When might a study be classified as "non-exempt" by the IRB?

A study is classified as "non-exempt" by the Institutional Review Board (IRB) when it involves more than minimal risk to participants or does not meet the specific criteria for exemption set forth in regulatory guidelines. Typically, studies that involve risks to participants, including physical, psychological, or social risks, require greater scrutiny and oversight to ensure that participants' rights and welfare are adequately protected.

The criteria for exemption typically include factors such as the type of research (e.g., minimal risk), the population being studied (e.g., information from adults rather than vulnerable populations), and the nature of the data collection methods. When a study fails to meet these criteria or involves higher levels of risk, it necessitates a full review process to assess risks, benefits, and ethical considerations before proceeding.

In contrast, a study that poses no risk, is conducted remotely, or involves only education-related surveys may qualify for exemption; therefore, they do not typically result in a non-exempt classification. Understanding the factors that lead to a non-exempt designation is crucial for researchers to ensure that their study protocols align with ethical standards and to adequately navigate the IRB approval process.