Tuesday, May 24, 2011

Ethical violations of informed consent

Ethics plays a very vital role in the conduct of a clinical trial. It is present in order to safe guard the physical health and mental integrity of a person. Taking about ethics what comes first to our mind is the importance of informed consent.

Informed consent is the consent given by an competent individual, who have been given all the necessary information about the trial and after having understanding and considering the information has come to a conclusion to take part in a trial without having been subjected to undue intimidation. It is a written signed and dated document done in presence of a impartial witness.

But this was not so always. There are different cases in the history of research that tells us about the unethical research conducted on the individuals.

During World War II in America and Britain president Franklin Roosevelt created an office of scientific research and development to combat diseases like dysentery influenza and malaria. One of the teams created a potential vaccine for dysentery.

This Vaccine was researched on orphans and mentally retarded individuals.Orphans developed high fever and died - Vaccines were proved a failure .Research Team felt that some sacrifices had to be made to benefit the society. An Anglican journal published that at least four residential schools were included in a clinical trial .5 year nutritional study was conducted in 1940’s with out the parents consent. The government presumed that research would benefit native communities.

One Dr. Southam who was an investigator at Memorial Sloan Kettering Cancer - centre was studying the immunology of cancer in cancer patients as well as healthy volunteers without their consent. Southam defended by stating that there was no risk that cancer would develop; and if he had mentioned the word ‘cancer’ it would have caused bizarre and defensive reactions in patients. He also defended saying that he had taken their oral consent. Dr.Henry Beecher, a physician in Harvard University published as many as 22 examples of unethical clinical trials in the New England journal in 1966.

Thus it is seen that a lot of ethical violations have happened in the history which had lead to establishment of ethical guidelines in clinical research.

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