PHLB09H3 Chapter Notes - Chapter 8: World Health Organization, Josef Mengele, Belmont Report
PHLB09- Reading 8 Chapter 6 – Human Research pp.221-41
• The 2 values that shape medical science is knowledge and beneficence
• The search for medical knowledge has lead us down some dark paths
o WW2- Nazi physicians performed a lot of bad experiments on prisoners and civilians
o A 1947 trial convicted many doctors of murders, tortures, and other atrocities committed in the
name of medical science
▪ Victims were infected with may diseases (cholera, smallpox, typhus, malaria and other
diseases), they were also given poison to see how would die, they were shot to simulate
battle wounds, frozen to death, starved to death, sterilized and mutilated
▪ Nazi doctor Josef Mengele liked to study twins
• Collected kids from concentration camps and he measured them, did, performed
features, performed cross transfusions, transplanted genitals and other organs
and he also created artificial Siamese twins
• He did comparative studies where he would infect one child then would kill both
for an autopsy
o Tuskegee Study- In 1932 they began a 40-year study where they took 600 poor black men and
400 of them had syphilis when they entered the study
▪ These men were deceived because they were never told that they had syphilis and they
were never treated even after the cure (penicillin) became available
o 1944-1974- the U.S. government did secret experiments of humans including children to study
the effect of radiation, many of them were exposed to hug doses of radiation
▪ many of them never consented for the experiment and they were never told of the
potential harm
o 1956 Willow brook State Hospital- a hospital for retarded people and people admitted to this
hospital naturally got hepatitis, but for the purposes of this experiment they used newly
admitted retarded children to infect (this brought up parental consent issues)
• stories like this was a shock to the public and it created policy makers for ethical human research
• Nuremberg Code- a set of minimal ethical principles meant to govern all scientific experiments involving
humans
• PRINCILPLES-Declaration of Helsinki, embraced by the World Medical Association (WMA) in 1964, the
1979 Belmont Report established by the congressionally established National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research and the 1993 international
guidelines for biomedical human research created by the World Health organization (WHO) and the
Council for International Organizations of Medical Sciences (CIOMS)
• The Science of Clinical Trials
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2
o clinical trial- a scientific study designed to test a medical intervention (a drug or a surgical
procedure)
o this study occurs to determine the treatments effect in the human body (testing for safety and
efficacy)
o clinical trials derive reliable answers while maximizing objectivity, minimizing bias and avoiding
errors
o clinical trial test effectiveness of a treatment on
▪ 1) an experimental group that gets the treatment to be evaluated
▪ 2) a control group that closely resembles the experimental group but with no treatment
o they can compare and study the differences
o control group allows us to see the progress of the treatment and see whether or not it was the
treatment or other factors (placebo effect) that created change
o Types of control groups
▪ Placebo control group (an inactive treatment)
• this allow researchers to look at placebo effect
▪ active control group- subjects get standard treatment already proven to work
o feature for clinical trial= blinding- a procedure for ensuring that subjects and/ or researchers
which interveners they received (standard treatment, treatment, placebo)
▪ to avoid bias
▪ double blinded= sujet ad researhers do’t ko hat treatets they reeied
▪ sigle lided= he just the sujet does’t ko hat treatet they reeied
o clinical trials must be randomized (assigning subjects randomly to both experimental and
control groups)
o control and experimental groups must be comparable in relevant characteristics so that they
can gather reliable data
o randomization minimizes bias (example: placing healthier subjects in the experimental group
and the latter in the control group)
o must perform multiple clinical trials to reach a conclusion and must pass phases 1-3
▪ phase I trial- test drugs on a few people for safety and adverse reactions ascertains safe
and unsafe doses
▪ phase II trial- investigators give the drugs to larger groups of subjects to get a
preliminary indication of its effectiveness and assessments on safety
▪ phase III trial- researchers have to establish the drug as effective and see how it
compares with the established treatments
▪ phase IV trials can occur after the drug is marketed
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Document Summary
Phlb09- reading 8 chapter 6 human research pp. 221-41. The 2 values that shape medical science is knowledge and beneficence. Princilples-declaration of helsinki, embraced by the world medical association (wma) in 1964, the. 1979 belmont report established by the congressionally established national commission for the. Protection of human subjects of biomedical and behavioral research and the 1993 international guidelines for biomedical human research created by the world health organization (who) and the. Council for international organizations of medical sciences (cioms) Ind. is invited to participate in research: duration of shifts, benefits that may come from this research, risks/ discomfort that may come from the experiment, alternate procedures the ind. could take, confidentiality measures. I(cid:374)(cid:448)estigator"s responsibility of medical services for the ind: therapy would be free for any research related injury, would the su(cid:271)je(cid:272)t/ su(cid:271)je(cid:272)t"s fa(cid:373)ily (cid:271)e (cid:272)o(cid:373)pe(cid:374)sated for disa(cid:271)ility or death fro(cid:373) i(cid:374)jury. Thailand so they used placebo control groups to make a cheaper azt.
