Which IRB review category is appropriate for minimal risk research that is not eligible for exemption?

Which IRB review category is appropriate for minimal risk research that is not eligible for exemption?

• A. Exemption (low-risk, fully anonymous research)
• B. Expedited (minimal risk not eligible for exemption)
• C. Full Board (higher risk or vulnerable populations)
• D. Not Applicable

Answer: (B)

IRB review pathways depend on how much risk the study presents and whether it qualifies for exemption. If a project is minimal risk but does not meet the specific criteria for exemption, it isn’t exempt and moves to expedited review. Expedited review means a smaller set of IRB members (often the chair or designated reviewers) evaluates the protocol rather than the full IRB meeting. This path is designed for studies that pose no more than minimal risk and fit the approved expedited categories, such as certain low-risk data collection or surveys. Exemption would apply only if the project matched one of the exempt categories, which isn’t the case here. A full board review is used for greater-than-minimal-risk studies or when the research involves vulnerable populations, not for this minimal-risk, non-exempt scenario. Not Applicable would imply no IRB review is needed, which isn’t accurate for this situation. So the most appropriate route is expedited review.

IRB review pathways depend on how much risk the study presents and whether it qualifies for exemption. If a project is minimal risk but does not meet the specific criteria for exemption, it isn’t exempt and moves to expedited review. Expedited review means a smaller set of IRB members (often the chair or designated reviewers) evaluates the protocol rather than the full IRB meeting. This path is designed for studies that pose no more than minimal risk and fit the approved expedited categories, such as certain low-risk data collection or surveys. Exemption would apply only if the project matched one of the exempt categories, which isn’t the case here. A full board review is used for greater-than-minimal-risk studies or when the research involves vulnerable populations, not for this minimal-risk, non-exempt scenario. Not Applicable would imply no IRB review is needed, which isn’t accurate for this situation. So the most appropriate route is expedited review.