chp 6.docx

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17 Apr 2012
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HUMAN RESEACH / CLINICAL TRIALS
Human research has lead to great advancements and disagreements among philosophers and scientists.
On one side, human research has led to the development of medical science why the development of
vaccines and treatments for polio, measles, yellow fever, hepatitis, and others. On the other side it has
also led down to some dark paths.
1) Nazi experiments
2) Tuskegee study
3) Radiation and children
To deal with such problems among human research numerous codes of ethics outlined on principles
governing human research or clinical trials.
1) The Nuremberg code
2) Declaration of helenski
3) The Belmont report
A human research or a clinical trial is normally an intervention of a drug or a treatment procedure to
determine the best possible effect. Clinical trials can derive reliable answers because they are carefully
configured, minimize bias and avoid errors.
A typical clinical trial consists of two groups: control group and the experimental group.
The control group is further divided into placebo control group and active control group.
Blinding and randomization are two processes in clinical trials that are required and necessary to show
that no person in the trial is treated unfairly.
A clinical trial occurs in three phases. Phase I phase II and phase III.
Many of the key features of clinical trials have provoked moral debate.
For a clinical trial to be morally permissible it has to follow 5 guidelines:
1) Subjects must give their informed consent.
2) The trial must be done in a way to minimize risk and maximize benefit.
3) Subjects must be selected fairly
4) Subject’s privacy and health data should be protected and confidentially should be
administered.
5) The trial must be reviewed and approved by an independent panel before it is conducted.
Autonomy, beneficence and justice are three means of moral principles that apply to human research.
Utilitarian, kentanian and rawls theories are applied to human research
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