In the United States, participants in medical studies reported
to the Economic Cycle Research Institute that they were motivated to take part in
research based on trust in their physicians, the potential to aid future
patients, or because they believed the study provided the best available
treatment. In Russia, the basis for
participation is different. A recent New
York Times article, “Russians
Eagerly Participate in Medical Experiments, Despite Risks,” describes how
Russian citizens are increasingly enduring the dangerous side effects of drug
trials. Why do Russians undergo this
ordeal? It is the only means to access
any form of medical care.
Sometimes,
the outcome proves to be worth the risk, or at least according to the
participant. Galina I. Malinina injected
herself daily with an experimental weight loss serum, and then enthusiastically
tolerated two weeks of intense vomiting as a result. However, at the conclusion of the study, she
related the pleasant results of increased energy, fitness, and even quality of
life. While this case demonstrates a
positive example, there are all-too-often serious side effects and no results
to show for it. On various occasions,
the ingestion of experimental antibiotics by Russian research subjects has
resulted in allergic reactions, loss of bowel control, vomiting, dizziness and
various of other negative side effects.
While pharmaceutical companies maintain that these trials
are intended to be experiments rather than treatments, Russians readily offer
their voluntary consent to act as guinea pigs and hope for the best. The Russian government has encouraged the
practice by signing a 2010 law that mandates that foreign drugs must be tested on Russians before entering the domestic
market. Though there are undeniable
economic benefits of conducting medical studies locally, the
participants’ motives and the possible side effects raise the question of
whether or not the benefits outweigh the risks.
The vast
majority of these trials involve significant risks to the patients’
health. However, in the eyes of Russian
participants, the benefits seem to far exceed any potential risk of harm. Americans generally have alternative means to
seek treatment, and thus predominantly focus on side effects and the potential
negative consequences. In contrast,
Russians do not dwell on the risks, and instead place precedence on the benefits. To them, medical research is just one more
risk in life, and the chance of a positive outcome will virtually always trump the
risk.
To a Westerner, there is obviously something that seems wrong with
this Russian phenomenon of eager research participants. But is there truly an ethical problem? Principle 16 of the Helsinki
Declaration states that “The
responsibility for the protection of research subjects must always rest with
the physician or other health care professional and never the research
subjects, even though they have given consent.”
Based on this notion, the physicians and medical personnel who are
conducting the studies are at fault for not exhibiting adequate concern for the
research subjects, even if the participants have provided voluntary informed
consent. Nevertheless, there seems to be
no clear-cut solution. Russian citizens
cannot simply be prevented from participating without being provided with a
reasonable alternative means to access medical care. Furthermore, there is no authority that is
willing and able to implement a change in policy. Unless the Russian state or society as a
whole can come up with a better option for these citizens, it seems that each
individual is entitled to make an autonomous decision as to whether or not to
participate in a potentially dangerous medical study.
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