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
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 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 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 Institutional Review Board (IRB) provides this review.<\/p>\n Once the full study protocol and all supporting materials have been developed, they need be submitted to the IRB for review and approval as a new submission<\/em>; the concept submission can then be closed.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":" 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…<\/p>\n","protected":false},"author":36,"featured_media":0,"parent":236,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-3676","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"","subtitle":"","call_to_action":"","hero_image_placement":"no_image","hero_media":"images","hero_pattern_option":"","hero_video":"","hero_image_landing":"","hero_image_landing_two":"","hero_image_landing_three":"","content_modules":[{"acf_fc_layout":"card_grid","anchor":"","css_class":"","title":"","description":"","background_color":"#FFFFFF","width":"width-medium","columns":"1","cards":[{"card_title":"","card_text":"Note: <\/strong>Subject recruitment, enrollment, and data collection can only take place under the IRB submission with the fully developed study protocol and materials, not<\/em> the concept study.","card_background_color":"#f4f4f4","card_hover_color":"transparent","card_link":"","card_hover_arrow":"","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""}]},{"acf_fc_layout":"text","anchor":"","css_class":"","title":"How to submit a concept study in Click IRB<\/h2>","content":"As with all other submissions, Institutional Review Board (IRB) review of concept studies is facilitated through the Click IRB module within the Integrated Online Research Administration (IORA) system. Step-by-step instructions for navigating the Click IRB system and submitting proposals for IRB review are available in the Click IRB: Study Staff Guide<\/a>.\r\n\r\nIn addition to these instructions, when submitting a concept study:\r\n
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Related resources<\/h2>","description":"","background_color":"#FFFFFF","width":"width-large","columns":"3","cards":[{"card_title":"
Click IRB resources<\/h5>","card_text":"","card_background_color":"#f4f4f4","card_hover_color":"#283faf","card_link":{"title":"Click IRB Resources","url":"https:\/\/www.rochester.edu\/ohsp\/click-irb\/","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"
Click IRB study staff guide<\/h5>","card_text":"","card_background_color":"#f4f4f4","card_hover_color":"#283faf","card_link":{"title":"","url":"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/ClickIRB_StudyStaffManual.pdf","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"
IRB overview<\/h5>","card_text":"","card_background_color":"#f4f4f4","card_hover_color":"#283faf","card_link":{"title":"IRB and RSRB Overview","url":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""}]}]},"yoast_head":"\n