Page 17 - Journal of Special Operations Medicine - Spring 2017

enlisted medics likely rely on the perceived research acu- never informed about the risks, procedures, research
men of commissioned clinicians, who, without a PhD, plan, or possibilities of sustained damage to them or
themselves may not have the research preparation that their partners. 8,9
those junior to them assume them to have. Interpreted
broadly, such research knowledge differentials oppress In the Willowbrook study, institutionalized residents
and prevent knowledge generation from medics, who with profound intellectual and developmental disabili-
then must rely on persons prepared at the doctoral level, ties—mostly children—at a state hospital were infected
who are likely far removed from medics’ battlefields of with hepatitis passively and even purposely infected via
practice. fecal-oral routes. 7

Like the Tuskegee experiments, the participants were
Ethical Research: The Basics
never informed of the protocols or risks, nor were the
Ultimately, adhering to research ethics depends on the family members responsible for their decisions, as the
person conducting the research. More than 60% of re- participants were vulnerable and unable to make deci-
search misconduct relates to individual failure to follow sions for themselves. Coercion was also used as a tool
1
ethical guidelines and to accurately report results. The for recruiting participants, as the parents of the chil-
Nuremberg Code outlined three fundamental rights for dren were told they could skip the long waitlist for a
human subjects in research situations: “voluntary and facility short on beds if they allowed their children to
informed consent, a favorable risk-to-benefit analysis, participate. 7
6
and the right to withdraw without repercussion.” Pri-
marily, the Nuremberg Code was created in response Both instances developed our current standards for ethi-
to the war crimes trial (Nuremberg trials) after World cal research by demonstrating the severe harm that results
War II, during which prisoners of war were subjected from denying self-governance and self- determination
to inhumane experiments under the guise of medical re- and obfuscating the risks and benefits from participants.
search. Despite US government influence in the Nurem- In these two examples, the ethical violations were simi-
6
berg trials, the United States did not adopt full research lar and the participants were (at that time) “devalued
8
6
regulations after the Nuremberg Code’s creation, and members of society.” The subversive way in which par-
those three fundamental rights did not protect research ticipants were recruited, through deception and coer-
participants from experimental harm. cion, exemplifies how such dishonesty can severely harm
populations, regardless of their mental capacities. In the
In 1964, the World Medical Association met in Helsinki, Tuskegee experiment, the poverty of the participants was
Finland, and added two codicils to the Nuremberg Code: used as a tool against them (i.e., the participants were
the interests of the subject should always be placed above not able to advocate for themselves in determining their
the interests of society, and every subject should receive ability to refute what educated physicians were impos-
the best known treatment : although these were positive ing on them). Neither study provided informed consent
6
additions, the result was far from comprehensive pro- to the participants, and their vulnerabilities were used
tection. This prompted a 1966 review of unethical re- as tools against them. After the misconduct from these
search by Dr Henry Beecher in the New England Journal studies was made publicly known, the government out-
of Medicine, which concluded that the ethics of a study lined the principles and regulations proposed through
should be determined at its genesis rather than at its con- the Belmont report. This report spearheaded the federal
clusion and that the lack of informed consent is harmful guidelines for human subjects research and the require-
6,7
to participants. Senator Ted Kennedy spearheaded the ments now presumably found within every IRB.
National Research Act of 1974, which led to the 1978
report of principles guiding ethical research conduct, For a person to have autonomy, he or she should be
6
known as the Belmont Report. The Belmont Report de- treated in a manner that allows him or her to govern
lineated minimum requirements for ethical human sub- his or her own decisions through understandable and
jects research: autonomy, beneficence, and justice. 6 thorough information via informed consent, in addition
to ensuring that no coercion or deception is practiced. 9
These regulations were in response to several examples
of unethical conduct; two are highlighted here in brief— “ Autonomy” also refers to the respect given to a person’s
the Tuskegee experiments and the Willowbrook study. right to the truth. In the Tuskegee experiment, decep-
In the Tuskegee experiments, poor minority (African tion was present in the misinformation provided to the
American) men were promised treatment for nonspe- participants in that they were told blood tests would
cific hematological disorders and then were infected be provided for “bad blood”—at the time (the 1930s),
with syphilis. The treatment—simple penicillin—was that misnomer referred to a constellation of clinical
8
withheld from those infected, and the participants were syndromes in addition to syphilis. From a social justice

How It Works xiii