A brief history of research ethics

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A brief history of research ethics
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• 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
  participants.
• 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

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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
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Lysenkoism

• 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
  Gulag.

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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
  included
• "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
  genius".
• 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

http//www.avert.org/his81_86.htm
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Scepticism

• 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
  science.

http//www.its.caltech.edu/dg/fusion.html
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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.

http//www.earthsky.com/Features/Articles/piltdown
.html http//www.tiac.net/cri/piltdown/piltdown.h
tml
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Probe Finds Scientist Faked Data Linking Cancer
to Electromagnetic Fields, By WILLIAM J.
BROADhttp//www.nytimes.com/library/national/scie
nce/072499sci-fake-data.html

• 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
  findings.
• 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
  cancer.

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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

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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
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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
  project.
• 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
  war.
• Szilard consistently stated that scientists must
  take responsibility for the results of their
  research.

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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
  bloodshed
• 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.

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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.

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