Historical Importance: Human Subject in Research During World War II inside the wall of the concentration camps, torture, mutilation, and death occurred, in the name of science, however these events yielded no scientific medical benefit. Adding to the insult the prisoners of war did not have nor were given the ability to consent to the heinous acts. The discovery of these acts, led to The Nuremburg Code which set forth 10 directives that guide moral, ethical, and legal aspects of human research. The 10 directives include the essential elements of: voluntary consent, experiments must yield knowledge or benefits that are not random in nature or cause undue risk, harm, disability, or death. Once these elements have been ascertained research must …show more content…
The potential fallout of leaked information poses compromise for the data, test subject and quite possibly affect outcomes. The 2003 regulation, Health Insurance Portability and Accountability Act, implemented measures to protect health information transmitted electronically through devices such as servers, laptops, computers and other storage devices. The Federal Regulation Title 45 Part 46, known as the common Rule further identifies human subject to include data obtained about subjects and identifiable private information, in doing so the information must be protected as well. (The Belmont Report, 1978). The atrocities involved in unethical human research led to the National Commission to establish the Protection of Human Subjects of Biomedical and Behavioral Research resulting in development of ethical codes of conduct and principles to guide research. The foundation of research rest on the principles of: Respect of Person, Beneficence, and Justice. Certainly as unethical practice overlaps in its occurrence, so does application of the Belmont Principles, research relies on complete data, as a result the consideration for protection of human subjects must include all aspects of human …show more content…
However, mechanism must be in place to prevent risk and undue influence or coercion for participation, with the subject being a potential recipient of the beneficial study outcomes. In regards for studies involving children, researchers must have permission from one of both parents or legal guardian and allowed in studies that have had preliminary studies in animals, adults or older children, however when the benefits outweigh the minimal risk children may be part of research. In 1998 the National Institute of Health, recognized that women with child bearing potential, must be represented in studies. The stipulation for safeguards such as prior studies for reproductive toxicity risk, animal studies, monitoring during the study, education for birth control and follow through care in the event of pregnancy. If no benefits are to be gained pregnant women must be excluded (Schwenzer, K.,
In this case study, there were a few incidents of violations of ethics. In 1998, Callahan recommends that researchers should follow the three ethical issues: Autonomy, beneficence, and human justice. Autonomy is the first ethical principle that a researcher should respect the participate and make sure that informed consent has been given. The participates of this study was not aware the risk or what the study was about and actually could not give consent legally because they were minors. Johnson and Tudor did not give full disclosure of this research to the minors, teachers, or matrons at the orphanage. Beneficence is the second ethical principle; the researcher should maximize
It is essential that health care researchers and/or managers abide by the Health Insurance Portability and Accountability Act of 1996 (HIPPA) before sharing any patient health information to the public. The Privacy Rule under HIPPA will permit the sharing of health information without patient permission for payment, treating, and health care operations, and other specified purposes (Koontz, 2015). In addition, the Security Rule under HIPPA is designed to ensure that patient health information is protected from the unauthorized disclosure and access (Koontz, 2015). After all, the increase in health information technology makes it easier for researchers to obtain patient health data (Largent, Joffe, & Miller, 2011). However, the health care researcher
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.).
Additionally human medical research studies often targeted those who came to public teaching institutions desperately seeking free medical treatment and who generally looked up to doctors and experimenters as experts in the field who were there to help them. While this motivation may seem logical, it is often faulty as many human medical research studies throughout history demonstrate that the motivation of medical researches is often not the care of those currently suffering from a particular condition but the future returns on the cures or medical treatments that may be discovered during the study (McKie). As with many such unethical studies, the participants often do not give consent and are not informed of known dangers to the procedure, medications or lack of treatment. The use of individuals who are poor, uneducated, and lack medical insurance in combination with prestigious university research institutions and the white coated, well-educated researchers motivated by discoveries of cures on the scientific frontier results in abuses of individuals.
The first ethical principle stated by the Belmont Report is respect for persons. “Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection” (The Belmont Report). The researcher must respect the subjects decisions and be obliged to allow them to take part of the experiment voluntarily. The second
The Belmont Report summarizes ethical principles and guidelines for research involving human subjects. Three core principles are identified: respect for persons, beneficence, and justice. Three primary areas of application are also stated. They are informed consent, assessment of risks and benefits, and selection of subjects. According to Vollmer and Howard, the Belmont Report allows for a positive solution, which at times may be difficult to find,
One ethical principle is that of respect for persons who are involved in the research. According to the Belmont Report (1979) this principle should honor a person and their autonomous choices, however, the report observes that not all individuals are “capable of self-determination” (sec. Part B 1. Respect for Persons). This incapability requires that those persons be protected (Belmont Report, 1979). Wertheimer (2011) corroborates this in stating that group soft-paternalism is implicit that research should not capitalize on or abuse vulnerable populations, or those population groups who are not able to make rational self-determination. The presence of group soft-paternalism by Wertheimer (2011) in exploiting vulnerable groups also supports the Belmont Report (1979) ethical principle of justice. This principle ensures that persons selected for research are not merely being selected based on their vulnerability (Belmont Report, 1979, sec. Part B 3.
The Belmont Report identified three principles essential to the ethical conduct of research with humans:
The proof is that there was a trial for German physicians who conducted these human experiments on concentration camp prisoners which were prosecuted as war criminals. Until now, the society still continue to discuss if it is acceptable in the medical community to consider the medical research data that were collected during these experimentations. Even some of these experiments had legitimate scientific purposes, the methods used violated the canons of medical ethics. Others were racial in nature, designed to advance Nazi racial theories. Most were simply bad science. Additionally, some believe there are major ethical problems with using the data collected in this unethical manner. Once a decision to use the data has been made, experts suggest that it must not be included as ordinary scientific research, just to be cited and placed in a medical journal. I agree with author Robert J. Lifton who suggested that citation of the data must contain a thorough expose' of exactly what tortures and atrocities were committed for that experiment. Citations of the Nazi data must be accompanied with the author's condemnation of the data as a lesson in horror and as a moral aberration in medical science. The author who chooses to use the Nazi data must be prepared to expose the Nazi doctors' immoral experiments as medical evil. I suggest that if I was a judge that time, I had most definitely torture the Germans in the same way as they tortured Jewish people. According to the philosophy written by Richard Matthews inside the book entitled "The Absolute Violation: Why Torture Must be Prohibited," he said “ It's a comprehensive refutation of the arguments in favor of torture, including act and rule utilitarianism, as well as "dirty
As a new employee, Larry has inherited quite an IT mess. There are many concerning aspects to the problems Larry must address, but first and foremost, is the Patient information leaks must be of top priority. There are any number of ways patient information can be leaked and this organization appears to be suffering from some of them. Let’s look at a few areas.
In 1979, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research published the Belmont Report. Centered around the concepts of justice, beneficence, and respect for persons, “this report would set forth the basic ethical principles for research involving human subjects” [4]. In 1981, the HHS and FDA revised existing federal regulations governing human subjects research to make those regulations compatible with the contents of the Belmont Report. This implementation of the Belmont Report led to the publication of The Federal Policy for the Protection of Human Subjects by HHS as part 46 of Title 45 of the Code of Federal Regulations (CFR)[5]. In 1991, this policy was adopted by eighteen federal agencies
The Nuremberg code is a set of ethical guidelines for human experimentation. The code was created due to the Nuremberg trials that took place in 1946. An American military hearing opened accusing physicians of committing war crimes on humans. The trails revealed that German physicians led medical experiments on many concentration camp prisoners. This was an issue because the experiments were done without any consent form from the participants. Due to the severity and cruelty of the experiments most of the participants died or were permanently crippled as a result.
Security breaches of EMRs vary from someone without consent viewing the patient’s information, to a hacker using the information to steal one’s identity. According to Privacy Rights Clearing House, more than 260 million data breaches have occurred in the United States, including those of health related records. Approximately 12 percent of data breaches involve medical organizations (Gellman, 2012). According to Redspin, a provider of Health Insurance Portability and Accountability Act risk analysis and IT security assessment services, more than 6 million individual’s health records were compromised during a period from August 2009 and December 2010 (Author Unknown, 2010). A provision of the Health Information Technology for Economic and Clinical Health (HITECH) Act requires all breaches affecting 500 or more people to be reported to the Department of Health and Human Services. This reporting is to be accomplished within 60 days of discovery. The Redspin report covering the period above involved 225 breaches of protected health information. The amount of people with access to an individual’s health record creates concern with confidentiality. According to the Los Angeles
They used these participants for study. This study lasted 40 years. In 1979, the Ethical Principles and Guidelines for the Protection of Human Subjects of Research were published (The Belmont Report). The Belmont Report proposed the following three basic principles for the evaluation of research involving human subjects:
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.