Part 2, Ch. 20 - Continuing Review

The IRB is required to review and approve all non-exempt research projects at intervals appropriate to the degree of risk, but not less than once a year [45 CFR 46.109(e) (DHHS) and 21  CFR 56.109(f) (FDA)].  This is called "continuing review.”  Continuing review for non-exempt research is required to occur as long as the research remains active for long-term follow-up of the research subject, even when the research is permanently closed to the enrollment of new subjects and all subjects have completed all research-related interventions and to occur when the remaining research activities are limited to collection of private identifiable information.

As described above, the Informed Consent Document(s) indicate the project's expiration date.  If a project initially received expedited review and risks to subjects remain minimal, the continuing review may be expedited (reviewed by the chair alone).  If a project initially received full board review, the project generally requires full board continuing review.  The calculation of the approval period for research is based on the date and length of time at which the IRB approved the protocol by either a convened Full Board meeting or through the expedite review process.