Overview
Researchers must take careful notice of potential unanticipated problems that involve risks to others and respond in a timely manner. This article provides a brief overview of the criteria for reporting an unanticipated problem involving risks to participants or others for research that is regulated by the University of Michigan Committee for the Protection of Human Subjects (UMCIRB) and the University of Illinois at Urbana-Champaign (UIUC) Institutional Review Board (IRB).
University of Michigan (UMCIRB)
Under the University of Michigan Committee for the Protection of Human Subjects, researchers must report any unanticipated problems that involve risks to participants or others for their research. An unanticipated problem is defined as any incident, experience, or outcome that is unexpected and poses a risk to the safety of the participants or others.
When an unanticipated problem arises, researchers must report it immediately to the UMCIRB using the appropriate forms. The Office of Research Compliance will evaluate the incident and assess the potential associated risks. Depending on the severity of the potential risks, the UMCIRB may suspend or terminate the research activity that posed the risk.
University of Illinois at Urbana-Champaign (UIUC) Institutional Review Board (IRB)
Under the University of Illinois at Urbana-Champaign Institutional Review Board, researchers must also report all potential unanticipated problems to the IRB. An unanticipated problem is also defined as any incident, experience, or outcome that is unexpected and poses a risk to the safety of the participants or others.
When an unanticipated problem arises, researchers must inform the IRB office as soon as possible to allow the office to evaluate the incident and assess the associated risks. As with the UMCIRB, the IRB office may suspend or terminate the research activity based on the severity of the potential risks.
Conclusion
It is important for researchers to be aware of potential unanticipated problems that may arise in their research and take the necessary steps to report them directly to the appropriate bodies. The University of Michigan Committee for the Protection of Human Subjects and the University of Illinois at Urbana-Champaign Institutional Review Board both require researchers to report any unanticipated problems that may involve risks to participants or others. The appropriate bodies must then evaluate the incident and decide whether to suspend or terminate the research activity based on the potential associated risks.