Which type of IRB review does not need formal approval but requires a determination?

The correct choice is Exempt review because this type of Institutional Review Board (IRB) review is designated for research that involves minimal risk to participants and meets specific criteria outlined in regulations. When a study is determined to be exempt, it does not require formal approval from the IRB before the research can begin. Instead, the researcher submits an exemption determination request to be reviewed by the IRB, which assesses whether the research fits the exemption categories.

In the context of research ethics, this streamlined process recognizes that certain types of studies either involve minimal risk or are unlikely to cause harm to participants. It helps facilitate research that may otherwise be bogged down by more extensive review processes while still ensuring that fundamental ethical standards are upheld.

Other forms of IRB review, such as full review and expedited review, do require formal approval before a study can commence. Full review involves a comprehensive assessment of research that poses more than minimal risk, while expedited review applies to studies that present no more than minimal risk and fit within specific categories defined by regulations but still necessitate IRB oversight and approval. Minimal risk review is not a distinct category per se but relates to the overall risk assessment that such forms may consider in their evaluations.