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Nuremberg Code

December 24, 2011

  • The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.
  • The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
  • The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
  • The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
  • The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
  • No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
  • The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
  • Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
  • The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
  • During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
  • During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject (Directives for Human Experimentation)

informed consent – “…The Nuremberg Code has not been officially adopted in its entirety as law by any nation or as ethics by any major medical association. Nonetheless, its influence on global human-rights law and medical ethics has been profound. Its basic requirement of informed consent, for example, has been universally accepted and is articulated in international law in Article 7 of the United Nations International Covenant on Civil and Political Rights (1966). Informed consent, with specific reliance on the Nuremberg Code, is also the basis of the International Ethical Guidelines for Biomedical Research Involving Human Subjects, the most recent guidelines promulgated by the World Health Organization and the Council for International Organizations of Medical Sciences (1993). The World Medical Association, established during World War II, has been accused of purposely trying to undermine Nuremberg in order to distance physicians from Nazi medical crimes. The election of a former Nazi physician and SS member, Hans-Joachim Sewering, to the presidency of that organization in 1992 added credibility to that accusation (Because of public criticism, Sewering later withdrew). Nonetheless, the various versions of the Declaration of Helsinki promulgated by the World Medical Association since 1964, although attempting to have peer review supplement informed consent and even supplant it as their central principle in the context of “therapeutic research,” all implicitly acknowledge Nuremberg’s authority. Both the Nuremberg Code and the Declaration of Helsinki served as models for the current U.S. federal research regulations, which require not only the informed consent of the research subject (with proxy consent sometimes acceptable, as for young children), but also prior peer review of research protocols by a committee (the institutional review board of the hospital or research institution) that includes a representative of the community. The Nuremberg Code focuses on the human rights of research subjects, the Declaration of Helsinki focuses on the obligations of physician-investigators to research subjects, and the federal regulations emphasize the obligations of research institutions that receive federal funds. Nonetheless, by insisting that medical investigators alone cannot set the rules for the ethical conduct of research, even when guided by beneficence and Hippocratic ethics, and by adopting a human-rights perspective that acknowledges the centrality of informed consent and the right of the subject to withdraw, the Nuremberg Code has changed forever the way both physicians and the public view the proper conduct of medical research on human subjects. Fifty years after Nuremberg, we recognize the human-rights legacy of the Nuremberg Code and are better able to face the critical challenge of applying the Code in its entirety and enforcing its human-rights provisions…” (Fifty Years Later: The Significance of the Nuremberg Code)

without the public’s consent – “…The Bush administration has quietly channeled tens of billions of dollars into chemical and biological weapons. Bush’s 2007 budget, for example, earmarked almost $2 billion for biodefense research and development via the National Institutes of Health alone. Research aims are often dubious. In October 2005, for example, US scientists resurrected the 1918 Spanish flu, a virus which had killed almost 50 million people. And a virologist in St. Louis has been working on a more lethal form of mousepox (related to smallpox) just to try stopping the virus once it has been created. Since the R&D is top secret and oversight limited, the public is rarely aware of escalating dangers. As of August 2007, for example, biological weapons laboratories across the country had reported 36 lost shipments and accidents for that year, almost double the number for all of 2004. In addition to challenging international non-proliferation agreements and risking a global arms race, the Bush administration’s surge in chemical and biological weapons spending raises questions over what deadly weapons may have been tested on populations abroad. And what may be tested domestically, with or without the public’s consent…” (Breaking the Nuremberg Code: The US Military’s Human-Testing Program Returns)

The Declaration of Helsinki was developed by the World Medical Association (WMA), as a set of ethical principles for the medical community regarding human experimentation, and is widely regarded as the cornerstone document of human research ethics. (WMA 2000, Bošnjak 2001, Tyebkhan 2003). It is not a legally binding instrument in international law, but instead draws its authority from the degree to which it has been codified in, or influenced, national or regional legislation and regulations (Human and Fluss 2001). Its role was described by a Brazilian forum in 2000 in these words “Even though the Declaration of Helsinki is the responsibility of the World Medical Association, the document should be considered the property of all humanity” (Human and Fluss 2001). The controversies and national divisions over the text have continued. The US FDA rejected the 2000 and subsequent revisions, only recognizing the third (1989) revision (Wolinsky 2006), and in 2006 announced it would eliminate all reference to the Declaration. After consultation, which included expressions of concern, a final rule was issued on April 28, 2008 replacing the Declaration of Helsinki with Good Clinical Practice effective October 2008. This has raised a number of concerns regarding the apparent weakening of protections for research subjects outside the United States. The NIH training in human subject research participant protection no longer refers to the Declaration of Helsinki. The European Commission refers to the fourth (1996) revision. While the Declaration has been a central document guiding research practice, its future has been called into question. Challenges include the apparent conflict between guides, such as the CIOMS and Nuffield Council documents. Another is whether it should concentrate on basic principles as opposed to being more prescriptive, and hence controversial. It has continually grown and faced more frequent revisions (Carlson 2004). The recent controversies undermine the authority of the document, as does the apparent desertion by major bodies, and any rewording must embrace deeply and widely held values, since continual shifts in the text do not imply authority. the actual claims to authority particularly on a global level, by the insertion of the word “international” in article 10 has been challenged. Carlson raises the question as to whether the document’s utility should be more formally evaluated, rather than just relying on tradition…” (Wikepedia)

The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War. (Wikepedia).

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