Incident Reporting (AE/ORIO)

Incident Report Types

Adverse Event (AE)

AEs are events that involve physical, social, economic, or psychological harm to subjects; or indicate the possibility of harm to others.  For research reviewed by the IRB-HSBS, an example of an AE would be a study involving questions or procedures that caused subjects to become upset to a degree unanticipated by the study team.  The study team files an AE with the IRB to report the possible psychological harm to the subjects. Due to the unexpectedness of the subjects' reaction, the IRB may determine this to be an "unanticipated problem."

Other Reportable Information and Occurences (ORIO)

The University of Michigan uses the term "ORIO" to cover multiple types of events associated with a human subjects study, including:

• Accidents/incidents involving subjects, data/specimens, or U-M facilities
• Protocol deviations or violations, whether deliberate or accidental 
• Complaints
• Lapses in IRB approval
• Audits, reports, or letters from federal oversight agencies

Most of the incidents reportable to the IRB-HSBS are ORIOs.  An example of an ORIO would be a data breach as the result of a lost or stolen laptop, or system hacking.  The study team files an ORIO with the IRB to report this event as “Accident/incidents involving subjects, data/specimens, or U-M facilities.”   In an event where the study team deliberately or accidently breached confidentiality (e.g., mailed identifiable psychological or blood test results to the wrong participant), this would be reported as a protocol deviation. 

Unanticipated Problems (UaP)

An “unanticipated problem” is an event, occurrence, incident, experience, information or outcome that is:

1. Unexpected (by the participants or investigators in terms of nature, severity, or frequency) given:

• the research procedures that are described in the IRB-approved research protocol, informed consent document, and data and safety monitoring plans; and
• the characteristics of the subject population being studied (i.e., the traits, behaviors, symptoms, diseases, life experiences, etc. being studied); and

2. Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by, or is linked in some significant way to the procedures involved in the research); and

3. Suggests that the research places subjects or others at a greater risk of, or actual, harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

The event must meet all three of the above criteria.  Depending on the nature of the incident, the study team reports the UaP as an Adverse Event or ORIO for IRB determination.  Per federal and institutional policies, the IRB reports unanticipated problems to the Office of the Vice President for Research, OHRP, and the sponsor (if necessary).

Adverse Event/ORIO Submission

Study teams can submit Adverse Event and ORIO reports online in U-M's eResearch Regulatory Management (eRRM) system.  The system steps to initiate the report are the same, but once you select the type of report (Adverse Event or ORIO), the system displays applicable information and options for that type of report.   See Resources below for step-by-step system instructions.  In general, researchers should wait until afer learning the IRB review outcome before making changes to the protocol in response to an AE or ORIO event.  However, changes may be made at the time of the incident in order to protect human subject safety or to mitigate risk that could result from the AE or ORIO event.  In such cases, the researcher should include this information in the AE or ORIO submission.

Roles & Responsibilities

Investigators and study teams are responsible for:

1. Identifying unanticipated problems
2. Analyzing the causes of these problems
3. Filing an AE/ORIO report in eResearch to alert the applicable U-M IRB
4. Responding appropriately to events and other problems involving risk to human subjects.  

The IRB-HSBS reviews the report and may:

• Acknowledge the report, requiring no further action on the part of the study team
• Require changes to the protocol, procedures, or informed consent process in order to protect human subjects
• Request more frequent continuing review or status reporting for the project
• Suspend or terminate the research in cases (rare) of unacceptable risk to subjects

The IRB reports events that demonstrate serious or continuing non-compliance to the Office of the Vice President for Research, OHRP, and the sponsor (if necessary).