An “unanticipated problem involving the risks to participants or others” is an event that meets the following three criteria. The event was:
- Related to the research, and
- Caused harm or increased the risk of harm to the participants or others
The Institutional Review Board (IRB) requires PIs to report an unanticipated problem within five days of becoming aware of the problem.
Examples of unanticipated problems include:
- An actual unforeseen harmful or unfavorable occurrence to participants or others that relates to the research protocol (injuries, side effects, etc.);
- An unforeseen development that potentially increases the likelihood of harm to participants or others in the future;
- A problem involving data collection, data storage, privacy, or confidentiality;
- A participant complaint about approved research procedures;
- New information about a research study that indicates a possible change in the research risks to participants (sources may include a publication in the literature, interim findings, safety information released by the sponsor or regulatory agency, or the safety monitoring report);
- Changes in approved research initiated without review and approval to eliminate apparent immediate hazards to the participants.
Section 9 of the IRB Policies and Procedures Manual provides further information regarding the review of unanticipated problems.