Do I have to submit every single protocol deviation (e.g. instance of non-compliance with the protocol) to the IRB?
Yes, however the timing of when you report the non-compliance may differ. If the non-compliance was within the control of the research team (e.g. a follow-up appointment was scheduled by the research team outside of the study window) it should be reported within 5 days of becoming aware of it using the problem report form available on the Institutional Review Board Meetings, Instructions, Forms and Samples page. All reports should contain a description of the deviation, why and when it occurred, and corrective action implemented, if any, to prevent future occurrence. If the non-compliance was not within the control of the research team it (e.g. the subject canceled a scheduled appointment and had to be rescheduled outside of the study window) the event can be reported at the time of continuation. However, if the event was not within the control of the research team but has in impact on subject safety or data integrity it should still be reported within 5 days of becoming aware of it. I
Related Questions
- The Scientific Review of Human Research Protocol form is needed to submit my protocol to the IRB. Why is this form needed and how many signatures are required?
- Do I need to submit an animal use protocol if I use crayfish, worms, snails, shrimp, fruit flies, or microorganisms in my research or teaching activities?
- Do I have to submit every single protocol deviation (e.g. instance of non-compliance with the protocol) to the IRB?
