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The protocol must be followed! Failure to do so is a violation and may be noncompliance. One of the most cited deficiencies in research compliance is failure to follow the protocol, failure to supervise others and failures in the use of consent forms.
Close out your IRB correspondence file with the approval letter. Make sure you have the final versions of all approved documents in one place.
Start a new IRB correspondence folder for any new reports or information toward continuing review.
3. Expiration Date and Continuing Review
The approval has an expiration date. Note it and put a reminder on your calendar. Either close it out or submit for renewal in enough time to have approval before the approval expires.
The approval letter tells you what must be reported to the IRB.
- Any problem encountered in the conduct of the study that is (1) unanticipated and (2) involves risk to subjects or others.
- Any failure to follow the agreed upon plan if that failure involves (a) any risk to subjects or (b) any harm to study outcomes (e.g., reduction of benefit).
- Any noncompliance with regulations or laws