n\n2. A disclosure of any appropriate alternative procedures or therapies that\nmight be advantageous for the person;\n\n3. An instruction that the person may withdraw his consent and discontinue\nparticipation in the human research at any time without prejudice to him;\n\n4. An explanation of any costs or compensation which may accrue to the person\nand, if applicable, the availability of third party reimbursement for the\nproposed procedures or protocols; and\n\n5. An offer to answer and answers to any inquiries by the person concerning the\nprocedures and protocols.\n\t\t\t“Institution” or “agency” means any facility,\nprogram, or organization owned or operated by the Commonwealth, by any political\nsubdivision, or by any person, firm, corporation, association, or other legal\nentity.\n\t\t\t“Legally authorized representative” means, in the following\nspecified order of priority, (i) the parent or parents having custody of a\nprospective subject who is a minor, (ii) the agent appointed under an advance\ndirective, as defined in § 54.1-2982, executed by the prospective subject,\nprovided the advance directive authorizes the agent to make decisions regarding\nthe prospective subject’s participation in human research, (iii) the legal\nguardian of a prospective subject, (iv) the spouse of the prospective subject,\nexcept where a suit for divorce has been filed and the divorce decree is not yet\nfinal, (v) an adult child of the prospective subject, (vi) a parent of the\nprospective subject when the subject is an adult, (vii) an adult brother or\nsister of the prospective subject or (viii) any person or judicial or other body\nauthorized by law or regulation to consent on behalf of a prospective subject to\nsuch subject’s participation in the particular human research. For the\npurposes of this chapter, any person authorized by law or regulation to consent\non behalf of a prospective subject to such subject’s participation in the\nparticular human research shall include an attorney in fact appointed under a\ndurable power of attorney, to the extent the power grants the authority to make\nsuch a decision. The attorney in fact shall not be employed by the person,\ninstitution, or agency conducting the human research. No official or employee of\nthe institution or agency conducting or authorizing the research shall be\nqualified to act as a legally authorized representative.\n\t\t\t“Minimal risk” means that the risks of harm anticipated in the\nproposed research are not greater, considering probability and magnitude, than\nthose ordinarily encountered in daily life or during the performance of routine\nphysical or psychological examinations or tests.\n\t\t\t“Nontherapeutic research” means human research in which there is\nno reasonable expectation of direct benefit to the physical or mental condition\nof the human subject.\n\nHISTORY: 1979, c. 38, \u00a7 37.1-234; 1986, c. 274; 1992, c. 603; 2002, c. 754.","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}}