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Important Human Subject

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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.,

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