What To Know CITI Research With Prisoners SBE Answers
Part Info
, 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 research
conducted by the Atomic Energy Commission, rendering some sterile and others badly burned. These are only two
examples of many experiments using prisoners as subjects.
In 1978, the United States (U.S.) Department of Health, Education, and Welfare, the predecessor to the U.S. Department 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 Involving 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.
Introduction
• Research with Prisoners
• Under Subpart C
• Only allowed if the research is material to the lives of the prisoners
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 federal regulations.
Part Info
, 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 research
conducted by the Atomic Energy Commission, rendering some sterile and others badly burned. These are only two
examples of many experiments using prisoners as subjects.
In 1978, the United States (U.S.) Department of Health, Education, and Welfare, the predecessor to the U.S. Department 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 Involving 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.
Introduction
• Research with Prisoners
• Under Subpart C
• Only allowed if the research is material to the lives of the prisoners
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 federal regulations.
