irb continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects

The IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must occur at least annually. This process ensures ongoing compliance with ethical standards, assesses whether risks remain minimized and reasonable in relation to benefits, reviews informed consent documents, monitors trial progress, and confirms no material changes have occurred since the prior review. Such continuing reviews generally require convened board review unless they meet criteria for expedited review. Additionally, the review must be submitted well in advance of the expiration date, often at least 6 weeks prior, to avoid lapses in approval.