What does it mean when research is described as 'minimal risk'?

When research is described as 'minimal risk,' it specifically means that the probability and magnitude of harm or discomfort that participants might experience are not greater than those ordinarily encountered in daily life. This concept is foundational in human research ethics, guiding researchers and review boards in determining the acceptability of risks involved in a study.

For example, a participant filling out a survey about their eating habits might experience a small amount of discomfort from discussing their weight or health, which is considered a minimal risk compared to more invasive procedures. This classification helps ensure that participants are not exposed to unnecessary levels of harm and that the nature of the research remains ethical.

In contrast, other options provided convey different ideas that do not align with the concept of minimal risk. For instance, stating that research will not involve human participants entirely negates the definition of research that includes human subjects, while describing risks as greater than everyday risks but less than major surgery suggests a level of risk that exceeds the minimal threshold. Similarly, claiming research is exempt from any oversight fails to address the ethical requirements that govern research involving participants, regardless of the risk level.