Deviations

This page describes ED/SBS IRB Deviations.

The ED/SBS IRB recognizes that deviations can occur for a variety of reasons, including:


Unanticipated problems and noncompliance that involve a potential risk to subjects or others should be reported to the IRB promptly as described in campus policies for reporting such events. Please see the campus policy on Noncompliance and Unanticipated Problems for more information on reporting timelines.

In general, when there is noncompliance on the part of the participant – study teams are encouraged to note in their records that the participant elected, (for example), not to complete/perform a given procedure, and why. If similar subject noncompliance occurs, study teams may want to consider submitting a Change of Protocol to modify this aspect of the study.

While not all inclusive, outlined below are examples of cases when minor deviations generally do not have to be reported to the IRB as they are not expected to affect the level of risk to participants nor data integrity: