Leslye Denisse Dias Duran

Seminar: Bioethics

Prof. Klaus Steigleder

Ruhr-Universität Bochum

Ethical considerations from prisoners in medical research: informed

consent, free choice and risk/benefit analysis.

Abstract

Medical research with prisoners, classified by the Common Rule guidelines, as a

vulnerable population, is an increasingly discussed topic within the field of
bioethics due to the number of ethical challenges it poses despite the efforts
conducted by governments from the 20th century to regulate and ensure that
participants rights are respected. Among these challenges, the more pressing
ones are informed consent in the context of questionable freedom of choice and
confronted by a situation of uneven bargaining power between inmates as
subjects and researchers.

Due to the numerous scandals that have arisen due to unethical experimentation ,
new guidelines for research with prisoners are now enforced in a way that many
experts consider crippling for the inmates. This paper will try to present an
overview of the position of prisoners in medical research, the regulatory efforts
made in recent history and will discuss the permissibility of research with inmates.

Key words: Medical research, captive groups, ethics.

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Introduction

Medical research is one of the most supported and funded fields of research
around the globe as it has been demonstrated that is pivotal for the development
of treatments, cures, medicines and other strategies to improve our general
quality of life. From treating diseases to products designed for aesthetics, medical
research has allowed humanity to have a better understanding of the workings of
living organisms and has given us the power to have some degree of control over
them.

As the National Committee on Vital and Health Statistics points out: “Clinically rich
information is now more readily available, in a more structured format, and able
to be electronically exchanged throughout the health and health care continuum.
As a result, the information can be better used for quality improvement , public
Health, and research, and can significantly contribute to improvements in health
and health care for individuals and populations” (NCVHS, 2007).

One of the most outstanding examples of this is the development of vaccines ;

thanks to them our life expectancy in average has increased dramatically.
According to the World Health Organization, in 1900 the life expectancy at birth
was around 38.1 years and on 2015 was measured approximately around 71.4
years on average.

Although it’s reasonable to agree with the assertion that medical research is
desirable and hold a great social value, it’s also a field that since its early days
have proven to be challenging in the ethical aspect due to the lack of uniformity
of the procedures and oversight to ensure that they comply with guidelines for
safety.

One of the most prominent cases recorded of abuse in medical research is the
Tuskegee Syphilis Study in Alabama. From 1932 to 1972 the U.S. Public Health
Service conducted a study to observe the natural progression of untreated syphilis
2
in African American male subjects. The study recruited 600 poor men from Macon
Country with the aid of the Tuskegee Institute. Out of the total participants, 399
were already infected with syphilis, but they were not informed about the disease.
Instead, they were told that they were going to be treated for ‘bad blood’ a term
commonly used to refer a group of illnesses as syphilis, anemia, and fatigue. As
compensation, the participants were given free meals, burial benefits and regular
access to healthcare, and were told that the study had a duration of six months .
(Emanuel et al., Pg. 89)

However, they were never treated of anything, not even when it was proven that
penicillin was an effective and safe cure for syphilis in 1947 . The purpose of the
study was to monitor and record the progression of the disease , so they let the
participants go through the effects of it that eventually led to death. Some
concerns were raised around the 60’s by a new investigator named Peter Buxtun
but were smothered to achieve the completion of the study that already has been
going for thirty years, which was the death of all subjects and the subsequent
autopsy that would provide the insight they were hoping to gain.

The fallout of the study came when Buxtun, who had abandoned the project after
not getting attention upon his ethical concerns and had enrolled into law school ,
brought the evidence to reporters in Washington. The story appeared on press
the 25th of July of 1972.

According to the information gained after the investigation was carried “28
participants had perished from syphilis, 100 more had passed away from related
complications, at least 40 spouses had been diagnosed with it, and the disease
had been passed to 19 children at birth” (Alsan and Wanamaker, 2018) The
Tuskegee study was a significant reason for the creation of the Office for Human
Research Protections (OHRP) and the Belmont Report.

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The role of prisons and prisoners

In order to address the topic of ethical challenges of prisoners as subjects in

medical research, first, we need to clarify the updated facts and circumstances
that make them a singled-out group amidst the general population of participants.

Throughout history, prisons have been used as places to hold offenders ,

effectively taking their freedoms, in a temporary fashion while they awaited
sentence, be that death, slavery or other alternatives (depending on the customs
of the society they were placed in) or to simply prevent them from committing
further felonies against the law and society. In other words, the general rationale
that has prevailed behind these facilities is punitive.

Punishment from a retributive standpoint based on the conception of societies

formed by social contracts counts imprisonment as legitimate because according
to this theory, individuals agree to give up some portion of their natural freedom
in exchange for protection. In fact, some authors point out that punishment on the
face of digression is desirable: “The second element of the retributive rationale is
that the criminal deserves the punishment and, indeed, has a right to be punished.
Only by forcing the individual to suffer the consequences of his actions does one
accord them the rights of an equal citizen” (Pollock, 2009. Pg. 4)

However, in the 19th century, the paradigm of retributive punishment drastically

changed and turned to one of rehabilitation. Prisons became “a laboratory in
which social work and psychiatry would work to help change people’s behavior ”
(Pollock. Pg. 11) and although at this point of history prisoners were considered
to be in a state of depravation that needed to be corrected using any means
necessary, this conception kept on progressing until the 1900 when it transformed
into one that considered that prisoners could be re-educated in their behaviors:
“the ideal model of correctional administration founded on the belief that trained
experts could administer individualized assessment and treatment that would

4
“diagnose” and “treat” the causes of criminality in the way that medical doctors
were able to cure other forms of illness” (Phelps, 2011).

Yet again, this ideal changed again with the dramatic increase of the number of
prisoners that reached 1.6 million in 2006 in the United States due to several
legislations and the change of rationale from rehabilitation to deterrence and
incapacitation. This, of course, affected the operational aspect of prisons which
were facing issues like overpopulation and worse living standards for inmates.

Acknowledging these circumstances is essential for the current research topic

because it allows us to present an updated context in which we can base the
problematic issues of free choice from the inmates and research participants
when conducting medical research. If the overall conditions they have access to
are dismal at best due to the legislation that keeps overpopulating the prisons ,
when presented with the opportunity of volunteering in certain experiments or
studies in exchange for an improvement or benefits, no matter how minimal, can
we assert that the subject is exercising free choice as is required by the different
protocols?

On other spectrum, prisoners are also singled out as a captive population and as
a vulnerable group. According to Professor Lisa Given1 in her book The SAGE
Encyclopedia of Qualitative Research Methods the term captive populations
refers to “participants who find themselves in a context (often an institution , e.g.,
a school, a prison, a hospital) where they are constrained and dependent on
others for their care and for access to them as research participants ” (Given,
2008). Captivity, then, is understood as a physical limitation that creates a
situation of dependency between the inmates and those who control the system
that keep them incarcerated.

1
Associate Dean, Research and Development, for the Faculty of Health, Arts and Design at Swinburne
University of Technology, Australia. She is President of the Association for Information Science and
Technology and has served on the College of the Australian Research Council.
5
As for vulnerability, it “applies to potential conditions of research participants in
which the participants, by virtue of some psychological, cognitive, physical,
medical, legal, socioeconomic, or age-related status, are deemed to be more
susceptible to lack of full understanding, manipulation, exploitation, or some other
possible harm within the research process” (Given). This definition establishes a
limitation based on the inmate’s status.

When we consider both items regarding prisoners, it’s clear that they are situated
under the conditions described which in sum means that researchers, institutions,
and governments must ensure the enforcement of an ethical framework that set
the parameters under which medical research is possible.

But why is this quality of being captive and vulnerable relevant for medical
research? Prisoners find themselves at a clear disadvantage regarding true free
choice. As we mentioned before, the environmental conditions they have are not
ideal to prevent the subtlest forms of coercion, and when we add the physical and
psychological conditions we arrive at the conclusion that there is the need to
actively reinforce a framework that at least aim to breach the gap between having
no other choice at all and the informed choice.

Unethical experimentation on prisoners

There is a lot of literature that details the multiple cases of abuse that have been
made throughout history to prisoners in the name of medical research.

In the United States, a study was conducted in Ranking State Prison in Mississippi
where Dr. Joseph Goldberg was commissioned by the U.S. Public Health Service
(USPHS) to study and find a potential cure for pellagra that was becoming
epidemic. He conducted a study with 11 prisoners that included dietary
modification with the purpose of inducing pellagra thus proving that the disease

6
was caused by specific nutrients or lack of those . The prisoners were promised
full pardon for their crimes in exchange for participating but as the report given by
Dr. Goldberg “after five months, during which time several prisoners began to
develop symptoms of the disease, the study concluded, with 6 of the 11
evidencing symptoms of pellagra. During those months, inmates who developed
the disease suffered so greatly that some were willing to forgo the pardon to
discontinue the study” (McDermott, 2013. Pg. 8) These inmates were not
informed of the potential risks and secondary effects that the study would
generate.

During World War II, two of the most infamous cases of unethical experimentation
occurred at the hands of the Nazi regime and the Japanese Army. Nazi scientists
and doctors took advantage of the concentration camps as research facilities with
the ideal conditions: thousands of potential subjects that had no other purpose
that awaits death confined and available to test any treatment or procedure with
little to zero consequences.

Under the regime, multiple experiments were reported including racial

anthropological research, brain research and neurology, military medical research
and medical and genetic experiments. Almost all these experiments were painful
and crippling for the subjects, and 90% of times resulted in the death . Joseph
Mengele, one of the most infamous researchers, was known for his
experimentation on twin children at the Auschwitz-Birkenau camp. Most of the
scientists and doctors that took part in the experiments and were prosecuted in
the Nuremberg Trials were sentenced to death . The terrible evidence that was
made after the war led to the creation of the Nuremberg Code in 1947 .

Also, during the Second World War, the Japanese army created the Unit 731, a
biological and chemical warfare development unit. The experiments were
performed on mainly Chinese and Soviet prisoners of war and included
vivisection, germ warfare attacks, frostbite testing, syphilis testing, forced
7
pregnancy and weapon testing. Another type of experimentation included the
development of defoliation bacilli bomb and the flea bomb used to spread bubonic
plague, thus enabling the launching of mass biological attacks. It has been
estimated that over 3,000 individuals were killed from inside experiments and tens
of thousands of field experiments. 2

Another outstanding case occurred in Holmesburg Prison in 1951. According to

the evidence, 1.200 inmates at this prison in Philadelphia were infected by an
outbreak of athlete's foot which prompted a revision by Dr. Albert M. Kligman, a
dermatologist from the University of Pennsylvania.

After treating them, Dr. Kligman stayed at the prison with permission of the
University and other authorities and between 1965 and 1966 performed multiple
experiments on inmates without their informed consent using dioxin , a highly toxic
substance as the baseline for the development of pharmaceutical products , that
exceeded even the protocols from pharmaceutical companies (Reiter , 2009. Pg.
501).

As it cited in the book Acres of Skin by Dr. Allen Hornblum a scientist that
discovered the activities carried at Holmesburg and decided unveiled the
mistreatment of the procedures, Dr. Kligman had used this term [acres of skin]
about the inmates on which he could experiment on. During his time at the prison,
he conducted experiments for the development of diverse products like
toothpaste, perfumes detergents, and skin creams. Among the most famous
attributed to Dr. Kligman is the Retin-A skin treatment.

Even though there was an investigation after the outbreak of the experiments and
many pharmaceutical companies and researchers were forced to bring their trials

2
In this case, after the surrender of the Japanese army in WWII, the majority of the evidence was
destroyed, and a deal was made surreptitiously between the Japanese and US governments, exchanging
immunity for information on the Soviets. No official apologies or reparation efforts have been made by
the Japanese government until now, although there are ongoing investigations on the matter.
8
to an end, the history of experimentation on inmates was not entirely over . For
example, in 2006 the company Hythian made contracts with several state
jurisdiction to conduct a drug addiction program: “As part of this program, state
judges “divert” drug court participants, who have been found in possession of
drugs, into an experimental treatment program called Prometa (…) The program
involves thirty days of treatment with three different drugs, none of which has been
approved for use in addiction treatment by the Food and Drug Administration
(FDA)” (Reiter. Pg. 503)

This study didn’t make the noise the Holmesburg study did , but it allows to
illustrate the fact that there is still a lot to be done about prison research especially
when each passing say the pharma companies gain more influence due to their
immense lobbying efforts to the governments.3

Guidelines for research with prisoners

The fundamental ethical purpose of a framework in medical research is to

minimize as much as possible the possibility of exploitation of subjects . As
researchers point out, participants in research are a necessary means of
obtaining the knowledge that can be used to improve health and healthcare . Thus,
principles for ethical research are a vital part of the regulations; these include
collaborative partnership, social value, scientific validity, fair participant selection,
favorable risk-benefit ratio, independent review, informed consent and respect for
participants. (Emanuel et al., Pg. 126)

Generally speaking regulatory efforts for biomedical research with humans started
with the Yellow Fever Commission and the Berlin Code in the 1900 , then the

3
Only in the US, the pharma industry spent $279,113,483 in lobbying different governmental institutions
and departments in order to influence several bills, among which are FDA reauthorizations and the
lowering of drug costs according to the agency OpenSecrets (https://www.opensecrets.org)
9
Reich Circular in 1931, the Nuremberg Code in 1947, the Declaration of Helsinki
in 1964, the U.S. Federal Regulations ‘Common Rule’ in 1974, the U.S. Belmont
Report in 1979, the Council for International Organizations of Medical Sciences
(CIOMS) Guidelines in 1993 and more recently, the World Health Organization
Guidelines for Good Clinical Practice Trials Informed consent on Pharmaceutical
Products in 1995 (Pont, 2008. Pg. 186)

Although the Nuremberg Code was the first that gained real attention and
compliance, previous legislation helped to create a ground of knowledge for the
structuring of the latter regulations. As we mentioned in the previous part, the
Nuremberg Code was the resulting document that came after the investigations
made by the allied forces at Nazi concentration camps where experimentation on
human beings was conducted without any care for human life.

It’s considered the most authoritative document on human experimentation and

established an orderly framework for biomedical research with human subjects .
It’s based on principles of natural law and human rights universally applicable,
and it’s formed by ten fundamental principles (Emanuel et al ., 2011. Pg. 139):

1. Voluntary consent as absolutely essential

2. There has to be high social value in the prospected result of the experiment
that cannot be achieved by other means
3. It has to be based on previous successful animal experimentation
4. It has to be designed to avoid unnecessary pain
5. If death is an expected outcome, there cannot be experimentation
6. The humanitarian benefit has to be greater than the risk
7. The experiment has to be carried in the best facilities possible
8. The research can only be conducted by professionals
9. The participant has the liberty to withdraw from the experiment at any given
point

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 10. The researcher has to put an end to the experiment whenever there is a
risk of death, injury or disability is a likely outcome

The main strength of the Nuremberg Code is the emphasis on informed consent
as the first and therefore, most important, component of ethical medical research.
As this principle is applicable to all participants non-withstanding the
circumstances they are in at the beginning of the study, they “should be made
known to him the nature, duration, and purpose of the experiment; the method
and means by which it is to be conducted; all inconveniences and hazards
reasonably to be expected; and the effects upon his health or person which may
possibly come from his participation in the experiment ” (Pont. Pg. 187). The
application of this first principle would put prisoners on a more even ground in
comparison to non-vulnerable groups as they have the right to receive the same
information as any other participant.

The 9th principle is also significant for prisoners as they have the freedom to stop
their participation in the experiment without fear of punishment . Here it would be
interesting to evaluate if withdrawal would also mean the withdrawal of the
compensation agreed upon at the beginning of the study.

The second guideline that added value to the case of prisoners is the Declaration
of Helsinki. This declaration is a compilation of ethical principles on
experimentation on human subjects developed by the World Medical Association
(WMA), and its purpose was to link the Nuremberg Code with the Geneva
Declaration from the standpoint of medical professionals. Initially, it was
composed of five principles in 1964:

1. Clinical research must conform to the moral and scientific principles that justify
medical research and should be based on laboratory and animal experiments or
other scientific facts.

2. Clinical research should be conducted only by scientifically qualified persons

and under the supervision of a qualified medical man.

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 3. Clinical research cannot legitimately be carried out unless the importance of
the objective is in proportion to the inherent risk to the subject.

4. Every clinical research project should be preceded by careful assessment of

inherent risks in comparison to foreseeable benefits to the subject or others.

5. Special caution should be exercised by the doctor in performing clinical

research in which the personality of the subject is liable to be altered by drugs or
experimental procedure.4

After this, there have been seven revisions (1983, 1989, 1996, 2000, 2004, 2008,
2013) that have added or further discussed the original principles or some of the
articles. Regarding the situation on prisoners, the Declaration of Helsinki brought
to light a crucial distinction in the Article 8:

Medical research is subject to ethical standards that promote respect for all
human beings and protect their health and rights. Some research populations are
vulnerable and need special protection. The particular needs of the economically
and medically disadvantaged must be recognized. Special attention is also
required for those who cannot give or refuse consent for themselves, for those
who may be subject to giving consent under duress, for those who will not benefit
personally from the research and for those for whom the research is combined
with care5

The classification of certain groups as more vulnerable than others and thus , in
need of protection when speaking of giving informed consent to participate in
medical research, encompass prisoners within its limits.

Finally, the Belmont report was the reaction to the Tuskegee syphilis experiment
outrage because it violated the two central concerns of the Nuremberg Code and
Declaration of Helsinki respectively: Informed consent and exploitation of

4
Declaration of Helsinki. Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964
5
Declaration of Helsinki. Article 8th. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June
1964; amended by the 29th WMA General Assembly, Tokyo, Japan, October 1975; 35th WMA General
Assembly, Venice, Italy, October 1983; 41st WMA General Assembly, Hong Kong, September 1989; 48th
WMA General Assembly, Somerset West, Republic of South Africa, October 1996, and the 52nd WMA
General Assembly, Edinburgh, Scotland, October 2000
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vulnerable groups. The subjects, African-American males in a state of
impoverishment, were misinformed since the start regarding risk/benefit ratio ,
duration, and possible outcomes.

The report has three underlined principles: respect for persons, beneficence and
justice. “Respect for persons applies to informed consent; beneficence applies for
risk/benefit assessment; and justice applies to the selection of research
participants” (Emanuel et al., Pg. 150). It’s considered one of the most influential
documents in the field of bioethics and its multiple branches because it addresses
the moral principles that support the regulations and give them meaning. In the
practical aspect, the government of the U.S. has made mandatory that institution
that require funding comply with the principles in the report and that present
evidence of adherence periodically.

The combination of these international guidelines, combined with in some cases,

guidelines exclusives for certain countries comprise regulations that in actuality
remain valid for the protection of prisoners in medical research. The aim of the
regulations is to balance the disadvantages that inmates have by constitution
given their status as prisoners and the circumstances surrounding their placement
and physical and psychological statuses.

Medical research with inmates

We have seen how at the beginning research with inmates faced troubles with
informed consent and the lack of real oversight to avoid harm to participants ;
greatly due to the numerous scandals involving unethical experimentation from
the early 1900s, governments and international institution started to develop
regulations in order to protect the rights of human subjects, among which were
prisoners.

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Nowadays, although there are still cases in which the regulations are not
completely respected, it is widely accepted that inmates have the right to be
protected against abuses and coercion in the participation on medical research,
experiments or clinical trials. According to Scientific American “about 60 percent
of the researchers and ethics committee members said that “prisoners should be
treated equally to other members of the population in terms of recruitment into
non-prison-specific research.” (Maron, 2014)

Furthermore, according to a recent study made to determine the perception of

inmates about exploitation during medical research, although 52.9% agreed that
joining the study was the only way to get the treatment they needed, and 24.3%
agreed that they only joined the study because they couldn't get the treatment
they needed in prison, 95.7% agreed that inmates should have the chance to join
more research studies. (Christopher, P. et all. 2016)

So, while the situation for prisoners in medical research have improved
dramatically in recent decades compared to the days of the Tuskegee Study, after
a long history of abuses and mistreatments executed by governments and
institutions, now there seems to be a sort of protectionism caused by the
regulatory efforts enforced that appears to limit the chances of this population to
participate in research.

In fact, the Subpart C of the Common Rule, officially named the regulation 45 CFR
part 46, only allows four scenarios in which research with prisoners is permissible:
Study of the possible causes, effects, and processes of incarceration, and of
criminal behavior; study of prisons as institutional structures or of prisoners as
incarcerated persons; research on conditions particularly affecting prisoners as a
class; and research on practices, both innovative and accepted, which have the
intent and reasonable probability of improving the health or well-being of the
subject.6

6
45 CFR 46. §46.306 Permitted research involving prisoners.
14
Even though these regulations were created, as it has been said, to protect the
rights of prisoners and prevent any coercion or exploitation, complains have been
raised because the regulations that basically only allow minimal risk experiments7,
limit too much the range of possible medical studies that they can access, and
that itself can be interpreted as a way of inequality when compared with other
groups. Professor Lawrence Gostin notes that “Although these are valid concerns,
human subject research not only imposes risks and burdens but can also confer
benefits. Modern advocacy movements have called for greater, not less, access
to clinical trials by women, persons living with HIV/AIDS, and patients with cancer”
(Gostin. 2008. Pg. 739)

Conclusion

As it often happens in this field, coming to an answer or a definitive conclusion is

difficult and imprecise. The questions about free choice and informed consent
have undoubtedly improved in the past hundred years and as a result we have
better and more prepared systems that recognize inmate’s human rights and that
actively look out to provide the protection they are entitled in their condition as
human beings.

The tension to find balance between too tight regulations and the ever-present
ambiguity when considering the factors that can be counted as coercive or unduly
influential when informed consent is involved will remain a discussion in progress.

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defined as the risk of harm normally encountered in their daily lives or in the routine medical, dental, or
psychological examination of healthy persons
15
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