The history of ethical regulations in human subjects research began with the
A: Declaration of Helsinki
B: Nuremberg Code
C: Common Rule
D: Belmont Report
The correct option is B.
Why option A is incorrect:
Declaration of Helsinki was established in 1964, so this act was after the Nuremberg Code.
Why option C is incorrect:
The common rule was established in 1981, which is not the beginning of the history of ethical regulations in human subjects’ research. Therefore, this option is also incorrect.
Why option D is incorrect:
The Belmont Report was approved in 1979, which was much later then Nuremberg Code approval, so this option is wrong.
The history of ethical regulation in human subjects began with the Nuremberg Code.
The history of ethical regulation in human subjects:
Before 1906, there were no specific regulations of the ethical use of human subjects in research, when the pure food and Drug act was approved. There were no Food and Drug Administration, no Institutional Review Board (IRB), no consumer regulations, and no Common Rules.
The Nuremberg Code was a direct result of the trial regarding prisoners used in the research. It was first established in 1948. The Nuremberg Code explains that “The voluntary consent of the human subject is absolutely essential.” It makes it clear that human subjects should give consent and that the benefits of research must outweigh the risks.
A petition was filed against 23 leading German administrators and physicians for their willing participation in war crimes.
The charges against them included that they have used thousands of prisoners in their research without any consent. Because of their experimentations, most of the prisoners died or crippled for their lifetime.
So, to keep humanity safe, the Nuremberg Code was established. It is the first international document that involves informed consent.
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