RESEARCH PARTICIPANTS
And the Evolution of Their Protection
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
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
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
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
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
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
WILLOBROOK SCHOOL
STUDY: 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.
WILLOBROOK SCHOOL
cont.
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.
MILGRAM OBIDIENCE
STUDIES
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’.
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.
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
Milgram’s 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.
Milgram’s 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.
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)
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
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
TRI COUNCIL cont.
Guiding ethical principles:
♦
♦
♦
♦
♦
♦
♦
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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 *
ETHICS CASE STUDY
ZIMBARDO’S 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.
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.
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!