Nuremberg Code is a set of 10 sophisticate principles regarding ethical clinical research on human being (Grodin, 1994). It is mainly for protection of subjects’ human right (Shuster, 1997), such as compulsory of informed consent and the equal authority of subjects as the physician-researcher to end the experiment.
1.2 Helsinki Declaration (1964)
Helsinki Declaration is a set of guidelines on clinical research for physician as their responsibility toward protection of their research subjects (Williams, 2008). World Medical Association (WMA) also encourage it is used as reference by other parties in conduction of clinical research (Bădărău, 2013). Compared with the Nuremberg Code, which mainly focuses on safeguard of the subjects, its core is about the obligations of physician-investigators and research institutions that received federal funds (Shuster, 1997). Helsinki Declaration also softened Nuremberg code by allowing proper research on subjects who are incapable of making consent but importance of public health should never precedence the right of the subjects (Williams, 2008). Therefore, it helps to balance the responsibility of physician toward the subjects and public health (Williams, 2008).
2 Historical Background
2.1 Nuremberg Code
In August 1947, the Nuremberg Code was formulated in Nuremberg, Germany (Utley, 1992). The principles of the Nuremberg Code grew out from the Doctors’ Trial which prosecute towards the Nazi doctors who had conducted vile human experiment during the World War II (1939-1945) (Shuster, 1997). Due to this trial, obligation of physician on human clinical research was started to be defined. The 10 principles were articulated by the judges meanwhile the authors included 2 U.S. physicians: L...
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...the significance of the Nuremberg Code. New England Journal of Medicine, 337, 1436-1440.
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Third world countries and underdeveloped nations have become the new proverbial Petri dish of experimentation and offer particular conditions which researchers would never be able to find in their home countries. This only serves to highlight the problem that inherently faces all research studies, the ethical debate in regards to the protection and rights of their subjects. Is it feasible to expect the same standards to apply in certain countries where an economical imbalance between what is possible and what is not can be the largest hurdle to overcome? These are key issues examined in the New England Journal of Medicine by author Marcia Angell, M.D., and co-authors Harold Varmus, M.D. and David Satcher, M.D. in their respective articles that consider the ethical standards that should prevail in such circumstances. Should researchers be upheld to universal standards, or are the standards more applicable in a “local” sense, where the conditions and the constraints of the location provide the context for how the principles should be applied?
During the process of research, professionals collect data or identifiable private information through intervention or interaction. While this is a vital part of the scientific and medical fields, every precaution must be taken by researchers to protect the participants' rights. Ethics, outlined by the Belmont report; requirements, described by the Department of Health and Human Services (DHHS); and regulations, laid out by the Food and Drug Administration (FDA) are verified by an Institutional Review Board (IRB). This procedure assures that all human rights are safeguarded during the entire research process.
"Nazi Medical Experimentation: The Ethics Of Using Medical Data From Nazi Experiments." The Ethics Of Using Medical Data From Nazi Experiments. N.p., n.d. Web. 09 Dec. 2013.
Denise Dudzinski, PhD, MTS, Helene Starks, PhD, MPH, Nicole White, MD, MA (2009) ETHICS IN MEDICINE. Retrieved from: http://depts.washington.edu/bioethx/topics/pad.html
Siegler, M., and W. Winslade. "Ethics in Medicine." Clinical Ethics. By A. R. Jonsen. 7th ed. N.p.:
In Auschwitz, a Doctor’s Eyewitness Account, Doctor Miklos Nyiszli tells his tale on the things he experienced and witnessed at one of the largest concentration camps in Germany. His story encounters the horrors of the camp, from a very unique point of view. In his struggle to survive and tell his tale, Nyiszli volunteered to work alongside a Nazi war criminal who conducted and performed experiments on innocents. Nyiszli was forced to perform horrific “scientific research” projects for his supervisor, the notorious, Doctor Josef Mengele. During his time there, he witnessed the inhumane and unjustified extermination of his own people. Because of his acquired position alongside Mengele, and some luck, he was able to escape alive and testify
1. Capp, Marshall B. "Ethical and Legal Issues in Research Involving Human Subjects: Do You Want a Piece of Me? -- Kapp 59 (4): 335 -- Journal of Clinical Pathology." BMJ Journals. J Clin Pathol, 18 Jan. 2006. Web. 11 Feb. 2012.
Steinbock, Bonnie, Alex J. London, and John D. Arras. "The Principles Approach." Ethical Issues in Modern Medicine. Contemporary Readings in Bioethics. 8th ed. New York: McGraw-Hill, 2013. 36-37. Print.
Ethics refers to the values and customs of a community at a particular point in time. At present, the term ethics is guided by the moral principles that guide our everyday actions. These moral principles guide the researcher into deciding what is ‘right’ or ‘wrong’. The foundation of medical ethics is governed by two philosophical frameworks that are deontology, and utilitarianism. However ultimately the ethics committees need to balance the risks, and benefits for the participants and the community associated with the particular research proposal. This balance is quite important as the well being of participants is at risk.7
During this time period, the human experimentations operated by the Nazi Party was the most heightened point of medicine pessimism. Jews in the camps were used as the research subjects for clinical experiments that could benefit the Nazi Party war soldiers’ conditions, or just to further emphasizing the eugenic pillar (Gere). As the result, the US turned its back to eugenics mainly because it was supported by Germany, its opponent during the war (Gere). After the victory of the Allied, the Nuremberg Doctors’ Trial was implemented to bring justice and executing war criminals (Gere). Many Nazi Party’s doctors had to pay for their crimes as the price for their barbaric experiments on human (Gere). As the result, the Nuremberg code was imposed as the first attempt for the medical ethnic regulation (Gere).
Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987; 317(3): 141-145
“It is a simple fact that many, if not most, of today’s modern medical miracles would not exist if experimental animals had not been available to medical scientists. It is equally a fact that, should we as a society decide the use of animal subjects is ethically unacceptable and therefore must be stopped, medical progress will slow to a snail’s pace. Such retardation will in itself have a huge ethical ‘price tag’ in terms of continued human and animal suffering from problems such as diabetes, cancer, degenerative cardiovascular diseases, and so forth.”
McGee, Glenn and Arthur L. Caplan. "Medical Ethics." Microsoft® Encarta® 98 Encyclopedia. © 1993-1997: Microsoft Corporation. CD-ROM.
20 Feb. 2014. Nardo, Don. A. Biomedical Ethics.
Unethical experiments have occurred long before people considered it was wrong. The protagonist of the practice of human experimentation justify their views on the basis that such experiments yield results for the good of society that are unprocurable by other methods or means of study ( Vollmann 1448 ).The reasons for the experiments were to understand, prevent, and treat disease, and often there is not a substitute for a human subject. This is true for study of illnesses such as depression, delusional states that manifest themselves partly by altering human subjectivity, and impairing cognitive functioning. Concluding, some experiments have the tendency to destroy the lives of the humans that have been experimented on.