What is required for the continuing review of a study posing more than minimal risk that was initially approved by a convened IRB?

The requirement for the continuing review of a study that poses more than minimal risk and was initially approved by a convened Institutional Review Board (IRB) is that it must occur within 12 months of the approval date. This is grounded in federal regulations, which mandate that IRBs conduct a review of ongoing research at least annually to assess the continued risk-benefit ratio of the study as new data and insights become available. This annual review ensures continued protection for human subjects and allows the IRB to monitor any potential changes in the risk profile of the study.

The emphasis on conducting the review within a 12-month timeframe ensures that the study remains compliant with ethical standards and regulatory requirements, thus safeguarding participant welfare throughout the study’s duration.

Other options do not align with the standard practices for continuing review: a convened IRB is the appropriate body for initial approval but not necessarily for ongoing review; limiting the review to only unanticipated problems neglects the broader scope of risks that may evolve over time; and suggesting that continuing review is only required if additional risks are identified undermines the proactive approach necessary in human subjects research.