RESEARCH PARTICIPANTS

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RESEARCH PARTICIPANTS

• And the Evolution of Their Protection

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In the beginning...

• Prior to World War II researchers had little
  concern for the treatment of human participants
  in research studies
• There were no formal protections for individuals
  involved in research

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1948....The Nuremberg Code
Standards for physicians to conform to when
carrying out experiements with human subjects

• The Nuremberg Code was the result of judgement
  concerning war crimes involving 23 Nazi
  physicians and administrators who conducted
  medical experiments on concentration camp
  prisoners
• These prisoners died or were permanently affected
  as a result of these experiements

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10 Standards of the Nuremberg Code

• Volunteers freely consent to participate
• Researchers fully inform volunteers concerning
  the study
• Risks associated with the study are reduced where
  possible
• Researchers are responsible for protecting
  participants against remote harms

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Nurmemburg Code cont.

• Participants can withdraw from the study at any
  time
• Qualified researchers conduct the study
• Cessation of the study if adverse effects emerge
• Society should benefit from study findings
• Research on humans should be based on previous
  animal or other previous work
• A research study should never begin if there is a
  reason to believe that death or injury may result

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POST NUREMBURG CODE
The abuses continue....

• There continued to be abuses of humans in
  research after 1948
• Some of these abuses occurred in the following
  studies
• Tuskeegee Syphilis Study 1932-1972
• Willowbrook State School 1963-1966
• (Viral Hepatitis)
• Milgram Obedience Study early 1960's

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TUSKEEGEE SYPHILIS STUDY
1932-1972

• The US public health service was trying to
  document the natural progression of syphilis
• 399 participants who were already infected with
  syphilis were recruited for the study - the
  participants did NOT know they had the disease
• Participants were told they were being treated
  for bad blood and denied any treatment for
  syphilis
• Participants were disadvantaged, rural black men

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WILLOBROOK SCHOOLSTUDY Viral Hepatitis
Willowbrook was a school constructed in 1938 for
mentally retarded children. It did not open for
this purpose until 1947 when the New York State
Department of Mental Hygiene took over the
building. Between 1963 and 1966 a very
controversial study was conducted at
Willowbrook. The subjects (all mentally
retarded children) were deliberately infected
with the Hepatitis virus. Early subjects were
fed extracts of stools from infected individuals,
and later sujects received injections of more
purified virus preparations. Researchers
justified their actions by claiming that the
students were likely to contract the virus anyway
while attending this school, and it was better to
have them medically supervised and in a study.
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WILLOBROOK SCHOOLcont.
During the course of these studies, the main
area of Willowbrook (with unaffected children)
was closed to new patients parents found that
the only way to have their child admitted to the
school was to agree to their participation in
medical studies. Many parents claimed not to
have been told exactly what the research studies
being done involved. More Scandals In 1972
Geraldo Rivera, conducted a series of
investigations at Willobrook and uncovered
deplorable conditions which included
overcrowding inadequate sanitary facilities, and
physical abuse of residents by staff. After a
class-action lawsuit was filed and settled, it
still took several more years before all of the
violations were corrected. In 1983, the State of
New York announced plans to close Willowbrook in
1987 the last child residents left the school
permanently.
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MILGRAM OBIDIENCESTUDIES
As a result of the happenings in Nazi Germany,
Stanley Milgram (a PhD. Student at the time)
devised a series of experiments to answer the
question Could it be that Eichmann and his
million accomplices in the Holocaust were just
following orders? Could we call them all
accomplices? Milgram began his work at Harvard
and initial research was done between 1961 and
1962. In response to a newspaper ad offering
4.50/hour, an individual was asked to take part
in a psychology experiment investigating memory
and learning. The individual was introduced to a
stern looking person in a white lab coat and a
pleasant and friendly co-subject. They were
then told that on was the teacher (participant)
and one was the learner.
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Milgram cont.
The learner was taken to a room and strapped in a
chair and an electrode was placed on his arm.
The learner was really an actor and was not
actually receiving any shocks, although the
teacher thought that he was. The teacher was
instructed to read a list of two word pairs and
ask the learner to read them back. If the
learner got the answer incorrect, the teacher was
supposed to shock the learner starting at 15
volts. The generator had switches ranging from
15 volts to 450 volts each was labelled (e.g.
Slight shock DANGER severe shock). The teacher
was to increase the shock each time the learner
missed a word. After several voltage increases,
the actor started to bang on the wall that
separated him from the subject (i.e. the
teacher), and complaining about a heart
condition. At times the worried teacher would
question the experimenter (i.e. man in the lab
coat) often asking who would be responsible for
any harmful effects on the learner. Upon
receiving the answer that the experimentor
assumed all responsibility, many of the subjects
then continued to shock the learner, even though
the were uncomfortable doing it.
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Milgram cont.
This study would not be allowed today as it would
be deemed unethical. The possible psychological
harm to the subject is the major stumbling block
in Milgrams research. However, many important
things were learned from the Milgram Obedience
study. The theory that only monsters or
sadistic people would inflict cruelty was
disproven. Milgrams findings show that
ultimately 65 of the teachers punished the
learners to the maximum voltage. None of the
subjects stopped before reaching 300
volts! Further studies showed that proximity of
teacher to learner or experimenter to
teacher affected the likelihood of maximum
shock delivery. However, 32 of participants
still delivered the full shock even when they
were required to hold the hand of the learner
while doing it.
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RESEARCH STANDARDS

• The Progression of Regulations Through the 1900's

The Nuremburg Code
U.S. Military 1948
The Belmont Report
U.S.A. 1979
Tri-Council Policy Statement
Canada 1998
The Memorandum of Understanding
Canada (NSERC and SSHRC)
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THE BELMONT REPORT
1979

• The US National Commission for the Protection
  of Human Subjects of Biomedical and Beharioral
  Research was created to identify ethical
  principles and develop guidelines
• They developed 8 guidelines, including the need
  for informed consent, assessment of risks and
  benefits, and selection of appropriate subjects

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TRI COUNCIL POLICY
Ethical Conduct for Research Involving Humans

• The Medical Research Council first made ethics
  guidelines in 1978 and then in 1987
• The MRC, NSERC and the SSHRC adopted a policy
  (hence tri council) in 1998
• As a condition of funding, the councils require
  that researchers and their institutions apply the
  ethical principles of the policy

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TRI COUNCIL cont.
Guiding ethical principles

• Respect for human dignity
• Respect for free and informed consent
• Respect for vulnerable persons
• Respect for privacy and confidentiality
• Respect for justice and inclusiveness
• Balancing harm and benefits
• Minimizing harm
• Maximizing benefits

PRESENTLY BEING UPDATED TO ADDRESS NEW
DEVLOPMENTS IN RESEARCH ETHICS
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ETHICS CASE STUDY
ZIMBARDOS PRISON EXPERIMENT

• College students who answered a city newspaper ad
  for participants in a study of prison life were
  personally interviewed, given a battery of
  personality tests, and completed background
  surveys that enabled the researchers to
  pre-select only those who were mentally and
  physically healthy, normal and well adjusted
• They were randomly assigned to role-play either
  prisoners or guards in the simulated prison
  setting constructed in the basement of Stanford
  University's Psychology Department.

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Zimbardo cont.
The major results of the study can be summarized
as follows

• many of the normal, healthy mock prisoners
  suffered such intense emotional stress reactions
  that they had to be released in a matter of days
  most of the other prisoners acted like zombies
  totally obeying the demeaning orders of the
  guards
• the distress of the prisoners was caused by
  their sense of powerlessness induced by the
  guards who began acting in cruel, dehumanizing
  and even sadistic ways.
• The study was terminated prematurely because it
  was getting out of control in the extent of
  degrading actions being perpetrated by the guards
  against the prisoners -all of whom had been
  normal, healthy, ordinary young college students
  less than a week before.

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Zimbardo cont.
What do you think???

• Do you see any ethical concerns in the design
  and approach of this study?
• How could the ethical issues be addressed?
• Are there any issues of bias in this study?
• Give an example of a study in which there is a
  bias in its construction (does not have to be a
  real study, can just be an example of poor study
  design)

PLEASE WRITE A BRIEF DESCRIPTION OF THE
ZIMBARDO STUDY IN YOUR NOTES, ALONG WITH THE
ANSWERS TO THE ABOVE QUESTIONS!
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