The continuing review of an approved and ongoing study that poses more than minimal risk and was initially approved by a convened Institutional Review Board (IRB) must meet the following criteria:

• It must be conducted by a convened IRB, meaning a majority of IRB members, including at least one member whose primary concerns are in nonscientific areas, must be present at the review.
• The continuing review is not limited to unanticipated problems but includes a comprehensive re-evaluation of the study's progress, risk to subjects, consent process, and any other relevant factors.
• This review must occur at least once every 12 months (within 12 months of the prior approval date) as a requirement under federal regulations (45 CFR 46.109(e)).
• The continuing review is mandatory regardless of whether additional risks have been identified; it ensures the study continues to meet ethical standards and regulatory criteria.
• The IRB during continuing review must reassess risk minimization, risk/benefit ratio, informed consent adequacy, monitoring plans, privacy protections, and subject protections, especially for vulnerable populations.

Thus, for more than minimal risk studies, an annual convened IRB continuing review is required to ensure ongoing protection of research subjects and compliance with regulatory standards.