What qualifies a study as showing "minimal risk" according to federal regulations?

The definition of "minimal risk" in the context of federal regulations refers to the likelihood of harm or discomfort anticipated in the research being no greater than what is ordinarily encountered in daily life or during routine physical or psychological examinations. This means that the probability and magnitude of harm experienced by participants are very low, making the study relatively safe. When assessing whether a study meets this criterion, it is fundamental that the risks involved are comparable to those found in everyday situations.

Maintaining participant confidentiality, ensuring their awareness of the study's purpose, or limiting data to only statistical analysis do not directly relate to the concept of minimal risk. The focus is specifically on the nature and likelihood of any potential harm rather than procedural aspects of data handling or participant awareness. Thus, determining a study's qualification as presenting minimal risk primarily hinges on assessing the likelihood of any harm occurring, which is accurately captured by the assertion that the likelihood of harm is negligible.