In what scenarios might a study's risk level be classified as "more than minimal risk"?

A study's risk level is classified as "more than minimal risk" when there is a potential for physical harm. This classification considers the likelihood and magnitude of harm that might befall participants as a result of their involvement in the study. Physical harm can include but is not limited to injuries, health-related issues, or any other adverse effects that could arise from participation.

Evaluating a study for risk involves examining the nature of the intervention, the procedures involved, and the potential consequences for participants. When there is a possibility that participants could experience physical harm, the risk escalates beyond what is considered minimal. Minimal risk typically refers to situations where the probability and magnitude of harm or discomfort anticipated are not greater than those encountered in daily life or during routine physical or psychological examinations.

In contrast, scenarios such as receiving rewards or collecting data anonymously do not inherently increase the level of risk to participants. Rewards can be part of research designs to enhance participation but do not introduce additional risks. Similarly, collecting data anonymously aims to protect participant confidentiality, which mitigates the risk rather than increases it. Lastly, when outcomes are certain, the study may be predictable, but it does not automatically imply that there’s no risk associated with participation.