Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB:
Must occur within 12 months of the approval date.
Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB:
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Yes, the continuing review of an approved and ongoing study that poses more than minimal risk must occur at least annually, which means it should be conducted within 12 months of the initial approval date. This requirement ensures that the Institutional Review Board (IRB) regularly evaluates the study to assess the risk to participants, verify that the study is still being conducted according to approved protocols, and determine whether the potential benefits still outweigh the risks involved. Regular reviews are critical for participant protection and ethical research conduct.
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