Unanticipated Problems Involving Risks to Subjects or Others

Prompt reporting of Unanticipated Problems Involving Risks to Subjects and Others (UPIRSO) is a condition of IRB approval and so stated in the initial approval letter. The IRB definition of a UPIRSO is:

Unanticipated Problems Involving Risks to Subjects and Others means any problem, event, occurrence or new information related to the research project that is unanticipated and may involve the increased risk of harm to subjects and others - whether or not any actual harm occurred.

UPIRSO reports are the responsibility of the Principal Investigator and must be filed electronically within 5 days of the PI's knowledge of the occurrence. In the event of a very serious UPIRSO, the IRB Office should be notified promptly by telephone.

A summary of all UPIRSOs and adverse events (for the reporting period) must be documented in the annual Continuing Renewal report.

Unanticipated problems include but are not limited to the following:

  • An actual unforeseen harmful or unfavorable occurrence to subjects or others that relates to the research protocol (injuries, side effects, deaths).
  • A problem involving data collection, data storage, privacy or breach of confidentiality.
  • A subject complaint about IRB-approved research procedures.
  • New information about a research study (e.g., a publication in the literature, interim findings, safety information released by the sponsor or regulatory agency, safety monitoring report) that indicates a possible increase in the risks of the research.
  • Changes in approved research initiated without IRB review and approval to eliminate immediate hazards to the subject.
  • Incarceration of a subject (if the study does not have IRB approval to enroll prisoners).
  • A sponsor-imposed suspension of a protocol due to possible increased risk.