References Overview

Federal regulations require an IRB to conduct substantive and meaningful continuing review of human subjects research that is within the jurisdiction of the IRB. This guidance outlines the criteria for continuing review, and investigator and IRB responsibilities. Continuing Review Frequency • Continuing review, sometimes referred to as “renewal, ” of all federally funded projects involving human subjects is required at least annually (see 45 CFR 46.109(d) and 21 CFR 56.109(d)) o Even if no changes are made, o Even if the only study activity is participant follow-up, and o Even if the only study activity is data analysis. • The IRB may require more frequent review depending on the level of risk