Instructor: Craig Bartholomaus
27 March 2013
What is an informed consent? What do we know about it? Where did it come from? What purpose does it serves? These days, there is a variance in what informed consent means. Its definition depends on what specific manner it accentuates in accordance with the pertinent setting of application. The American Medical Association (AMA) has definitions on a clinical setting and on the field of research. However it is defined, informed consent was the product of a period of work and experience.
Informed consent is the cornerstone of human subject research protection. (Rowbotham et al.)
The principles of informed consent were laid down in the context of American medical practice in a landmark case dating from the 1914: Schloendorf vs New York Hospital Society (Bennett). Following a surgical procedure was carried out a patient who had previously refused the surgery, the judge ruled that every human being of adult years and of sound mind has a right to determine what shall be done with his own body.
In 1947, during the after-effects of the Second World War, the Nuremberg trials of Nazi war criminals; to address the inhuman research practices of the Nazi scientists, the Nuremberg Code was composed. It is generally considered as the initial document implementing ethical principles in human research on the foundation of informed consent (Vollman and Winau). The Nuremberg Code consists of 10 principles, and it addressed three positions about informed consent. First, that voluntary consent is vital for human participants in research. Secondly, the human subject must be free to withdraw participation if so chosen. And thirdly, the researcher must be able to cease the experiment at any given time, if there is probable cause to believe that advancement might result in the injury, disability, or death of a human subject. (Office for Human Research Protection - U.S. Dept. of Health and Human Services)
The Nuremberg Code was followed by the Declaration of Helsinki in 1964. The World Medical Assembly (WMA) met in Helsinki, Finland, and established for the medical society the basic ethical principles of research involving human subjects and human experimentation. (World Medical Assn.)
Regarded as, perhaps, the most unethical medical research study in the United States was the Tuskegee syphilis experiment. Beginning in 1932, the Public Health Service along with the Tuskegee Institute, researchers recruited and enrolled 600 African-American poverty-stricken sharecroppers; 399 with syphilis and 201 without the disease. The purpose was to study that natural progression of the untreated disease, in the hopes of justifying treatment programs for African-Americans. By 1947, Penicillin had become the established treatment for syphilis, however the Tuskegee researchers elected to withhold drug information and treatment from its subjects. This unethical study continued on for 40 years, until in 1972 when the press learned about its existence which caused its termination. (“Human Subject Research Legislation”)
Besides unethical research in biomedical science, there were also reported unethical behavioral, sociological, and psychological trials. The Milgram obedience experiment and the Stanford prison experiment were a couple of infamous ones. (“Human Subject Research Legislation”)
Questions also arose about ethics in biomedical research and the practice of informed consent in the 1950’s, where concerns raised regarding prevalent use of the well-known HeLa cells by scientists. HeLa cells are cell lines that were taken from a black tobacco farmer from Clover, Virginia named Henrietta Lacks. She was diagnosed with cervical cancer, and during one of her treatments at Johns Hopkins Hospital, tissue samples were removed from her unknowingly – without her request and permission. She was also...