The IRB’s responses to report forms are never punitive. Prompt, good-faith reporting of deviations is always to the benefit of the study team. Failure to report important (also called “major” or “significant”) deviations is in itself possible serious noncompliance that may necessitate additional (Institutional Review Board) IRB reporting. If a study team is in doubt as to whether a deviation meets the definition of possible serious or continuing noncompliance, it is generally better to submit a report form.
Additional Resources
For more information about report forms and protocol deviations, please reference UUSOP-07 and the IRB’s website:
https://qualitycompliance.research.utah.edu/sop-library/uu-sop-07.php
https://irb.utah.edu/submit-application/forms/
FDA has also recently issued draft guidance on protocol deviations for public comment: