Medical Experiments Essay Example

moral standards regarding human subject research

In 1953, the Nuremberg Code was composed to enforce the standards considered during the Nuremberg trials through federal policy. It reemphasized voluntary consent of human subjects, stating it as “absolutely essential”. The Nuremberg Code also accentuated the criteria for the safety and state of the human subject. It declared “proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death”. These two essential requirements in the Nuremberg Code altered human subject research around the world for the better, but many Americans did not consider that the events in World War II or the Nuremberg Code were relevant to their own practices in that field of research. They believed the Nuremberg Code to be prudent only to the Nazis; thus, the procedure for developing nationwide regulation was temporarily delayed.

Coincidentally, the same year the Nuremberg Code was created, physicians began speculating that blacks responded differently to diseases than Caucasians. They decided to observe the progression of syphilis in Negroes when left untreated. The physicians used a group of male Negroes in Macon County, Alabama, who had acquired syphilis, but were never informed due to the ongoing research. The subjects were mostly illiterate and had a lack of education; therefore, they could not have consented to the experiment. They were also deprived of the necessary and abundant substance, penicillin, which could have easily treated their disease. This inclined the public to move toward regulation, due to the fact that it was hitting so close to home.

In 1999, Eileen Welsome published “The Plutonium Files.” Through her book, American citizens soon became aware

of experiments performed on people in the U.S. during the 1940s that were similar to the experiments performed in the Holocaus. For example, at that time, it was deemed necessary to the needs of the U.S. to have knowledge of the effects of plutonium on humans. Army Colonel Stafford Warren performed lethal medical research on hospitalized patients in World War II to learn of such effects. He was responsible for injecting plutonium into eighteen innocent patients in 1945. It is a relief to many that, at this time, doctors and nurses are trusted with the welfare of their patients and do everything in their power to sustain patients’ well-being.

The Willowbrook Hepatitis Experiment also generated deliberation when the U.S. public learned about it. Around 1964, at the Willowbrook State Hospital in New York, mentally handicapped children were injected with the hepatitis virus. Their inability to consent to such an experiment sparked society as cruel and unfeeling. This act went against the Nuremberg Code and attacked a soft spot of society’s heart: the children; thus, it created a massive need to be more aware of other human research projects.

In 1966, Henry Beecher presented violations regarding human subject research at medical institutions in both America and Britain in his article, the New England Journal of Medicine. Soon there was media coverage on the Tuskegee Syphilis Experiment, the Willowbrook State Hospital study, and others. As a result, the U.S. Public Health Service issued basic ground rules to protect human subjects. These ground rules were further developed in 1971. The guidelines identified the necessity for well-versed consent from people participating in PHS-funded research before the start of the study. Moreover,

ad hoc advisory committees were created by the U.S. Congress to conduct congressional investigations and hearings in the early 1970s to observe the problems.

In 1974, the National Research Act, which established the National Commission for the Protection of Human Subjects of Biochemical and Behavioral Research, was passed by Congress. Their job was to suggest ethical guidelines regarding human research. They accomplished this through The Belmont Report (1979), seventeen reports concerning numerous complications of human experimentation. The most famous and important proposals were published in it. It was inspired by the Declaration of Helsinki, a similar document to The Belmont Report, but with little legal status, issued in 1964. The Belmont Report was similar to the Nuremberg Code because it was a set of fundamental ethical standards regarding human subject research, but it was directed specifically toward the U.S.

The Belmont Report recognized three essential and moral principles necessary to govern medical research involving human subjects: respect for persons, beneficence, and justice. History often reveals that experiments performed without consent commonly use people viewed as “less worthy” in society. Those levels of disrespect toward the lower-class expose them as targets of degradation in society, which is made worse by their forced participation in experiments. Such persons are unable to negate the experiment, and would need informed consent procedures or maximum benefit-minimum harm analysis. Furthermore, justice stated that anyone could participate in human subject research, making it harder to pin one class as worse than the others. The recommendations outlined in The Belmont Report became distinguished as the Common Rule in 1981 and were enforced by the IRB, Institutional Review Board.

During wartime and medical movements, many physicians were

desirous to receive the results of experiments using human subjects. In earlier times, there was neither enough knowledge to understand the operation of the experiments, nor enough medicine. Most subjects were in a filthy condition where they were emotionally scarred or in tremendous pain. This changed as the Holocaust and experiments in the U.S. brought the atrocious crimes to the attention of the public. Articles such as The Belmont Report and the Declaration of Helsinki, were put in place to protect the human subjects involved. Additionally, policies and commissions were established to enforce the Common Rule and principles proposed. In 1953, the NIH stated that no matter what the intentions of the experiment seem to be, 'The welfare of the patient takes precedence over every other consideration' .