What is the difference between minimal risk and greater than minimal risk?

The distinction between minimal risk and greater than minimal risk is crucial in research ethics and IRB considerations. Minimal risk refers to the likelihood and severity of harm or discomfort that participants might experience, which is not greater than what they would encounter in their daily lives or during routine physical or psychological examinations. This means that studies classified as minimal risk involve procedures that pose only slight risks to participants.

In contrast, greater than minimal risk involves more serious potential harms or discomfort that could be greater than what individuals might regularly face in their daily experiences. Research that entails greater than minimal risk requires more extensive safeguards to protect participants, as well as meticulous ethical oversight.

This understanding is essential for determining the level of review needed by an IRB, as research posing greater than minimal risk requires a more thorough evaluation to ensure the safety and wellbeing of participants. This differentiation helps in framing appropriate consent processes and making necessary risk mitigation decisions in research settings.