Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), and Other Required Reporting
Investigators and research staff are responsible for reporting information concerning the approved research to the IRB 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 research 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 ORIO and/or amendment submission within 7 days after the action is taken). This includes all information with the potential to impact the risk or benefit assessments of the research.
Failure to follow these requirements may require the institution to take disciplinary actions, restrict research privileges, and report the non-compliance to government agencies and/or study sponsor.
- Unanticipated Problems Guidance
- UM Adverse Events Reporting Timetable
- External Adverse Events Timetable
- Humanitarian Use Device (HUD) Reporting for HUDs under a Humanitarian Device Exemption (HDE)
- Other Reportable Information and Occurrences Timetable and Guidance
- Retrospective Data Analysis Studies--Required Reporting
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 FDA, UMHS Compliance Office, DSMB, or Privacy Offices). Additional information regarding reporting responsibilities is found in the UM Human Research Protection Program Operations Manual, part 12.
Why are these reports required by the IRB?
IRBs are charged by Federal regulations, the Dean of the Medical School, and the University's Vice President for Research with the oversight of human subjects research conducted by faculty, students, or staff of the University, the Medical School, and the University of Michigan Health System. This is a cooperative mission carried out through a relationship between the IRBs and investigators.
Human subjects research may include interactions and/or interventions 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.
An essential element of human subjects protection is identifying, analyzing the causes of, and responding appropriately to expected and unexpected adverse events, as well as unanticipated problems involving risks to subjects or others. Investigators are required to identify and help analyze the events and to formulate responses.
The 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 protocol and/or informed consent process to protect research subjects.
Adverse Events (AE) Reporting
AEs are 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 unexpected harmful effects, and unexpected harms of an interaction or an intervention.
The 'Study-Specific' AE Reporting Option
Instead of using the UM Standard Timetable, investigators can propose a plan designed for their study. A study-specific plan is encouraged for minimal to moderate risk studies that are not under FDA oversight. Many sponsored studies include an AE reporting plan. Know your options! Follow this link for more information.
AEs may be caused by:
- the test article or test procedure
- other aspects of the interaction or intervention
- the subject's underlying condition
- the subject's concurrent standard treatment
- research information that is disclosed inappropriately.
The 'Study-Specific' AE Reporting Option
Instead of using the UM Standard Timetable, investigators can propose a plan designed for their study. A study-specific plan is encouraged for minimal to moderate risk studies that are not under FDA oversight. Many sponsored studies include an AE reporting plan. Know your options!.
AEs may be definitely related, probably related, possibly related, unlikely to be related, or definitely not related to the research. 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).
AEs 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.
Other Reportable Information or Occurrences (ORIO)
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 FDA, DSMB, or an analysis from the sponsor. 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 human subject protection regulations or policies. Investigators must also report any/all changes in research, including closure of accrual or completion of a study.
Please see the ORIO pages for more details.
Retrospective data analysis studies that involve no interactions with any human subjects are only required to report unanticipated problems, and harms or risks of harm directly attributable to the research. Typically this is limited to inappropriate invasions of privacy, breaches of confidentiality, potential breaches of confidentiality, data loss, or data security issues.
Unanticipated Problems Involving Risks to Subjects or Others (UaPs)
Some AEs and ORIOs require special attention by investigators and IRBs when they meet the criteria of constituting a UaP. A brief list of the criteria is below and additional guidance is at the indicated link below.
UaP Assessment Criteria
|1||The nature, severity, or frequency of the event(s) or information was NOT expected, given descriptions in the study documents or the characteristics of the subject population being studied.|
|2||There is a reasonable possibility that the procedures involved in the research caused or are linked in a significant way to the problem.|
|3||The event(s) or information suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized (including physical, psychological, economic, or social harm).|
|Follow this link for more information about making an 'unanticipated problem' assessment.|
Updated 11/14/11 (formatting only).