Which type of IRB review does not require IRB approval but requires a determination by a designated individual (such as an IRB member or experienced staff person)?

Which type of IRB review does not require IRB approval but requires a determination by a designated individual (such as an IRB member or experienced staff person)?

• A. Expedited
• B. Exempt
• C. Full Board
• D. Conditional

Answer: (B)

Exemption status is the type of review where no IRB approval is required, but a determination of exemption is made by a designated individual, such as an IRB member or experienced staff. If the study fits one of the exempt categories and involves minimal risk, the reviewer can decide that it qualifies for exemption without convening the full IRB and without issuing a formal approval. This contrasts with expedited or full board reviews, where some form of IRB approval is still granted (even if by a designated reviewer for expedited), and with any unrecognized category like conditional, which isn’t a standard IRB pathway.

Exemption status is the type of review where no IRB approval is required, but a determination of exemption is made by a designated individual, such as an IRB member or experienced staff. If the study fits one of the exempt categories and involves minimal risk, the reviewer can decide that it qualifies for exemption without convening the full IRB and without issuing a formal approval. This contrasts with expedited or full board reviews, where some form of IRB approval is still granted (even if by a designated reviewer for expedited), and with any unrecognized category like conditional, which isn’t a standard IRB pathway.