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
Cited: Bennett, Matthew. A History of Informed Consent. Ventana Center for Psychotherapy, 2000. Web. 6 Mar. 2013. “Human Subject Research Legislation in the United States.” Wikipedia. Wikimedia Foundation, 9 Dec. 2012.Web. 8 Mar. 2013. International Conference on Harmonisation (ICH). International Conference on Harmonisation –Guideline for Good Clinical Practice. Web. 6 Mar. 2013. Partners Human Research Committee. Informed Consent of Research Subjects. Web. 11 Mar. 2013. “Schloendorff v. Society of New York Hospital.” Wikipedia. Wikimedia Foundation, 16 Nov. 2012. Web. 6 Mar. 2013. Skloot, Rebecca. The Immortal Life of Henrietta Lacks. Crown, 2009. Print. “Stanford Prison Expirement.” Wikipedia. Wikimedia Foundation, 31, Mar. 2013. Web. 27 Mar. 2013. Vollmann, Jochen, and Winau, Rolf.”Nuremberg Doctors’ Trial” BMJ 313 (1996): 1445-1449. Print. World Medical Association. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. Web. 7 Mar. 2013.