How do the regulations define “minimal risk” for research involving prisoners?
For research involving prisoners, the regulations at subpart C of 45 CFR part 46 define “minimal risk” as follows: Minimal risk is 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 healthy persons (45 CFR 46.303(d)). The wording of the subpart C definition differs in several ways from the definition of “minimal risk” in subpart A of 45 CFR part 46, which applies generally to research involving human subjects. The differences are: • The subpart C definition refers to “physical or psychological harm” rather than “harm or discomfort” as in subpart A. • The subpart C definition compares the probability and magnitude of harm in the research to the probability and magnitude of those harms normally encountered in daily life, or in “routine medical, dental, or psychological examinations,” rather than in daily life or “routine physical or psychological examinations o
