CITI Research with Prisoners SBE with Complete Solutions
1. 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
, CITI Research with Prisoners SBE with Complete Solutions
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
2. Defining Prison- 45 CFR 46.303 (Protection of Human Subjects 2018)
ers 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
1. 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
, CITI Research with Prisoners SBE with Complete Solutions
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
2. Defining Prison- 45 CFR 46.303 (Protection of Human Subjects 2018)
ers 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
