Ethical imperatives

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Ethics in Research
Medical school research committee Iman adibi
i_adibi_at_med.mui.ac.ir
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Titles to be discussed

• Importance of the subject of ethics
• How ethics was born in the field of research
• History and examples
• Principles of research ethics
• Introduction to some guidelines

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Improvement of modern medicine will not occur
without the support of human trials

• Researcher will choose the drug instead of the
  patient
• Patient will can not choose thedrug or placebo
  because of randomization
• No chance will remain because of blindness
• Few researchers idea VS all other opposition

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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.

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Ethical imperatives

• To improve quality and quantity of life by
  advancing the knowledge and application of
  biomedical science
• ? biomedical research

• To protect human subjects
• respect for persons
• beneficence
• justice
• ? research ethics

VS
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ORIGINS OF RESARCH ETHICS

• Hippocratic tradition (460BC 200AD)
• experience is uncertain or experiment is
  perilous ?
• Edward Jenner (1789) first, do unto self
• cowpox ? own son
• Thomas Percival (1803) peer review
• no such trial should be instituted without a
  previous consultation of the physicians or
  surgeons according tom the nature of the case.
• Walter Reed (1900) written consent from
  volunteer
• Yellow fever experiments
• Prussian Ministry of Religious, Educational and
  Medical Affairs (1900) 1st clear ethical
  standards for modern medical research

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Research ethics born from previous abuses

• Experiments in Nazi Germany (1942- 1945)
• Tuskegee syphilis study (1932 1972)
• 400 African American were not told that they had
  syphilis, nor were they offered treatment
• Hepatitis at the Willowbrook State School (1956
  1970)
• mentally retarded children deliberately infected
  with hepatitis virus
• Cancer research at the Jewish Chronic Disease
  Hospital (1963)
• liver cancer cells injected into 22 senile
  patients
• Milgrams Obedience Tests at Yale (1960 1963)
  use of deception on subjects

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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.

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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.

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Nuremburg

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

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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.

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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)

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M.H. Pappworth in 1967

• No physician is justified in placing science or
  the public welfare first and his obligation to
  the individual, who is his patient or subject,
  second. No doctor, however great his capacity or
  original his ideas, has the right to choose
  martyrs for science or for the general good.
• Pappworth M.H. Human Guinea Pigs Boston Beacon
  Press, 1967 pg. 27

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Principles

• Respect for human dignity
• Beneficence / Non-Maleficence
• Utility
• Justice

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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.

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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).

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Utility

• Make best use of scarce resources
• Research participants are a valuable resource
• Ensure value of the research question
• Ensure quality of method

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Justice

• within a population, the benefits of the research
  should be balanced against the burdens of the
  research
• for each participant, a balance of burdens and
  benefits should be sought

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WORLD MEDICAL ASSOCIATION DECLARATION OF
HELSINKIAdopted 1964, last amended 2000

• Some important paragraphs
• Medical progress is based on research which
  ultimately must rest in part on experimentation
  involving human subjects.
• In medical research on human subjects,
  considerations related to the well-being of the
  human subject should take precedence over the
  interests of science and society.

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WORLD MEDICAL ASSOCIATION DECLARATION OF
HELSINKIAdopted 1964, last amended 2000

• Medical research is subject to ethical standards
  that promote respect for all human beings and
  protect their health and rights.
• The subjects must be volunteers and informed
  participants in the research project.
• The right of research subjects to safeguard their
  integrity must always be respected.

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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

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Research Ethics is NOT against research On the
contrary, it facilitates research
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• Both authors and publishers have ethical
  obligations.
• In publication of the results of research, the
  investigators are obliged to preserve the
  accuracy of the results.
• Negative as well as positive results should be
  published or otherwise publicly available.
• Sources of funding, institutional affiliations
  and any possible conflicts of interest should be
  declared in the publication.
• Reports of experimentation not in accordance with
  the principles laid down in this Declaration
  should not be accepted for publication.
• WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI
  
• Ethical Principles for Medical Research Involving
  Human Subjects

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Scientific adequacy

• Research must be justifiable in terms of its
  potential contribution to knowledge.
• Research design must account for, or avoid
  biases, in
• participant selection
• data collection
• data analysis
• data interpretation
• researchers must have adequate expertise to
  conduct the project and analyse the data

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Titles to be discussed

• Importance of the subject of ethics
• How ethics was born in the field of research
• History and examples
• Principles of research ethics
• Introduction to some guidelines

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