Overview of Continuing Review Activities and Required Reports

During the initial review of a protocol, the Board makes a determination regarding the required frequency for reporting information related to the research.

FDA regulations regarding continuing review require an IRB to conduct continuing review of the research at intervals appropriate to the degree of risk, but not less than once per year [21 CFR § 56.108(a)(1) and § 56.109(f)]. For a few types of research, however, full Board review is conducted more frequently than once a year. The Board may also direct review more frequently than annually for other research as deemed appropriate.