BIOETHICS

1. What are your thoughts with regards to the conduct of research studies in the past? Cite actual
cases of inhumane/unethical conduct of research.
• It is horrifying to know that many of the study participants refused to — or were unable
to — give their permission. They were sometimes enticed to participate by promises of
better health or a little monetary reward. Other instances, facts about the trial were
revealed but not the degree of the hazards.
• Moreover, most people are aware of some of the horrible medical experiments that have
occurred in the past and have resulted in human rights violations. These studies were
either forced or pressured into participation under false pretenses. The Nazi experiments,
the Tuskegee syphilis research, the Stanford Prison Experiment, and the CIA's LSD tests
are just a few of the most well-known instances.

The Prison Doctor Who Did Testicular Transplants

• From 1913 to 1951, eugenicist Leo Stanley was the chief surgeon at San Quentin State
Prison, California’s oldest correctional institution. After performing vasectomies on
prisoners, whom he recruited through promises of improved health and vigor, Stanley
turned his attention to the emerging field of endocrinology, which involves the study of
certain glands and the hormones they regulate. He believed the effects of aging and
decreased hormones contributed to criminality, weak morality, and poor physical
attributes. Transplanting the testicles of younger men into those who were older would
restore masculinity, he thought.

• Stanley began by using the testicles of executed prisoners — but he ran into a supply
shortage. He solved this by using the testicles of animals, including goats and deer. At
first, he physically implanted the testicles directly into the inmates. But that had
complications, so he switched to a new plan: He ground up the animal testicles into a
paste, which he injected into prisoners’ abdomens. By the end of his time at San Quentin,
Stanley did an estimated 10,000 testicular procedures.

The Oncologist Who Injected Cancer Cells into Patients and Prisoners
• During the 1950s and 1960s, Sloan-Kettering Institute oncologist Chester Southam
conducted research to learn how people’s immune systems would react when exposed to
cancer cells. In order to find out, he injected live HeLa cancer cells into patients,
generally without their permission. When patient consent was given, details around the
true nature of the experiment were often kept secret. Southam first experimented on
terminally ill cancer patients, to whom he had easy access. The result of the injection was
the growth of cancerous nodules, which led to metastasis in one person.
Next, Southam experimented on healthy subjects, which he felt would yield more
accurate results. He recruited prisoners, and, perhaps not surprisingly, their healthier
immune systems responded better than those of cancer patients. Eventually, Southam
returned to infecting the sick and arranged to have patients at the Jewish Chronic Disease
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Hospital in Brooklyn, NY, injected with HeLa cells. But this time, there was resistance.
Three doctors who were asked to participate in the experiment refused, resigned, and
went public.
• The scandalous newspaper headlines shocked the public, and legal proceedings were
initiated against Southern. Some in the scientific and medical community condemned his
experiments, while others supported him. Initially, Southam’s medical license was
suspended for one year, but it was then reduced to a probation. His career continued to be
illustrious, and he was subsequently elected president of the American Association for
Cancer Research.

The Aptly Named ‘Monster Study’

• Pioneering speech pathologist Wendell Johnson suffered from severe stuttering that
began early in his childhood. His own experience motivated his focus on finding the
cause, and hopefully a cure, for stuttering. He theorized that stuttering in children could
be impacted by external factors, such as negative reinforcement. In 1939, under
Johnson’s supervision, graduate student Mary Tudor conducted a stuttering experiment,
using 22 children at an Iowa orphanage. Half received positive reinforcement. But the
other half were ridiculed and criticized for their speech, whether or not they actually
stuttered. This resulted in a worsening of speech issues for the children who were given
negative feedback.
• The study was never published due to the multitude of ethical violations. According to
The Washington Post, Tudor was remorseful about the damage caused by the
experiment and returned to the orphanage to help the children with their speech. Despite
his ethical mistakes, the Wendell Johnson Speech and Hearing Clinic at the University of
Iowa bears Johnson's name and is a nod to his contributions to the field.

The Dermatologist Who Used Prisoners as Guinea Pigs

• One of the biggest breakthroughs in dermatology was the invention of Retin-A, a cream
that can treat sun damage, wrinkles, and other skin conditions. Its success led to fortune
and fame for co-inventor Albert Kligman, a dermatologist at the University of
Pennsylvania. But Kligman is also known for his nefarious dermatology experiments on
prisoners that began in 1951 and continued for around 20 years. He conducted his
research on behalf of companies including DuPont and Johnson & Johnson.
• Kligman’s work often left prisoners with pain and scars as he used them as study subjects
in wound healing and exposed them to deodorants, foot powders, and more for
chemical and cosmetic companies. Dow once enlisted Kligman to study the effects of
dioxin, a chemical in Agent Orange, on 75 inmates at Pennsylvania's Holmesburg Prison.
The prisoners were paid a small amount for their participation but were not told about the
potential side effects.
In the University of Pennsylvania’s journal, Almanac, Kligman’s obituary focused on
his medical advancements, awards, and philanthropy. There was no acknowledgement of
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his prison experiments. However, it did mention that as a “giant in the field,” he “also
experienced his fair share of controversy.”

The Endocrinologist Who Irradiated Prisoners

• When the Atomic Energy Commission wanted to know how radiation affected male
reproductive function, they looked to endocrinologist Carl Heller. In a study involving
Oregon State Penitentiary prisoners between 1963 and 1973, Heller designed a
contraption that would radiate their testicles at varying amounts to see what effect it had,
particularly on sperm production. The prisoners also were subjected to repeated biopsies
and were required to undergo vasectomies once the experiments concluded.
• Although study participants were paid, it raised ethical issues about the potential coercive
nature of financial compensation to prison populations. The prisoners were informed
about the risks of skin burns, but likely were not told about the possibility of significant
pain, inflammation, and the small risk of testicular cancer.

2. What are the significances of the policies/rules/codes (as provided below) in the conduct of
research studies?

• In reaction to many scandals, the Belmont Report (Belmont Report: Ethical Principles
and Guidelines for the Protection of Human Subjects of Research, 1978) led in a
significant shift in human subjects-based research. The concept of autonomy appears to
have been thrust into the discourse and has since been the major motivator of ethical
conduct in human subjects-based research. Indeed, the history of human subjects-based
research has revealed that moral responsibilities such as beneficence and nonmaleficence,
as well as appeals to scientists' goodness, are insufficient. As a result, enforcing the
concept of autonomy was the most effective manner of enforcing justice. The notion of
autonomy was formalized in the form of informed permission for study participation, and
it was quickly adopted, formally or informally, in medical and clinical ethics.

• The Declaration of Helsinki was created by the World Medical Association as a

declaration of ethical principles to guide physicians and other participants in medical
research involving human beings. Medical study on identifiable human material or
identifiable data covers research on human beings. It is the physician's responsibility to
promote and protect the public's health. The knowledge and conscience of the physician
are devoted to the performance of this task.

The Nuremberg Code, which was written after the conclusion of the Doctor's trial in
Nuremberg in 1947, has been recognized as a watershed moment in medical and research
ethics. This code was based on the Guidelines for Human Experimentation of 1931,
according to a closer analysis. The similarity between these documents is startling. It's
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regrettable that the Nuremberg Code's creators passed it off as their own work. There is
evidence that the defendants in the trial requested that their acts be assessed according to
the German Guidelines of 1931.

3. Relate the videos to relevant policies in the conduct of research which you find applicable in
the cases provided in the video.
THE MEDICAL RESEARCH OF JENNER IN 1796
• He inoculates a small kid with milkmaid pus and challenges him with a live virus within a
short period. Despite the fact that it was a world-record-breaking triumph. This is plainly
immoral because Jenner's experiment may have put the child's life at danger if the
sickness had killed him. In this scenario, the following policies are relevant:
- The WHO Standards: Risks and potential benefits. In ethically acceptable
research, risks have been minimized (both by preventing potential harms and
minimizing their negative impacts should they occur) and are reasonable in
relation to the potential benefits of the study
- The Nuremberg Code 6 where it is stated that-The degree of risk to be taken
should never exceed that determined by the humanitarian importance of the
problem to be solved by the experiment.
- The principle of non-maleficence (doing no harm) and principle of beneficence
(acting in the patient’s best interest) can also be applied.

J. MARION SIMS, CONSIDERED THE FATHER OF GYNECOLOGY

• People hold him in high respect because of his considerable contribution to the field of
gynecological research. The reality about his medical study and experimentation, on the
other hand, is not anything to be proud of. Slave Sims have been used to test items used
in gynecological and medical operations. His slaves are kept in a hut at the back of his
property. He is doing treatments and testing on these captives without anesthetic or
painkillers. Experimenting with C-sections to see if the slave is pregnant or not. In this
scenario, the following policies are relevant:
- Respect for persons. This principle encompasses both respect for human beings'
autonomy and the imperative of safeguarding vulnerable persons.
- Justice. The need to apportion the burden and rewards of research properly is
central to research justice.
 - Informed consent process. The notion of respect for individuals is the ethical
underpinning of informed consent.
- Study population selection and research recruitment: no class or group of
individuals endures more than its fair share of the responsibilities of research
involvement.
- Non-maleficence (doing no harm)
- Beneficence. The responsibility of beneficence mandates that research optimize
the benefit-to-harm ratio for individual participants and the study program as a
whole, rather than merely promoting well-being.
- The right to disengage and abandon a research study at any time.

THE MENGELE’S TWIN STUDIES (1940S)

• Dr. Joseph Mengele's research during World War II tries to make his passion a reality. It
was to imitate the Hitler youngsters' blonde, blue-eyed model. He devised a method for
mass-producing it through genetic engineering. He conducted his research on identical
twins, doing the experiment on one and comparing the results to the other. Toxic
injections into the arm and eyes are used in his experiment. Approximately 3000 twins
are slain in total. In this scenario, the following policies are relevant:
- Respect for persons. This principle encompasses both respect for human beings'
autonomy and the imperative of safeguarding vulnerable persons.
- The right to disengage and abandon a research study at any time.
- Non-maleficence (doing no harm)
- Justice. The need to apportion the burden and rewards of research properly is
central to research justice.
- Informed consent process. The notion of respect for individuals is the ethical
underpinning of informed consent.
- Beneficence. The responsibility of beneficence mandates that research optimize
the benefit-to-harm ratio for individual participants and the study program as a
whole, rather than merely promoting well-being.
- Study population selection and research recruitment: no group or class of
people endures more than its fair share of the responsibilities of research
involvement.
TUSKEGEE SYPHILIS STUDY (1932-1972)
• Is a notorious American medical research organization noted for unethical testing and
exploitation of African-American victims. The participants were not informed that they
had syphilis or that it may be spread through sexual contact. Arsenic, bismuth, and
mercury were given to some of the patients. Following the failure of a previous trial, it
was decided to keep the individuals alive until they died, and all therapy was terminated.
In this scenario, the following policies are relevant:
- Respect for persons. This principle encompasses both respect for human beings'
autonomy and the imperative of safeguarding vulnerable persons.
- The right to disengage and abandon a research study at any time.
- Non-maleficence (doing no harm)
- Justice. The need to apportion the burden and rewards of research properly is
central to research justice.
- Informed consent process. The notion of respect for individuals is the ethical
underpinning of informed consent.
- Beneficence. The responsibility of beneficence mandates that research optimize
the benefit-to-harm ratio for individual participants and the study program as a
whole, rather than merely promoting well-being.
- Study population selection and research recruitment: no group or class of
people endures more than its fair share of the responsibilities of research
involvement.

WILLOWBROOK HEPATITIS EXPERIMENTS (1950S-1970S)

• This is a Willow Brook State School experiment for students with intellectual challenges.
Participants had little say in whether or not they wanted to participate, and they were held
in deplorable conditions such as being confined in a filthy cramped room filled with
excrement and grime. In this scenario, the following policies are relevant:
- Respect for persons. This principle encompasses both respect for human beings'
autonomy and the imperative of safeguarding vulnerable persons.
- Informed consent process. The notion of respect for individuals is the ethical
underpinning of informed consent.
- The right to disengage and abandon a research study at any time.
• STANLY MILGRAM’S STUDY ON OBEDIENCE is considered unethical because
he used deception in gathering the participants for his study and they weren’t allowed to
withdraw from the study. The relevant policies applicable in this case are:
- Informed consent process. The notion of respect for individuals is the ethical
underpinning of informed consent.
- The right to disengage and abandon a research study at any time.

• STANFORD PRISON EXPERIMENT is a social psychology study in which college

students became prisoners or guards in a simulated prison environment. The study was
considered unethical considering including lack of fully informed consent, the right to
withdraw, and debriefing and the protection from physical and psychological harm. The
relevant policies applicable in this case are:
- Informed consent process. The notion of respect for individuals is the ethical
underpinning of informed consent.
- The right to disengage and abandon a research study at any time.
- Protection of Participants from bodily and psychological harm.
References:
Futterman, A. (2021, January 11). 5 Unethical Medical Experiments Brought Out of the
Shadows of History. Discover Magazine. https://www.discovermagazine.com/health/5-
unethicalmedical-experiments-brought-out-of-the-shadows-of-history

Erwin B. Montgomery Jr. (2021). Belmont Report - an overview | ScienceDirect Topics. ScienceDirect.
https://www.sciencedirect.com/topics/medicine-and-dentistry/belmont-report

https://www.who.int/bulletin/archives/79(4)373.pdf

The Nuremberg Code–A critique. (2011, April). PubMed Central (PMC).

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3121268/

khanacademymedicine. (2015, April 3). Milgram experiment on obedience | Behavior | MCAT | Khan
Academy. YouTube. https://www.youtube.com/watch?v=PJFzqfLMBIw&feature=youtu.be

S. (2015, September 16). Willowbrook: The Last Great Disgrace - Trailer of 28-minute documentary
(developmental disability). YouTube. https://www.youtube.com/watch?
v=rPBhuaxpL90&feature=youtu.be

V. (2018, December 19). The Stanford Prison Experiment. YouTube. https://www.youtube.com/watch?

v=KND_bBDE8RQ&feature=youtu.be

Y. (2011, March 17). 21. The Tuskegee Experiment. YouTube. https://www.youtube.com/watch?

v=3KL7lcWMkz0&feature=youtu.be