"Adverse events that are anticipated by the researcher must be discussed as part of the IRB proposal, and the possibility of such effects must be made known to study participants as part of the informed consent process. If expected adverse events occur during such research, no special reporting to the Office for Human Research Protections (OHRP) is required.

Adverse events that are unanticipated in their nature, severity, or frequency require immediate attention. Although such events are most likely to occur in medical experiments, they are not unknown in behavioral or psychological studies. If your research is HHS supported, then you should become familiar with regulations regarding such incidents. Please consult the document here and explore the links contained therein."