Medical Ethics

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Medical Ethics

• Kazem Heidari

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• From the time immediately after World War II
  until the early 1990s,there was a gradually
  developing consensus about the key ethical
  principles that should underlie the research
  endeavor.

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• Nuremberg code
• 1947

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• Tuskegee syphilis study

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• Helsinki declaration
• WORLD MEDICAL ASSOCIATION
• 1964

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• COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF
  MEDICAL SCIENCES
• 1982

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• The health of my patient will be my first
  consideration.

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• Medical progress is based on research which
  ultimately must rest in part on experimentation
  involving human subjects.
• Most prophylactic, diagnostic and therapeutic
  procedures involve risks and burdens.

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• Research Investigators should be aware of the
  ethical, legal and regulatory requirements for
  research on human subjects in their own countries
  as well as applicable international requirements.

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• It is the duty of the physician in medical
  research to protect the life, health, privacy,
  and dignity of the human subject.
• Medical research should be based on a thorough
  knowledge of the scientific literature, other
  relevant sources of information, and on adequate
  laboratory and, where appropriate, animal
  experimentation.

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• The independent ethics committee should be in
  conformity with the laws and regulations of the
  country in which the research experiment is
  performed

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Principles

• voluntary participation
• people not be coerced into participating in
  research

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• Captive audiences prisons, universities, and
  places like that
• The right of research subjects to safeguard their
  integrity must always be respected.

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• Informed consent
• Each potential subject must be adequately
  informed
• Aims
• methods
• sources of funding
• any possible conflicts of interest
• institutional affiliations of the researcher
• the anticipated benefits
• potential risks of the study and the discomfort
  it may entail.

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Informed consent

• Prospective research participants must be fully
  informed about the procedures and risks involved
  in research and must give their consent to
  participate.
• Ethical standards also require that researchers
  not put participants in a situation where they
  might be at risk of harm as a result of their
  participation.

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Informed consent

• The physician should be particularly cautious if
  the subject is in a dependent relationship with
  the physician or may consent under duress.

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Informed consent

• Research on individuals from whom it is not
  possible to obtain consent, should be done only
  if the physical/mental condition that prevents
  obtaining informed consent is a necessary
  characteristic of the research population.
• approval of the review committee
• obtained as soon as possible from the individual
  or a legally authorized surrogate

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• Confidentiality
• They are assured that identifying information
  will not be made available to anyone who is not
  directly involved in the study.
• Anonymity the participant will remain anonymous
  throughout the study

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• Right to service
• When a new treatment or program may have
  beneficial effects, persons assigned to the
  no-treatment control may feel their rights to
  equal access to services are being curtailed.

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Ethics in other subjects

• A study must employ a scientifically valid design
  to answer the research question. Shoddy science
  is never ethical

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• A study must address a question of sufficient
  value to justify the risk posed to participants.
  Exposing subjects even to low risk to answer a
  trivial question is unacceptable

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• Study findings must be reported accurately and
  promptly. Methods, results and conclusions must
  be reported completely and without exaggeration
  to allow practising clinicians to draw reasonable
  conclusions.
• Negative as well as positive results should be
  published or otherwise publicly available.

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• Authorship criteria should be considered

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Any question?