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CITI Research with Prisoners SBE with Complete Solutions
- Introduction 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 med- ical 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 research conducted by the Atomic Energy Commission, rendering some sterile and others badly burned. These are only two examples of many experiments using prison- ers as subjects.In 1978, the United States (U.S.) Department of Health, Education, and Welfare, the predecessor to the U.S. De- partment of Health and Human Services (HHS), issued additional regulations providing safeguards for prisoners
as research subjects -- Subpart C: "Additional Protections
Pertaining to Biomedical and Behavioral Research Involv- ing Prisoners as Subjects." These regulations address the fact that prisoners are under constraints that could affect their ability to make truly voluntary and un-coerced decisions to participate in research. Subpart C imposes strict limits on the involvement of prisoners as research subjects. The only research that may be conducted with prisoners as subjects is research that is material to the lives of the prisoners.• Research with Prisoners • Under Subpart C • Only allowed if the research is material to the lives of the prisoners 1 / 2
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CITI Research with Prisoners SBE with Complete Solutions
- Defining Prison-
ers Note - the U.S. Department of Justice (which includes the National Institute of Justice and the Federal Bureau of Prisons and other agencies) complies with the pre-2018 Requirements of the Common Rule, but is not a signatory to the 2018 Requirements (the revised Common Rule with a general compliance date of 21 January 2019). Also, additional requirements exist for research conducted with the consent of the Bureau of Prisons (BOP) and each BOP facility may have unique rules and requirements that researchers should be aware of and comply with. These are not addressed in this module.Learning Objectives
By the end of this module, you should be able to:
Examine and apply the definition of "prisoner" in the fed- eral regulations.List the four categories of permissible research with pris- oners allowed by the federal regulations.Identify issues to consider when designing research to be conducted with prisoners.Identify issues related to accessing prison populations.Describe the regulatory obligations of an Institutional Re- view Board (IRB) reviewing prisoner research 45 CFR 46.303 (Protection of Human Subjects 2018)
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 in- carceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.Included in this definition are those individuals in hospitals
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