Defining Minimal Risk

Defining Minimal Risk

Introduction:

On May 7, 2026, Mark Fox, MD, PhD, MPH, presented "Defining Minimal Risk" for this TREATS talk. 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. However, this definition raises certain questions—more specifically, 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, Mark Fox, MD, PhD, explored the question of how minimal risk should be defined.