Pure Food And Drug Act Essay

546 Words3 Pages

The Pure Food and Drug Act was passed in 1906. Before this there were no regulations of clinical trials in human subjects for research. Additionally, there were no consumer regulations, no Food and Drug Administration (FDA), no Common Rule, and no Institutional Review Boards (IRBs).
The Nuremberg Code had the biggest impact on research with human subjects and was the first international document that required voluntary consent from human subjects. It established that “voluntary consent of the human participant is absolutely essential” because human subjects in research should give consent and that the benefits of the research must be greater than the risks. It was established in 1948 because of an American military tribunal, which opened criminal …show more content…

It was a sedative approved in Europe but was not approved in the United States by the FDA. The drug 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 and they didn’t give informed consent. Consequently, approximately 12,000 babies were born with severe deformities.
In 1962, the U.S. Senate established the Kefauver Amendments under Food, Drug and Cosmetic Act. These amendments were designed to ensure drug efficacy and safety. This required pharmaceutical companies to prove to the FDA that their products were safe for consumption before placing them on the market.
The Declaration of Helsinki was established in 1964 by the World Medical Association, which, guided medical doctors and human subject researchers to do research based on results from laboratory and animal experimentation. Additionally, it required that protocols be reviewed by an independent committee before experimenting on human subjects and that human subjects are medically qualified for the research. Moreover, the Declaration of Helsinki embraced informed consent form research subjects, which was ushered by previous