{"id":28,"date":"2016-12-06T14:24:16","date_gmt":"2016-12-06T14:24:16","guid":{"rendered":"https:\/\/www.vdh.virginia.gov\/institutional-review-board\/?page_id=28"},"modified":"2025-10-31T13:33:21","modified_gmt":"2025-10-31T13:33:21","slug":"determination-of-irb-review","status":"publish","type":"page","link":"https:\/\/www.vdh.virginia.gov\/institutional-review-board\/determination-of-irb-review\/","title":{"rendered":"Determination of IRB Review"},"content":{"rendered":"<h2>Human Subject Research<\/h2>\n<p>Not all research requires IRB review. However, any human subject research is usually subject to review and approval by the VDH IRB. This includes:<\/p>\n<ul>\n<li>Research conducted by VDH<\/li>\n<li>Research conducted by outside investigators in collaboration with VDH<\/li>\n<li>Research conducted by outside investigators using VDH data.<\/li>\n<\/ul>\n<h2>Decision-Making Process<\/h2>\n<p>In brief, the decision-making process is divided into five key decision steps:<\/p>\n<ol>\n<li>Is the project considered research?<\/li>\n<li>Does the project involve human subjects?<\/li>\n<li>Does the project qualify for exemption review?<\/li>\n<li>Does the project qualify for expedited review?<\/li>\n<li>May informed consent and\/or its documentation be waived or altered?<\/li>\n<\/ol>\n<h2>IRB Decision Charts &amp; Guidance<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/decision-charts-2018\/index.html\" target=\"_blank\" rel=\"noopener\">Office for Human Research Protections (OHRP) Decision Charts<\/a> &#8211; developed to provide guidance for institutional review boards (IRBs), investigators and others on whether an activity is research involving human subjects that must be reviewed by an IRB.<\/li>\n<li><a href=\"https:\/\/www.vdh.virginia.gov\/content\/uploads\/sites\/73\/2016\/12\/Public-Health-Practice-versus-Research.pdf\" target=\"_blank\" rel=\"noopener\">Council of State and Territorial Epidemiologists (CSTE) Public Health Practice versus Research<\/a> &#8211; There is frequently a gray area between public health practice and research. Although consensus has not yet been reached on this issue, this report provides helpful guidance.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Human Subject Research Not all research requires IRB review. However, any human subject research is usually subject to review and approval by the VDH IRB. This includes: Research conducted by VDH Research conducted by outside investigators in collaboration with VDH Research conducted by outside investigators using VDH data. Decision-Making Process In brief, the decision-making process [&hellip;]<\/p>\n","protected":false},"author":657,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_lmt_disableupdate":"no","_lmt_disable":"","footnotes":""},"tags":[],"class_list":["post-28","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Determination of IRB Review - Institutional Review Board (IRB)<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.vdh.virginia.gov\/institutional-review-board\/determination-of-irb-review\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Determination of IRB Review - Institutional Review Board (IRB)\" \/>\n<meta property=\"og:description\" content=\"Human Subject Research Not all research requires IRB review. However, any human subject research is usually subject to review and approval by the VDH IRB. This includes: Research conducted by VDH Research conducted by outside investigators in collaboration with VDH Research conducted by outside investigators using VDH data. 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