Who was tried in the Nuremburg Military Tribunals and why?
Doctors who committed war crimes against humanity including medical experiments on concentration camp inmates and other human subjects without consent
What was the outcome of the Nuremburg Military Tribunals?
After 140 days of proceedings with testimony of 85 witnesses and submission of 1,500 documents, American judges convicted 16 doctors on 8/20/1947. Seven were sentenced to death and executed 6/2/1948.
What historical document was born from the Nuremberg Military Tribunals?
The Nuremberg Code (1947)
According to the Nuremberg Code (1947), all unnecessary physical and mental suffering and injury…
should be avoided
According to the Nuremberg Code (1947), voluntary consent of the human subject is…
absolutely essential
According to the Nuremberg Code (1947), the experiment must yield….
generalizable knowledge that could not be obtained in any other way and is not random and unnecessary in nature
According to the Nuremberg Code (1947), animal experimentation should…
precede human experimentation
According to the Nuremberg Code (1947), no experiment should be conducted if there is reason to believe…
death of disabling injury will occur
According to the Nuremberg Code (1947), the degree of risk to subject should…
never exceed the humanitarian importance of the problem
According to the Nuremberg Code (1947), risk to subjects should be minimized through…
proper preparations
According to the Nuremberg Code (1947), experiments should only be conducted by…
scientifically qualified investigators
According to the Nuremberg Code (1947), subjects should always be at liberty to…
withdraw from experiments
According to the Nuremberg Code (1947), investigators must be ready to end an experiment at any stage if…
there is cause to believe that continuing the experiment is likely to result in injury, disability, or death to the subject
The Declaration of Helsinki (1964) emphasized what?
Brought about by the need for human research as opposed to human experimentation and better defined the criteria for consent
What organization originally adopted the Declaration of Helsinki?
The World Medical Association General Assembly
What did the Declaration of Helsinki (1964) provide recommendations for?
Recommendations guiding physicians in biomedical research involving human subjects
The Declaration of Helsinki (1964) reiterated the basic ethical principles from what document?
The Nuremberg Code
According to the Declaration of Helsinki (1964), informed consent must be obtained from who?
The subject or legal guardian
According to the Declaration of Helsinki (1964), design and performance of experimental procedure must be…
formulated in a clear protocol
According to the Declaration of Helsinki (1964), research protocols should be transmitted to…
a specially appointed independent committee for consideration, comment and guidance
Who ran the Tuskegee Study of Untreated Syphilis in the Negro Male?
The US Public Health Service and the Tuskegee Institute
What was the purpose of the Tuskegee Experiments?
To justify treatment programs for black Americans
When were the Tuskegee Experiments intiated?
1932
What were the the concerns with the Tuskegee experiments?
-No informed consent
-Misleading advertisement
-Had to agree to autopsy to have funeral costs covered
-Treatment denied to some patients
-Risky spinal tap diagnostic
Who broke the story of the Tuskegee Experiments?
Peter Buxton told the story to an Associated Press reporter
When did the Tuskegee Study end?
1972, 25 years after a cure was known and publicly available
How were participants in the Tuskegee experiments impacted?
28 died from syphilis, 100 died from related diseases, and 40 wives and 19 children were infected
What historical document was the direct result of the Tuskegee Syphilis Trial?
The Belmont Report (1979)
When was the Henry K Beecher paper published?
Published in 1966
How was the Belmont Report (1979) developed?
The report of the National Commission for the Protecting of Human Subjects in Biomedical and Behavioral Research, founded as a result of the national Research Act passed by Congress in 1974
The Belmont Report (1979) defines the boundaries between and
Practice and research
According to the Belmont Report (1979), practice is defined as
interventions designed solely to enhance well-being of the patient with reasonable expectation of success
According to the Belmont Report (1979), research is defined as
activity designed to test a hypothesis and draw a conclusion to develop or contribute to generalized knowledge
According to the Belmont Report (1979), the informed consent process is an example of what foundation of ethical research?
Respect for persons
According to the Belmont Report (1979), treating people as independence is an example of what foundation of ethical research?
Respect for persons
According to the Belmont Report (1979), respect for persons means that those with diminished authority are entitled to…
Protection
According to the Belmont Report (1979), subjects entering into research voluntarily and with adequate information is an example of what foundation of ethical research?
Respect for persons
According to the Belmont Report (1979), concerns for privacy and confidentiality are an example of what foundation of ethical research?
Respect for persons
According to the Belmont Report (1979), respecting decisions, protecting from harm, and securing well-being are examples of what foundation of ethical research?
Beneficence
According to the Belmont Report (1979), beneficence is defined as…
Doing no harm and maximizing benefits while minimizing possible risks
What is the opposite of malfeasance as described in the Belmont Report (1979)?
Beneficence
According to the Belmont Report (1979), justice implies…
fairness and is manifested in equitable selection of subjects for research
According to the Belmont Report (1979), justice means that selection of subjects for research should be based on…
reasons directly related to the problem being studied, not systematic selection of a class of individuals due to compromised position, manipulability, etc.
What does the Belmont Report (1979) say about who should receive benefits of research?
Benefits should not be restricted to those who can afford it, and research should not involve persons from groups not likely to benefit from application of the research
What did the Henry K Beecher Paper reveal
22 published medical studies where patients had been experimented on with no expected benefit to them, showing that unethical studies were widespread and represented a systemic problem in medical research rather than exceptions
Human Radiation Experiments (1945-1957)
The Atomic Energy Commission conducted secret and classified radiation experiments and releases on unknowning Americans to assess how the human body metabolizes radioactive material.