{"id":30404,"date":"2021-01-19T20:25:41","date_gmt":"2021-01-20T01:25:41","guid":{"rendered":"https:\/\/www.campbell.edu\/?page_id=30404"},"modified":"2025-10-23T11:47:54","modified_gmt":"2025-10-23T15:47:54","slug":"determine-if-your-project-requires-irb-review","status":"publish","type":"page","link":"https:\/\/www.campbell.edu\/about\/leadership\/provost\/institutional-review-board\/for-investigators\/determine-if-your-project-requires-irb-review\/","title":{"rendered":"Determine If Your Project Requires IRB Review"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">Investigators engaged in human subject research are required to obtain either a Determination of Registration, Exempt Determination, or IRB approval before research activities begin.\u00a0<\/span><span style=\"font-weight: 400;\">To determine if your project requires IRB review, you will need to <strong>first determine that your project meets both the federal definitions of <\/strong><\/span><strong><em>research<\/em> and <em>human subjects<\/em>.<\/strong><\/p>\n<h2>Are you doing research?<\/h2>\n<p><span style=\"font-weight: 400;\">Research is defined as \u201ca systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.\u201d<\/span><\/p>\n<h2>Does the research involve human subjects?<\/h2>\n<p><span style=\"font-weight: 400;\">The human subject is \u201ca living individual about whom an investigator (whether professional or student) conducting research:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens;\n<p><em>OR<\/em><\/p>\n<p><\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens.<\/span><\/li>\n<\/ul>\n<h2><span style=\"font-weight: 400;\">Tools to Help You Determine<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Use our <\/span><a href=\"https:\/\/assets.campbell.edu\/wp-content\/uploads\/2022\/01\/IRB-HSR-Determination-Worksheet.v.1.20.22.docx\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Human Subjects Research Determination Worksheet<\/span><\/a><span style=\"font-weight: 400;\"> and the <\/span><a href=\"https:\/\/assets.campbell.edu\/wp-content\/uploads\/2018\/09\/Guidance-Projects-Not-Meeting-the-Definition-of-Research.v1.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">IRB Guidance: Projects Not Meeting the Definition of Research<\/span><\/a><span style=\"font-weight: 400;\"> to assist you in carefully considering whether your project meets the federal definitions discussed above. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">If after completing the worksheet and reading the guide, you are unsure whether your project requires review contact the <\/span><a href=\"mailto:irbadmin@campbell.edu\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">IRB Office<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">If your study does meet the definition of human subject research, you will most likely need IRB approval to conduct your research project<\/span><span style=\"font-weight: 400;\">. <\/span><b>Human subject research activities may not begin until determination or IRB approval is issued by the IRB.<\/b><\/p>\n<h2>Is Campbell University engaged in human subjects research?<\/h2>\n<p><span style=\"font-weight: 400;\">The IRB will review research for which Campbell University is engaged.\u00a0<\/span><span style=\"font-weight: 400;\">An institution is considered engaged in human subjects research when its employees or agents for the purpose of the research project obtain:<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Data about the subjects of the research through intervention or interaction with them;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Identifiable private information about the subjects of the research; or<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">The informed consent of human subjects for the research.<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">If you are conducting the human subject research as part of your affiliation with Campbell University (i.e., in your capacity as a faculty, student, staff, etc.), then Campbell University is engaged.\u00a0 <strong>When you collaborate with institutions outside of Campbell University, Campbell&#8217;s engagement as well as the other institution&#8217;s engagement needs to be determined by the IRB.<\/strong> For more information about engagement of research, see <\/span><a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/guidance-on-engagement-of-institutions\/index.html\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">OHRP\u2019s guidance on the engagement of institutions in human subjects research<\/span><\/a><span style=\"font-weight: 400;\"> or\u00a0 <a href=\"https:\/\/assets.campbell.edu\/wp-content\/uploads\/2022\/01\/Guidance-Determining-Engagement-in-Research.v1.pdf\">Guidance: Determining Engagement in Research<\/a>. These guidance documents include scenarios and examples of when an institution is or is not engage in human subjects research.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Investigators engaged in human subject research are required to obtain either a Determination of Registration, Exempt Determination, or IRB approval&hellip; <\/p>\n<div class=\"link--more\"><span>More<\/span><span> on this post<\/span><\/div><\/p>\n","protected":false},"author":162,"featured_media":0,"parent":30352,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"coauthors":[190,281,304],"class_list":["post-30404","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Determine If Your Project Requires IRB Review - Institutional Review Board - Campbell University<\/title>\n<meta name=\"description\" content=\"Resources to help investigators determine if a project requires Institutional Review Board (IRB) review and approval.\" \/>\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.campbell.edu\/about\/leadership\/provost\/institutional-review-board\/for-investigators\/determine-if-your-project-requires-irb-review\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Determine If Your Project Requires IRB Review - 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