Bioethics of the medico-biological experiments. The modern concept of the evidence-based medicine. The bioethical comittees

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Bioethics of the medico-biological experiments. The modern concept of the evidence-based medicine. The bioethical comittees

Содержание

2. Ethical experiments on humans are absolutely necessary for the progress of medicine.
3. Definitions Research - a systematic investigation designed to develop or contribute to generalizable knowledge. Human Subject
4. HISTORY OF HUMAN SUBJECT RESEARCH
5. 1st century B.C, Cleopatra devised an experiment to test the accuracy of the theory that it
6. 1796 - Edward Jenner injects healthy eight-year-old James Phillips first with cowpox then three months later
7. 1845-1849: J. Marion Sims, "the father of gynecology" performed multiple experimental surgeries on enslaved African women
8. 1900: Walter Reed injects 22 Spanish immigrant workers in Cuba with the agent for yellow fever
9. Nazi human experimentation
10. Nazi human experimentation was a series of medical experiments on large numbers of prisoners mainly from
11. Freezing experiments Nazi doctors submerged victims in vats of icy water for periods of up to
12. Twins experiments Dr. Josef Mengele. Experimented on 1,000 pairs of twins. Mengele’s experiments also included attempts
13. Nazi human experimentation After the experiment was over, these twins were usually murdered and their bodies
14. Tuberculosis Experiments Dr. Kurt Heissmeyer injected the tuberculosis bacteria directly into the lungs of his victims
15. High Altitude Experiments In 1942 Doctor Rascher used a decompression chamber to simulate high altitude conditions.
16. Phosgene Gas Nazis subjected concentration camp prisoners to Phosgene gas in an attempt to find an
17. Transplant Experiments Limbs of the prisoners needlessly amputated. Every attempt to transplant a limb or joint
18. Sea Water Experiments Nazi doctor Hans Eppinger tried to make seawater drinkable, but failed. Scientists forced
19. Poison Experiments The Nazis also used poison to torture and kill inmates. One was a combination
20. Artificial Insemination Experiments Clauberg established Auschwitz Block 10 as laboratory. There was a constant fear in
21. Wound Experiments Doctor Rascher tried to develop a blood coagulant to treat hemorrage. He tested his
22. Sulfanilamide Experiments Wounds deliberately inflicted on the experimental subjects were infected with bacteria such as streptococcus,
23. Jewish Skeleton Collection Doctor August Hirt, Professor of Anatomy at Strassburg University, wished to acquire a
24. Unit 731 Some of the numerous atrocities committed by the commander Shiro Ishii and others under
25. The Nuremberg Doctors Trial On August 19, 1947, the judges delivered their verdict in the "Doctors'
26. In April of the same year, Dr. Leo Alexander had submitted to the Counsel for War
27. Condensed Nüremberg Code 1. Voluntary, informed consent of every human subject. 2. Experiment must be designed
28. Condensed Nüremberg Code 6. The degree of risk taken by subjects should never exceed the importance
29. Effect of the Nuremberg code The Code had little impact on researchers, who thought that: the
30. Formation of the World Medical Association The World Medical Association (WMA) was organized in 1947.
31. Declaration of Helsinki 1964 - the World Medical Association develops a code of research ethics which
32. Declaration of Helsinki The Declaration includes principles on: Safeguarding research subjects. Informed consent Minimising risk Adhering
33. Experimental horrors after Nürnberg Code The Tuskegee syphilis experiment was conducted in 1932 -1972 in Tuskegee,
34. These men, for the most part illiterate sharecroppers from one of the poorest counties in Alabama,
35. By 1947, penicillin had become the standard treatment for syphilis. But the Tuskegee scientists continued the
36. (1950 - 1953) The CIA begins Project Bluebird (renamed Project Artichoke in 1951) in order to
37. Injections of cancer cells Intradermal injections of live human cancer cells into 22 chronically ill. The
38. Hepatitis in retarded children Severely retarded children at the Willowbrook State Hospital in New York injected
39. Poison laboratory of the Soviets The Soviets tested a number of deadly poisons on prisoners from
40. The Aversion Project South Africa’s apartheid army forced white lesbian and gay soldiers to undergo ‘sex-change’
41. In 2011, drug giant Pfizer paid $75 million to settle claims that children in Kano state,
42. WHAT TO DO?
43. INTRODUCTION TO THE 7 PRINCIPLES 1) Social Value 2) Scientific Validity 3) Fair Subject Selection 4)
44. Experiments on animals first Animal experiments must be conducted before any human experiments.
45. Only do new experiments The researchers must do a through search of the medical and biological
46. Design of experiment The experiment should be conducted in a scientific manner, with a double-blind fashion,
47. It is unethical to give a control group of people a placebo.
49. CONSENT: ELEMENTS OF INFORMED CONSENT: • COMPETENCE • DISCLOSURE • UNDERSTANDING • VOLUNTARINESS
50. Consent Two originals with subject's signature witnessed by at least one person. Failure to obtain such
51. Take care of subjects after the trial A. free medical care for the remainder of his
52. Patient safeguard before advancement of science The interests and safeguard of patients come first than the
53. Bioethics Committees The International Bioethics Committee (IBC) is a body of 36 independent experts that follows
54. Bioterrorism: Background and Significance
55. History of Biological Warfare 1346 Siege of Kaffa; plague 1763 French and Indian War; smallpox WW
56. History of Biological Warfare 1941 George W. Merck named U.S. civilian head of Chemical Warfare Service
57. History of Biological Warfare 1972 Biological Weapons Convention 1979 Accidental release of B. anthracis spores at
58. Domestic Biological Terrorism 1984 Rajneeshee cult members contaminate salad bar with Salmonella typhimurium in Oregon 1992
59. Rajneeshee Cult, Salmonella - Oregon, 1984
60. Biological Terrorism Use of biological agents to intentionally produce disease or intoxication in susceptible populations -
61. MN Patriots Council, Douglas County, 1991
62. Sarin Gas Attack, Tokyo Subway, 1995
63. Operation Desert Storm
64. Ken Alibek - U.S.S.R. Program
65. Level A Bioterrorism Agents Anthrax (Bacillus anthracis) Smallpox (Variola major) Plague (Yersinia pestis) Botulism toxin (Clostridium
66. Biological Terrorism? Epidemiologic Clues Tight cluster of cases High infection rate Unusual or localized geography Unusual
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Слайд 2

Ethical experiments on humans are absolutely necessary for the progress of

medicine.

Слайд 3

Definitions
Research - a systematic investigation designed to develop or

contribute to generalizable knowledge.
Human Subject - a living individual about whom
an investigator conducting research obtains:
– data through intervention or interaction with the individual,
or
– identifiable private information

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HISTORY OF HUMAN SUBJECT RESEARCH

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1st century B.C,
Cleopatra devised an experiment to test the accuracy of

the theory that it takes 40 days to fashion a male fetus fully and 80 days to fashion a female fetus.

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1796 - Edward Jenner injects healthy eight-year-old James Phillips first with

cowpox then three months later with smallpox and is hailed as discoverer of smallpox vaccine.

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1845-1849: J. Marion Sims, "the father of gynecology" performed multiple experimental

surgeries on enslaved African women without the benefit of anesthesia.
One woman was made to endure 34 experimental operations for a prolapsed uterus.

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1900: Walter Reed injects 22 Spanish immigrant workers in Cuba with

the agent for yellow fever paying them $100 if they survive and $200 if they contract the disease.

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Nazi human experimentation

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Nazi human experimentation
was a series of medical experiments on large

numbers of prisoners mainly from across Europe by the Nazi German regime in its concentration camps mainly in the early 1940s, during World War II and the Holocaust.

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Freezing experiments
Nazi doctors submerged victims in vats of icy water for

periods of up to five hours in an attempt to find ways to treat German pilots forced to eject into icy ocean water.

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Twins experiments
Dr. Josef Mengele.
Experimented on 1,000 pairs of twins.
Mengele’s

experiments also included attempts to change eye color by injecting chemicals into children’s eyes, various amputations of limbs and other brutal surgeries.

Слайд 13

Nazi human experimentation
After the experiment was over, these twins were

usually murdered and their bodies dissected.
He supervised an operation by which two Gypsy children were sewn together to create conjoined twins;
This caused gangrene and death.

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Tuberculosis Experiments
Dr. Kurt Heissmeyer injected the tuberculosis bacteria directly into the

lungs of his victims at the Neungamme concentration camp.
He was responsible for the deaths of at least 200 people.

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High Altitude Experiments
In 1942 Doctor Rascher used a decompression chamber to

simulate high altitude conditions.
He dissected several of the victims' brains, while they were still alive, to demonstrate that high altitude sickness was a result of the formation of tiny air bubbles in the blood vessels of the subarachnoid part of the brain.

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Phosgene Gas
Nazis subjected concentration camp prisoners to Phosgene gas in an

attempt to find an antidote to the compound.
The Nazis intentionally exposed victims to the gas, causing unbearable irritation in the lungs.

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Transplant Experiments
Limbs of the prisoners needlessly amputated.
Every attempt to transplant

a limb or joint was a failure.
Sections of muscle, bone and nerves were also removed in fruitless attempts to regenerate those body parts.

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Sea Water Experiments
Nazi doctor Hans Eppinger tried to make seawater drinkable,

but failed. Scientists forced about 90 Gypsies to drink only seawater, and deprived them of all food or fresh water.

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Poison Experiments
The Nazis also used poison to torture and kill inmates.

One was a combination of phenol and cyanide.
Other experiments included adding toxic chemicals to food or shooting prisoners with poison bullets.

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Artificial Insemination Experiments
Clauberg established Auschwitz Block 10 as laboratory.
There was

a constant fear in Block 10 of being killed, sterilized, or inseminated by Clauberg.

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Wound Experiments
Doctor Rascher tried to develop a blood coagulant to treat

hemorrage.
He tested his patented coagulant by observing the rate of blood drops that would ooze from freshly cut amputation stumps of living and conscious prisoners at the Dachau crematorium.

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Sulfanilamide Experiments
Wounds deliberately inflicted on the experimental subjects were infected with

bacteria such as streptococcus, gas gangrene and tetanus. Circulation of blood was interrupted by tying off blood vessels at both ends of the wound to create a condition similar to that of a battlefield wound.

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Jewish Skeleton Collection
Doctor August Hirt, Professor of Anatomy at Strassburg University,

wished to acquire a large collection of Jewish skulls and skeletons to form a museum dedicated to the extinct Jewish race.
In 1943, 115 persons were gassed at the Natzweiller-Struhof Concentration Camp. The corpses were immediately transported to the Anatomy Pavilion of the Strassburg University Hospital.

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Unit 731
Some of the numerous atrocities committed by the commander Shiro

Ishii and others under his command in Unit 731 include: vivisection of living people (including pregnant women who were impregnated by the doctors), prisoners had limbs amputated and reattached to other parts of their body, some prisoners had parts of their bodies frozen and thawed to study the resulting untreated gangrene. Humans were also used as living test cases for grenades and flame throwers. Prisoners were injected with strains of diseases, disguised as vaccinations, to study their effects. To study the effects of untreated venereal diseases, male and female prisoners were deliberately infected with syphilis and gonorrhea via rape, then studied.

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The Nuremberg Doctors Trial
On August 19, 1947, the judges delivered their

verdict in the "Doctors' Trial" against Karl Brandt and several others.
The 23 defendants were charged with murder, torture, and other atrocities committed under the guise of medical science. 15 were found guilty and 7 were sentenced to death.

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In April of the same year, Dr. Leo Alexander had submitted to the

Counsel for War Crimes six points defining legitimate medical research. The trial verdict adopted these points and added an extra four. The ten points constituted the "Nuremberg Code".

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Condensed Nüremberg Code
1. Voluntary, informed consent of every human subject.
2.

Experiment must be designed to yield results for the good of society.
3. Animal experimentation should precede experiments on humans.
4. Must avoid all unnecessary physical and mental suffering and injury.
5. Do not perform experiments in which death or disabling injury will occur.

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Condensed Nüremberg Code
6. The degree of risk taken by subjects should

never exceed the importance of the problem to be solved by experiment.
7. Proper preparations should be made to protect the experimental subject against even remote possibilities of injury, disability, or death.
8. The experiment should be conducted only by scientifically qualified persons.
9. Human subject may withdraw consent at any time.
10. Scientist must terminate experiment at any time, if is likely to result in injury, disability, or death to the experimental subject

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Effect of the Nuremberg code
The Code had little impact on researchers,

who thought that:
the principles in the Code were already implicit in their work
it was simply a document to condemn the Nazi atrocities and to convict the Nazi doctors.
Problems with the code:
did not have the strength of law
applied to only non-therapeutic human subjects research.

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Formation of the World Medical Association
The World Medical Association (WMA) was

organized in 1947.

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Declaration of Helsinki
1964 - the World Medical Association develops a code

of research ethics which came to be known as the DECLARATION OF HELSINKI
reinterpretation of the Nuremberg Code + addressed medical research with therapeutic intent.
Journal editors began to require that research be performed in accordance with the Declaration.

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Declaration of Helsinki
The Declaration includes principles on:
Safeguarding research subjects.
Informed

consent
Minimising risk
Adhering to an approved research plan/protocol
The Declaration is considered a fundamental document in the ethics of healthcare research.

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Experimental horrors after Nürnberg Code
The Tuskegee syphilis experiment was conducted

in 1932 -1972 in Tuskegee, Alabama by the U.S. Public Health Service to study the natural progression of untreated syphilis in 399 poor black men who thought they were receiving free health care from the U.S. government.

Слайд 34

These men, for the most part illiterate sharecroppers from one of

the poorest counties in Alabama, were never told what disease they were suffering from or of its seriousness. Informed that they were being treated for “bad blood,” their doctors had no intention of curing them of syphilis at all.

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By 1947, penicillin had become the standard treatment for syphilis. But

the Tuskegee scientists continued the study without treating any participants and withholding penicillin and information about it from the patients.

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(1950 - 1953)
The CIA begins Project Bluebird (renamed Project Artichoke in

1951) in order to find ways control individuals "through special interrogation techniques," "enhance memory" and use "unconventional techniques, including hypnosis and drugs" for offensive measures .
They used LSD.

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Injections of cancer cells
Intradermal injections of live human cancer cells into

22 chronically ill.
The subjects were not told that the injection contained cancer cells, because the physicians "did not wish to stir up any unnecessary anxieties in the patients" who had "phobia and ignorance" about cancer.

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Hepatitis in retarded children
Severely retarded children at the Willowbrook State Hospital

in New York injected with hepatitis virus. Consent forms implied that children were to receive a vaccine against hepatitis, when the protection was actually from a hopefully "subclinical" infection.

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Poison laboratory of the Soviets
The Soviets tested a number of deadly

poisons on prisoners from the Gulag (“enemies of the people”), including mustard gas, ricin, digitoxin and many others. The goal of the experiments was to find a tasteless, odorless chemical that could not be detected post mortem. Candidate poisons were given to the victims, with a meal or drink, as “medication”.

Слайд 40

The Aversion Project
South Africa’s apartheid army forced white lesbian and gay

soldiers to undergo ‘sex-change’ operations in the 1970′s and the 1980′s, and submitted many to chemical castration, electric shock, and other unethical medical experiments.

Слайд 41

In 2011, drug giant Pfizer paid $75 million to settle claims

that children in Kano state, Nigeria, were injured or killed by non-consensual administration of its experimental meningitis drug Trovan.

Слайд 42

WHAT
TO
DO?

Слайд 43

INTRODUCTION TO THE 7 PRINCIPLES
1) Social Value
2) Scientific Validity
3) Fair Subject

Selection
4) Favorable risk-Benefit ratio
5) Independent review
6) Informed consent
7) Respect for enrolled Subject

Слайд 44

Experiments on animals first
Animal experiments must be conducted before any

human experiments.

Слайд 45

Only do new experiments
The researchers must do a through search of

the medical and biological literature before doing any human experiments.

Слайд 46

Design of experiment
The experiment should be conducted in a scientific manner,

with a double-blind fashion, with a control group.

Слайд 47

It is unethical to give a control group of people a

placebo.

Слайд 48

Слайд 49

CONSENT:
ELEMENTS OF
INFORMED CONSENT:
• COMPETENCE
• DISCLOSURE
• UNDERSTANDING
• VOLUNTARINESS

Слайд 50

Consent
Two originals with subject's signature witnessed by at least one person.
Failure

to obtain such written consent is a presumption that informed consent was not obtained.
Each subject shall have not sign a consent form until at least 24 hours after it was given to the subject.

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Take care of subjects after the trial
A. free medical care for

the remainder of his life B. payment of loss wages and C. funeral expenses.

Слайд 52

Patient safeguard before advancement of science
The interests and safeguard of patients

come first than the interest of science and society.

Слайд 53

Bioethics Committees
The International Bioethics Committee (IBC) is a body of 36

independent experts that follows progress in the life sciences and its applications in order to ensure respect for human dignity and freedom. It was created in 1993.
The IBC provides the only global forum for reflection in bioethics.

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Bioterrorism: Background and Significance

Слайд 55

History of Biological Warfare
1346 Siege of Kaffa; plague
1763 French and Indian

War; smallpox
WW I German program; anthrax, glanders
1925 Geneva protocol bans biological weapons
WW II Japanese program; anthrax, plague, cholera, shigella

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History of Biological Warfare
1941 George W. Merck named U.S. civilian head of

Chemical Warfare Service later changed to War Research Service
1946 U.S. announces its involvement in bioweapons research
1969 Nixon eliminates offensive biological warfare program

Слайд 57

History of Biological Warfare
1972 Biological Weapons Convention
1979 Accidental release of B. anthracis

spores at bioweapons research center, Sverdlovsk, U.S.S.R
1989-92 Scientists from the former U.S.S.R. involved in biological weapons research defect to the West

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Domestic Biological Terrorism
1984 Rajneeshee cult members contaminate salad bar with Salmonella typhimurium

in Oregon
1992 Ricin attack planned by Minnesota militia
2001 Anthrax releases in FL, DC, NY, NJ

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Rajneeshee Cult, Salmonella - Oregon, 1984

Слайд 60

Biological Terrorism
Use of biological agents to intentionally produce disease or intoxication

in susceptible populations - humans, animals, or plants - to meet terrorist aims

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MN Patriots Council, Douglas County, 1991

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Sarin Gas Attack, Tokyo Subway, 1995

Слайд 63

Operation Desert Storm

Слайд 64

Ken Alibek - U.S.S.R. Program

Слайд 65

Level A Bioterrorism Agents
Anthrax (Bacillus anthracis)
Smallpox (Variola major)
Plague (Yersinia pestis)
Botulism toxin

(Clostridium botulinum)
Tularemia (Francisella tularensis)
Viral hemorrhagic fevers (VHF)

Слайд 66

Biological Terrorism? Epidemiologic Clues
Tight cluster of cases
High infection rate
Unusual or localized geography
Unusual

clinical presentation
Unusual time of year
Dead animals

Bioethics of the medico-biological experiments. The modern concept of the evidence-based medicine. The bioethical comittees

Содержание

Ethical experiments on humans are absolutely necessary for the progress of

Definitions Research - a systematic investigation designed to develop or

HISTORY OF HUMAN SUBJECT RESEARCH

1st century B.C,Cleopatra devised an experiment to test the accuracy of

1796 - Edward Jenner injects healthy eight-year-old James Phillips first with

1845-1849: J. Marion Sims, "the father of gynecology" performed multiple experimental

1900: Walter Reed injects 22 Spanish immigrant workers in Cuba with

Nazi human experimentation

Nazi human experimentation was a series of medical experiments on large

Freezing experimentsNazi doctors submerged victims in vats of icy water for

Twins experimentsDr. Josef Mengele. Experimented on 1,000 pairs of twins. Mengele’s

Nazi human experimentation After the experiment was over, these twins were

Tuberculosis ExperimentsDr. Kurt Heissmeyer injected the tuberculosis bacteria directly into the

High Altitude ExperimentsIn 1942 Doctor Rascher used a decompression chamber to

Phosgene GasNazis subjected concentration camp prisoners to Phosgene gas in an

Transplant ExperimentsLimbs of the prisoners needlessly amputated. Every attempt to transplant

Sea Water ExperimentsNazi doctor Hans Eppinger tried to make seawater drinkable,

Poison ExperimentsThe Nazis also used poison to torture and kill inmates.

Artificial Insemination ExperimentsClauberg established Auschwitz Block 10 as laboratory. There was

Wound ExperimentsDoctor Rascher tried to develop a blood coagulant to treat

Sulfanilamide ExperimentsWounds deliberately inflicted on the experimental subjects were infected with

Jewish Skeleton CollectionDoctor August Hirt, Professor of Anatomy at Strassburg University,

Unit 731Some of the numerous atrocities committed by the commander Shiro

The Nuremberg Doctors TrialOn August 19, 1947, the judges delivered their

In April of the same year, Dr. Leo Alexander had submitted to the

Condensed Nüremberg Code1. Voluntary, informed consent of every human subject. 2.

Condensed Nüremberg Code6. The degree of risk taken by subjects should

Effect of the Nuremberg codeThe Code had little impact on researchers,

Formation of the World Medical AssociationThe World Medical Association (WMA) was

Declaration of Helsinki1964 - the World Medical Association develops a code

Declaration of HelsinkiThe Declaration includes principles on: Safeguarding research subjects. Informed

Experimental horrors after Nürnberg CodeThe Tuskegee syphilis experiment was conducted