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Code of ethics in clinical trial

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Nuremberg code, Helsinki's code and Belmonte report

Nuremberg code, Helsinki's code and Belmonte report

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  • 1. Ethical Principles: Nuremberg code, declaration of Helsinki and Belmonte report Dr Urmila M. Aswar Department of Pharmacology, SIOP, Narhe
  • 2. Pre WWII Edward Jenner (1789) Smallpox Vaccine Louis Pasteur (1885) Rabies Vaccine Walter Reed (1900) Yellow Fever
  • 3. Introduction During the Nuremberg War Crimes Trials, 23 German doctors were charged with crimes against humanity for “performing medical experiments upon concentration camp inmates and other living human subjects, without their consent, in the course of which, the defendants committed the murders, brutalities, cruelties, tortures, atrocities, and other inhuman acts.” No law that differentiated between legal and illegal experiments.
  • 4. The Nuremberg Code (1947) As part of the verdict, the Court enumerated some rules for "Permissible Medical Experiments", now known as the “Nuremberg Code”. These rules include
  • 5. 1. Consent • The voluntary consent of the human subject is absolutely essential. • Able to exercise free power of choice, without the intervention of any element of force. • Should have sufficient knowledge and comprehension of the elements of the subject matter involved. • He should be made known the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted. • All inconveniences and hazards reasonable to be expected; and the effects upon his health which may possibly come from his participation in the experiment
  • 6. 2. Benefit to society The experiment should be such as to yield fruitful results for the betterment of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
  • 7. 3. Previous base of study The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment
  • 8. 4. Avoid sufferings • The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
  • 9. 5. No death No experiment should be conducted where there is a prior reason to believe that death or disabling injury will occur.
  • 10. 6. Humanity first • The degree of risk to be taken should never exceed the benefit.
  • 11. 7. Facilities • Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
  • 12. 8. TEAM: Scientifically qualified • The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
  • 13. 9. Discontinuation by subject During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
  • 14. 10. Right to Physician During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.
  • 15. Declaration of Helsinki Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects Adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964 and as revised by the World Medical Assembly in Tokyo, Japan in 1975, in Venice, Italy in 1983, and in Hong Kong in 1989 and the 48th General Assembly, Somerset West, Republic of South Africa, October 1996 “Concern for the interests of the subject must always prevail over the interests of science and society.”
  • 16. Declaration of Helsinki • The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association. • Common document of human research ethics
  • 17. • The Declaration is morally binding on physicians, and that obligation overrides any national or local laws or regulations.
  • 18. The fundamental principle is respect for the individual their right to self determination and the right to make informed decisions regarding participation in research, both initially and during the course of the research. The investigator's duty is solely to the patient or volunteer, and while there is always a need for research, the subject's welfare must always take precedence over the interests of science and society. Ethical considerations must always take precedence over laws and regulations
  • 19. Recognition of vulnerables The recognition of the increased vulnerability of individuals and groups calls for special vigilance. It is recognized that when the research participant is incompetent, physically or mentally incapable of giving consent, or is a minor, then allowance should be considered for surrogate consent by an individual acting in the subjects best interest.
  • 20. Post WWII • Willowbrook study (1950s) mentally retarded children were deliberately infected with hepatitis virus • Jewish Chronic Disease Hospital, Brooklyn (1960s) Live cancer cells were injected into 22 senile patients without telling them. • Humphries (1970) Tearoom Trade: Impersonal Sex in Public Places • Questioned about identity
  • 21. Henry K Beecher Article “Ethics and clinical research” Henry K. Beecher New Engl J Med 274 (1966):1354-60 • 22 published medical studies presenting risk to subjects without their knowledge or approval • Published in some of the most prestigious journals and conducted at some of the most prestigious institutions • Laid the foundation for current guidelines on informed consent and human experimentation.
  • 22. Public Health Service Policy • NIH Director requested that the National Advisory Health Council review human subject protections • Council recommended prior institutional review for PHS supported research to: – Protect of the rights and welfare of the subjects – Assure appropriate methods of informed consent – Determine acceptable balance of risks and benefits • Adopted as Public Health Service policy in 1966 • Beginnings of the Institutional Review Board (IRB)
  • 23. Tuskegee Syphilis Study American medical research project conducted by the U.S. Public Health Service from 1932 to 1972, examined the natural course of untreated syphilis in black American men. The subjects, all impoverished sharecroppers from Macon county, Alabama, were unknowing participants in the study; they were not told that they had syphilis, nor were they offered effective treatment.
  • 24. National Research Act • 1973 Kennedy Hearings befor health committee at Washington “Quality of Health Care - Human Experimentation” • 1974 National Research Act (by US congress) – Established the “National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research” – Required IRBs at institutions
  • 25. The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research April 18, 1979
  • 26. The Belmont Report Summarizes • Ethical principles and guidelines for research involving human subjects. • Three core principles are identified: respect for persons, beneficence, and justice. • Three primary areas of application are also stated: Informed consent, Assessment of risks and benefits, and Selection of subjects