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A brief history of research ethics


Twenty-six Nazi physicians are tried at Nuremberg, Germany, for research ... see themselves as a community under siege, there is little internal criticism. ... – PowerPoint PPT presentation

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Title: A brief history of research ethics

A brief history of research ethics
  • A Brief History of informed consent in the USA
  • 1947
  • Twenty-six Nazi physicians are tried at
    Nuremberg, Germany, for research atrocities
    performed on prisoners of war. This results in
    the Nuremberg Code, the first internationally
    recognized code of research ethics, issued by the
    Nazi War Crimes Tribunal (a prototype for later
    codes of ethics).
  • 1940s
  • A series of research abuses starts in Tuskegee,
    Alabama. In one study on the natural history of
    untreated syphilis, poor, black males are
    uninformed of their disease and denied treatment
    even after a treatment is found in 1947. The
    abuses are revealed in 1972.
  • 1962
  • The Kefauver-Harris Bill is passed to ensure
    greater drug safety in the United States after
    thalidomide (a new sleeping pill) is found to
    have caused birth defects in thousands of babies
    born in Western Europe.
  • 1964
  • The 18th World Medical Assembly meets in
    Helsinki, Finland, and issues recommendations to
    guide physicians in biomedical research involving
    human subjects.
  • 1974
  • The National Commission for the Protection of
    Human Subjects of Biomedical and Behavioral
    Research is established, and the National
    Research Act is passed by Congress. This Act
    prompted the establishment of IRB's at the local
    level and required IRB review and approval of all
    federally funded research involving human
  • 1979
  • The National Commission for the Protection of
    Human Subjects of Biomedical and Behavioral
    Research publishes The Belmont Report Ethical
    Principles and Guidelines for the Protection of
    Human Subjects of Research -- a guide for U.S.
    research with human subjects.
  • 1993
  • The Albuquerque Tribune publicizes 1940s
    experiments involving plutonium injection of
    human research subjects and secret radiation
    experiments. Indigent patients and mentally
    retarded children were deceived about the nature
    of their treatment.
  • 1994
  • President Clinton creates the National Bioethics
    Advisory Commission (NBAC).
  • 1995

Is it ethical to patent gene sequences?
  • Research commissioned by the Guardian shows that
    pharmaceutical companies, biotech firms of all
    sizes, government institutes and universities
    have filed patents on a staggering 127,000 human
    genes or partial human gene sequences. They have
    patented genes which make our brains work, which
    build our bones, which make our livers grow,
    which keep our hearts beating, which can give
    increased chances of getting cancer and which may
    predict our likelihood of becoming addicted to
    drugs. They've patented genes even before they
    know what they do they've taken out speculative
    patents on treatments based on genes even though
    no such treatments exist.

James Meekin the Guardian, Wednesday November
15, 2000
  • Lysenko was a peasant-born agronomist and who
    rejected Mendel's ideas because they contradicted
    the Marxist doctrine of dialectical materialism.
    Through a process he called vernalization, he
    would "train" spring wheat to be winter wheat and
    thus increase the number of annual harvests.
    Lysenko believed all living organisms passed on
    to succeeding generations characteristics
    acquired in their lifetime. This untested theory
    was at odds with what Lysenko scathingly called
    "alien bourgeois" genetics, but Soviet scientists
    who dared disagree risked being sent to the

An example of a dispute over priority The
discovery of HIV
  • In May 1983, doctors at the Institute Pasteur in
    France reported that they had isolated a new
    virus, which they believed was the cause of AIDS.
    Little notice was taken of this announcement at
    the time, but a sample of the virus was sent to
    the Centers for Disease Control (CDC) in Atlanta,
    USA. A few months later the virus was named
    lymphadenopathy-associated virus or LAV, patents
    were applied for, and a sample of LAV was sent to
    the National Cancer Institute.
  • On April 22nd 1984, Dr Mason of the CDC was
    reported as saying"I believe we have the cause
    of AIDS.He was referring to the French virus,
    LAV, and he was basing his opinion on the
    findings made in the preceding weeks by the
    researchers at the Pasteur Institute who had
    discovered the virus the previous year.
  • Just one day later, on April 23th, the United
    States Health and Human Services Secretary
    Margaret Heckler announced that Dr. Robert
    Gallo of the National Cancer Institute had
    isolated the virus which caused AIDS, that it was
    named HTLV-III, and that there would soon be a
    commercially available test for the virus. It was
    a dramatic and optimistic announcement that also
  • "We hope to have a vaccine against AIDS ready
    for testing in about two years.and it concluded
    with "yet another terrible disease is about to
    yield to patience, persistence and outright
  • The same day patent applications were filed
    covering Gallo's work, but it was clearly a
    possibility that LAV and HTLV-III were the same
    virus 63 64. The scientific papers regarding
    Gallo's discovery of HTLV-III were published on
    4th May. By 17th May, private companies were
    already applying to the Department of Health
    Human Services for licences to develop a
    commercial test, which would detect evidence of
    the virus in blood, a test which it had already
    been said would be used to screen the entire
    supply of donated blood in the USA

  • Scientists take nothing on trust
  • E.g. cold fusion
  • Cold Fusion is a pariah field, cast out by the
    scientific establishment. Between Cold Fusion and
    respectable science there is virtually no
    communication at all. Cold fusion papers are
    almost never published in refereed scientific
    journals, with the result that those works don't
    receive the normal critical scrutiny that science
    requires. On the other hand, because the
    Cold-Fusioners see themselves as a community
    under siege, there is little internal criticism.
    Experiments and theories tend to be accepted at
    face value, for fear of providing even more fuel
    for external critics, if anyone outside the group
    was bothering to listen. In these circumstances,
    crackpots flourish, making matters worse for
    those who believe that there is serious science
    going on here.
  • The origins of Cold Fusion have been loudly and
    widely documented in the press and popular
    literature. Pons and Fleischmann, fearing they
    were about to be scooped by a competitor named
    Steven Jones from nearby Brigham Young
    University, and with the encouragement of their
    own administration, held a press conference on
    March 23, 1989 at the University of Utah, to
    announce what seemed to be the scientific
    discovery of the century. Nuclear fusion,
    producing usable amounts of heat, could be
    induced to take place on a table-top by
    electrolyzing heavy water, using electrodes made
    of palladium and platinum, two precious metals.
    If so, the world's energy problems were at an
    end, to say nothing of the fiscal difficulties of
    the University of Utah. What followed was a kind
    of feeding frenzy, science by press conference
    and e-mail, confirmations and disconfirmations,
    claims and retractions, ugly charges and
    obfuscation, science gone berserk. For all
    practical purposes, it ended a mere 5 weeks after
    it began, on May 1st, 1989, at a dramatic session
    of The American Physical Society, in Baltimore.
    Although there were numerous presentations at
    this session, only two really counted. Steven
    Koonin and Nathan Lewis, speaking for himself and
    Charles Barnes, all three from Caltech, executed
    between them a perfect slam-dunk that cast Cold
    Fusion right out of the arena of mainstream

Scientific hoaxes
  • Piltdown man was proclaimed genuine by several of
    the most brilliant British scientists of the day
    Arthur Smith Woodward, Arthur Keith and Grafton
    Elliot Smith.

.html http//www.tiac.net/cri/piltdown/piltdown.h
Probe Finds Scientist Faked Data Linking Cancer
to Electromagnetic Fields, By WILLIAM J.
  • A US federal probe has found that a scientist at
    the Lawrence Berkeley Laboratory in Berkeley,
    Calif., faked what had been considered crucial
    evidence of a tie between electromagnetic
    radiation and cancer. The disclosure appears to
    strengthen the case that electric power is safe.
  • Robert P. Liburdy, a cell biologist at the
    laboratory, an arm of the Energy Department, was
    found to have published two papers with
    misleading data. Investigators said Liburdy
    eliminated data that did not support his
    conclusions. After the investigation, he resigned
    quietly from the Lawrence Berkeley Laboratory in
    March and has agreed to withdraw his research
  • Federal officials say his misrepresentations
    helped him win 3.3 million in grants from the
    National Institutes of Health, the Department of
    Energy and the Department of Defense to
    investigate a link between electric power and

Nazi science
  • The Nazi euthanasia project
  • Mengele's twin studies at Auschwitz
  • Nazi sterilization experiments
  • Dachau hypothermia and high altitude experiments
  • Buchenwald biological warfare experiments
  • Nazi medicine's role in genocide

The Tuskagee syphilis study
  • In a scientific study of the effects of syphilis
    over several decades in black populations around
    Tuskagee in USA sufferers were not properly
    treated to allow the disease to progress so that
    the effects could be studied
  • The study was continued until 1972

The scientific team
As part of the study lumbar punctures were made
without informed consent
Ethical Atomic scientists
  • Leo Szilard was one of the first physicists to
    realise the potential of a nuclear chain reaction
    for developing an atomic bomb.
  • In 1939he wrote a letter to President Roosevelt
    pointing out the danger if the Nazis were the
    first to develop an a-bomb (he got his friend
    Albert Einstein to sign the letter).
  • Working on the development of the bomb (the
    Manhattan project) he was outspoken against the
    secrecy that prevented scientists on the project
    talking to each other because it slowed down the
  • In 1945 with the defeat of Hitler he questioned
    the need to use the bomb and co-produced the
    Franck Report warning of the dangers of a nuclear
  • Szilard consistently stated that scientists must
    take responsibility for the results of their

Darwinianism and Racial theories
  • Darwinism was used as a justification for racism
  • In the subtitle to The Origin of the Species,
    Darwin wrote "The Preservation of Favoured Races
    in the Struggle for Life."
  • 2) Darwinism was used as a justification for
  • Darwin proposed that a deadly "struggle for
    survival" takes place in nature. The hrase
    survival of the fittest was not Darwins but
    nevertheless was seen to give scientific support
    military aggression
  • 3) Darwinism was used to support eugenics
  • The concept of human improvement through
    selective breeding, known as eugenics, was
    proposed by Darwin's cousin, Francis Galton, who
    took his uncle's ideas about the selective
    breeding of animals a step further. Haeckel an
    important supporter of Darwinianism in Germany
    supported the development of eugenics there and
    suggested the use of euthanasia on disabled
    people. His ideas were implemented by the Nazis.

Biological Determinism
  • While Darwin didn't subscribe to the idea that
    biological traits can determine human behavior
    a theory known as biological determinism many
    people proceeded to draw this conclusion from
    their reading of Darwin.
  • Cesare Lombroso, an Italian doctor, studied the
    bodies of renowned criminals. Based on a variety
    of factors, from epilepsy to brain circumference,
    he developed a theory of the "born criminal."
    Lombroso asserted that some people he called
    them atavists were throwbacks to primitive man,
    and this accounted for their destructive
    behaviour. The causes of crime are therefore
    biological, beyond an individual's control.

  • http//www.globalethics.org/index.htm
  • For recent examples
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