{"id":2602,"date":"2016-07-07T17:14:39","date_gmt":"2016-07-07T21:14:39","guid":{"rendered":"https:\/\/www.bumc.bu.edu\/irb\/?page_id=2602"},"modified":"2017-07-05T14:04:16","modified_gmt":"2017-07-05T18:04:16","slug":"definitions","status":"publish","type":"page","link":"https:\/\/www.bumc.bu.edu\/irb\/submission-requirements\/when-to-submit\/definitions\/","title":{"rendered":"Definitions"},"content":{"rendered":"<p><b>Clinical investigation<\/b><span style=\"font-weight: 400;\"> is defined as any experiment that involves a test article and one or more human subjects and that is either subject to requirements for prior submission to the FDA, or the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit.<\/span><\/p>\n<p><b>Employees or agents <\/b><span style=\"font-weight: 400;\">refers to individuals who act on behalf of, exercise authority or responsibility for, or perform activities designated by Boston Medical Center or Boston University.<\/span><\/p>\n<p><b>Human subject <\/b><span style=\"font-weight: 400;\">is defined as a living individual;<\/span><\/p>\n<ul type=\"i\">\n<li><span style=\"font-weight: 400;\">About whom a researcher obtains information or biospecimens\u00a0through <\/span><i><span style=\"font-weight: 400;\">intervention or interaction<\/span><\/i><span style=\"font-weight: 400;\"> with the individual, and uses, studies, or analyzes the information or biospecimens; or <\/span><\/li>\n<li><span style=\"font-weight: 400;\">About whom a researcher obtains, uses, studies, analyzes, or generates<\/span><i><span style=\"font-weight: 400;\"> identifiable<\/span><\/i> <i><span style=\"font-weight: 400;\">private information<\/span><\/i><span style=\"font-weight: 400;\"> about the individual or identifiable biospecimens; or <\/span><\/li>\n<li><span style=\"font-weight: 400;\">Who is or becomes a subject (either a healthy human or a patient) in research, either as a recipient of the test article or as a control\u00a0or upon whose specimens, either identified or not identified, an investigational device is used. <\/span><\/li>\n<\/ul>\n<p><i><span style=\"font-weight: 400;\">Intervention<\/span><\/i><span style=\"font-weight: 400;\"> includes both physical procedures by which information or biospecimens are gathered (for example, venipuncture) and manipulations of the subject or the subject&#8217;s environment that are performed for research purposes. <\/span><i><span style=\"font-weight: 400;\">Interaction<\/span><\/i><span style=\"font-weight: 400;\"> includes communication or interpersonal contact between investigator and subject. <\/span><br \/>\n<i><span style=\"font-weight: 400;\">Private information<\/span><\/i><span style=\"font-weight: 400;\"> includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). <em>Identifiable private information<\/em> is private information for which<\/span><span style=\"font-weight: 400;\"> the identity of the subject is or may readily be ascertained by the investigator or associated with the information. An <em>identifiable biospecimen<\/em> is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.<\/span><\/p>\n<p><b>Research <\/b><span style=\"font-weight: 400;\">is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.<\/span>\u00a0For purposes of this definition, a systematic investigation is the use of a predetermined method to gain information by collecting and analyzing data. Generalizable knowledge is conclusions that can be applied to circumstances outside of the specific instances of the investigation.<\/p>\n<p><span style=\"font-weight: 400;\">More information about definitions and IRB policies may be found by <\/span><span style=\"font-weight: 400;\"><a title=\"Contact Us\" href=\"https:\/\/www.bumc.bu.edu\/irb\/contact-us\/\">contacting us<\/a> <\/span><span style=\"font-weight: 400;\">or at <\/span><span style=\"font-weight: 400;\"><a title=\"HRPP Policies and Procedures\" href=\"http:\/\/www.bumc.bu.edu\/ohra\/hrpp-policies\/\">HRPP Policies and Procedures<\/a><\/span><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Clinical investigation is defined as any experiment that involves a test article and one or more human subjects and that is either subject to requirements for prior submission to the FDA, or the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application [&hellip;]<\/p>\n","protected":false},"author":1250,"featured_media":0,"parent":2599,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/2602"}],"collection":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/users\/1250"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/comments?post=2602"}],"version-history":[{"count":9,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/2602\/revisions"}],"predecessor-version":[{"id":3311,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/2602\/revisions\/3311"}],"up":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/2599"}],"wp:attachment":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/media?parent=2602"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}