Biomedical Engineering Reference
In-Depth Information
( Nationalsozialistische Deutsche Arbeiterpartei ), i.e., Nazis. The defendants argued
that they had operated under a military-duty standard requiring them to carry out
orders, that the experiments aimed to protect German fliers and soldiers, and that the
“good of the state” took precedence over the individual. 9 The defendants asserted
that no law distinguished between legal and illegal experiments.
The Tribunal declined to excuse conduct merely because a defendant was
“political”. The legal implications resonate powerfully today. German Courts and
the North Atlantic Treaty Organization (NATO) divorce the political character or
leanings of a party from any consideration of the moral standards of bioscience and
medicine that govern conduct. The Nuremberg tribunal recognized the importance
of Hippocratic ethics and the maxim of nonharm ( primum non nocere ), requiring
physicians to do more than necessary to protect human research subjects, rooted in
the precepts that parties must give informed consent to participate in an experiment
and retain the right to withdraw from it. Nuremberg merged Hippocratic ethics and
the protection of human rights into one code (Shuster 1997).
Working with Dr. Andrew Ivy, Dr. Leo Alexander submitted to the Counsel for
War Crimes six points that defined legitimate medical research, to which the Court
added an additional four. The ten points that constituted the Nuremberg Code (“The
Nuremberg Code”; Germany 1949) hold that the voluntary consent of the human
subject is absolutely essential. This means that the person involved should have legal
capacity to give consent; should be so situated as to be able to exercise free power of
choice, without the intervention of any element of force, fraud, deceit, duress, over-
reaching, or other ulterior form of constraint or coercion; and should have sufficient
knowledge and comprehension of the elements of the subject matter involved, so
as to enable him/her to make an understanding and enlightened decision. As such,
neurotechnologies may be used in those circumstances in which a person can be
predisposed to believe they exercise free power of choice.
This latter element requires that before the acceptance of an affirmative decision
by the experimental subject, there should be made known to him/her the nature,
duration, and purpose of the experiment; the method and means by which it is to be
conducted; all inconveniences and hazards reasonably to be expected; and the effects
upon his/her health or person, which may possibly come from his/her participation
in the experiment. The duty and responsibility for ascertaining the quality of the
consent rests upon each individual who initiates, directs, or engages in the experi-
ment. It is a personal duty and responsibility which may not be delegated to another
with impunity. Moreover, the nature of the research should entail that:
1. The experiment should be such as to yield fruitful results for the good of
society, unprocurable by other methods or means of study, and not random
and unnecessary in nature.
2. The experiment should be so designed and based on the results of animal
experimentation and knowledge of the natural history of the disease or
other problem under study, through which the anticipated results will jus-
tify the performance of the experiment.
3. The experiment should be so conducted as to avoid all unnecessary physical
and mental suffering and injury.
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