{"id":16746,"date":"2026-07-13T17:03:34","date_gmt":"2026-07-13T21:03:34","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=16746"},"modified":"2026-09-29T13:49:55","modified_gmt":"2026-09-29T17:49:55","slug":"deviations","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/resources\/deviations\/","title":{"rendered":"Deviations"},"content":{"rendered":"","protected":false},"excerpt":{"rendered":"","protected":false},"author":82,"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-16746","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"Deviations","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":"text","anchor":"","css_class":"","title":"

Description<\/h2>","content":"A\u00a0deviation<\/strong> is ANY departure from the defined procedures and treatment plans as outlined in the protocol version or application version submitted and previously approved by the IRB. Deviations have the potential to place participants at risk and can also undermine the scientific integrity of the study, thus jeopardizing the justification for the research.\r\n\r\nDeviations are\u00a0unplanned<\/em>\u00a0and\/or\u00a0unintentional<\/em> events. Any changes in the IRB-approved research protocol should not be initiated without submission of an amendment for IRB review and approval.\u00a0 If such changes are initiated before IRB approval for the change is given, a deviation has occurred.\u00a0 Sometimes the deviation is the result of an act or omission to act by the PI or research team, but it is also possible that the deviation is the result of an act or omission to act by a participant.\u00a0 For example, a participant did not follow the instructions provided by the study team from the protocol, and thus, data collection was not possible; this still represents a deviation from the protocol.","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"text","anchor":"","css_class":"","title":"

Criteria for Reporting Deviations<\/strong><\/h2>","content":"The URochester IRB requires researchers to submit deviations that meet one or more<\/strong>\u00a0of the following criteria:\r\n