{"id":18266,"date":"2026-09-10T17:05:46","date_gmt":"2026-09-10T21:05:46","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=18266"},"modified":"2026-09-29T10:46:04","modified_gmt":"2026-09-29T14:46:04","slug":"new-study-application","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/irb-submissions\/new-study-application\/","title":{"rendered":"New Study Application"},"content":{"rendered":"","protected":false},"excerpt":{"rendered":"","protected":false},"author":82,"featured_media":0,"parent":16286,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-18266","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"New Study Application","subtitle":"A new study application is used for any study that is being considered for initial review and approval.","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":"text","anchor":"","css_class":"","title":"","content":"<h2><strong>Defining human subjects research<\/strong><\/h2>\r\nHuman subject research is defined by the Office of Human Research Protections in\u00a0<a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/section-46.102\">45 CFR 46.102<\/a>. A clinical investigation is defined by the Food and Drug Administration in\u00a0<a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/part-50\/section-50.3#p-50.3(c)\">21 CFR 50.3(c)<\/a>. Research that meets either of these definitions must be reviewed by URochester IRB.\r\n\r\nOnly OHSP and URochester IRB have the authority to determine whether the research URochester faculty, staff, and students are conducting is considered human subject research. Individual investigators cannot make human subject research determinations on their own.\r\n\r\n[su_spacer size=\"40\"]\r\n<h2><strong>New Study Application Requirements<\/strong><\/h2>\r\nInvestigators applying for any initial approval of a proposed research protocol must submit a completed New Study Application form. The form is submitted via the\u00a0<a href=\"https:\/\/rochesterirb.huronresearchsuite.com\/\">Click IRB system<\/a>.\r\n\r\nConsent documents, recruitment materials, questionnaires\/surveys, interview scripts, and other documents that may be required for review are uploaded as part of the application in Click IRB.\r\n\r\nThe Principal Investigator is responsible for the overall conduct of the research, including submission of the IRB application. While individual tasks, such as completing the application forms, may be delegated to research team members, the information submitted is the responsibility of the PI.","background_color":"#ffffff","width":"width-medium"}]},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>New Study Application - Office for Human Subject Protection<\/title>\n<meta name=\"description\" content=\"A New Study Application is used for any study that is being considered for initial 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.rochester.edu\/ohsp\/irb-review\/irb-submissions\/new-study-application\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New Study Application - Office for Human Subject Protection\" \/>\n<meta property=\"og:description\" content=\"A New Study Application is used for any study that is being considered for initial IRB review and approval.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/irb-submissions\/new-study-application\/\" \/>\n<meta property=\"og:site_name\" content=\"Office for Human Subject Protection\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-29T14:46:04+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/irb-review\\\/irb-submissions\\\/new-study-application\\\/\",\"url\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/irb-review\\\/irb-submissions\\\/new-study-application\\\/\",\"name\":\"New Study Application - 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