{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/32.1-162.19.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/32.1-162.19.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/32.1-162.19.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/32.1-162.19.html"}],"law_id":80228,"edition_id":1,"section_id":80228,"structure_id":16381,"section_number":"32.1-162.19","catch_line":"Human research review committees","history":"1979, c. 38, \u00a7 37.1-236; 1986, c. 274; 1992, c. 603; 2002, c. 754; 2007, c. 413.","full_text":"A\n\nEach institution or agency which conducts or which proposes to conduct or authorize human research shall establish a human research review committee. The committee shall be composed of representatives of varied backgrounds to ensure the competent, complete, and professional review of human research activities conducted or proposed to be conducted or authorized by the institution or agency. No member of the committee shall be directly involved in the proposed human research or have administrative approval authority over the proposed human research except in connection with his responsibilities as a member of the committee.B\n\nNo human research shall be conducted or authorized by such institution or agency unless the committee has reviewed and approved the proposed human research project giving consideration to (i) the adequacy of the description of the potential benefits and risks involved and the adequacy of the methodology of the research; (ii) if the research is nontherapeutic, whether it presents more than a minimal risk to the human subjects; (iii) whether the rights and welfare of the human subjects involved are adequately protected; (iv) whether the risks to the human subjects are outweighed by the potential benefits to them; (v) whether the risks to subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk and, whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes; (vi) when some or all of the subjects are likely to be incapable of making an informed decision regarding consent or are otherwise vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, whether additional safeguards have been included in the study to protect the rights and welfare of these subjects; (vii) whether the informed consent is to be obtained by methods that are adequate and appropriate and whether the written consent form is adequate and appropriate in both content and language for the particular research; (viii) whether the persons proposing to conduct the particular human research are appropriately competent and qualified; and (ix) whether the criteria for selection of subjects are equitable. The committee shall require periodic reports from each existing human research project to ensure that the project is being carried out in conformity with the proposal as approved.C\n\nThe regulations of an institution or agency may authorize the committee to conduct an expedited review of a human research project which involves no more than minimal risk to the subjects if (i) another institution’s or agency’s human research review committee has reviewed and approved the project or (ii) the review involves only minor changes in previously approved research and the changes occur during the approved project period.D\n\nEvery person engaged in the conduct of human research or proposing to conduct human research shall affiliate himself with an institution or agency having a research review committee, and the human research which he conducts or proposes to conduct shall be subject to review and approval by such committee in the manner set forth in this section.E\n\nEach human research review committee of a state institution or agency shall ensure that an overview of approved human research projects and the results of such projects are made public on the institution’s or agency’s website unless otherwise exempt from disclosure under the Virginia Freedom of Information Act (§ 2.2-3700 et seq.).","order_by":null,"text":{"0":{"id":287197,"text":"Each institution or agency which conducts or which proposes to conduct or authorize human research shall establish a human research review committee. The committee shall be composed of representatives of varied backgrounds to ensure the competent, complete, and professional review of human research activities conducted or proposed to be conducted or authorized by the institution or agency. No member of the committee shall be directly involved in the proposed human research or have administrative approval authority over the proposed human research except in connection with his responsibilities as a member of the committee.","type":"section","prefixes":["A"],"prefix":"A","entire_prefix":"A","prefix_anchor":"A","level":1,"next_prefix":"B"},"1":{"id":287198,"text":"No human research shall be conducted or authorized by such institution or agency unless the committee has reviewed and approved the proposed human research project giving consideration to (i) the adequacy of the description of the potential benefits and risks involved and the adequacy of the methodology of the research; (ii) if the research is nontherapeutic, whether it presents more than a minimal risk to the human subjects; (iii) whether the rights and welfare of the human subjects involved are adequately protected; (iv) whether the risks to the human subjects are outweighed by the potential benefits to them; (v) whether the risks to subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk and, whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes; (vi) when some or all of the subjects are likely to be incapable of making an informed decision regarding consent or are otherwise vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, whether additional safeguards have been included in the study to protect the rights and welfare of these subjects; (vii) whether the informed consent is to be obtained by methods that are adequate and appropriate and whether the written consent form is adequate and appropriate in both content and language for the particular research; (viii) whether the persons proposing to conduct the particular human research are appropriately competent and qualified; and (ix) whether the criteria for selection of subjects are equitable. The committee shall require periodic reports from each existing human research project to ensure that the project is being carried out in conformity with the proposal as approved.","type":"section","prefixes":["B"],"prefix":"B","entire_prefix":"B","prefix_anchor":"B","level":1,"prior_prefix":"A","next_prefix":"C"},"2":{"id":287199,"text":"The regulations of an institution or agency may authorize the committee to conduct an expedited review of a human research project which involves no more than minimal risk to the subjects if (i) another institution’s or agency’s human research review committee has reviewed and approved the project or (ii) the review involves only minor changes in previously approved research and the changes occur during the approved project period.","type":"section","prefixes":["C"],"prefix":"C","entire_prefix":"C","prefix_anchor":"C","level":1,"prior_prefix":"B","next_prefix":"D"},"3":{"id":287200,"text":"Every person engaged in the conduct of human research or proposing to conduct human research shall affiliate himself with an institution or agency having a research review committee, and the human research which he conducts or proposes to conduct shall be subject to review and approval by such committee in the manner set forth in this section.","type":"section","prefixes":["D"],"prefix":"D","entire_prefix":"D","prefix_anchor":"D","level":1,"prior_prefix":"C","next_prefix":"E"},"4":{"id":287201,"text":"Each human research review committee of a state institution or agency shall ensure that an overview of approved human research projects and the results of such projects are made public on the institution’s or agency’s website unless otherwise exempt from disclosure under the Virginia Freedom of Information Act (§ 2.2-3700 et seq.).","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":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},"next_section":{"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},"metadata":false,"official_url":"https:\/\/law.lis.virginia.gov\/vacode\/32.1-162.19\/","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 2007, chapter 413<\/a>.<\/p>","references":[{"id":69032,"section_number":"51.5-132","catch_line":"Commissioner to establish regulations regarding human research","order_by":null,"url":"\/51.5-132\/"}],"refers_to":[{"id":55569,"section_number":"2.2-3700","catch_line":"Short title; policy","order_by":null,"url":"\/2.2-3700\/"}],"permalink":{"id":203497,"object_type":"law","relational_id":80228,"identifier":"32.1-162.19","token":"32.1\/5.1\/32.1-162.19","url":"\/32.1-162.19\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/32.1-162.19\/","token":"32.1\/5.1\/32.1-162.19","dublin_core":{"Title":"Human research review committees","Type":"Text","Format":"text\/html","Identifier":"\u00a7 32.1-162.19","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t

A.<\/span> Each institution<\/span> or agency<\/span> which conducts or which proposes to conduct or authorize human research<\/span> shall establish a human research<\/span> review committee. The committee shall be composed of representatives of varied backgrounds to ensure the competent, complete, and professional review of human research<\/span> activities conducted or proposed to be conducted or authorized by the institution<\/span> or agency<\/span>. No member of the committee shall be directly involved in the proposed human research<\/span> or have administrative approval authority over the proposed human research<\/span> except in connection with his responsibilities as a member of the committee. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

B.<\/span> No human research<\/span> shall be conducted or authorized by such institution<\/span> or agency<\/span> unless the committee has reviewed and approved the proposed human research<\/span> project giving consideration to (i) the adequacy of the description of the potential benefits and risks involved and the adequacy of the methodology of the research; (ii) if the research is nontherapeutic, whether it presents more than a minimal risk<\/span> to the human subjects; (iii) whether the rights and welfare of the human subjects involved are adequately protected; (iv) whether the risks to the human subjects are outweighed by the potential benefits to them; (v) whether the risks to subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk and, whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes; (vi) when some or all of the subjects are likely to be incapable of making an informed decision regarding consent or are otherwise vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons<\/span>, or economically or educationally disadvantaged persons<\/span>, whether additional safeguards have been included in the study to protect the rights and welfare of these subjects; (vii) whether the informed consent<\/span> is to be obtained by methods that are adequate and appropriate and whether the written consent form is adequate and appropriate in both content and language for the particular research; (viii) whether the persons<\/span> proposing to conduct the particular human research<\/span> are appropriately competent and qualified; and (ix) whether the criteria for selection of subjects are equitable<\/span>. The committee shall require periodic reports from each existing human research<\/span> project to ensure that the project is being carried out in conformity with the proposal as approved. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

C.<\/span> The regulations of an institution<\/span> or agency<\/span> may authorize the committee to conduct an expedited review of a human research<\/span> project which involves no more than minimal risk<\/span> to the subjects if (i) another institution<\/span>’s or agency<\/span>’s human research<\/span> review committee has reviewed and approved the project or (ii) the review involves only minor<\/span> changes in previously approved research and the changes occur during the approved project period. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

D.<\/span> Every person<\/span> engaged in the conduct of human research<\/span> or proposing to conduct human research<\/span> shall affiliate himself with an institution<\/span> or agency<\/span> having a research review committee, and the human research<\/span> which he conducts or proposes to conduct shall be subject to review and approval by such committee in the manner set forth in this section. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

E.<\/span> Each human research<\/span> review committee of a state institution<\/span> or agency<\/span> shall ensure that an overview of approved human research<\/span> projects and the results of such projects are made public on the institution<\/span>’s or agency<\/span>’s website unless otherwise exempt from disclosure under the Virginia Freedom of Information Act (§ 2.2-3700<\/a> et seq.). <\/i><\/a><\/p><\/section>","plain_text":" CODE OF VIRGINIA\n\nHUMAN RESEARCH REVIEW COMMITTEES (\u00a7 32.1-162.19)\n\nA. Each institution or agency which conducts or which proposes to conduct or\nauthorize human research shall establish a human research review committee. The\ncommittee shall be composed of representatives of varied backgrounds to ensure\nthe competent, complete, and professional review of human research activities\nconducted or proposed to be conducted or authorized by the institution or\nagency. No member of the committee shall be directly involved in the proposed\nhuman research or have administrative approval authority over the proposed human\nresearch except in connection with his responsibilities as a member of the\ncommittee.\n\nB. No human research shall be conducted or authorized by such institution or\nagency unless the committee has reviewed and approved the proposed human\nresearch project giving consideration to (i) the adequacy of the description of\nthe potential benefits and risks involved and the adequacy of the methodology of\nthe research; (ii) if the research is nontherapeutic, whether it presents more\nthan a minimal risk to the human subjects; (iii) whether the rights and welfare\nof the human subjects involved are adequately protected; (iv) whether the risks\nto the human subjects are outweighed by the potential benefits to them; (v)\nwhether the risks to subjects are minimized by using procedures that are\nconsistent with sound research design and that do not unnecessarily expose\nsubjects to risk and, whenever appropriate, by using procedures already being\nperformed on the subjects for diagnostic or treatment purposes; (vi) when some\nor all of the subjects are likely to be incapable of making an informed decision\nregarding consent or are otherwise vulnerable to coercion or undue influence,\nsuch as children, prisoners, pregnant women, mentally disabled persons, or\neconomically or educationally disadvantaged persons, whether additional\nsafeguards have been included in the study to protect the rights and welfare of\nthese subjects; (vii) whether the informed consent is to be obtained by methods\nthat are adequate and appropriate and whether the written consent form is\nadequate and appropriate in both content and language for the particular\nresearch; (viii) whether the persons proposing to conduct the particular human\nresearch are appropriately competent and qualified; and (ix) whether the\ncriteria for selection of subjects are equitable. The committee shall require\nperiodic reports from each existing human research project to ensure that the\nproject is being carried out in conformity with the proposal as approved.\n\nC. The regulations of an institution or agency may authorize the committee to\nconduct an expedited review of a human research project which involves no more\nthan minimal risk to the subjects if (i) another institution’s or\nagency’s human research review committee has reviewed and approved the\nproject or (ii) the review involves only minor changes in previously approved\nresearch and the changes occur during the approved project period.\n\nD. Every person engaged in the conduct of human research or proposing to conduct\nhuman research shall affiliate himself with an institution or agency having a\nresearch review committee, and the human research which he conducts or proposes\nto conduct shall be subject to review and approval by such committee in the\nmanner set forth in this section.\n\nE. Each human research review committee of a state institution or agency shall\nensure that an overview of approved human research projects and the results of\nsuch projects are made public on the institution’s or agency’s\nwebsite unless otherwise exempt from disclosure under the Virginia Freedom of\nInformation Act (§ 2.2-3700 et seq.).\n\nHISTORY: 1979, c. 38, \u00a7 37.1-236; 1986, c. 274; 1992, c. 603; 2002, c. 754;\n2007, c. 413.","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}}