Environmental Health Research On Humans - Ethical Issues

In the famous Belmont Report, several guidelines regarding informed consent, assessment of risk and benefits, and selection of subjects in addition to ethical practice and procedure in the area of human research are outlined. The Belmont Report attempts to summarize the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Belmont Report, 1979). In particular I would like to discuss the standards for informed consent, assessment of risk and benefits, and selection of test subjects drawn out by the Belmont Report. These three areas of interest are said to be the applications of the general

The art of medicine and curing diseases was not always approached in a scientific way. In fact, many advances occurred between 1919 to 1939, after technological advances allowed scientists to apply the scientific method to medical research. At this time, the ethics of using patients as test subjects either for new medicines or as samples for further testing were not considered. An extreme example of this was the Nazi’s using concentration camp inmates – including children – to run painful and invasive experiments. More modern examples are not so easy to identify as unethical, however. While amputating a leg to develop methods to deal with fractures and war wounds is obviously unethical, harvesting cells to develop a vaccine is not so clear cut, as the disadvantage to the patient is hard to identify. Coming from the various Nazi testing and especially the Nuremberg testing and trials, another code of ethics was developed, called the Nuremberg Code.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

Observational study design examined on the basis of exposure and health outcome. The exposure of interest is the factor that either causes, Prevents, or treats the outcome. It is important to consider whether the exposure was accurately defined and measured because exposure misclassification stems from broad definitions and inaccurate measurements. (Aschengrau & Seage, 2008). According to Munnoch et al. (2008), study conducted to investigate the S.Saintapaul infection

More than 90 percent of new drugs fail to make it into the public's hands. That 90 percent is also proven too toxic to even get past actual patient testing. Distinguished medical professionals find out if new medicines are toxic through various testings of which include human testing. Most of these test subjects include medical students as well as prisoners. Medical experiments have been conducted in prisoners for years. Not all of these tests however were properly practiced. Attached to these experiments are either great rewards for the medical community or unlawful controversy. The World Medical Association in 1961 failed to propose that prisoners should not be used as the subject of experiments. This was mostly because the experiments performed were unlawful and

Based from this experiments, The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research was submitted in April 18,1979 to …….? (“Impact,” n.d.).

There are laws to allow only safe research but dangerous research still occurs anyways. For example in Pennsylvania Prisoners Were Human Guinea Pigs in Army Mind-Drug Test it says, “320 prisoners were injected with varying doses of 16 drugs in secret chemical warfare experiments” (Epstien 1). Different substances that are used in chemical warfare were tested on prisoners which is clearly a dangerous test to perform where casualties would be expected. This was secret research performed by the military and was comparable to the research that was performed on Jews in the concentration camps such as Auschwitz. Another example of dangerous research is, “he used radioactive materials, hallucinogenic drugs, and carcinogenic materials on prisoners” (Urbina

The Nuremburg Code of ethics, was established after human research atrocities in World War II created a standard of ethics. This ethical standard provided the general public with confidence and trust in that human participants involved in research will be respected and receive moral treatment. Unfortunately, the Tuskegee study undermined established ethical boundaries and it violated many aspects of informed consent, autonomy, nonmaleficence as well as many other ethical principles (Riggs,

Human experimentation has a history of scandal that often shapes people’s views of the ethics of research. Often the earliest cited case is English physician Edward Jenner’s development of the smallpox vaccine in 1796,where he injected an eight-year-old boy child with pus taken from a cowpox infection and then deliberately exposed her to an infected carrier of smallpox. Although Jenner’s experiment was successful and it confirmed his theory, the method of

World governments have frequently relied on unknowing participants and or prisoners of war for experimentation. While these experiments range vastly concerning procedures, outcomes, and justification, they all existed to outsmart international enemies efficiently. The government bioethics conspiracy I researched is Project MKUltra. This was a secretive CIA program that experimented with mind control, hallucinogenic drugs, and the behavioral engineering of humans from 1953 to 1973. Because the program existed for a couple decades, it encompassed a wide-range of experiments, types of patients, and immense secrecy. More often than not, test subjects were not aware of tests to be conducted and thought they were participating in standard medical tests at first. Despite the program coming to a halt, many believe human experimentation is still ongoing and don’t see a future without secret government research.

Science, medicine, and psychology are powerful tools capable of increasing human understanding of the world, curing diseases, or assisting individuals in living more fulfilling lives. The potential for good is drastic; however, a potential for hurt exists as well. Although history is full of stories documenting the positives of research, events of scientific research hurting individuals still haunt history. These events, including the Holocaust and the Tuskegee experiments, demonstrate instances where scientific research on human beings is clearly unethical and damaging. Due to horrific events such as these, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research published the Ethical Principles and Guidelines for the Protection of Human Subjects of Research, or Belmont Report, in 1979.

This research will contain a few limitations. The first will be that it will be impossible to survey the entire United States so just a selected area of places in the most 5 polluted areas in the U.S. will be surveyed. Second, there is a possibility that accurate answers will not be obtained because the participants will not be completely honest in answering the questions. To decrease this issue, we will inform each participant that the survey is confidential and no information will be released to anyone outside of the study. (Perfect!).

The study continued for 40 years. Often called the “longest non-therapeutic experiment on human beings in medical history, “the study was exposed to the world on 25 July 1972. This controversial and unethical study ended officially in November 1972. The records generated from the 40-year study underscore the informational and evidentiary value in holding the U.S. government accountable. Today the original records are in the custody of the National Archives Southeast Region Center in Atlanta, Georgia.

The Nuremberg Doctors Trial of 1946 is the preeminent case recognizing the importance of medical ethics and human rights specifically about human research subjects. The defendants in the trials include Nazi leadership, physicians, and investigators prosecuted for conducting unethical and inhumane medical experiments on civilians and prisoners of war resulting in extreme pain, suffering, permanent injury and often death. The Nuremberg Code, borne of these trials, establishes ethical guidelines for human experimentation to ensure the rights of subjects in medical research. Herein, this writer will first identify and discuss ethical dilemmas presented in the Nuremberg case followed by three

Observational epidemiology is a study of disease where “the investigator ascertains exposure and outcome without assignment to an intervention” Observational studies have made important contributions to the knowledge and understanding of health-related conditions. These studies usually involve a large group of individuals as in a community. The purpose of this type of study is to determine the