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.
STEINFELS, P. & LEVINE, C. 1976. Biomedical Ethics and the Shadow of Nazism: A Conference on the Proper Use of the Nazi Analogy in Ethical Debate, April 8, 1976, The Center.
TRIAL, N. 1946. From “Trials of war criminals before the Nuremberg Military Tribunals under control council law no. 10” Vol, 2. Nuremberg, October.
TYEBKHAN, G. 2003. Declaration of Helsinki: The ethical cornerstone of human clinical research. Indian Journal of Dermatology, Venereology, and Leprology, 69, 245.
UTLEY, G. J. A. E. R. 1992. The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation: Human Rights in Human Experimentation, Oxford University Press.
WILLIAMS, J. R. 2008. The Declaration of Helsinki and public health. Bulletin of the World Health Organization, 86, 650-652.
Cohen, Baruch C. “Jewish Law-Articles.” Jewish Law-Articles (The Ethics of Using Medical Data from Nazi Experiments). Web. 17 Jan. 2014.
Bioethics is the use of morals in science. If there had been more bioethics in Henrietta Lacks’s case, her doctors may have used their morals to not take the cells from her body without her permission or at least let her family know they had. Sixteen years before her case, the Nuremberg Code had been created which stated 10 codes of ethics to be used during human experimentation. However, it was not a law and few doctors even knew it existed.The issue of informed consent was also brought up in 1957 but doctors testified it was unnecessary. However on June 30th, 1974,17 years later, a law was passed requiring informed consent for all federally funded research. The issue of bioethics affected HeLa and many began to doubt if the doctors at Johns Hopkins had really been ethical. In conclusion, Henrietta Lacks and her “immortal” cells helped the field of science and its future
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.
Southam’s practice, beginning with the Code’s number 1 rule, “The voluntary consent of the human subject is absolutely essential.” Other rules under the Nuremberg Code were broken as well, however all of these egregious behaviors of researchers, more so than just Southam, have influenced the tight research protocols in place today. As Dr. Hardy shared information on research protocols, she consistently referred back to a strict system of regulations that, at times, may seem a little extreme. The alternative, a system permitting researchers like Southam, would be a far harder bullet to bite. In the end, I am glad these systems are in place to try to ensure a trust between patients and
In the United States, the basis for ethical protection for human research subjects in clinical research trials are outlined by the Belmont Report developed in the late 1970’s. This document, published by the Nation Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, highlights three important basic principles that are to be considered when any clinical trial will involve human research subjects. They are; respect for persons, beneficence, and justice. (Chadwick & Gunn, 2004)
Those who were affected by the testing in hospitals, prisons, and mental health institutions were the patients/inmates as well as their families, Henrietta Lacks, the doctors performing the research and procedures, the actual institutions in which research was being held, and the human/health sciences field as a whole. Many ethical principles can be applied to these dilemmas: Reliance on Scientific Knowledge (1.01), Boundaries of Competence (1.02), Integrity (1.04), Professional and Scientific Relationships (1.05), Exploitative Relationships (1.07, a), Responsibility (2.02), Rights and Prerogatives of Clients (2.05), Maintaining Confidentiality (2.06), Maintaining Records (2.07), Disclosures (2.08), Treatment/Intervention Efficacy (2.09), Involving Clients in Planning and Consent (4.02), Promoting an Ethical Culture (7.01), Ethical Violations by Others and Risk of Harm (7.02), Avoiding False or Deceptive Statements (8.01), Conforming with Laws and Regulations (9.01), Characteristics of Responsible Research (9.02), Informed Consent (9.03), and Using Confidential Information for Didactic or Instructive Purposes (9.04), and Debriefing (9.05). These particular dilemmas were not really handled until much later when laws were passed that regulated the way human subjects could be used for research. Patients
Wiesel, Elie. Foreword. Doctors from Hell : The Horrific Account of Nazi Experiments on Humans. 2005. Xix. Print.
Varmus , Harold, and David Satcher. "Ethical Complexities of Conducting Research in Developing Countries." New England Journal of Medicine. 337.14 1003-1005. Web. 9 Feb. 2014.
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
Nelson, James. (1973). Human Medicine: Ethical Perspectives on New Medical Issues. Minneapolis: Augsburg Publishing House.
Looking beyond the Nuremberg Code and applying it to modern medical research ethics, there are many challenges that it poses. Many have argued that the Code tries to provide for all unforeseen events, which restricts the researcher by requiring him to anticipate every situation, demanding the impossible. The most important contribution of the Code is the first principle, which says that voluntary consent of the human subject is absolutely essential. The subject involved should have legal capacity to give consent, should have free power of choice, as well as sufficient knowledge and comprehension of the experiment. This restricts that populations upon which some experiment may be conducted, since many do not have “legal capacity”. For instance, studies of mental illness and children’s diseases have been curtailed because neither of these populations has the legal capacity to give consent. Another group of people, prisoners, are never really able to give voluntary consent since they might be enticed by financial rewards, special treatment, and the hope of early release in exchange for participating in the human experimentation projects. British biostatitcian Sir Austin Bradford Hill also questioned whether it was important to inform a research subject who was receiving a placebo since it does...
"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.
In December 1946, the War Crimes Tribunal at Nuremberg indicted 20 Nazi physicians and 3 administrators for their willing participation in carrying out the harmful research on unwilling human subjects. Thus, Nuremberg code was the first international code for the ethics to be followed during human subject research. It was permissible medical experiments implemented in August 1947. The code also provides few directives for clinical trials (3). Syphilis study at Tuskegee in 1974 was the most influential event that led to the HHS Policy for Protecti...
The history of medical research in the twentieth century provides abundant evidence which shows how easy it is to exploit individuals, especially the sick, the weak, and the vulnerable, when the only moral guide for science is a naive utilitarian dedication to the greatest good for the greatest number. Locally administered internal review boards were thought to be a solution to the need for ethical safeguards to protect the human guinea pig. However, with problems surrounding informed consent, the differentiation between experimentation and treatment, and the new advances within medicine, internal review boards were found to be inadequate for the job. This led to the establishment of the National Bioethics Advisory Commission by President Bill Clinton in the hopes of setting clear ethical standards for human research.
During the transformation of the medical cosmologies, as the voice of the patients became less important, the doctors or medical investigators started to ignore about moral ethics or social responsibilities. During the era of Laboratory Medicine, doctors and medical investigators treat the sickness based on the particular cell instead of looking the patients’ body system (Jewson, 2009). They focus more on the cell that is related to the sickness and hope that they could discover new things that could help them attract sponsorship. During the implication of Hospital Medicine, medical investigators would disclose their discoveries in order to attract the attention of sponsors, unlike during the era of Bedside Medicine when discoveries were confidential (Jewson, 2009). This action is considered unethical towards the patients. Therefore, in order to prevent unethical behaviour among the doctors, solutions are carried out in modern days. For example, the Graduate Australian Medical School Admission Test (GAMSAT) contains one section that is tested on the reasoning in humanities and social science (GAMSAT, 2014). This is to emphasis on the thinking, logical and plausible reasoning and thus could show the suitability of a person in being a doctor. The Patients’ Right Act established to also ensure that the patients’