UW Research

minimal risk

The University of Washington applies the definition of minimal risk provided in the specific federal regulations that apply to a particular study. When federal regulations do not apply to a study, the Common Rule definition of minimal risk is used. The UW IRB and HSD consider all risks when making risk assessments, including physical, psychological, social, economic, and legal.

Common Rule (45 CFR 46.102), Food and Drug Administration (21 CFR 56.201), Department of Defense (32 CFR 219.102) The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than that ordinarily encountered in daily life* or during the performance of routine physical or psychological examinations or tests.

*It is UW policy to apply an absolute definition of minimal risk. This means the reference point is the daily life in the general population, not the experiences of any particular study population. Minimal risk should be applied in a manner that recognizes that risks are procedure-specific and population-dependent, but that the notion of “acceptably-low” risk is fixed (the same) across populations. When the harms and discomforts of the proposed research as they are anticipated to impact the participants are judged to fall below this acceptably-low risk threshold, the research is said to be “minimal risk”.

Unlike the Common Rule and the FDA, the DoD (DoD Instruction 3216.02) requires the absolute definition of minimal risk noting that the definition of minimal risk does not include the inherent risks that certain subjects face in their everyday life, such as those: (a) encountered by Service members, law enforcement, or first responders while on duty; (b) resulting from or associated with high-risk behaviors or pursuits; or (c) experienced by individuals whose medical conditions involve frequent tests or constant pain.

Prisoners (45 CFR 46.303d) The probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of a healthy person. This definition is from the Common Rule and is applied by the UW to all research regulated by only the Common Rule and to research that is not governed by any federal regulations.