{"id":161,"date":"2010-09-02T19:33:36","date_gmt":"2010-09-02T23:33:36","guid":{"rendered":"http:\/\/www.marshall.edu\/ori\/?page_id=161"},"modified":"2019-02-20T13:38:03","modified_gmt":"2019-02-20T18:38:03","slug":"what-is-human-subject-research","status":"publish","type":"page","link":"https:\/\/www.marshall.edu\/ori\/office-of-research-integrity\/human-subject-research\/where-do-i-begin\/what-is-human-subject-research\/","title":{"rendered":"What is human subject research?"},"content":{"rendered":"<p style=\"\"><a href=\"https:\/\/www.marshall.edu\/ori\/human-subject-research\/where-do-i-begin\/\">Return to &#8220;Where Do I Begin?&#8221;<\/a><\/p>\n<p>Activities are human subject research under U.S. Department of Health and Human Services (DHHS) regulations when they meet the DHHS definition of <strong>\u201cresearch\u201d <\/strong>(45 CFR \u00a746.102(l)) and involve a<strong> \u201csubject\u201d <\/strong>as defined in DHHS regulations (45 CFR \u00a746.102(e)).<\/p>\n<p>Activities are human subject research under U.S.\u00a0Food and\u00a0Drug Administration (FDA)\u00a0regulations when they meet the FDA definition of <strong>\u201cresearch\u201d<\/strong> (21 CFR \u00a750.3(c), 21 CFR \u00a756.103(c), 21 CFR \u00a7312.3(b) or 21 CFR \u00a7812.3(h)) and involve a <strong>\u201csubject\u201d<\/strong> as defined in FDA regulations (21 CFR \u00a750.3(g), 21 CFR \u00a756.103(e), 21 CFR \u00a7312.3(b) or 21 CFR \u00a7812.3(p)).<\/p>\n<p><strong>Research<\/strong><br \/>\nUnder DHHS regulations (45 CFR \u00a746.102(l)), research\u00a0is defined as:\u00a0 <em>A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.<\/em><\/p>\n<p>Under FDA regulations (21 CFR \u00a750.3(c)), research is defined as:\u00a0 <em>Any experiment that involves a test article and one or more human subjects, and that either is subject to requirements for prior submission to the Food and Drug Administration.<\/em><\/p>\n<p><strong>Human Subject<\/strong><br \/>\nUnder DHHS Regulations (45 CFR \u00a746.102(e)), a human subject\u00a0is defined as:\u00a0 <em>A living individual about whom an investigator (whether professional or student) conducting research: <\/em><\/p>\n<p style=\"\"><em>(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or <\/em><\/p>\n<p style=\"\"><em>(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. <\/em><\/p>\n<p>Under FDA regulations (21 CFR \u00a750.3(g), a human subject is defined as:<\/p>\n<p style=\"margin-left: 40px\"><em>An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A participant may be either a healthy human or a patient.<\/em><\/p>\n<p style=\"margin-left: 40px\"><em>Or in the case of a medical device: A human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A participant may be in normal health or may have a medical condition or disease.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Return to &#8220;Where Do I Begin?&#8221; Activities are human subject research under U.S. Department of Health and Human Services (DHHS) regulations when they meet the DHHS definition of \u201cresearch\u201d (45 CFR \u00a746.102(l)) and involve a \u201csubject\u201d as defined in DHHS regulations (45 CFR \u00a746.102(e)). Activities are human subject research under U.S.\u00a0Food and\u00a0Drug Administration (FDA)\u00a0regulations when<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":141,"menu_order":2,"comment_status":"open","ping_status":"closed","template":"page-sidebar-right.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-161","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/pages\/161","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/comments?post=161"}],"version-history":[{"count":0,"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/pages\/161\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/pages\/141"}],"wp:attachment":[{"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/media?parent=161"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}