University of Washington Human Subjects Manual

V. Adverse Events, Adverse Effects, Side Effects

Expected Adverse Events
Unexpected Adverse Events

1. Expected adverse events
   

   Adverse events that may be reasonably anticipated to arise as a result of study procedures should be described in the consent form. Expected adverse events need not be reported to the Human Subjects Review Committees on an individual basis. At the time of renewal, the researcher must report the incidence of these adverse events.

   If, in the course of conducting the study, the investigators find that the expected adverse events are occurring with a greater frequency than anticipated or at a higher level of severity than expected, they should report this to the Human Subjects Review Committee as soon as the finding is noted. The consent form language describing the risks should be appropriately revised and subjects already enrolled in the research should be appropriately advised. The Committee may request that the researcher advise already enrolled subjects of these changes.

2. Unexpected or more serious than expected adverse events
   

   Occasionally, adverse events occur during the course of a research activity that were unanticipated or are more serious than expected. In these cases, the investigator should contact the Human Subjects Division within twenty-four hours of learning of an adverse event. The investigator will be sent an adverse event report form to complete. The report will be sent to the Human Subjects Review Committee for a determination about whether the study should be modified to reduce the risks or the consent form should be revised to include the unanticipated adverse effects. An additional copy will be sent to the Office of Risk Management.

   The death of any study subject should be reported immediately to the Human Subjects Division. The only exception is when the study is conducted among subjects who are expected to have a high rate of mortality from their underlying condition, and the investigator has absolutely ruled out any connection between any study procedure and the subject's death.