{"id":863,"date":"2018-05-29T04:47:54","date_gmt":"2018-05-29T04:47:54","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/adverse-events-aes-other-reportable-information-and-occurrences-orios-other\/"},"modified":"2026-02-23T11:16:57","modified_gmt":"2026-02-23T16:16:57","slug":"adverse-events-aes-other-reportable-information-and-occurrences-orios-other","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/adverse-events-aes-other-reportable-information-and-occurrences-orios-other\/","title":{"rendered":"Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), &amp; Other Required Reporting"},"template":"","categories":[24],"tags":[],"content-type":[41],"topic":[76,42,43,66],"update-type":[],"class_list":["post-863","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","content-type-guidance","topic-adverse-events-other-reportable-information-and-occurrences","topic-application-types","topic-eresearch-regulatory-management-errm","topic-investigator-study-team-responsibilities"],"acf":{"use_legacy_editor":true,"updated_date":"2018-06-11 10:00:00","update_notice":false,"author":"IRBMED","summary":"<a class=\"gtip\" href=\"\/medschool\/glossary\/investigator\">Investigators<\/a> and research staff are responsible for reporting information concerning the <a class=\"gtip\" href=\"\/medschool\/glossary\/approved-decision\">approved<\/a> research to the <a class=\"gtip\" href=\"\/medschool\/glossary\/institutional-review-board-irb\">IRB<\/a> in a timely fashion, understanding and adhering to the reporting guidance provided here and on the detail pages linked below, and not implementing any changes to the <a class=\"gtip\" href=\"\/medschool\/glossary\/research\">research<\/a> prior to IRB approval of the change via an amendment application (when changes are necessary to eliminate apparent immediate hazards to the subject, implement the change and report by an <a class=\"gtip\" href=\"\/medschool\/glossary\/other-reportable-information-or-occurrence-orio\">ORIO<\/a> and\/or amendment submission within\u00a0<a class=\"gtip\" href=\"\/medschool\/glossary\/7-calendar-days\">7 calendar days<\/a>\u00a0after the action is taken). This includes all information with the potential to impact the <a class=\"gtip\" href=\"\/medschool\/glossary\/risk\">risk<\/a> or <a class=\"gtip\" href=\"\/medschool\/glossary\/benefit\">benefit<\/a> assessments of the research.\r\n\r\nFailure to follow these requirements may require the institution to take disciplinary actions, restrict research privileges, and report the <a class=\"gtip\" href=\"\/medschool\/glossary\/non-compliance\">non-compliance<\/a> to government agencies and\/or study <a class=\"gtip\" href=\"\/medschool\/glossary\/sponsor\">sponsor<\/a>.\r\n\r\nSee the ClinicalTrials.gov site for <a href=\"https:\/\/prsinfo.clinicaltrials.gov\/results_definitions.html#AdverseEventsDefinition\">adverse event definitions<\/a>.","button_links":null,"related_content":[738,734,732,774,761,770],"legacy_path":"adverse-events-aes-other-reportable-information-and-occurrences-orios-other","legacy_node_id":522,"legacy_related_nids":"276, 263, 261, 316, 303, 312","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"Required Reporting","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<ul>\r\n \t<li><a href=\"\/medschool\/guidance\/unanticipated-problems-involving-risks-subjects-or-others\">Unanticipated Problems Guidance<\/a><\/li>\r\n \t<li><a href=\"\/medschool\/guidance\/adverse-event-reporting\">UM Adverse Events Reporting Timetable<\/a><\/li>\r\n \t<li><a href=\"\/medschool\/guidance\/external-adverse-event-ae-reporting\">External Adverse Events Timetable<\/a><\/li>\r\n \t<li><a href=\"\/medschool\/guidance\/humanitarian-use-device-requirements-u-m-physicians-investigators\">Humanitarian Use Device (HUD) Reporting for HUDs under a Humanitarian Device Exemption (HDE)<\/a><\/li>\r\n \t<li><a href=\"\/medschool\/guidance\/other-reportable-information-or-occurrence-orio\">Other Reportable Information and Occurrences Timetable and Guidance<\/a><\/li>\r\n<\/ul>\r\n<strong>Please note that this guidance is for reporting to the IRBMED only and does not satisfy required reporting by an investigator to other internal or external oversight agencies or departments (e.g., the <a class=\"gtip\" href=\"\/medschool\/glossary\/food-and-drug-administration-fda\">FDA<\/a>, UMHS Compliance Office, <a class=\"gtip\" href=\"\/medschool\/glossary\/data-and-safety-monitoring-board-dsmb\">DSMB<\/a>, or Privacy Offices).\u00a0<\/strong>Additional information regarding reporting responsibilities is found in the UM Human Research Protection Program\u00a0<a href=\"https:\/\/hrpp.umich.edu\/resource\/operations-manual\/\">Operations Manual<\/a> part 12.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"Why are these reports required by the IRB?","legacy_section_text":"IRBs are charged by Federal regulations, the <a class=\"gtip\" href=\"\/medschool\/glossary\/dean\">Dean<\/a> of the Medical School, and the University's Vice President for <a class=\"gtip\" href=\"\/medschool\/glossary\/research\">Research<\/a> with the oversight of <a class=\"gtip\" href=\"\/medschool\/glossary\/human-subject-0\">human subjects<\/a> research conducted by faculty, students, or staff of the University, the Medical School, and the University of Michigan Health System.<em>\u00a0This is a cooperative mission carried out through a relationship between the IRBs and investigators.<\/em>\r\n\r\nHuman subjects research may include <a class=\"gtip\" href=\"https:\/\/www.ecfr.gov\/current\/title-45\/part-46#p-46.102(e)(3)\">interactions<\/a> and\/or <a class=\"gtip\" href=\"https:\/\/www.ecfr.gov\/current\/title-45\/part-46#p-46.102(e)(2)\">interventions<\/a> directly with subjects or involve the collection or analysis of information created or received by the Health System in caring for its patients or from other private or public sources.\r\n\r\nAn essential element of human subjects protection is identifying, analyzing the causes of, and responding appropriately to expected and <a class=\"gtip\" href=\"\/medschool\/glossary\/unexpected-adverse-event\">unexpected adverse events<\/a>, as well as <a class=\"gtip\" href=\"\/medschool\/glossary\/unanticipated-problem-involving-risks-subjects-or-others-upirso-uap\">unanticipated problems<\/a> involving <a class=\"gtip\" href=\"\/medschool\/glossary\/risk\">risks<\/a> to subjects or others. <a class=\"gtip\" href=\"\/medschool\/glossary\/investigator\">Investigators<\/a> are required to identify and help analyze the events and to formulate responses.\r\n\r\nThe IRB is required to make independent judgments concerning the significance of events and information in the context of the research project and the need for changes to the study <a class=\"gtip\" href=\"\/medschool\/glossary\/protocol\">protocol<\/a> and\/or <a class=\"gtip\" href=\"\/medschool\/glossary\/informed-consent\">informed consent<\/a> process to protect research subjects.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"Adverse Events (AE) Reporting","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<a class=\"gtip\" href=\"\/medschool\/glossary\/adverse-event-ae\">Adverse Events (AEs)<\/a>\u00a0are events that involve physiological, social, economic, or psychological harm to subjects. These adverse events may also indicate risks of harm to additional subjects or others. AEs include expected and <a class=\"gtip\" href=\"\/medschool\/glossary\/unexpected\">unexpected<\/a> harmful effects, and unexpected harms of an\u00a0<a class=\"gtip\" href=\"https:\/\/www.ecfr.gov\/current\/title-45\/part-46#p-46.102(e)(3)\">interaction<\/a>\u00a0or an\u00a0<a class=\"gtip\" href=\"https:\/\/www.ecfr.gov\/current\/title-45\/part-46#p-46.102(e)(2)\">intervention<\/a>.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"The 'Study-Specific' AE Reporting Option","legacy_section_text":"Instead of using the\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/adverse-event-reporting\">U-M Standard Timetable<\/a>, <a class=\"gtip\" href=\"\/medschool\/glossary\/investigator\">investigators<\/a> can propose a plan designed for their study. A study-specific plan is encouraged for minimal to moderate risk studies that are not under <a class=\"gtip\" href=\"\/medschool\/glossary\/fda-oversight\">FDA oversight<\/a>. Many sponsored studies include an AE reporting plan. Know your options! For more information, view the <a href=\"\/medschool\/guidance\/study-specific-adverse-event-ae-reporting-plans\">Study-Specific Adverse Event (AE) Reporting Plans<\/a> guidance.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"AEs may be caused by:","legacy_section_text":"<ul>\r\n \t<li>the\u00a0<a class=\"gtip\" href=\"\/medschool\/glossary\/test-article\">test article<\/a>\u00a0or\u00a0test procedure<\/li>\r\n \t<li>other aspects of the\u00a0interaction\u00a0or\u00a0intervention<\/li>\r\n \t<li>the subject's\u00a0<a class=\"gtip\" href=\"\/medschool\/glossary\/underlying-condition\">underlying condition<\/a><\/li>\r\n \t<li>the subject's\u00a0concurrent standard treatment<\/li>\r\n \t<li>research information that is disclosed inappropriately.<\/li>\r\n<\/ul>\r\nAEs may be <a class=\"gtip\" href=\"\/medschool\/glossary\/definitely-related-adverse-event\">definitely related<\/a>, <a class=\"gtip\" href=\"\/medschool\/glossary\/probably-related-adverse-event\">probably related<\/a>, <a class=\"gtip\" href=\"\/medschool\/glossary\/possibly-related-adverse-event\">possibly related<\/a>, <a class=\"gtip\" href=\"\/medschool\/glossary\/unlikely-related-adverse-event\">unlikely to be related<\/a>, or <a class=\"gtip\" href=\"\/medschool\/glossary\/unrelated-adverse-event\">definitely not related<\/a>\u00a0<em>to the research<\/em>. To be considered \"related\" to the research does not simply mean caused by a test agent like a survey, an investigational drug or device, but encompasses all procedures that are done solely for research purposes (i.e. they would not have taken place had the subject not been in the study).\r\n\r\nAEs may be observed in the specified project or in other research settings similar to that of the specified project, or in projects involving a similar intervention.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"Other Reportable Information or Occurrences (ORIO)","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"Regulations require investigators to report information and events beyond adverse events. Events in which no one suffered an adverse event (i.e. actual harm) but indicate risk(s) of potential adverse events must be reported. The IRB must be apprised of reports from other oversight entities that are received by an investigator such as a report from the <a class=\"gtip\" href=\"\/medschool\/glossary\/food-and-drug-administration-fda\">FDA<\/a>, <a class=\"gtip\" href=\"\/medschool\/glossary\/data-and-safety-monitoring-board-dsmb\">DSMB<\/a>, or an analysis from the <a class=\"gtip\" href=\"\/medschool\/glossary\/sponsor\">sponsor<\/a>. Also, any event or information that may increase risks, may alter the risk-benefit assessment, may affect subjects' willingness to participate in the research, or may represent a departure from applicable <a class=\"gtip\" href=\"\/medschool\/glossary\/human-subject-0\">human subject<\/a> protection regulations or policies. Investigators must also report any\/all changes in research, including closure of accrual or completion of a study.\r\n\r\nPlease see the\u00a0<a href=\"\/medschool\/guidance\/other-reportable-information-or-occurrence-orio\">ORIO page<\/a>\u00a0for more details.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"Unanticipated Problems Involving Risks to Subjects or Others (UaPs or UPIRSOs)","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"Some <a class=\"gtip\" href=\"\/medschool\/glossary\/adverse-event-ae\">AEs<\/a> and <a class=\"gtip\" href=\"\/medschool\/glossary\/other-reportable-information-or-occurrence-orio\">ORIOs<\/a> require special attention by investigators and IRBs when they meet the criteria of constituting a <a class=\"gtip\" href=\"\/medschool\/glossary\/unanticipated-problem-involving-risks-subjects-or-others-upirso-uap\">Unanticipated Problem<\/a>. Unanticipated Problems meet <strong>all of the following criteria<\/strong>:\r\n\r\n1.\u00a0 <strong><a class=\"gtip\" href=\"\/medschool\/glossary\/unexpected\">Unexpected<\/a> <\/strong>(in terms of nature, <a class=\"gtip\" href=\"\/medschool\/glossary\/severity\">severity<\/a>, or frequency);\r\n\r\n2.\u00a0 <strong>Related or possibly related to participation in the research<\/strong>; and\r\n\r\n3.\u00a0 Suggests that the research places subjects or others at <strong>a greater risk of harm<\/strong> than was previously known or recognized.\r\n\r\nSee the <a href=\"\/medschool\/guidance\/unanticipated-problems-involving-risks-subjects-or-others\">Unanticipated Problems Involving Risks to Subjects or Others<\/a> page and <a href=\"https:\/\/hrpp.umich.edu\/resource\/operations-manual\/\">U-M HRPP Operations Manual<\/a> Part 12.II for more details.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null}],"update_notice_type":[],"update_notice_start":"","update_notice_end":"","update_notice_text_blocks":null,"global_contact_block":false,"contact_name":"","contact_email":"","contact_additional_info":"Contact us at\u00a0<a href=\"mailto:irbmed@umich.edu\">irbmed@umich.edu<\/a>\u00a0or 734-763-4768 \/ (Fax 734-763-1234)\r\n\r\n2800 Plymouth Road, Ann Arbor, MI 48109-2800\r\n\r\nA <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-contacts-roster#irbmed-staff\">list of IRBMED staff<\/a> is available at our website.\r\n\r\nEdited By: <a href=\"mailto:larkspur@umich.edu\">larkspur@umich.edu<\/a>\r\nLast Updated: February 23, 2026 11:15AM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/863","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document"}],"about":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/types\/document"}],"version-history":[{"count":4,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/863\/revisions"}],"predecessor-version":[{"id":1881,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/863\/revisions\/1881"}],"acf:post":[{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/770"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/761"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/774"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/732"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/734"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/738"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=863"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=863"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=863"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=863"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=863"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=863"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}