{"id":3676,"date":"2024-01-04T15:48:47","date_gmt":"2024-01-04T20:48:47","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=3676"},"modified":"2024-02-06T13:28:30","modified_gmt":"2024-02-06T18:28:30","slug":"concept-studies","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/resources\/concept-studies\/","title":{"rendered":"Concept Studies"},"content":{"rendered":"<p>A concept study is an idea (concept) for a research study, which is submitted for IRB review prior to the development of a complete protocol.<\/p>\n<p>A concept study application allows for Institutional Review Board (IRB) review and approval of a study that is still in the concept stage of development; it is a mechanism to review <em>funded<\/em> proposals which provide a period of time (and sometimes funding) for the full development of the study protocol, measures, consent forms, recruitment materials, etc.<\/p>\n<p><strong>These types of submissions are typically only necessary when a funding agency\/organization requires documentation of IRB review prior to the development of full study protocol.<\/strong> For example, the National Science Foundation (NSF) requires certification or its equivalent from the IRB in order to recommend funding involving human subject proposals; a concept study submission is the mechanism by which the Research Subjects Review Board (RSRB) provides this review.<\/p>\n<p><strong>Once the full study protocol and all supporting materials have been developed, they need be submitted to the IRB for review and approval <em>as a new submission<\/em>; the concept submission can then be closed.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A concept study is an idea (concept) for a research study, which is submitted for IRB review prior to the development of a complete protocol. A concept study application allows&hellip;<\/p>\n","protected":false},"author":36,"featured_media":0,"parent":236,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-3676","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Concept Studies - Office for Human Subject Protection - University of Rochester<\/title>\n<meta name=\"description\" content=\"Reference the definition of a concept study, and learn how to submit a concept study in Click IRB. 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