This page describes ED/SBS IRB Deviations.
The ED/SBS IRB recognizes that deviations can occur for a variety of reasons, including:
- Unanticipated problems
- Noncompliance on the part of the research team
- Noncompliance on the part of the participant
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:
- Minor formatting changes to study instruments that do not alter the content.
- A study visit outside of the protocol-specified timeline/visit window, particularly if the deviation is the result of, or at the request of the study participant. Repeated deviations of this type would suggest that a Change should be submitted to adjust the Study Design to allow for more flexibility in scheduling or to otherwise address the deviation in timing.
- A single use of one unstamped consent form, provided that the text in the consent form was identical to the most currently approved consent form at the time of consent. When this type of deviation is identified, Study Teams should assess if there are study procedures in place to ensure that the same or similar action is avoided in the future.
- An instance when the appropriate approved assent process for an individual in a given age range is not followed (written assent obtained when oral assent is appropriate according to IRB approval, and vice versa). When this type of deviation is identified, Study Teams should assess if there are study procedures in place to ensure that the same or similar action is avoided in the future.
- An instance where a questionnaire, instrument, or procedure was not administered, as long as it was not used to monitor subject safety (e.g. assessment for suicidality). If two or more of the same type of deviation have occurred, contact the IRB office to see if reporting is required and submit a Change application to address the change(s) that need to be made to Study Design.