4.2 - Prisoners

Prisoners are persons involuntarily confined or detained in a penal institution. The term encompasses individuals sentenced to such institutions under a criminal or civil statute, individuals detained in other facilities by virtue of statutes of commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing. Special DHHS regulations applying to prisoners may be found in 45 CFR 46, Subpart C. No research may be conducted with prisoners unless the following conditions have been met:

  • the research examines (a) the possible causes, effects, and processes of incarceration and criminal behavior; provided that the research poses no more than minimal risk or inconvenience to the subjects; (b) prisons as institutional structures or prisoners as incarcerated persons; (c) conditions particularly affecting prisoners as a class; or (d) practices (both innovative and accepted) having the intent and reasonable probability of improving the health and well being of the subjects;
  • the possible advantages of participation must not be of such a magnitude that they impair the subjects' ability to weigh the risks against the benefits of participation;
  • the risks must be commensurate with risks that would be accepted by nonprisoner volunteers;
  • subject selection must be fair to all prisoners;
  • there is adequate assurance that participation will not affect the prisoner's chance of parole, and the prisoner is informed of this fact in advance of participation.