Biomedical Engineering Reference
In-Depth Information
relevant. For example, Article III prohibits “outrages upon personal dignity, in par-
ticular humiliating and degrading treatment” (ICRC 1977).
Much of the current discourse about neuroscience is focused upon how that
provision applies to neuropharmacological agents (Moreno 2012). It would apply as
well to other potentially coercive measures that employ current and future iterations
of neurotechnology. A key challenge is that neurotechnology will advance faster than
policy or the judiciary system can ascertain and move into domains of potential use
and misuse yet to be discovered. The Additional Protocols to the Geneva Convention
do not explicitly address neurotechnology. But a reasonable interpretation would
impose definable constraints upon the scope of scientific techniques or technologies
applied within a clinical or research setting. Here arises a key challenge. As cutting-
edge technologies emerge, balancing the anticipated reasonable benefits of a “novel
treatment” or approach against the potential harm or burden it may cause can be dif-
ficult, especially in ambiguous situations or when managing a crisis.
The 1991 Iraq conflict, Operation Desert Shield, well illustrates the conundrum.
United States and allied military advisors were concerned that Saddam Hussein
would order the use of sarin nerve gas or biological weapons (e.g., anthrax bacte-
ria). The Iraqi forces also had botulinum toxin, which can quickly cause respira-
tory paralysis and death. There was no time to conduct clinical trials on available
antidotes. The Pentagon needed to ensure that its force was fit for duty, and wanted
to give pyridostigmine bromide (PB) pills to counter nerve gas, even though the
benefits were uncertain. About 250,000 troops elected to take them. In theory a
voluntary act, however, many troops felt pressured to take them (Moreno 1999). 15
Also administered was a botulism vaccine that the Food and Drug Administration
(FDA) considered “investigational” and that was never approved for the military to
use against chemical weapons. Record keeping was poor and it is not clear how
many were vaccinated. The FDA waived the normal informed consent provisions
based upon the need to protect combat troops. The FDA's position has been heav-
ily criticized for violating the precepts adopted into law as a result of the Belmont
Report (Levine 1991). The report embraces three principles: respecting people
through informed consent for research; beneficence, for example, do no harm while
maximizing benefits; and justice, by ensuring that procedures are well considered
(Belmont Report 1979). 16 Critics charge that “investigational” is a term applied to
any drug the FDA has not approved and is often mistaken for a drug that is the object
of research.
Critics charged that the Pentagon administered drugs that failed to conform to
federal standards that define research and that characterizing the drugs as “investi-
gational new drugs” was a canard in that they had not been properly researched. 17
Health and Human Services (HHS) rules define research as an activity designed to
test a hypothesis, permit conclusions to be drawn, and thus to develop or contribute
to knowledge that can be generalized (Belmont Report 1979). Commanders argued
that they acted to prevent horrific injuries by administering “the best preventive
or therapeutic treatment” available (FDA 1990). 18 A U.S. district court sided with
the military, dismissing a suit to declare unlawful the FDA rule that permitted the
military to administer the drugs and enjoin their administration without informed
consent.
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