NUREMBERG
CODE
Unethical Experiments
Regulation of human subjects research in US
ETHICAL PRINCIPLES
All of the information about IRBs that you never really wanted to know
100
This code was the product of what "war"?
WWII
100
Poor black men in Alabama were observed for more than 40 years to study the natural history of syphilis, and medication was withheld even when effective treatment became available 1932-1972
Tuskegee Syphilis Study
100
In this year year Institutional Review Boards were established as as having required oversight authority for federally sponsored research
1974
100
A positive obligation to do good
Beneficence
100
Number of members on an IRB
At least 5
200
This code was first published in this journal.
Journal of the American Medical Association
200
Developmentally disabled children residing in an overcrowded state institution formerly located on Staten Island were deliberately infected with hepatitis B to help researchers seeking an effective preventive vaccine
Willowbrook hepatitis experiments
200
This report, produced in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, lists basic principles of medical ethics
The Belmont Report
200
Primum, non nocere: First, do no harm
Non-maleficence
200
IRBs evaluate if adequate protections in place to safeguard ______ (if they are being studied).
Vulnerable populations
300
This is absolutely essential based on the Nuremberg Code
Voluntary consent of the human subjects
300
U.S. researchers deliberately infected people with syphilis to study effects of antibiotic therapy 1946-1948
Guatemala syphilis study
300
Federal Policy for the Protection of Human Research Subjects, issued by 15 federal departments and agencies in 1991, standardizing human subjects protection across the federal government
The Common Rule
300
Failure to adhere to the principles of non-maleficence
negligence
300
These must be true in order for ____ to be possible: purpose, procedures and potential risks of the study must be clear to the subject
Informed consent
400
These should be avoided during experiments with human subjects.
physical and mental suffering and injury
400
1952: injected live cancer cells into inmates at Ohio State Prison 1962: injected live cancer cells into elderly patients of the Jewish Chronic Disease Hospital in Brooklyn
Chester Southam’s (Sloan-Kettering Institute) cancer studies
400
What office, housed in the Department of Health and Human Services (DHHS) has oversight responsibility for human subjects research in the U.S.
The Office Of Human Research Protection (OHRP)
400
treating every person the same way
Justice
400
Conflicts of interest can arise in what three levels
investigator, IRB, institution
500
During the experiment who has the liberty to terminate the experiment
The human subject and the experimenter
500
Alfred Kligman (University of Pennsylvania) infected hundreds of prisoners at what prison in Pennsylvania with a variety of pathogens in order to test new therapies in the period from 1951-1974
Holmesburg State Prison
500
This is the last year that the US recognizes revisions for the Declaration of Helsinki
1989 U.S. does not recognize any revisions after 1989, rejecting 2000 revisions and all subsequent revisions. In 2008 FDA eliminated need for U.S. researchers to abide by the Declaration of Helsinki
500
The right of persons to make decisions about their own health and life in the context of medical treatment and participation in research
Autonomy
500
Privacy must be protected through
Confidentiality
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