Subpart C: "Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects"
i. Here a prisoner is defined as, “any person who is involuntarily confined or detained in a penal institution. The term is indicated to encompass individuals sentenced to an institution under a criminal or civil statues or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing” (Gostin, Vanchieri, Pope 102).
ii. Minimal risk is defined as, “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” (Gostin, Vanchieri, Pope 79). iii. Under Subpart C, only four categories of research involving prisoners are allowed (Gostin, Vanchieri, Pope 80): 1. Study of the possible causes, effects, and process of incarceration, and of criminal behavior that provides no more than minimal risk. 2. Study of prisons as institutional structures, or prisoners as incarcerated persons that provides no more than minimal risk. 3. Study on conditions that affect prisoners as a “class” or population. Examples would include research on hepatitis, which has a higher prevalence rate in prisons. (consultation with Federal Register required) 4. Study on the probability of improving the health or well-being of prisoners. (consultation with Federal Register required). |