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Incident Reporting (AE/ORIO)

Reporting Policies & Procedures

HRPP Operations Manual, Part 12, Section III - unanticipated problems

The IRB-HSBS adopted the reporting guidelines and timetables described on the IRBMED website (see References & Resources below).

U-M's IRB System

To log on to eResearch Regulatory Management System (eRRM):  www.eresearch.umich.edu

For eRRM information, see the Regulatory Management website

For system instructions to enter an AE/ORIO report, see Resources below

Federal regulations and university policy require investigators to report promptly to the IRB certain events, incidents, and/or information.

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 breach of confidentiality expectations resulting from a data breach, such as a lost laptop or system hacking.  The study team files an ORIO with the IRB to report the protocol deviation/violation.   

Unanticipated Problems (UaP)

An "unanticipated problem" is an event, occurrence, or information that is not expected by the research participants or investigators in terms of its nature, severity, or frequency given the:

  • Procedures as described in the study documents (e.g.,  IRB application, protocol, data and safety monitoring plans)
  • Characteristics or qualities typically found in the eligible study participants (i.e., the traits, behaviors, symptoms, diseases, life experiences, etc. being studied)
  • Possibility that the event or information has been caused by, or is linked in a significant way to, the research
  • Potential for greater risk of, or actual, harm to the subjects or others than was previously known or recognized.  The harm may be physical, psychological, economic, or social.     

Depeding 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.

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).

References and Resources

  • Creating an Adverse Event / ORIO (PDF) eResearch Regulatory Management (eRRM) system instructions to create and submit an adverse event or other reportable inforamation/occurence report for IRB review.  Provided by ITS.
  • IRBMED Adverse Event, ORIO, & Other Reporting U-M Medical School website that details the procedures and guidelines for reporting adverse events, other reportable information/occurrences, and unanticipated problems involving risks to human subjects.  This is a good resource for all U-M investigators.

Questions?

For questions regarding IRB reporting requirements (e.g., policy, procedure) contact:

IRB Health Sciences and Behavioral Sciences
Phone: (734) 936-0933
Fax: (734) 936-1852
irbhsbs@umich.edu

For help using eResearch Regulatory Management, contact:

ITS Service Center
(734) 764-HELP (764-4357)
4HELP@umich.edu 
online service request (login required)