The history of conducting research with prisoners has been problematic. As a group, prisoners have been a population of convenience; researchers knew where they were and would be, often for many years. In addition, prisoners lived under controlled conditions conducive to research. It was generally accepted to use prisoners as research subjects for testing medicines, drugs, and medical devices without regard to the risks, benefits, and rights of those individuals.
As documented in Acres of Skin: Human Experiments at Holmesburg Prison (Hornblum 1998), prisoners were used in lieu of laboratory animals to test the toxicity of cosmetics. In other experiments, prisoners were irradiated in ...view middle of the document...
• Identify issues related to accessing prison populations.
• Describe the regulatory obligations of an Institutional Review Board (IRB) reviewing prisoner research.
Part 46.303 of Subpart C (Protection of Human Subjects 2009) defines a prisoner as follows:
Prisoner means any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
Included in this definition are those individuals in hospitals or alcohol and drug treatment facilities, who are under court order. Individuals in work-release and house arrest programs also qualify as prisoners. Individuals on parole are not considered prisoners. The definition applies to both minors and adults.
Research Allowed Under the Federal Regulations
The regulations at 45 CFR 46.306 (Protection of Human Subjects 2009) allow prisoners to be involved in four categories of research. Most social and behavioral sciences research falls into the first two categories:
1 Study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects.
2 Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects.
3 Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on diseases such as hepatitis and HIV which are more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults).
4 Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subjects. Studies that require the assignment of prisoners to control groups in which they may not benefit from the research may need federal-level review.
Examples of social and behavioral sciences research in the categories listed above include:
• Age at first arrest as a predictor of adult criminal history
• Effects of overcrowding on prison populations
• The influence of prison-awarded incentives (such as promotions in custody level) on retention in substance abuse treatment programs
• The use of true crime/detective stories as bibliotherapy
• Social support systems in prisons
• The functioning of pseudo-families in prison
Designing Prison Research
Informed consent requires the ability to choose freely, without coercion and without undue influence. Because the autonomy...