How Do You Think Two Crucial Research Events—the Creation of the Nuremberg Code and the U.S. Public Health Service Syphilis Study at Tuskegee—Influenced the Role of Institutional Review Boards (Irbs) in the Study Design Process?
The great weight of the evidence before us to effect that certain types of medical experiments on human beings, when kept within reasonably well-defined bounds, conform to the ethics of the medical profession generally. The protagonists 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. All agree, however, that certain basic principles must be observed in order to satisfy moral, ethical and legal concepts.
Clinical research has expanded tremendously in the past few decades and consequently there has been growing interest in the ethical guidelines that are being followed for the protection of human subjects. This review summarizes historical scandals and social responses chronologically from World War II to the Death of Ellen Roche (2001) to emphasize the lessons we must learn from history. International ethical guidelines for studies with human subjects are also briefly described in order to understand the circumstances of clinical research. The tasks and responsibilities of the institutions and investigators in human subject research to preserve the safety and welfare of research subjects are summarized. Next, several debated ethical issues and insights are arranged as controversial topics. he Nuremberg Code comprises such principles as informed consent and absence of coercion; properly articulated scientific experimentation; and beneficence towards experiment participants . The code states that : 1) Voluntary informed consent is essential without any coercion; 2) Human experiments should be designed and based upon prior animal experimentation; 3) Expected scientific outcomes should justify the experiments; 4) The experiment should be conducted only by qualified scientists; 5) The experiment should be conducted in a way that avoids all unnecessary physical and mental suffering and injury; 6) There should be no expectation of death or disabling injury from the experiment. In 1953, the World Medical Association (WMA) was provoked to make drafts that would apply the Nuremberg Code to the practice of human experiment in the medical community. Known as the Declaration of Helsinki, it was an expansion upon the Nuremberg Code and was first adopted in 1964. It has been revised several times (1975, 1983, 1989, 1996, 2000 and most recently in 2008) according to the modern ethical theory and current clinical and research practice.
Nevertheless, in spite of Genie case, the participants of the Milgram experiment were volunteers. But, trying to prevent the persons from leaving, Milgram placed them in a stressful situation. This part can be considered as a violation. According to the Nuremberg Code, “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 Nuremberg Code”, 1947). Moreover, the Code says that all the participants should be free to stop the experiment. Those parts of the Code apply to such experiments as the Milgram. In case of the Milgram experiment we can find the nonobservance of those statements. The Belmont Report, as well as the Nuremberg Code, indicates an importance of the personal freedom within the research. The principle of justice as a fairness distribution is also applies to such experiments as the Milgram, emphasizing an importance of the equal treatment of all participants of the experiment. Informed Consent also indicates the necessity of the equal treatment and the importance of protection of mentally and physically ill people. The consent of the experiment was not informed. Thus, the participants agreed to take part in the learning program, not the obedience.They suppose that this research is absolutely confidential and do not want to provide any information that can be recorded. If the participants of the research get learn that the scientist requires such kind of materials, they can easily refuse him. As the result, the researcher would not get some important elements for his work. The details of the personal life cannot be shared with public within the library and information science without the knowledge of the participants. Therefore, the researchers have to produce an adequate protection of the identity of the participants of the research, for instance, by electing the anonymous responses. Such methods help participants be sure of their physical and legal protection.
In a word, there is little doubt that the Code was prepared after studying the Guidelines, but no reference was made to the Guidelines, for reasons that are not known. Using the Guidelines as a base document without giving due credit is plagiarism; as per our understanding of ethics today, this would be considered unethical. The Nuremberg Code has fallen by the wayside; since unlike the Declaration of Helsinki, it is not regularly reviewed and updated. The regular updating of some ethics codes is evidence of the evolving nature of human ethics.
Jones, P. E. (1995). Contradictions and Unanswered Questions in the ‘Genie’ Case: A Fresh Look at the Linguistic Evidence. Language & Communications, vol. 15, No. 3, pp. 261-280.
Neuman, W. L. (2012). Basics of Social Research: Qualitative and Quantitative Approaches (3 rd ed.).Boston: Pearson; Prentice Hall.
National Institutes of Health. (1947). Nuremberg Code. Web.
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report. Web.