{"id":16976,"date":"2026-07-17T15:22:08","date_gmt":"2026-07-17T19:22:08","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=16976"},"modified":"2026-09-29T13:46:56","modified_gmt":"2026-09-29T17:46:56","slug":"unanticipated-problems","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/resources\/unanticipated-problems\/","title":{"rendered":"Unanticipated Problems"},"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-16976","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"Unanticipated Problems","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":"Investigators must report all potential unanticipated problems and events to the IRB.\r\n\r\n<strong>Unanticipated problems<\/strong>\u00a0(UPs) are defined as\u00a0<strong>any incident, experience, or outcome that meets all of the following criteria<\/strong>:\r\n<ul>\r\n \t<li><strong>Unexpected<\/strong>\u00a0(unforeseen by the researcher or the research participant) in terms of nature, severity, or frequency, given the research procedures and the subject population being studied;<\/li>\r\n \t<li><strong>Related or probably\u00a0related to participation in the research<\/strong>, or if the event or problem probably or definitely affects the safety, rights and welfare of current participants;<\/li>\r\n \t<li>Suggests that the<strong>\u00a0research places subjects or others at a\u00a0greater risk of harm<\/strong>\u00a0(including physical, psychological, economic or social harm) than was previously known or recognized.<\/li>\r\n<\/ul>","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"text","anchor":"","css_class":"","title":"<h2 id=\"how_to_report_a_potential_unanticipated_problem_3\" tabindex=\"-1\">How to Report a Potential Unanticipated Problem<\/h2>","content":"The Investigator must consider each problem, event, or new information and decide whether or not it represents an Unanticipated Problem using the criteria above.\r\n<h4>If Unanticipated Problem Criteria Are Met:<\/h4>\r\nReport the problem, event, or information using the <a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/rsrb-submissions\/reports-of-new-information\/\">Report of New Information application (RNI)<\/a>. The RNI must be submitted promptly, within <strong>10 business days<\/strong> from the time the investigator learns of the event.\r\n\r\nIf you will be making changes to the study based on the information you are reporting, a modification will be needed.\r\n\r\nIf 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.\r\n\r\nIn the RNI application, be sure to state that you are submitting a modification as part of your corrective and preventive action plan.\r\n<h4>If Unanticipated Problem Criteria Are Not Met:<\/h4>\r\n<ol>\r\n \t<li>Document in the research record how the problem\/event\/information does not meet the UP Criteria.<\/li>\r\n \t<li>Summarize the problem\/event\/information in the next Continuing Review application.<\/li>\r\n<\/ol>","background_color":"#f4f4f4","width":"width-medium"},{"acf_fc_layout":"text","anchor":"","css_class":"","title":"<h2 id=\"examples_of_potential_unanticipated_problems_4\" tabindex=\"-1\">Examples of Potential Unanticipated Problems<\/h2>","content":"<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/adverse-events\/\">Adverse events<\/a><\/li>\r\n \t<li>A <a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/breaches-of-confidentiality\/\">breach of confidentiality or privacy<\/a> that involves real or potential risk (e.g., unauthorized use or disclosure of protected health information)<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/adverse-device-effects\/\">Adverse device effects<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/data-safety-monitoring-plans\/\">Data and safety monitoring reports<\/a>\u00a0that indicate that frequency or magnitude of harms or benefits may be different than initially presented to the IRB<\/li>\r\n \t<li>A publication that shows that the risks or potential benefits or the research may be different than initially presented to the IRB<\/li>\r\n \t<li>Change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research protocol<\/li>\r\n \t<li>Incarceration of a participant\u00a0in a protocol not approved to enroll prisoners<\/li>\r\n \t<li>Complaints from participants\u00a0or others involved in the research that indicate unexpected risks or cannot be resolved by the research team<\/li>\r\n \t<li>Warning or determination letters issued by any funding agency or regulatory body including Office of Human Research Protections (OHRP), Department of Health and Human Services (DHHS), Food and Drug Administration (FDA)<\/li>\r\n<\/ul>","background_color":"#ffffff","width":"width-medium"}]},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - 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