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Principles of ethics in biomedical research
The importance of ethics in research
The importance of ethics in research
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Recommended: Principles of ethics in biomedical research
From 1946 to 1947, the Nuremberg War Crime Trials took place, withfifteen of twenty-three German physicians and research scientist-physicians found guilty of criminal human experimentation projects. The trial court attempted to establish a set of principles of human experimentation that could serve as a code of research ethics. The result was the Nuremberg Code, which attempted to provide a natural law-based set of universal ethical principles. Looking beyond the Nuremberg Code and applying it to modern medical research ethics, there are many challenges that it poses. Many have argued that the Code tries to provide for all unforeseen events, which restricts the researcher by requiring him to anticipate every situation, demanding the impossible. The most important contribution of the Code is the first principle, which says that voluntary consent of the human subject is absolutely essential. The subject involved should have legal capacity to give consent, should have free power of choice, as well as sufficient knowledge and comprehension of the experiment. This restricts that populations upon which some experiment may be conducted, since many do not have “legal capacity”. For instance, studies of mental illness and children’s diseases have been curtailed because neither of these populations has the legal capacity to give consent. Another group of people, prisoners, are never really able to give voluntary consent since they might be enticed by financial rewards, special treatment, and the hope of early release in exchange for participating in the human experimentation projects. British biostatitcian Sir Austin Bradford Hill also questioned whether it was important to inform a research subject who was receiving a placebo since it does...
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...n such that it was a physician’s duty or role to act in the best interest of their patient and safeguard the health of the people. It was a set of professional guidelines written by physicians for physicians as opposed to the Code, which was written by jurists for use in a legal trial. The Declaration of Helsinki was also a much longer document than the Nuremberg Code and thus laid out more principles and with less room for uncertainty.
The two sets of principles are just ethical principles and nothing more. Neither of them has any legally binding authority or means of enforcement. The adequate protection of human research subjects is not guaranteed under these codes, we just have to trust that they are being treated properly. The Code should be rewritten so that there is some enforcement of the principles instead of just hoping that doctors will behave ethically.
Those who were affected by the testing in hospitals, prisons, and mental health institutions were the patients/inmates as well as their families, Henrietta Lacks, the doctors performing the research and procedures, the actual institutions in which research was being held, and the human/health sciences field as a whole. Many ethical principles can be applied to these dilemmas: Reliance on Scientific Knowledge (1.01), Boundaries of Competence (1.02), Integrity (1.04), Professional and Scientific Relationships (1.05), Exploitative Relationships (1.07, a), Responsibility (2.02), Rights and Prerogatives of Clients (2.05), Maintaining Confidentiality (2.06), Maintaining Records (2.07), Disclosures (2.08), Treatment/Intervention Efficacy (2.09), Involving Clients in Planning and Consent (4.02), Promoting an Ethical Culture (7.01), Ethical Violations by Others and Risk of Harm (7.02), Avoiding False or Deceptive Statements (8.01), Conforming with Laws and Regulations (9.01), Characteristics of Responsible Research (9.02), Informed Consent (9.03), and Using Confidential Information for Didactic or Instructive Purposes (9.04), and Debriefing (9.05). These particular dilemmas were not really handled until much later when laws were passed that regulated the way human subjects could be used for research. Patients
Furthermore, these doctors had no legal or ethical codes to conduct experimentations or research on African Americans. For example, during 1998, “172 employees, all but one of them black, sued Lawrence Berkeley Laboratory when they learned that they had secretly been tested for syphilis, pregnancy, and sickle-cell trait without their knowledge that the blood and urine they had supplied during required physical examinations would be tested…” (314). This indicates that there was no consent from these blacks and scientists where secretively testing immunities for sickle-cell on them without any permission whatsoever. The release of this experiment was against the Americans with Disabilities Act and these researchers had no right to release information without the patient’s consent. Furthermore, experiments that had no patient’s consent varied from blisters “to see how deep black skin went” to threatening surgeries, sterilization, inoculations, and not tested pharmaceuticals (54). Without consent, all experiments are considered as unethical. A patient’s consent is important because it is huge determination of privacy and respecting the patient’s wishes. Without any consent, it is indicating that patient’s do not have rights about their own privacy, which was against the law during colonial times and in present days. Some ethical guidelines include the right to withdraw from the study
During the process of research, professionals collect data or identifiable private information through intervention or interaction. While this is a vital part of the scientific and medical fields, every precaution must be taken by researchers to protect the participants' rights. Ethics, outlined by the Belmont report; requirements, described by the Department of Health and Human Services (DHHS); and regulations, laid out by the Food and Drug Administration (FDA) are verified by an Institutional Review Board (IRB). This procedure assures that all human rights are safeguarded during the entire research process.
As the human species develops, medicine follows suit. Researchers look down medicinal avenues which promise a better life-- a longer life. However, red and blue paint cannot engender purple paint without proper mixing. Thus, health sciences cannot expand without thorough experimentation. The Nazis exemplified this concept of “thorough experimentation” with their cruel and inhumane medical experiments. The trials varied in nature and reason. Some of the “experiments had legitimate scientific purposes, though the methods that were used violated the canons of medical ethics. Others were racial in nature, designed to advance Nazi racial theories. [However,] Most were simply bad science.” (jewishvirtuallibrary.org). The medical experiments performed by the Nazis were vast and highly divergent, but they can generally be divided into three categories: racial experimentation, war-injury experimentation, and pharmaceutical testing.
"Nazi Medical Experimentation: The Ethics Of Using Medical Data From Nazi Experiments." The Ethics Of Using Medical Data From Nazi Experiments. N.p., n.d. Web. 09 Dec. 2013.
What has been achieved by prosecuting Nazis alleged to have committed crimes against the Jews?
All around the world, every minute of everyday someone encounters a moral dilemma whether it is minuscule or monumental. Going against ones religious or moral beliefs can be problematic; it may in fact be so moving that it causes one to reexamine their entire thought process. Before the Holocaust, Hitler campaigned in Germany with promises that Germany will be great again, people took these promises like candy and followed his every word. Soon they were so loyal to Hitler that they never stood up for the innocent people being murdered. Many tentatively followed each order shouted at them. When told to kill, they killed; when told to scare, they scared; when told to harm, they harmed. Each order had the same response with the occasional bout of deviation.
The Nuremberg trial was built up to be the trial of the century. In the word's of Norman Birkett, who served as a British alternate judge: it was "the greatest trial in history" . The four most intriguing characters of this trial were of vast contradiction to each other; there was Herman Georing the relentless leader, Joachim von Ribbentrop the guilty and indecisive follower of Hitler, Hjalmar Schacth the arrogant financial wizard of the Rich and Albert Speer the remorseful head of armament and munitions. Three of the four allies wanted the Nazi leaders to be executed without a trial Winston Churchill said, "They should be rounded up and shot like dog's" but the Americans persuaded the other allies that a trial would be most beneficial from a public relations standpoint, so now with the allies agreed the stage for Nuremberg was set.
In the United States, the basis for ethical protection for human research subjects in clinical research trials are outlined by the Belmont Report developed in the late 1970’s. This document, published by the Nation Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, highlights three important basic principles that are to be considered when any clinical trial will involve human research subjects. They are; respect for persons, beneficence, and justice. (Chadwick & Gunn, 2004)
Judgment at Nuremberg The Nuremberg trials took place between 1945 and 1949 and were used to judge the acts of over a hundred judges accused of committing war crimes. The movie "Trials at Nuremberg" dealt specifically with the justice trials. The justice trials adjudicated the criminal responsibility of judges accused of enforcing immoral, unjust, and inhumane laws set by the Nazi party. =
There are weaknesses in professional guidelines and rules because they are unable to provide the directives for moral reasoning and action is health care situations. Many people state that biomedical ethics provides a framework and emphasis on the person rather than the professional code and legal policy (Beauchamp and Childress, 2001). On the other hand they serve a purpose to provide some direction for professionals however codes of practise do not dismiss.
The reading on, “The ‘Four Principles’ Approach to Health Care Ethics” outlines the four principles of ethics. The reading first discusses the origins of principles and healthcare ethics. In the past, there were no rules on how physicians could treat their patient. In Europe and Asia they mainly focused on preventing disease and harm, while maximizing health benefits. During the 1970s and 1980s, principles for bioethics were formed. These principles were easy to understand and use for people with all different types of professional background. Beauchamp and Childress published a book called, Principles of Biomedical Ethics, which reviews the set of basic rules for bioethics. The rules are respect for autonomy, nonmaleficence, beneficence, and justice. Respect for autonomy means to recognize that the people have rights and choices.
In December 1946, the War Crimes Tribunal at Nuremberg indicted 20 Nazi physicians and 3 administrators for their willing participation in carrying out the harmful research on unwilling human subjects. Thus, Nuremberg code was the first international code for the ethics to be followed during human subject research. It was permissible medical experiments implemented in August 1947. The code also provides few directives for clinical trials (3). Syphilis study at Tuskegee in 1974 was the most influential event that led to the HHS Policy for Protecti...
Unethical experiments have occurred long before people considered it was wrong. The protagonist of the practice of human experimentation justify their views on the basis that such experiments yield results for the good of society that are unprocurable by other methods or means of study ( Vollmann 1448 ).The reasons for the experiments were to understand, prevent, and treat disease, and often there is not a substitute for a human subject. This is true for study of illnesses such as depression, delusional states that manifest themselves partly by altering human subjectivity, and impairing cognitive functioning. Concluding, some experiments have the tendency to destroy the lives of the humans that have been experimented on.
Furthermore, human experimentation has not only expanded medical advancements, but it also enforced new laws. In an article written by Michael Carome, he discusses a seminal paper written and published by Dr. Henry Beecher about the new regulations for human experimentation. "Disclosures of unethical research such as those made by Beecher prompted the federal government four decades ago to issue regulations intended to protect human subjects involved in research and prevent unethical studies. These regulations, which were last updated in 1991, are based on three fundamental ethical principles: respect for persons, beneficence and justice" (Carome). These regulations had not been put into place until the government was aware of them. Since there