The principal investigator is responsible for detecting and documenting adverse events, as well as reporting this information to the IRB and, in some cases, to the study sponsor. An adverse event is any undesirable and unintended, although not necessarily unexpected, negative consequence for the subject from participation in the study. Adverse events include all types of harm-physical, psychological, social, legal, or economic. An example of an adverse event in social-behavioral research would be a confidentiality breach, where private information about a subject is revealed to individuals outside the study team.
Some adverse events may be classified as serious and/or unexpected. A serious adverse event is generally thought of as a detrimental physical or psychological occurrence in a subject. Examples of serious adverse events include situations where, as a result of participation in the study, the subject’s livelihood or social standing is threatened, the subject has been hospitalized or incarcerated, or the subject’s social support network has been severely disrupted. All potential serious adverse events should be identified in an investigator’s research protocol. An unexpected event is any adverse event that is not described in the protocol or an event whose severity exceeds that described in the current approved protocol. In social-behavioral research, unexpected events include complaints from subjects, problems encountered during data collection, the loss of confidential data, and results that differ significantly from what was expected (e.g., subjects score higher on a depression scale than expected and are referred for follow up therapy).
At Yale University any complaint, adverse event, or unexpected event that occurs in the process of conducting social-behavioral research involving human subjects must be reported to the IRB at least annually in the protocol renewal application. Serious adverse events or events leading to confidentiality breaches should be reported to the IRB within five working days by letter, phone, or e-mail. This communication should include the protocol number and describe the adverse event and any corrective actions or interventions that are being taken. To protect the confidentiality of the subject, only the subject number should be included in the notification. The IRB will respond within five working days with a written notice of any action taken by the IRB.