Federal regulations require that research should be conducted according to the plans reviewed and approved by the IRB. Instances where this does not occur, either inadvertently due to circumstances beyond the investigator’s control, or due to errors by research personnel, are considered violations and must be reported to the IRB.
Refer to Examples of Serious or Minor Protocol Violations to help you determine if a violation is:
- serious (submit the Protocol Violation Report Form within 5 working days of awareness) or
- minor (record event on the Minor Protocol Violation Log and submit with the study’s Research Report Form at the end of the IRB approval period).