Science has always relied on experimentation and research in trying to arrive at logical conclusion based on the results of such research. Clinical tests have always been performed on human and non-human subjects. Without thorough regulation in the industry, some researchers have used humans as test subjects, in some cases, against their will. Such cases were prevalent in mid 1900s when medical science was advancing at a very fast rate. However, these scientists did not value ethical concerns of the test subjects and thus these subjects faced inhuman conditions and in most cases died from the experimentation. There was need to provide industry guidelines on ethical issues clinical tests.
Events leading to Belmont Report and Nuremburg Code
According to the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979), the Public health Services targeted impoverished black men in Tuskegee Alabama. In this particular experiment, the service was looking to understand how syphilis would spread without treatment. To perform the experiment, 600 men were selected, 399 of these subjects had contacted the disease with the rest free 201 of the disease. In the 40 year old study, the Public Health Service simply monitored the spread of the disease among the remaining 201 test subjects. In return, the Public Health Service would provide the subjects with free medic al care, food and promise of burial .
The unethical part of this experiment is that the Public Health Services knew that these men suffered syphilis and did not know that they had disease. Even with this knowledge, medical personnel did not treat the patients rather watched as it spread among the men . Additionally, these black men did not know that they were participating in a medical experiment. They had not provided their express consent to participate in the experiment. Revelation of the Tuskegee experiment brought to the fold unethical practices by clinical researchers.
Of more concern is that American researchers did not contain this practice to the United States. According to Miller, Vandome, & John (2009) the United States Public Health Services went to Guatemala between 1946 and 1948 and intentionally infected prisoners and patients in mental hospital with syphilis and gonorrhea. These inhuman experimentation methods prompted the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
Similarly, the Nuremberg Code was arrived at after the famous Subsequent Nuremberg Trails that were held soon after Nazi Germany forces lost the Second World War to the Allies . The Nuremberg trials were a series of U.S. military trials against the surviving members of Hitler’s Nazi regime. Under the Third Reich, German scientists were involved in clinical human experimentation that in most cases ended in mass murder of test subjects. Hitler’s scientists were tasked with eliminating the weaker Jewish gene and the development of a superior Aryan gene .
Proceedings at these trails found terrifying experimentation methods used by Nazi doctors. These doctors used test subjects without their consent using prisoners of simply civilians in occupied territories. Doctors would choose test subject in concentration camps and subject them to brutalities and extreme inhuman treatment. Eventually these test subjects died and the number of dying subjects was astronomical . Nuremburg proceedings found that some specific codes of conduct were necessary to help direct medical experimentation. Though it was not directly incorporated into either German of American laws, it provided guidelines for several laws regarding ethical clinical test practices.
Ethical Considerations of the Belmont Report and Nuremburg Codes
Both the Nuremburg Code and the Belmont Report have largely attempted to provide guidelines on ethical practices in clinical experimentation. The Nuremburg report provided ten points that medical test experts should abide by. The very first point that the Code identifies is voluntary consent of a human test subject. The code identifies voluntary consent to be extremely essential in ensuring ethical practice. This implies that the human test subject should be in legal capacity to provide such consent. The condition for capacity to provide legal consent ideally implies that minors and persons with mental disabilities should not be involved as test subjects are they lack legal capacity to provide such consent .
Other points of the codes express that experiment should be performed if the results will go along in improving nature of human life. Research should also be performed by qualified personnel with highest degree of skills to ensure that test subjects are well taken care of. The code further direct that medical researcher should take necessary measures to ensure that mental and physical suffering is reduced as much as possible.
Similarly, Belmont Report provides principles that guide in ethical clinical research practices. One such principle is respect for persons. This principle has two ethical considerations. The first ethical consideration is that individuals should be treated as autonomous agents with capability to make decisions and persons with diminished autonomy should be protected . According to the baker report autonomous research subjects should be informed of all procedures and possible effects that they will undergo during the research. After the subjects have been fully informed, they should be allowed to decide whether to participate or not.
Persons with diminished autonomous capability such as persons with mental disabilities and minors should be involved in clinical experiments. These groups of person are not in a position to make informed decisions and are protected by the law.
The second principle under the Belmont Report is beneficence. The ethical direction is that researchers must take every measure to ensure that subjects are free from any harm while at the same time getting the most from the research. The final principle is Justice. In this case, benefits and burdens from any clinical research must be distributed among all the parties involved in equal measure .
Conclusion
Both the Belmont Report and Nuremburg Code strive to ensure that clinical research is done in an ethical with respect for human life and dignity. Proper selection of test subjects should be done and these subjects should provide legal consent to participating in the clinical test. Experiment should minimize physical or mental suffering as much as possible. Finally, the experiment should be performed if it would improve human lives.
References
Miller, F. P., Vandome, A. F., & John, M. (2009). Belmont Report. New Jersey: VDM Publishing House Ltd.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
Schmidt, U. (2004). Justice at Nuremberg. Leo Alexander and the Nazi Doctors' Trial. Basingstoke: Palgrave.
Weindling, P. (2001). The Origins of Informed Consent: The International Scientific Commission on Medical War Crimes, and the Nuremberg Code. Journal of the History of Medicine 75 (1) , 37-71.
