Today I Learn… I make a point of learning something new everyday. This is what I learn each day

1, Dec 14, 2009

Ethics and Clinic Research, Protection of Human Subjects (1)

Filed under: Clinical Research — admin @ 12:06 am

It gives one such a warm fuzzy feeling to learn that the protection of human subjects, all of us, constitutes the heart of all the current rules and regulations regarding clinic research. Nearly all of them came into being in response to certain atrocities inflicted against human subjects.

The first and foremost important international document is Nuremberg Code of 1947, developed for the Nuremberg Military Tribunal as standards by which to judge the human experimentation conducted by the infamous Nazis doctors. The Code captures the basic principles of all clinic trials. That is, it is absolutely essential to have voluntary participation and “the voluntary consent of the human subject.” And the “experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.”

Further more protection follows. “During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, … that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.”

In the late 1950s a case involved Thalidomide emphasized the need for more regulation in drug development. Thalidomide was not approved by the FDA, yet it was prescribed to control sleep and nausea throughout pregnancy, but it was soon found that taking this drug during pregnancy caused severe deformities in the fetus. Many patients did not know they were taking a drug that was not approved for use by the FDA. Some 12,000 babies were born with severe deformities due to thalidomide. Thus, the 1962 “Kefauver Amendments” was added to the Food, Drug and Cosmetic Act. It ensures drug efficacy and greater drug safety.

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