{"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":{"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":"<h2>Description<\/h2>","content":"A\u00a0<strong>deviation<\/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\u00a0<em>unplanned<\/em>\u00a0and\/or\u00a0<em>unintentional<\/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":"<h2><strong>Criteria for Reporting Deviations<\/strong><\/h2>","content":"The URochester IRB requires researchers to submit deviations that meet <strong>one or more<\/strong>\u00a0of the following criteria:\r\n<ul>\r\n \t<li><strong>Intended to eliminate apparent immediate hazard<\/strong>\u00a0to a research participant (such as changing the dose of a medication due to possible toxicity);<\/li>\r\n \t<li><strong>Caused possible harm<\/strong>\u00a0to participants or others, or places them at increased risk of harm - including physical, psychological, economic, or social harm, such as a breach of confidentiality;<\/li>\r\n \t<li><strong>Possible serious or continued non-compliance<\/strong>\u00a0(such as a deviation that has happened previously and is now being repeated).\r\n<ul>\r\n \t<li><strong>Serious non-compliance\u00a0<\/strong>is an act or omission to act that resulted in significant harm (physical, psychological, safety, or privacy) or significantly increased the possibility of harm to the rights and welfare of research participants.<\/li>\r\n \t<li><strong>Continuing non-compliance<\/strong> is a\u00a0pattern of repeated actions or omissions to act that suggests a future likelihood of recurrence, and that indicates a deficiency in the ability or willingness to comply with Federal regulations or the policy, requirements, and determinations of the IRB governing human subject research.<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\nThe IRB recognizes that some deviations pose no conceivable threat to participant safety or scientific integrity. For example, when the subject misses a study visit, and the only available reschedule date is outside the study visit window, but no study procedures are missed. In this case, the subject may not incur possible harm from a missed procedure meant to maintain or evaluate the subject's safety and welfare. \u00a0As such, reporting is left to the discretion of the PI within the context of the guidelines above. Though a deviation may not pose a conceivable threat or possible harm, it may represent possible continuing non-compliance.<strong>\u00a0<\/strong>","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"text","anchor":"","css_class":"","title":"<h2><strong>How to Report a Deviation<\/strong><\/h2>","content":"The Investigator must consider each deviation and decide whether or not it meets the reporting criteria above.\r\n<h4><strong>Criteria Are Met:<\/strong><\/h4>\r\nReport the deviation using the RNI Application. The RNI must be submitted promptly, within 10 business days from the time the investigator learns of the deviation.\r\n<ol>\r\n \t<li>In the Click IRB system, \"Create\" a <a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/irb-submissions\/reports-of-new-information\/\">Report of New Information (RNI)<\/a> application. \u00a0An RNI can be created from the main dashboard or from within a study's workspace using the Report of New Information button in the lefthand menu.<\/li>\r\n \t<li>Complete the RNI application with as much information as possible.<\/li>\r\n \t<li>Select the study or studies that are related to the deviation you are reporting.<\/li>\r\n \t<li>If you will be making changes to the study based on the information you are reporting, a modification will be needed. \u00a0Once the modification application has been created, it will be available to select as a related submission in the RNI application (#8) if you have selected the parent study. \u00a0Use the help text (question button) in the RNI application #8 for assistance if the modification is not showing up in the list of options.<\/li>\r\n \t<li>Once you have completed the RNI and linked it to any studies or modifications applicable, select \"Submit RNI\".<\/li>\r\n<\/ol>\r\n<h4><strong>Criteria Are Not Met:<\/strong><\/h4>\r\n<ol>\r\n \t<li>Document in the research record how the deviation does not meet the reporting criteria.<\/li>\r\n \t<li>Log the deviation such that it can be evaluated in the future if other deviations occur.<\/li>\r\n<\/ol>","background_color":"#f4f4f4","width":"width-medium"}]},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - 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