Bioethics Midterm Exam QUESTIONS
AND CORRECT ANSWERS
The Nuremberg Code - CORRECT ANSWER The Nuremberg Code, consisting of ten
principles ensuring the rights of subjects in medical research, is a document that emerged from the
Doctor's Trial. Specifically, it was formulated in August 1947 in Nuremberg, Germany by American
judges sitting in judgment of Nazi doctors accused of conducting murderous and torturous human
experiments in the concentration campus. A set of research ethics principles for human
experimentation, the Nuremberg Code challenged the traditional Hippocratic doctor-patient
relationship, extending Hippocratic ethics to focus on and protect the rights of subjects in human
experimentation. The Code not only requires the voluntary consent of the human subject (principle 1),
but it also emphasizes physician-researchers protecting the best interests of their subjects and the
ability for subjects to actively protect themselves.
Not only does the Nuremberg Code have links with WWII and the use of prisoners in Nazi
concentration camps for medical experimentation, but it also shows the important role that physicians
(Andrew Ivy, Leo Alexander, and Werner Leibbrand) had in the prosecution of Nazi doctors and in the
formulation of the Code. The Code was also initially dismissed by the Western world as a "code for
barbarians" and not for civilized physicians and investigators. Moreover, although not officially
accepted as law by any nation or as an official set of ethical guidelines by any association, the
Nuremberg Code is considered to be the most important document in the history of the ethics of
medical research and its idea of informed consent has been universally accepted. Its influence can be
seen alongside the Declaration of Helsinki, with its human research ethics guidelines being seen in
IRBs and federal regulations today.
Henry Beecher - CORRECT ANSWER Henry Beecher was a famous American
anesthesiologist, medical ethicist, and investigator at Harvard Medical School. Often regarded as a
prominent whistleblower with regard to ethically problematic research studies, Beecher was an active
advocate of research ethics in human experimentation during the late 1950s and early 1960s in the
United States. He published an article in JAMA in 1959 on his views of ethics and clinical research
and later presented a paper to journalists at a 1965 conference that discussed examples of unethical
experimental studies.
Although his attempts broke the status quo within the biomedical community and helped spur
coverage of the unethical conduct involving human subjects in research, Beecher received backlash
from his colleagues and frequent rejections from medical journals. Undeterred, following a number of
revision attempts, Beecher ultimately published his landmark 1966 article in NEJM which cited 22
examples of unethical experimental studies, including the Willowbrook Study and the Cancer study.
This article established Beecher's authority in drawing attention to unethical research and urging
American physician-researchers to have accountability for the ethics of their research. Furthermore,
he emphasized the ideas that investigators should strive to obtain fully informed consent, an
,experiment is ethical or not at its inception, and that an editorial responsibility exists in addition to the
investigator. Beecher's 1966 NEJM article exposed the widespread nature of ethical problems in
medical research, stirred national conversation regarding these issues, and called for doctors to be
responsible investigators. Moreover, ethically questionable American studies are now being openly
published and discussed during the time period.
Willowbrook Study, Saul Krugman - CORRECT ANSWER The Willowbrook Study was one
of the unethical experimental studies presented by Henry Beecher in his landmark 1966 NEJM article.
Hepatitis studies from the 1950s to early 1970s were led by Dr. Saul Krugman and his co-workers at
an overcrowded and understaffed New York State Institution for mentally disabled children. Hepatitis
was known to be a major problem at Willowbrook, and Dr. Krugman noticed that those infected with
the disease recovered and appeared to be immune to future outbreaks. Thus, he decided to try and
examine potential degrees of immunity to hepatitis by deliberately injecting children with the virus
through either fecal milkshakes or injections. In addition, some children would receive gamma
globulin, a blood protein that contains antibodies. Specifically, the study involved 700 children
divided into 2 groups, and Krugman investigated the different transmission routes and different
courses of disease across these populations.
This research study led to important breakthroughs in the understanding and treatment of hepatitis and
also confirmed that the disease was caused by two separate viruses: hepatitis A and hepatitis B. At the
same time, however, this study brought forth a significant amount of bioethical concerns and debates.
The consent letter to parents revealed that they were not truly informed about the risks of the study,
and the study involved using a vulnerable, institutionalized population for the experiment. Parents and
children were also unfairly induced to participate in the study, receiving certain benefits such as
admission to a cleaner ward while the researchers took advantage of a poorly-maintained institution.
Often regarded as one of the most unethical medical experiments performed on children in the United
States, the Willowbrook Study was a turning point in how medical research
Andrew Ivy - CORRECT ANSWER Andrew Ivy was a well-known American physiologist and
scientist who had a central role in shaping medical research ethics during the Doctor's Trial in
Nuremberg, Germany in the late 1940s, which dealt with the judgment of Nazi doctors accused of
conducting murderous and torturous human experiments in the concentration camps. Ivy was
appointed by the AMA as its representative at the trial. He also had first-hand knowledge of the
Stateville Penitentiary experiments on malaria that took place in Illinois, which the Nazi defendants
attempted to equate to those performed on inmates in the concentration camps.
In response, he sought to differentiate the malaria experiments in the United States from the Nazi
experiments by establishing the Green Committee, exonerating the United States from unethical
research claims. Ivy used this report during the trial to justify the American experiments and refute
any similarities with the Nazi experiments. During the Doctor's Trial, Ivy also presented three
research principles prioritizing the consent of the human subject, results of animal experimentation,
and the administration of the experiment by scientifically qualified persons. The judges adopted much
of the language proposed by Ivy and other physicians in constructing the Nuremberg Code.
, The Belmont Report - CORRECT ANSWER The Belmont Report was written partly in
response to the controversial Tuskegee Syphilis Study (1932-1972). Peter Buxton also played a
pivotal role in exposing the unethical conduct of the Tuskegee Study and sparking massive backlash.
Following the Tuskegee Study, Congress passed the National Research Act, creating the National
Commission for the Protection of Human Subjects of Biomedical and Behavioral Research which
ultimately created the Belmont Report in the mid-to-late 1970s. The Report attempts to summarize the
basic ethical principles and guidelines for research involving human subjects and provide an
analytical framework that will guide the resolution of ethical problems in human subjects research.
Specifically, the Belmont Report not only identifies three core principles - respect for persons,
beneficence, and justice - but it also distinguishes between clinical and non-therapeutic research and
emphasizes informed consent, risk/benefit assessment, and the selection of research subjects. The
Belmont Report is one of the leading documents concerning ethics and medical research, bringing in
bioethical principles that have become the essential requirements for the ethical conduct of human
subjects research. Additionally, the Belmont Report represents bioethics emerging as a more solidified
field in the 1970s, with these initial transitions from internal discussions and codes to regulations
paving the way for more detailed federal regulations seen today on institutional review boards,
research ethics committees, and informed consent.
The Green Committee - CORRECT ANSWER The Green Committee was formed during the
Doctor's Trial in Nuremberg, Germany in the 1940s to investigate the ethics of the malaria
experiments in Illinois. Specifically, however, it was geared towards differentiating U.S.
experimentation from Nazi experimentation in order to declare American innocence in medical
research and establish the United States as a positive ethical standard. Andrew Ivy, one of the central
physicians at the Doctor's Trial, responded to Nazi criticism of American research by encouraging the
Illinois governor to formulate the Green Committee.
In addition to Andrew Ivy, the committee consisted of well-known doctors, a lawyer, rabbi, priest, and
Oscar Mayer. Interestingly, however, the committee never met, and Ivy falsely testified during the
trial that the committee had written a report. In actuality, Ivy had written the report, justifying the
prison research done in the States and refusing to acknowledge any similarities with the Nazi
experiments. The Green report was eventually published in JAMA once the committee met after the
trial. It was used as a basis in subsequent decades to justify medical research on U.S. prisoners.
Tuskegee Experiment - CORRECT ANSWER The Tuskegee Experiment is an infamous
historical study that took place from 1932-1972. It was conducted by the United States Public Health
Service in Macon County, Alabama and targeted a population of 600 impoverished, African American
sharecroppers. Specifically, there were 400 men with latent syphilis and 200 controls. The research
study aimed to understand the natural progression of untreated syphilis even after penicillin had been
discovered as an effective treatment. Furthermore, none of the men were told that they had the disease
AND CORRECT ANSWERS
The Nuremberg Code - CORRECT ANSWER The Nuremberg Code, consisting of ten
principles ensuring the rights of subjects in medical research, is a document that emerged from the
Doctor's Trial. Specifically, it was formulated in August 1947 in Nuremberg, Germany by American
judges sitting in judgment of Nazi doctors accused of conducting murderous and torturous human
experiments in the concentration campus. A set of research ethics principles for human
experimentation, the Nuremberg Code challenged the traditional Hippocratic doctor-patient
relationship, extending Hippocratic ethics to focus on and protect the rights of subjects in human
experimentation. The Code not only requires the voluntary consent of the human subject (principle 1),
but it also emphasizes physician-researchers protecting the best interests of their subjects and the
ability for subjects to actively protect themselves.
Not only does the Nuremberg Code have links with WWII and the use of prisoners in Nazi
concentration camps for medical experimentation, but it also shows the important role that physicians
(Andrew Ivy, Leo Alexander, and Werner Leibbrand) had in the prosecution of Nazi doctors and in the
formulation of the Code. The Code was also initially dismissed by the Western world as a "code for
barbarians" and not for civilized physicians and investigators. Moreover, although not officially
accepted as law by any nation or as an official set of ethical guidelines by any association, the
Nuremberg Code is considered to be the most important document in the history of the ethics of
medical research and its idea of informed consent has been universally accepted. Its influence can be
seen alongside the Declaration of Helsinki, with its human research ethics guidelines being seen in
IRBs and federal regulations today.
Henry Beecher - CORRECT ANSWER Henry Beecher was a famous American
anesthesiologist, medical ethicist, and investigator at Harvard Medical School. Often regarded as a
prominent whistleblower with regard to ethically problematic research studies, Beecher was an active
advocate of research ethics in human experimentation during the late 1950s and early 1960s in the
United States. He published an article in JAMA in 1959 on his views of ethics and clinical research
and later presented a paper to journalists at a 1965 conference that discussed examples of unethical
experimental studies.
Although his attempts broke the status quo within the biomedical community and helped spur
coverage of the unethical conduct involving human subjects in research, Beecher received backlash
from his colleagues and frequent rejections from medical journals. Undeterred, following a number of
revision attempts, Beecher ultimately published his landmark 1966 article in NEJM which cited 22
examples of unethical experimental studies, including the Willowbrook Study and the Cancer study.
This article established Beecher's authority in drawing attention to unethical research and urging
American physician-researchers to have accountability for the ethics of their research. Furthermore,
he emphasized the ideas that investigators should strive to obtain fully informed consent, an
,experiment is ethical or not at its inception, and that an editorial responsibility exists in addition to the
investigator. Beecher's 1966 NEJM article exposed the widespread nature of ethical problems in
medical research, stirred national conversation regarding these issues, and called for doctors to be
responsible investigators. Moreover, ethically questionable American studies are now being openly
published and discussed during the time period.
Willowbrook Study, Saul Krugman - CORRECT ANSWER The Willowbrook Study was one
of the unethical experimental studies presented by Henry Beecher in his landmark 1966 NEJM article.
Hepatitis studies from the 1950s to early 1970s were led by Dr. Saul Krugman and his co-workers at
an overcrowded and understaffed New York State Institution for mentally disabled children. Hepatitis
was known to be a major problem at Willowbrook, and Dr. Krugman noticed that those infected with
the disease recovered and appeared to be immune to future outbreaks. Thus, he decided to try and
examine potential degrees of immunity to hepatitis by deliberately injecting children with the virus
through either fecal milkshakes or injections. In addition, some children would receive gamma
globulin, a blood protein that contains antibodies. Specifically, the study involved 700 children
divided into 2 groups, and Krugman investigated the different transmission routes and different
courses of disease across these populations.
This research study led to important breakthroughs in the understanding and treatment of hepatitis and
also confirmed that the disease was caused by two separate viruses: hepatitis A and hepatitis B. At the
same time, however, this study brought forth a significant amount of bioethical concerns and debates.
The consent letter to parents revealed that they were not truly informed about the risks of the study,
and the study involved using a vulnerable, institutionalized population for the experiment. Parents and
children were also unfairly induced to participate in the study, receiving certain benefits such as
admission to a cleaner ward while the researchers took advantage of a poorly-maintained institution.
Often regarded as one of the most unethical medical experiments performed on children in the United
States, the Willowbrook Study was a turning point in how medical research
Andrew Ivy - CORRECT ANSWER Andrew Ivy was a well-known American physiologist and
scientist who had a central role in shaping medical research ethics during the Doctor's Trial in
Nuremberg, Germany in the late 1940s, which dealt with the judgment of Nazi doctors accused of
conducting murderous and torturous human experiments in the concentration camps. Ivy was
appointed by the AMA as its representative at the trial. He also had first-hand knowledge of the
Stateville Penitentiary experiments on malaria that took place in Illinois, which the Nazi defendants
attempted to equate to those performed on inmates in the concentration camps.
In response, he sought to differentiate the malaria experiments in the United States from the Nazi
experiments by establishing the Green Committee, exonerating the United States from unethical
research claims. Ivy used this report during the trial to justify the American experiments and refute
any similarities with the Nazi experiments. During the Doctor's Trial, Ivy also presented three
research principles prioritizing the consent of the human subject, results of animal experimentation,
and the administration of the experiment by scientifically qualified persons. The judges adopted much
of the language proposed by Ivy and other physicians in constructing the Nuremberg Code.
, The Belmont Report - CORRECT ANSWER The Belmont Report was written partly in
response to the controversial Tuskegee Syphilis Study (1932-1972). Peter Buxton also played a
pivotal role in exposing the unethical conduct of the Tuskegee Study and sparking massive backlash.
Following the Tuskegee Study, Congress passed the National Research Act, creating the National
Commission for the Protection of Human Subjects of Biomedical and Behavioral Research which
ultimately created the Belmont Report in the mid-to-late 1970s. The Report attempts to summarize the
basic ethical principles and guidelines for research involving human subjects and provide an
analytical framework that will guide the resolution of ethical problems in human subjects research.
Specifically, the Belmont Report not only identifies three core principles - respect for persons,
beneficence, and justice - but it also distinguishes between clinical and non-therapeutic research and
emphasizes informed consent, risk/benefit assessment, and the selection of research subjects. The
Belmont Report is one of the leading documents concerning ethics and medical research, bringing in
bioethical principles that have become the essential requirements for the ethical conduct of human
subjects research. Additionally, the Belmont Report represents bioethics emerging as a more solidified
field in the 1970s, with these initial transitions from internal discussions and codes to regulations
paving the way for more detailed federal regulations seen today on institutional review boards,
research ethics committees, and informed consent.
The Green Committee - CORRECT ANSWER The Green Committee was formed during the
Doctor's Trial in Nuremberg, Germany in the 1940s to investigate the ethics of the malaria
experiments in Illinois. Specifically, however, it was geared towards differentiating U.S.
experimentation from Nazi experimentation in order to declare American innocence in medical
research and establish the United States as a positive ethical standard. Andrew Ivy, one of the central
physicians at the Doctor's Trial, responded to Nazi criticism of American research by encouraging the
Illinois governor to formulate the Green Committee.
In addition to Andrew Ivy, the committee consisted of well-known doctors, a lawyer, rabbi, priest, and
Oscar Mayer. Interestingly, however, the committee never met, and Ivy falsely testified during the
trial that the committee had written a report. In actuality, Ivy had written the report, justifying the
prison research done in the States and refusing to acknowledge any similarities with the Nazi
experiments. The Green report was eventually published in JAMA once the committee met after the
trial. It was used as a basis in subsequent decades to justify medical research on U.S. prisoners.
Tuskegee Experiment - CORRECT ANSWER The Tuskegee Experiment is an infamous
historical study that took place from 1932-1972. It was conducted by the United States Public Health
Service in Macon County, Alabama and targeted a population of 600 impoverished, African American
sharecroppers. Specifically, there were 400 men with latent syphilis and 200 controls. The research
study aimed to understand the natural progression of untreated syphilis even after penicillin had been
discovered as an effective treatment. Furthermore, none of the men were told that they had the disease
