For a study posing more than minimal risk that was initially approved by a convened IRB, continuing review must occur when?

For a study posing more than minimal risk that was initially approved by a convened IRB, continuing review must occur when?

• A. Not required if the study is more than minimal risk.
• B. Must occur within 6 months.
• C. Must occur within 12 months of the approval date.
• D. Must occur within 24 months.

Answer: (C)

The idea being tested is how often ongoing oversight by the IRB is required for studies that carry more than minimal risk once they’ve been approved by a convened IRB. Because the risks and protections can change as a study progresses, the IRB must re-review the study at least once a year to ensure the risk-benefit remains acceptable, consent procedures stay accurate, and safety monitoring is still adequate. Therefore, the continuing review should occur within 12 months of the approval date. The other timings aren’t consistent with this standard: continuing review is not optional for more-than-minimal-risk research, it isn’t required every six months, and it isn’t postponed for two years.

The idea being tested is how often ongoing oversight by the IRB is required for studies that carry more than minimal risk once they’ve been approved by a convened IRB. Because the risks and protections can change as a study progresses, the IRB must re-review the study at least once a year to ensure the risk-benefit remains acceptable, consent procedures stay accurate, and safety monitoring is still adequate. Therefore, the continuing review should occur within 12 months of the approval date. The other timings aren’t consistent with this standard: continuing review is not optional for more-than-minimal-risk research, it isn’t required every six months, and it isn’t postponed for two years.