Unanticipated problems in research and reporting
In the event that there are unforeseen circumstances that arise during the research that increase the risk of harm to subjects that are related to study procedures, these must be reported to the IRB.
Events that fall under “Unanticipated problems” could include being hacked, issues discovered with testing locations, or multiple subjects having an emotional reaction to a previously minimal risk study. These events must be, as their name implies, 1. Unforeseen and could not have been predicted, i.e. not because of flaws in the research parameters process 2. Related or possibly related to the study, i.e. would not have happened had the study not occurred and 3. Must present an increase in risk to the subjects over the approved parameters by the IRB. This third distinction is an important note: if a study is examining trauma and is listed as above minimal risk, if subjects exhibit emotional responses and receive counseling as per the research parameters, there is no need to treat this as an unanticipated problem.
These problems must be reported promptly to the IRB. In most cases, this means as soon as possible and each IRB will define the time schedules different (every IRB is required to have a response protocol for unanticipated problems). The IRB will then review the issues and may choose to modify the study, staff, parameters or suspend or terminate the study, amongst other options.