IRBs are required to review research protocols no less than once per year, with exceptions [§46.109(e) and §46.109(f)]. Research protocols that meet one of the following may not be required to submit for annual continuing review:
- Research eligible for expedited review,
- Research that is limited to data analysis of identifiable private information or identifiable biospecimens, or
- Research that accesses follow-up clinical data that subjects undergo as a part of their clinical care
Note that release from the requirement for Continuing Review does not release the Investigator from other regulatory requirements such as submitting modifications and amendments for review and approval prior to implementation and submission of reportable events. Failure to do so may result in a finding of non-compliance. Investigators are also required to submit a Termination Report upon completion of the study. Investigators will receive an annual system-generated notification.
Protocols eligible for release from Continuing Review must be granted the release unless a valid reason to renew is documented by the IRB. Issues that may prohibit release from Continuing Review include but are not limited to the following situations:
- Require additional regulatory or ancillary oversight (e.g. RDRC, COI)
- FDA Regulated
- Include international or non-local sites
- New findings require additional oversight
- History of non-compliance