{"id":436,"date":"2023-12-22T12:54:13","date_gmt":"2023-12-22T17:54:13","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=436"},"modified":"2026-09-09T17:43:12","modified_gmt":"2026-09-09T21:43:12","slug":"exemptions","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/exemptions\/","title":{"rendered":"Exemptions"},"content":{"rendered":"

OHSP policy<\/a> requires Institutional Review Board (IRB) review of all human subject research conducted or supported by employees or agents of the University of Rochester. This includes research that falls into one of the exemption categories defined by Department of Health and Human Service (HHS) regulation (45 CFR 46.104<\/a>).<\/p>\n

Based on review requirements, ‘IRB exemption’ does not mean that review by the University of Rochester’s Institutional Review Board is not required. Rather, ‘exempt’ means that once the IRB confirms the research meets exemption criteria, further reporting to the IRB is not required (provided there are no changes to the research, nor reports of new information).<\/p>\n

For a description of IRB exemption categories, review our Exempt Status Guidance<\/a>.<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

OHSP policy requires Institutional Review Board (IRB) review of all human subject research conducted or supported by employees or agents of the University of Rochester. This includes research that falls…<\/p>\n","protected":false},"author":36,"featured_media":0,"parent":356,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-436","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"RSRB (IRB) Exemptions","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":"accordion_new","anchor_id":"","classes":"","title":"

IRB submission requirements and review process<\/h2>","description":"","background":"decorative","background_color":"#ffffff","style":"row_blank","expand":"yes","accordions":[{"acf_fc_layout":"accordion","accordion_title":"How to submit","icon":"","row_content":"All proposals must be submitted for review via Click IRB<\/a>.<\/em>\r\n\r\nThe Investigator submitting the research must meet the qualifications and requirements of Principal Investigator, as defined in OHSP Policy 901: Investigator Responsibilities<\/a>.\r\n\r\nFor student projects, faculty mentors must be included as study team members and be identified as PI Proxy<\/a>.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Materials required for submission","icon":"","row_content":"Minimally, all submissions must include a study protocol and completed Data Security Assessment Form [icon name=\"file-word\" prefix=\"fas\"]<\/a>. Study protocol templates are available as follows:\r\n