What is one of the requirements for clinical research & using human subjects?
that it applies not to only one person but that it is generalizable scientific knowledge that could help many people.
What are the 3 ethical principles that guide research today?
- Nuremberg Code (applies to the world)
- Helsinki Delcaration of the World Medical Association
- Belmont Report (US Fed regulations)
T/F Nazi human experimentation is a good example of clinical medical research.
False. Under the guise of helping people & research. caused death, disfigurement, permanent disability. Experiments to support the Third reich. No informed consent.
What were some of the cruel experiments that were done at Auschwitz?
genetic experiments on twins
sterilization experiments-large # ppl @ once (looked @ radiation as option)
What were some of the cruel experiments that were done at Ravensbruck?
bone, muscle, nerve transplantation
purposefully created wounds on subjects to look @ wound healing. Looked @ how wounds healed w/o blood supply. Intentionally infected wounds to see what they could do for their soldiers.
sulfonamide experiments
What were some of the cruel experiments that were done at Dachau?
immunization & treatment of malaria.
killed like 500 ppl w/ malaria.
sea water experiments (looked @ ways that ppl could drink sea water for survivable). Starved subjects.
What were some of the cruel experiments that were done at Sachsenhausen & Natzweiler?
mustard gas
What were some of the cruel experiments that were done at Buchenwald?
poison. do an autopsy & see the effects.
In an effort to figure out how to treat hypothermia…many conc’n camps did experiments w/ ______?
freezing experiments
**made prisoners sit in ice cold bath for hours.
unfortunately, got important info from these experiments. Do we utilize this knowledge?
What happened in Tuskegee in 1932?
Infected black men w/ syphilis & left it untreated. Watched the natural hx of this disease.
What is bad blood used to mean?
syphilis
anemia
fatigue
Was the Tuskegee study done w/ informed consent?
not really. consented to join study & be examined. Didn’t know what would be involved & were given incentives of medical care, insurance & meals.
How long did the Tuskegee study go on?
was supposed to go on for 6 months but continued on for 40 years!!
What did the 1946 Judiciary Council of the AMA say? Did ppl follow this right away?
- informed voluntary consent had to occur prior to research study
- animal experimentation must begin first
- experiment must be performed under proper medical protection & management.
- *didn’t follow it!
When PCN became the syphilis drug of choice…what happened?
the subjects of the Tuskegee study weren’t given it!
Were there ever radiation experiments done on human subjects?
YES 1944-1974
studied effects of radiation on human subjects
**done on cancer its & pregnant women, children, prisoners, military. Vulnerable subjects.
although small traces, unlikely to have caused harm.
Non-therapeatuic research on children in the US increased lifetime risk for what?
thyroid cancer
T/F When total body irradiation w/ acute injuries & other radiation experiments were done in the US they were directly violating policies of human rights at the time & were done w/o thought of minimization of risk.
False. they “tried” to minimize risk & there weren’t policies in place @ the time.
What happened to the Uranium miners of the Marshall islands?
mined uranium for weapons use.
high levels of radon exposure
gov’t didn’t warn in time
miners died.
T/F The gov’t released small amounts of radiation into the environment to study weapons operations, equipment safety & environmental effects. Releases for experiments were secret.
True. Caused serious distrust of the gov’t. Even H1n1 was questioned by everyday Americans.
What is the Nuremberg Code & when was it drafted?
1947 - Drafted during the Nuremberg War Crimes
Set of standards for judging physicians and scientists who had conducted biomedical experiments on concentration camp prisoners.
The Doctors Trial
What are the 10 things that are required for research according to the Nuremberg code?
- voluntary consent of human subject
- yield fruitful results for the good of society
- designed & based on animal experiments & natural hx
- conducted to avoid unnecessary physical/mental suffering.
- Not conducted if apriori reason to believe that death or disabling injury will occur.
- Risk should not exceed that determined by the humanitarian importance of the problem to be solved. Ex: not conjoined twin studies!
- Protections made to protect subject from remote possibility of injury, disability, or death
- conducted only by scientifically qualified persons
- subjects ALWAYS at liberty to exit study
- scientist must terminate at any stage if he has reasonable cause to believe that the experiment will cause injury, disability, or death to the subject.
What is involved in voluntary consent?
Legal capacity
Able to exercise free power of choice
Without force, fraud, deceit, duress, constraint or coercion
Sufficient knowledge and understanding
Prior to consenting should be made aware of the nature, duration, and purpose of the experiment, the methods and means, all inconveniences and hazards to be expected, and effects upon health that may come from participation
What happened at Willowbrook State school in Staten Island, NY? 1956
- school for MR children
- children given hepatitis to track the development of the viral infection
- said they would likely get it @ this school b/c of the outbreak & then they could study cures.
- lasted for 14 years.
- tried to give gamma globulin injections
