VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

18.2. Protocol Violation & Deviations Protocol violations and deviations occur when there is a variance in a research study between the protocol that has been reviewed and approved by the IRB and the actual performance within the research study. A protocol violation or deviation may rise to the level of noncompliance. If any member of the research team or any other knowledgeable individual obtains information concerning violations or deviations, he or she is obligated to report this information to the IRB. The reporting of protocol violations and deviations is problematic because the working definition of what constitutes violations and deviations is variably understood and applied. Moreover, those obligated to file reports of violations or deviations with the IRB often have a personal interest in the research protocol on which the violation or deviation occurred. Protocol Violations In any of the following cases, the variance in the research study should be considered a protocol violation: • The variance has harmed or increased the risk of harm to one or more research participants; • The variance has damaged the scientific integrity of the data collected for the study; • There is evidence of willful or knowing misconduct on the part of the investigator(s); or • The investigator has demonstrated other serious or continuing noncompliance with federal, state, or local research regulations. Some examples of protocol violations are: • Enrolling subjects who do not fall within the range of exclusion/inclusion criteria established by the protocol without prior IRB approval. • Adding, removing or modifying a research instrument (or adding to an existing instrument) in a survey study without prior IRB approval. Protocol Deviations In any of the following cases, the variance in the research study should be considered a protocol deviation: • The variance has no substantive effect on the risks to research participants; • The variance has no substantive effect on the value of the data collected (i.e., the variance does not confound the scientific analysis of the results); or • The variance did not result from willful or knowing misconduct on the part of the investigator(s). Some examples of protocol deviations are: • Performing a planned procedure on a different timetable than previously specified in the research protocol because of an unforeseen disruption such as a subject’s vacation. • A mechanical failure (such as a recording device malfunctioning) that affects the protocol. IRB Notification and Response When the IRB receives notification of a protocol violation, the violation must be reviewed by the Chair and/or designated members of the IRB before being presented at a meeting of the convened

VCOM Institutional Review Board Policies and Procedures

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