This article examines the ethical responsibilities of health care facilities following large-scale adverse events in the medical setting. These events range in severity and scope and pose difficult ethical questions about whether and how to disclose the adverse event to patients.

The authors discuss several representative adverse events and two ethical frameworks that can be used to develop the most ethical response to adverse events. They then define key elements of policy to guide hospitals and health care providers through their response to adverse events.

Key Findings:

• The scope and harm from adverse events varies considerably, from faulty disinfection with extremely low risk of any harmful transmission to systematic flawed breast cancer testing that resulted in misdiagnosis of patients.
• The ethical requirement to disclose adverse events varies based on the individual case, but the default should be to disclose adverse events unless a robust and ethically-justified case can be made in favor of nondisclosure.
• Institutions should have a clear policy for managing adverse events, since they occur fairly frequently. Institutions should create a look-back investigation to identify the root cause of the adverse event and to prevent its reoccurrence.
• Institutions should approach adverse events with the assumption that media coverage of the event is inevitable, and should respond to the media in an honest and transparent manner.
• Institutions should promptly establish procedures to test and treat patients affected by the adverse event.

The disclosure of large-scale adverse events can pose a dilemma to health care institutions. While the severity and scale may affect how the institution responds to the adverse event, the management of an adverse event should generally include prompt disclosure, transparency, and thorough follow-up with patients potentially exposed to harm.