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Belmont Report

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Belmont Report: Informed Consent and Subject Selection

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 principles of research. Informed consent is broken down into three checkpoints: information, comprehension, and voluntariness. Assessment of Risks and Benefits has two similar components: identifying the nature and scope of the risks and benefits, and then the systematic assessment. Then there is the selection of subjects which is just an evaluation of the appropriateness of a group used in a research study. I will discuss these concepts as they apply to the infamous artificial heart case study. Informed consent is the application of the general principle of respect for persons. Remember, respect for persons requires that subjects be given the opportunity to choose what will or will not happen to them (Belmont Report, 1979). The first tier in the analysis of the consent process is distribution of information. When using human subjects to conduct a study, the participants must be provided with all of the necessary information in order to make an informed and autonomous decision on whether or not they want to participate in the study. Generally speaking, information to be given to potential participants includes: the research

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