Q. What is a continuing review and why are they required by the IRB?

A. Per the Department of Health and Human Services (HHS) regulations at 45 CFR part 46, studies that are deemed “expedited” or are reviewed during a convened IRB meeting must submit an annual report

to the Tufts IRB regarding the research activities that have taken place in the last year. The types of information that are required are: new COI forms from all study team members, the number of records reviewed/subjects consented within the last year, and any incidents that should be reported such as a report from the sponsor or a subject withdrew from the study. Ann-Marie Billig will help you prepare this report each step of the way!