Link : http://www.saunalahti.fi/~makako/mind/


Human Experiments: Sliding Backward

Congressman
Christopher Smith


Since the Nuremberg trials, the image of humans used as
laboratory animals has been etched into America’s, if not the world’s, cultural
psyche. The Nazi atrocities prompted creation of the Nuremberg code of
universal medical ethics. America’s laws, modeled on this code, strictly forbid
experiments on humans without obtaining their informed consent. But that
recently changed.


Americans typically are trustful that they will not be
used as human guinea pigs. This explains why American’s were so outraged a few
years ago when they learned of syphilis experiments on black men in Tuskegee
beginning in the 1940s who did not give their consent. It seemed inconceivable
that such a thing could occur in our own country. Despite these deeply
disturbing disclosures, however, the government recently relaxed the ethical code
for research. The Food and Drug Administration issued a new rule last October
that allows human experiments on patients without their consent.


The stated goal of the new regulations is to permit
medical advances in treating life-threatening conditions when current
treatments are either unproven or prove useless. A commendable goal, however,
is little comfort to those individuals who find they have been experimented on
without their consent. The primary motivation for the rule is not to help the
patients experimented on, but to collect data. While FDA points out that the
experiments may help patients, they also may hurt them. The Nuremberg code
clearly places the patient’s welfare as the overriding consideration in medical
procedures.


Experiments on humans can help doctors develop better
ways to treat illnesses. And that is why FDA relaxed the rule. But Dr. Arthur
Dyck, professor of Population Ethics at Harvard University, points out that
this new regulation risks “some very troubling dangers … The Nuremberg
code said there must be consent, and for darn good reason.”


Under the new rule, researchers may conduct
experiments on anyone, including fetuses, prisoners, and pregnant women. FDA
argues that its system is very protective of patients. For instance, the
government is setting up an institutional review board (IRB) that will
“ensure that risks to subjects are minimized.” But any risks beyond
standard care appropriately should only be made by the patients themselves.


To complement the IRB, the agency establishes
procedures to consult with representatives from patients’ communities. But
these precautions do not address the potential concerns of the individuals
themselves. Typically, IRB and community representatives will not know the
incapacitated individual. Indeed, these people likely will be preselected from
the pool of those who believe these kinds of experiments are acceptable. Else
the rule would be meaningless.


At the heart of this rule is the basic question who
decides whether a person with “diminished autonomy” may be included
in human experimental research? Dr. Dianne Irving, a former biochemist at
National Institute for Health and a Ph.D. medical ethicist at DeSales School of
Theology says there is an inherent conflict between advancing the interests of
the patient and those of science, especially “if the doctor who is doing
the research is also giving the permission” to use experimental technology
on the patient. And that is what may happen here.


In the past, researchers needed the consent of a legal
guardian. But under the new rules, researchers may waive this requirement is it
is not feasible to contact them, or the window for decision-making is short.
Any researcher who does so is supposed to obtain the consent of a family
member. But again, the researcher can waive this if not feasible. And if a
family member refuses, the researcher is not prohibited from proceeding if he
finds another family member who consents. Although the final rule requires
researchers to detail their efforts to contact guardians or family members if
they proceed without contacting them, this is an after-the-fact justification
by the researcher that is difficult to verify.


FDA specifically refused to establish any independent
“ombudsman” to verify – before the patient’s rights are waived -
whether efforts to contact guardians or family members were adequate, or
whether the patient is adequately protected. This leaves the decision to the
researcher, and that may also be a conflict.


The vast majority of researchers are decent, honorable
people dedicated to serving society. But the Nuremberg code of universal
medical ethics exists to prevent those few self-serving researchers from taking
advantage of patients unable to protect themselves. It also protects them from
honorable researchers who may become blinded to the concerns of the patient in
their eagerness to explore potentially life-saving therapies. The simple fact
remains that we as Americans have a right to receive standard care in emergency
situations. And we have the right to determine for ourselves what life saving
procedures are preferable. Regrettably, the FDA regulations may compromise
these rights.


Christopher Smith is a member of the U.S. House of
Representatives, where he chairs the International Relations Subcommittee on
International Operations and Human Rights.



Link : http://www.adti.net/html_files/reg/dd/ddsmith.htm

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