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History of Research Ethics

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Yet research and teaching was done on African Americans as subjects and models ... drug during pregnancy caused severe deformities in the fetus ... – PowerPoint PPT presentation

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Title: History of Research Ethics


1
History of Research Ethics
  • Examples that have
  • lead to current standards

2
Early American History
  • (1721-23) Rev. Cotton Mather and Dr. Zabdiel
    Boyleston vs. Dr. William Douglass
  • Mid-1800s) African Americans in Antebellum period
  • Slave corpses procured for research and
    dissection
  • The cure for Vesico-Vaginal fistula Dr. Sims
    performed experimental surgical procedures on
    African American female slaves.

3
The inconsistency of research on African Americans
  • Physicians of this period gave supposed medical
    evidence of African Americans physiological and
    mental inferiority based on the idea of inherent
    biological differences
  • Yet research and teaching was done on African
    Americans as subjects and models with no
    attention to supposed differences that would call
    into question the applicability of the results to
    caucasians.

4
Nuremburg exposes Nazi experiments
  • Malaria prisoners infected with malaria and
    given supposedly anti-malarial drugs. Many died
    from the drugs.
  • Mustard gas prisoners intentionally wounded and
    wounds infected with mustard gas, or forced to
    inhale mustard gas.
  • Sulfanilamide prisoners infected with bacterial
    culture , gangrene culture wood shavings or glass
    shards. Then treated with sulfanilamide for
    wound infection. Control group not given
    sulfanilamide.

5
Nuremburg
  • Typhus prisoners injected with anti-typhus
    vaccine, then infected with typhus. Control
    group infected , but not to given the treatment.
    Others infected with typhus, to ensure the virus
    remained active in the prison camps.
  • Poisons various poisons to prisoners in their
    food. Most died immediately, and those who did
    not die were killed for autopsy.
  • Incendiary bombs prisoners burned with
    phosphorus material from English incendiary bombs
    so doctors could examine the wounds.

6
Nuremburg
  • Sterilization because sterilization by surgical
    means was too costly and time-consuming prisoners
    were subjected to chemical sterilization and
    x-ray sterilization experiments
  • Hypothermia
  • Twins studies

7
Thalidomide
  • In the late 1950s, thalidomide was approved as a
    sedative in Europe it was not approved in the
    United States by the FDA.
  • drug during pregnancy caused severe deformities
    in the fetus
  • Many patients did not know they were taking a
    drug that was not approved for use by the FDA,
    nor did they give informed consent.
  • 12,000 babies born with severe deformities.

8
Beecher published these cases in 1964
  • Melanoma transplanted from daughter to healthy
    volunteering mother in hope that the tumor
    antibodies might help the patient (who died on
    the day of the transplant.)
  • Live cancer cells inserted into patients in
    Jewish Chronic disease hospital without informed
    consent
  • Beechers examples and others demonstrate that
    leaving ethical analysis up to individual
    investigators has not adequately protected
    subjects

9
Tuskeegee (1932-1972)
  • Prior to penicillin, experiment to follow the
    natural history of syphilis in African American
    males near Tuskeegee AL (1932)
  • Unnecessary because a study on the natural
    history had already been completed in Oslo
  • After proven that penicillin cured syphilis, the
    experiment was continued without offering the
    subjects the cure and in fact preventing them
    from treatment by local physicians (1948)

10
Belmont Report (1972-74)
  • Respect for persons
  • Beneficence
  • Justice
  • Informed consent
  • Risk benefit ratio
  • Selection of subjects

11
Respect for persons
  • Always treat persons as ends in themselves, never
    merely as means to an end
  • Research subjects must participate only after
    informed consent
  • Subjects who begin a study may change their minds
    and withdraw at any time, regardless of whether
    study completed.

12
Informed consent
  • Must entail mental capacity to understand
  • Lack of coercive or undue influences
    (voluntariness)
  • Comprehension
  • Known risks and possibility of unknown risks
  • Whether any potential for direct benefit
  • Whether placebo arms or randomization
  • No penalty or loss of care from refusal

13
Beneficence
  • (i) Inhumane treatment of human subjects never
    morally justified.
  • (ii) Risks reduced to those necessary to achieve
    the research objective, often by alternative
    procedures.
  • (iii) When risk of serious impairment, review
    committees must insist on the justification of
    the risk (likelihood of benefit to the subject --
    or, in rare cases, to the manifest voluntariness
    of the participation).

14
Justice
  • Selection of subjects must not
  • Impose risks and burdens of research on
    vulnerable or disadvantaged subject groups
    unfairly (such as the Tuskeegee experiment)
  • Distribute benefits of research participation and
    applicability of results unfairly to Favored or
    advantaged groups (such as the framingham heart
    study of white males)

15
Asilomar (1975)
  • Conference on the unknown risks of re-combinant
    DNA research
  • Fear that replication of such vectors as e. coli
    , if recombined with DNA from tumors or herpes
    would replicate and spread
  • Beginning of the NIH Recombinant DNA Advisory
    Committee (RAC)
  • Rules for lab standards for containment and
    bio-safety committee review

16
Human Genome Initiative (HGI) 1988-present
  • Letter from 83 clergy representing wide array of
    religious groups concerned about moral
    implications of HGI to President Reagan
  • James Watson creates Ethical Legal and Social
    Implications Division of HGI to address ethical
    concerns
  • Research on anticipated ethical and social
    problems in order to minimize the risks and
    unintended consequences of HGI before the results
    were available and applied.

17
Issues in research with women, children and
minorities
  • Reactions to Thalidomide, Tuskeegee, Willowbrook,
    etc protected vulnerable populations from
    research
  • Invisibility of women also left them out of
    research, such as Framingham study.
  • 1990s corrective action was implemented
  • NIH requires when feasible inclusion of women
    children and minorities

18
Issues in international research
  • HIV-AZT study
  • After demonstration of effectiveness in US and
    France, trials of other protocols were done vs.
    placebo instead of equivalency studies
  • Fair benefits
  • Collaboration
  • Transparency

19
Stem cell research and human cloning
  • US. Ban on new cell lines for embryonic stem
    cells in federally funded research (2001)
  • British policy allowing use up to 14 days old
  • Proposals to ban even private embryonic stem cell
    research
  • Ban on reproductive cloning in humans (1998)

20
Therapeutic misconception
  • Patients who come to high powered medical centers
    for treatment are not sufficiently aware that
    research protocols are experimental
  • Inherent conflict of interest
  • Difficult to correct

21
Issues in reporting of data
  • Data torturing
  • Underreporting data
  • Authorship
  • Ownership of data
  • Commercialization and conflicts of interest

22
Scientific misconduct
  • Elias Alsabti who apparently plagiarized as many
    as 60 scientific papers during the late 1970s
  • John Darsee whose scientific career in
    cardiovascular research appears to have included
    a series of fabricated experiments
  • William Summerlin whose work in immunology in the
    early 1970s was challenged when skin grafts on
    mice were found to have been drawn with a black
    marking pen

23
Scientific Misconduct
  • Robert Gallo's claims to priority in the
    isolation and identification of the AIDS virus
  • David Baltimore's involvement in an immunological
    experiment that still cannot be replicated by
    other researchers
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