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Programska knjižnica 9. Lošinjskih dana bioetike - Hrvatsko ...

Programska knjižnica 9. Lošinjskih dana bioetike - Hrvatsko ...

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kon toga donesena je i Helsinška deklaracija koja jasno razdvaja terapijsko<br />

od neterapijskog eksperimentiranja.<br />

Etičke vrijednosti prisutne su u mnogim dokumentima: načelo solidarnosti,<br />

načelo zaštite ljudskog života, slobodni i informirani pristanak, te načelo<br />

totaliteta. Etička prosudba o zahvatima na fetusima i embrijima prije<br />

svega treba voditi računa o uvjetima embrija ili fetusa (živog ili mrtvog) te<br />

o ciljevima koji vode eksperimentiranje.<br />

BIOETHICAL ASPECTS OF CLINICAL AND<br />

PHARMACOLOGICAL EXPERIMENTATION ON HUMANS<br />

Experiments on human beings are researches which consider human<br />

body as an object trying to discover unknown or not enough known effects<br />

of certain drugs, vaccines or treatments. This insures certain degree of safety<br />

in further application. Nevertheless, the problem appears because only<br />

the experiments on humans are necessary for the final verdict. Although<br />

the data from these experiments become common heritage, a risk of human<br />

rights violations is often present and real, even today.<br />

The power of test is emphasized in drugs as well as in experimentation.<br />

Drugs represent the basic way of protection of health, which is understood<br />

not only as an absence of sickness, but more as an aspiration towards complete<br />

physical, mental and social welfare.<br />

There are four phases in drug research: toxicological research, pilot–<br />

therapy research, research on a large number of patients, and research after<br />

commercialization of the drug. Experiment is finished when we get to<br />

know all the factors, and deviations are minimal or nonexistent.<br />

The first international document which regulates this kind of research<br />

is the Nuremberg Code in 1947, created as a result of the shock of civil<br />

awareness after dealing with criminal experiments conducted by Nazi doctors.<br />

Soon after, the Declaration of Helsinki was brought, which clearly<br />

differentiates therapeutic from non-therapeutic experimentation.<br />

Ethical values are present in many of the documents: principle of solidarity,<br />

principle of protecting human life, free and informed consent, and<br />

principle of totality. Ethical judgment on experimentation on fetuses or<br />

embryos should first of all consider the conditions in which embryos or<br />

fetuses (alive or dead) are, as well as the goals of the experiments.<br />

40

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