What is the definition of minimal risk for prisoner research?
The definition of minimal risk for research involving prisoners can be found at 45 CFR 46.303(d). This definition, promulgated in 1978, differs from the definition of minimal risk in subpart A of 45 CFR 46. See 45 CFR 46. 102(i). For research involving prisoners, the definition of minimal risk requires reference to physical or psychological harm, as opposed to harm or discomfort, to risks normally encountered in the daily lives, or routine medical, dental or psychological examination of healthy persons.
