Generally minimal risk means that in a study involving human participants, the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in one’s daily life or during routine physical examinations or tests (45 CFR 46.102(j)). However, this definition raises certain questions. The daily lives of different participants often look vastly different. For instance, a firefighter is likely going to encounter much greater risk in their day-to-day life as compared to an office worker. In this case should minimal risk be defined based on the context of the study, or the category of the subject?
Examining a study in which athletes were asked to run at high speeds on a treadmill, Dr. Fox explores the question of how minimal risk should be defined. Should we look at the risk that comes inherently with sprinting and treadmill use, or should we look at the participants being athletes when defining minimal risk? For many athletes, treadmill use constitutes part of their daily life—but that does not mean it is without risk. Dr. Fox explores this and other relevant questions in his talk, which is now available to watch along with other TREATS talks on our reference page.