The Significance of the Nuremberg Code and Belmont - Report Example

Patient Rights and Ethical Issues: The Significance of the Nuremberg and Belmont Report Patient rights and ethical issues were disregarded for a long time before the government decided to create a set of rules on medical researches involving human participants. This paper expounds on the significance of the Nuremberg Code and the Belmont Report in relation to patient rights and ethical issues on clinical trials conducted on high risk diseases. The history of the evolution of such guidelines is explained such as the various incidents all over the world that exposed the horrendous procedures that clinical trials brought to its human participants. Current policies being implemented today by different agencies are also described. New issues regarding ethical concerns as evident in an AIDS-related research in developing countries is thoroughly presented. Furthermore, the impact of the Nuremberg Code and the Belmont Report on current clinical trial policies and how these affect special populations or group of people are also classified. Keywords: Nuremberg Code, Belmont Report, AIDS, patient rights, ethical issues. Patient Rights and Ethical Issues: The Significance of the Nuremberg Code and Belmont Report Biomedical and behavioral researches as embodied in clinical trials are essential in the development of new treatments and procedures of various diseases especially those that are considered as high risks. These studies provide information about the biology and nature of diseases which, in turn, give the researchers sufficient knowledge in creating prevention measures or cure. According to Dr. Eugene Passamani (1991), “Clinical trials have thus become a preferred means of evaluating an ever increasing flow of innovative diagnostic and therapeutic maneuvers. The randomized, double-blind clinical trial is a powerful technique because of the efficiency and credibility associated with treatment comparisons involving randomized concurrent controls.” However, issues concerning disregard of patient rights and the unethical use of human participants in clinical research over the years gave rise to the evolution of guidelines such as the Nuremberg Code and the Belmont Report to ensure the welfare and safety of its voluntary participants. Until 1906, there were no known protocols or code of practice that are being followed concerning the ethical use of human participants in research studies. The aftermath of World War II intensified the appeal to develop a strict universal set of guidelines when the truth about the horrific medical exploration of Nazi German physicians conducted in concentration camps was exposed to the public. It was reported that thousands of prisoners were forcefully subjected to medical experiments, “which included subjecting the victims to extreme temperatures, mutilating surgeries and deliberate infection with lethal pathogens” (Stone, 2004, p. 8). Most of the victims either died or suffered irreparable damage physically, physiologically and mentally. In December 9, 1946, a trial was conducted against twenty-three German doctors and administrators by the American military tribunal for taking part in crimes against humanity and war crimes. This incident gave way to the creation of the Nuremberg Code in 1948 which is considered as “the first international normative framework regulating the standards of research clinical trials” (Lotte, 2005, p. 34). The code demands that the human participant in any clinical trial or research has voluntary consented to participate in the project and that the benefits of the research must be greater than the potential harm that it may bring. The first principle comprehensively clarified the need to create such guidelines, “The voluntary consent of the human subject was absolutely essential. 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, deceit, 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” (The Nuremburg Code). As a result, ten basic principles in conducting research were established stressing the need of informed consent from the human participants. Still, these rules do not convey the rule of law and “did not establish a method that would ensure that its rules were enforced by the physicians/scientists conducting research” (Escobedo, et al., 2007, p. 2.1). As a consequence, the policies merely had an effect to worldwide medical researches involving human subjects. Moreover, reported incidents on unethical treatment of human subjects in clinical studies continue to emerge over the years. During the 1950s, the United States experienced first-hand the horrendous consequence of research malpractice. The sedative Thalidomide, although a permitted drug in Europe, was prescribed to pregnant mothers in the United States to regulate sleep and nausea without seeking approval from the Food and Drug Administration (FDA). After giving birth, over 12,000 babies were affected of severe abnormalities brought by the drug. Most of the patients were not aware of the sedative’s issue with the FDA and were not asked to give informed consent in taking the medicine. Because of this, the Kefauver Amendments to the Food, Drug and Cosmetic Act were enacted to law in 1962, guaranteeing the effectiveness of products as approved by the FDA to ensure safety and efficiency of drugs in the market (History of Ethics, par. 5-6). In addition, the World Medical Association established a more defined protocol for the protection of human subjects in medical researches by forming the Declaration of Helsinki in 1964. As Escobedo et al. (2007, p. 2.2) pointed in their study, the Declaration of Helsinki as compared to the Nuremburg Code “offered more protection to participants by establishing the need for independent guidance about an experiments protocol from scientists who were not involved in the research project.” Since the Declaration was implemented as an international code of research ethics, it eventually became the foundation of good clinical practices of the modern times. The guidelines also gave possess the authority to reject publication of research projects that are not reviewed by third party institutions (History of Ethics, par. 7). The most disconcerting research project involving human participants ever exposed in the United Sates was the Tuskegee Syphilis Study conducted by the U.S. Public Health Service from 1932 to 1972. The study was reported as a research involving the following, “600 low-income African-American males, 400 of whom were infected with syphilis, were monitors for 40 years. Free medical examinations were given; however, participants were not told about their disease. Even though a proven cure (penicillin) became available in the 1950s, the study continued until 1972 with participants being denied treatment. In some cases, when participants were diagnosed as having syphilis by other physicians, researchers intervened to prevent treatment. Many participants died of syphilis during the study” (History of Ethics, par. 9). The project only ceased its operations upon the leakage of the issue to public knowledge in 1973. Hence, the National Research Act of 1974 was passed into law to strengthen the protection of human participants in clinical studies. This gave way to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research that was legislated to classify the ethical principles biomedical and behavioral research encompassing human subjects. They are also tasked to strictly oversee that research studies are following their guidelines (National Commission on the Protection of Human Subjects of Biomedical and Behavioral Research). Furthermore, the Commission formulated the Belmont Report in 1979, which identified the important ethical principles essential to research projects comprising human participants. The report encompasses guidelines to encapsulate the three basic ethical principles of autonomy or respect, beneficence and justice for human beings. Each person’s rights must be protected, his safety is considered with outmost importance throughout the study and the benefits that one can achieve should outweigh the risks involved in the project. On the other hand, the application of the Report includes informed consent, assessment of risks and benefits and selection of participants. As a rule, the participants must be fully aware of the procedures of the clinical trials and is joining the research voluntarily; the benefits and risks involving the study are meticulously explained to him and underwent fair selection processes (Escobedo et al., 2007, p. 2.3). The creation of the Nuremburg Code and Belmont Report has “helped generate, form the body of knowledge we depend on for guidance in ethical conduct and moral reasoning” (Coughlin, 1997, p. 30). These policies do not only promote the safety of human subjects in clinical trials but the protection of the participants are also assured by means of confidentiality and privacy particularly for high risk diseases like AIDS. However, new ethical issues are apparent in recent years especially in researches in the international setting. Because of economic reasons, participants of clinical trials conducted in developing countries tend to suffer from severe disadvantages compared to same researches being conducted in industrialized countries. For instance, an ethical controversy in international research regarding basic ethical procedures such as voluntary informed consent was exposed in 1997, involving the research of the National Institutes of Health (NIH) in the United States and other countries. The study was designed to explore the maternal-to-infant transmission of HIV and test the hypothesis that the transmission can be reduced significantly when the treatment is continuously taken by mothers as early as the 14th week of pregnancy. Treatments were commenced flawlessly in the United States but the participants in developing countries, namely Thailand and Africa, received lower dosage of the treatment AZT in order to support the expensive cost of drug in a placebo controlled trial. Even worse, the living conditions in these countries have denied the women subjects to early prenatal care, resulting in late initiation of the treatment. As a result, the project failed to take effect in participants in developing countries although the ACTG 076 procedure has been proven effective when properly administered (Shapiro, 2001). Ideally, experimental treatments for placebo-controlled trials must be constant in any participating country of the study. It is unethical to deny a participant of effective treatment procedures just because of the inequalities brought by poverty in their current location. More so, the researchers must be aware of the consequences of introducing clinical trials in a different country and refuse to provide the participants the proper treatment dosages (Shapiro, 2001). Today, agencies like the National Bioethics Advisory Commission (NBAC) and Institutional Review Board (IRB) continue to address concerns involving patient rights and ethical issues both on researches in the United States and international researches sponsored by or of interest with the U.S. Federal regulations are regularly reviewed and public dialogues are actively encouraged to ensure applicable protection of research subjects (Shapiro, 2001). The same action is also given to special populations such as prisoners, persons with disabilities and minors among others to ensure that the arm of the law reaches them as well. These groups are handled with necessary care considering their vulnerability brought by coercive environment, poor health status, educational disadvantage, social support and other factors (Stone, 2004). Nevertheless, the implementation of rules and policies in medical researches involving human participants is an essential tool in ensuring that the basic human rights and ethical concerns of the human subjects are primarily considered with outmost importance. The creation of guidelines such as the Nuremburg Code and Belmont Report championed the welfare and safety of research participants against possible irreparable damages that the experimental treatments may bring them. As the modern times approach, new ethical issues also emerge. As such, the agencies mandated to ensure patient rights and ethical policies in clinical trials with human participants must continue to review the current guidelines to properly address different situations in the future. References Coughlin, S. (1997). Ethics in epidemiology and public health practice: Collected works. Quill Publications. Escobedo, C., Guerrero, J., Lujan, G., Ramirez, A., & Serrano, D. (2007). Ethical issues with informed consent. Bio-Ethics Issue, 1. Retrieved on August 9, 2012 from http://cstep.cs.utep.edu/research/ezine/ezine-ethicalissueswithinformedconsent.pdf. History of ethics. (n.d.). Retrieved on August 9, 2012 from Claremont Graduate University website, http://www.cgu.edu/pges/1722.asp. Lott, J. (2005). Module three: Vulnerable/special participant populations. Developing World Bioethics, 5(1), 30-37. National Commission on the Protection of Human Subjects of Biomedical and Behavioral Research. (n.d.). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Retrieved on August 10, 2012 from http://ohsr.od.nih.gov/guidelines/belmont.html. Passamani, E. (1991). Clinical trials – are they ethical? The New England Journal of Medicine, 324, 1592. Shapiro, H. (2001). Ethical and policy issues in international research clinical trials in developing countries: Report and recommendations of the National Bioethics Advisory Commission. DIANE Publishing Company. The Nuremburg Code. (n.d.) Retrieved on August 10, 2012 from http://hss.gov.ohrp/references.nurcode.htm. Read More