Historical Cases of Unethical
Research
We’ve Come a Long Way,
But Not Quite Far Enough
Tuskegee Syphilis Study
• In 1932, the Tuskegee Syphilis Study was a 40-year
project administered by the US Public Health
Service in Macon County, Alabama.
• The American Government promised 400 men free
treatment for bad blood which had become an
epidemic in the county. The treatment was never
given to the men and was in fact withheld.
Tuskegee Syphilis Study
• The study sample was made up of poor African
American men who were told that they had "bad
blood".
• These men did not receive standard treatment for
syphilis even when penicillin was available later
during the study.
• The men in the study were not informed of the
research design and it's risks to them.
Tuskegee Syphilis Study
• Symbolized the medical misconduct and blatant
disregard for human rights that takes place in the
name of science.
• The investigators were government physicians,
respected men of science, who published their
reports of the study in medical journals.
• The burden of medical experimentation has
historically been borne by those least able to
protect themselves.
Tuskegee Syphilis Study
• The government doctors who participated in
this study failed to obtain informed consent
from the subjects.
• The study's unethical features did not come to
light until 1972 when Jean Heller broke the
story.
• By this time, over one hundred of the infected
men died and others suffered from serious
syphilis related conditions. Wives and children
had been infected.
Tuskegee Syphilis Study
• When a class action civil suit of $1.8 billion
was filed against those who were involved in
the study.
• The case never came to trial.
• Each participant only received $37,500 in
damages, and the heirs of the deceased
received $15,000.
Research abuse by Nazi doctors
during World War II
• 23 German physicians practiced unethical
medical experiments on Jews, gypsies, and
political prisoners
• Most of the subjects of these experiments died or
were permanently crippled as a result.
Nazi Experimentation
• Experiments aimed at facilitating the
survival of Axis military personnel
– Used a low-pressure chamber to determine the
maximum altitude from which crews of
damaged aircraft could parachute to safety.
– Freezing experiments using prisoners to find an
effective treatment for hypothermia.
– Testing of various methods of making seawater
potable
Nazi Experimentation
• Developing and testing pharmaceuticals and
treatment methods for injuries and illnesses
– Testing vaccines and sera for the prevention and
treatment of contagious diseases, including
malaria, typhus, tuberculosis, typhoid fever,
yellow fever, and infectious hepatitis.
– Bone-grafting experiments
– Subjected prisoners to phosgene and mustard
gas in order to test possible antidotes.
Nazi Experimentation
• Experiments to advance the racial and
ideological tenets of the Nazi worldview
– Medical experiments on twins.
– Studies to determine how different "races"
withstood various contagious diseases.
– Research to establish "Jewish racial inferiority."
– Mass sterilization experiments.
Nazi Experimentation
• In 1947, Nuremberg Code and other
international codes of ethics written to
protect research participants.
– Under this code, the physicians were convicted
for crimes against humanity.
– This also led to standards in research requiring
that subjects participate voluntarily and are
informed of the risks of the research.
Willowbrook Hepatitis Study
• From 1963 to 1966, the Willowbrook Study
involved a group of children diagnosed with
mental retardation, who lived at the
Willowbrook State Hospital in Staten Island,
New York.
• These innocent children were deliberately
infected with the hepatitis virus
Willowbrook Hepatitis Study
• The study's purpose was to study the
history of the disease when left untreated
and later to assess the effects of gamma
globulin as a therapeutic intervention.
• This study involved the deliberate infection
of the children and the attempts to
convince the parents to enroll them in the
study in exchange for admission to the
hospital (which was deliberately short of
space).
• New York Senator Robert Kennedy and a
television crew visit Willowbrook State
school in Staten Island NY.
• He stated that the residents of these
institutions were “denied access to
education and are deprived of their civil
liberties.”
• Later that same year, he addressed a
joint session of the NYS Legislature on
the “dehumanizing conditions” of the
State’s institutions
Project Shipboard Hazard and Defense (SHAD)
1963 to 1969
• The U.S. Army performed tests which involved
spraying several U.S. ships with various biological
and chemical warfare agents, while thousands of
U.S. military personnel were aboard the ships.
• The personnel were not notified of the tests, and
were not given any protective clothing.
• Chemicals tested on the U.S. military personnel
included the nerve gases VX and Sarin, toxic
chemicals, and a variety of biological agents.
In 1979, the federal government developed
regulations of ethical principals and standards
that are contained in the Belmont Report.
• Ethical principals upon which a research
study is evaluated in the United States.
• Moral basis of the present US Federal
regulations of human subject research
conduct with Federal funds from the
majority of Federal agencies
• Forerunner of Institutional Review Board.
Three Guiding Principles
of Ethical Research
• Respect for Individuals
• Beneficence
• Justice
Respect for Individuals
• Individuals act as autonomous agents
• Individuals who are not capable of acting as
autonomous agents are entitled to special
protections
– Minors
– Mentally incapacitated persons
– Prisoners
Beneficence
• Guided by two basic principles:
– Do no harm
– Maximize benefits and minimize potential harms
• Risks should be in proportion to potential
benefits
• Research design should ensure valid results
Justice
• Benefits and risks of human research
should be fairly distributed
• Social vs. individual justice
Current Regulations
• Regulations to protect public welfare,
human subjects and establish the IRB.
– 1981
– Department of Health and Human Services
(DHHS) and the Food and Drug Administration
(FDA) issued regulations based on the Belmont
Report.
Current Regulations
Federal Policy for the Protection of Human
Subjects, or "Common Rule."
– 1991
– DHHS regulations were formally adopted by
more than a dozen other Departments and
Agencies that conduct or fund research
involving human subjects
Main elements of the Common Rule
Requirements for:
• assuring compliance by research institutions;
• researchers obtaining and documenting informed
consent;
• Institutional Review Board (IRB) membership,
function, operations, review of research, and
record keeping.
• additional protections for certain vulnerable
research subjects-- pregnant women, prisoners,
and children
The role of the IRB is to protect the
rights and welfare of individual
research subjects.
The IRB assures that:
1. risk to subjects are minimized
2. risk to subjects are reasonable in relation to anticipated
benefits,
3. selection of subjects is equitable, i.e. fair
4. informed consent is sought form each subject or his/her
legally authorized representative,
5. informed consent is appropriately documented,
6. when appropriate, the research plan makes provisions
for monitoring data collection,
7. privacy and confidentiality of research subjects is
appropriately protected, and
8. when some or all of the subjects are likely to be
vulnerable to coercion or undue influence, additional
safeguards have been included.
In 1987 the US Supreme Court ruled in United
States v. Stanley, 483 U.S. 669, that a U.S.
serviceman who was given LSD without his consent,
as part of military experiments, could not sue the
U.S. Army for damages.
Dissenting the verdict in U.S. v. Stanley, Justice
Sandra Day O'Connor stated:
No judicially crafted rule should insulate from liability the
involuntary and unknowing human experimentation alleged
to have occurred in this case. Indeed, as Justice Brennan
observes, the United States played an instrumental role in
the criminal prosecution of Nazi officials who experimented
with human subjects during the Second World War, and the
standards that the Nuremberg Military Tribunals developed
to judge the behavior of the defendants stated that the
'voluntary consent of the human subject is absolutely
essential ... to satisfy moral, ethical, and legal concepts.' If
this principle is violated, the very least that society can do is
to see that the victims are compensated, as best they can
be, by the perpetrators.
Sandra Day O’Connor
So, now what?
From 1988 to 2008, the number of overseas
clinical trials for drugs intended for American
consumption increased by 2,000%, to
approximately 6,500 trials.
These trials are often conducted in areas with
large numbers of poor and illiterate people
who grant their consent by signing an "X" or
making a thumb print on a form.
On January 15, 1994, President Bill Clinton formed
the Advisory Committee on Human Radiation
Experiments (ACHRE).
Created to investigate and report the use of human
beings as test subjects in experiments involving the
effects of ionizing radiation in federally funded
research.
So, it’s all better now, right?
In August 2010, the U.S. weapons manufacturer
Raytheon announced that it had partnered with
a jail in Castaic, California in order to use
prisoners as test subjects for a new non-lethal
weapon system that "fires an invisible heat
beam capable of causing unbearable pain.”
What is Ethics in Research
& Why is it Important?
• “Misconduct probably results from
environmental and individual causes, i.e.
when people who are morally weak, ignorant,
or insensitive are placed in stressful or
imperfect environments.” (Resnik, 2012, p8)
Considering the analogies discussed…
• And reflecting on the quote from the Ethics paper
– Write a 1-2 page story about a researcher faced with an
ethical dilemma who chooses to behave in an unethical
manner.
• What did he/she do?
• What happened as a result?
• How did the researcher feel before, during, and after the
unethical act(s)?