Conducting the Study - Responding to Breaches of Confidentiality

Even in well-designed protocols, breaches of confidentiality can occur due to unforeseen events. Examples of these events include the loss of research data during a burglary of a home, a conversation about a subject in a public place that is overheard, or the observation of a subject meeting with an investigator studying an unlawful activity by a third party who may have knowledge of the study, such as a law enforcement officer. The sharing of identifiable research data or biological samples with investigators outside of the research team, such as names or medical record numbers on films, is another example. These breaches of confidentiality are treated as adverse events and must be reported and/or discussed with the IRB approving the protocol. The IRB, in consultation with the investigator, will determine appropriate follow-up action to the incident, including making changes to the protocol before continuing the study.