Protocol deviations that are the result of subjects’ behavior do not require reporting to the IRB unless they meet ANY of the following criteria:

• The incident(s) suggest that a subject’s safety is being affected, or
• The incident(s) adversely impinge upon the integrity, accuracy and/or reliability of the research data from the subject, or
• A pattern of protocol deviations occurs that indicate a need for changes in the protocol or informed consent document(s).

When an individual subject demonstrates a pattern of repeated noncompliance with the study protocol, the research team should consider withdrawing the participant from the study and/or revising the protocol. If the subject deviation requires reporting to the IRB an unanticipated problem report should be submitted.