Nazi physicians were responsible for performing malicious experiments on prisoners in the concentration camps. The Belmont Report was created later after the discovery of the Tuskegee Syphilis Experiment. In this study, which was conducted from 1930-1972, African American men were deceived into thinking they were being treated for syphilis when they actually were not. Even after the discovery that penicillin was an effective treatment for this disease, many men were still left untreated and left to die unnecessarily. The Doctors Trial was one of the main trials conducted after World War II in Nuremberg, Germany.
This was an international trial made up of judges from the United States, Britain, France, and the former Soviet Union. This trial involved 23 defendants, 20 of them being physicians, all accused of torturing and murdering prisoners in concentration camps with the use of medical experiments. Sixteen of the 23 defendants were found guilty and sentenced to death, life in prison, 25 years, fifteen years and ten years in prison. The remaining seven were acquitted. After conclusion of the trial, the judges felt a strong need for an additional way to protect human research subjects.
This is when they created the ten research principles now known as The Nuremberg Code. As the Hippocratic ethics was great for physician-patient relationships, it did not fit so well with scientific research. Everything changes because the primary goal of the physician is no longer the patient, but instead the results of his or her experiment. The Nuremberg Code solves this conflict. The first and main principle of the Nuremberg Code makes the voluntary consent of human subjects absolutely essential. Experiments should not be random or unnecessary; they should be in search of beneficial results.
It should be based on experimentation of animals and help prove positive effects are the result. Mental and physical suffering or injury should absolutely be avoided. No study shall be performed when there is a risk of death or severe injury involved. The potential risks should never exceed the potential benefits. Sufficient preparations must be made and acceptable facilities must be used in order to protect against injuries, disabilities, or death. Only qualified individuals may perform such studies and the highest possible skill and care shall be applied throughout the entire process.
Subjects will always hold the power to end the experiment at any time they feel is necessary for their own well-being. And last of all the scientist in charge must end an experiment as soon as there might be any reason to believe that there is a possibility that continuation of the study could result in injury, disability, or death to any of the participating subjects. In Tuskegee Syphilis Experiment the Nuremberg Code was disregarded and still continued to be sponsored by the U. S. government. The reason for this may be because the code and principles were not regulated and could not be enforced by laws.
In 1978 the Department of Health and Human Services (HHS) published the Belmont Report. The Belmont Report is made up of three basic ethical principles which are: respect for persons, beneficence, and justice. All persons asked to be in a study should have total autonomy and complete control of their decisions. For beneficence researcher should not only attempt to achieve maximum benefits for the subjects, but also minimize all risks. Justice states all people should be treated fairly and benefits and problems should be distributed fairly as well. These are now regulation guidelines and remain the main focus to protect humans as subjects.
To this present day the Belmont Report continues to be used as a reference for institutional review boards (IRB) which ensure that human based research follow all ethical regulations and guidelines. Anytime experiments on humans are being conducted, ethical issues will always be involved. With the creation of these two documents it helps determine whether a clinical trial is ethical or not. First of all the experiment must have some kind of social or scientific value in which it may produce results that will benefit health and well-being or even increase knowledge on a certain subject.
Only qualified scientists or physicians are allowed to perform such studies using methods and techniques that will produce reliable results. Subjects must be chosen fairly. The risks of the study must be minimized while the benefits maximized, or at the least benefits and risks should be proportionate. Informed consent means subjects will be informed on the purpose of the research, its risks, benefits, and alternatives. This helps to make informed decisions and also subject have the power to end the study at any time.
Subjects will also be provided confidentiality, information on any new discoveries and results of the studies. These documents not only provide protection and safety for test subjects, but it also protects certain individuals from being participants in any studies. There are certain populations or groups of people that cannot be selected for studies for certain reasons. Adults are preferred subjects over children. Individuals must be competent in order to give informed consent, which would eliminate using mentally ill people as subjects for a study.
Prisoners should also be excluded as test subjects as they are already in a forced position. There must be a certain criteria met in order to use any of these subjects in a research study. I find it to be a real shame that the Nuremberg Code was overlooked in many studies performed in the United States after its creation. It was not regulated and it was not against the law to not follow these codes of ethics on research. Although it took a series of unfortunate events to come up with the Belmont Report, it sure is nice to know there is protection now for human test subjects.
The creation of Institutional Review Boards (IRB) to enforce that studies are being conducted under ethical guidelines and researchers are following these rules was essential in helping to improve the search for better health in this country. This will continue to guide our effort as well as change when other issues arise. The good thing is that I do not seeing it ever changing much more as all the most important ethical issues is covered by these documents when performing any research on human subjects.