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Tishk International University Faculty of Science Medical Analysis Department
Medical Ethics and Professionalism
Spring Semester 2020-2021
History of Ethics Lect. 4
Dr. Karwan M-Amen [email protected]
Learning Outcomes
By the end of this session, you will be able to… n Explain the concept of medical ethics n Define Nuremberg Code n Explain Declaration of Helsinki n Identify the Belmont Report
Part I
Introduction
n Prior to 1906, there were no regulations regarding the ethical use of human participants in research.
n There were no consumer regulations, no Food and Drug Administration (FDA), no Common Rule, and no Institutional Review Boards (IRBs).
The Hippocratic Oath
n The Hippocratic oath (600 B.C. – 100 A.D.): medical protocol through the centuries and as such determined the professional attitude of generations of physicians in modern medicine for the 2500 years.
Declaration of Geneva
n The Declaration of Geneva (The Modern Hippocratic Oath) is one of the World Medical Association’s (WMA) oldest policies adopted by the 2nd General Assembly in Geneva in 1947. It builds on the principles of the Hippocratic Oath, and is now known as its modern version.
n It also remains one of the most consistent documents of the WMA. With only very few and careful revisions over many decades, it safeguards the ethical principles of the medical profession.
Declaration of Geneva Versions
n Declaration of Geneva – version 1948 n Declaration of Geneva – version 1968 n Declaration of Geneva – version 1983 n Declaration of Geneva – version 1994 n Declaration of Geneva – version 2005 n Declaration of Geneva – version 2006
Nuremberg Code n The most dramatic and well-known chapter in the
history of research with human participants opened on December 9, 1946, when an American military tribunal opened criminal proceedings against 23 leading German physicians and administrators for their willing participation in war crimes and crimes against humanity.
n Among the charges were that German Physicians conducted medical experiments on thousands of concentration camp prisoners without their consent.
n Most of the participants of these experiments died or were permanently crippled as a result.
Nuremberg Code cont.
n As a direct result of the trial, the Nuremberg Code was established in 1948, stating that participants should give consent and that the benefits of research must outweigh the risks.
n the Nuremberg Code was the first international
document which advocated/supported voluntary participation and informed consent.
Nuremberg Code Elements n The voluntary consent of the human subject is
absolutely essential.
n The experiment should be such as to yield, fruitful results for the good of society.
n The experiment should be designed and based on the results of animal experimentation.
Nuremberg Code Elements cont. n The experiment should be so conducted as to
avoid all unnecessary physical and mental suffering and injury.
n Proper preparations should be made and adequate facilities provided to protect the experimental subject against possibilities of injury, disability, or death.
n The experiment should be conduct only by scientifically qualified persons.
Tishk International University Faculty of Science Medical Analysis Department
Medical Ethics and Professionalism
Spring Semester 2020-2021
History of Ethics Lect. 4 Part II
Dr. Karwan M-Amen [email protected]
Part II
Thalidomide
n In the late 1950s, thalidomide was approved as a sedative in Europe; it was not approved in the United States by the FDA.
n The drug was prescribed to control sleep and nausea throughout pregnancy, but it was soon found that taking this drug during pregnancy caused severe deformities in the fetus.
n 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.
n Some 12,000 babies were born with severe deformities due to thalidomide.
Declaration of Helsinki
n In 1964, the WMA established recommendations guiding medical doctors in biomedical research involving human participants.
n The Declaration governs international research ethics and defines rules for "research combined with clinical care" and "non-therapeutic research.”
n The Declaration of Helsinki was revised in 1975, 1983, 1989 and 1996 and is the basis for Good Clinical Practices used today.
Declaration of Helsinki Elements
Issues addressed in the Declaration of Helsinki: u Research with humans should be based on the results
from laboratory and animal experimentation u Research protocols should be reviewed by an
independent committee prior to initiation u Informed consent from research participants is necessary u Research should be conducted by medically/
scientifically qualified individuals u Risks should not exceed benefits
Tuskegee Syphilis Study (1932-1972)
n During a research project conducted by the U.S. Public Health Service
n 600 low-income African-American males, 400 of whom were infected with syphilis, were monitored for 40 years.
n Participants were not told about their disease. n Participants being denied treatment. n Many participants died of syphilis during the study. n The study was stopped in 1973 by the U.S. Department of Health,
Education, and Welfare only after its existence was publicized and it became a political embarrassment.
National Research Act (1974)
n Due to the publicity from the Tuskegee Syphilis Study, the National Research Act of 1974 was passed.
n The National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to:
• Identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human participants
• Develop guidelines which should be followed to assure that such
research is conducted in accordance with those principles.
The Belmont Report
n The Belmont Report is one of the leading works concerning ethics and health care research.
n Its primary purpose is to protect subjects and participants in clinical trials or research studies.
n The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research prepared the Belmont Report in 1979.
n This report consists of 3 principles: beneficence, justice, and respect for persons.
The three basic principles and their corresponding applications are:
Learning Objectives
Now, you will be able to…
n Explain the concept of medical ethics n Define Nuremberg Code n Explain Declaration of Helsinki n Identify the Belmont Report
Thank you
