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Ethical Principles Of Clinical Studies Essay

1152 words - 5 pages

The introduction of any innovation or invention in medical technology requires sufficient testing to determine its safety and effectiveness. The fact that the clinical studies are performed on people generates significant ethical debate regarding respect towards those patients. It is interesting to discover that this ethical debate gained significant attention after WWII, during the Nuremberg War Crime Trials, where judgments for those who conducted biomedical experiments on prisoners were determined (The Belmont Report, 3). The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created to define ethical guidelines for research involving ...view middle of the document...

This emphasizes the need for informed consent, as individuals must be able to decide what happens to them. Informed consent consists of three different components: information, comprehension, and voluntariness (7). The first, information, provides the subject with a sufficient understanding of what the study will entail so that the subject can make a decision as to whether or not to participate. The second, comprehension, ensures that the subject has understood the information provided to them about the study. The third, voluntariness, states that valid consent can only be given if it was done so voluntarily, without coercion. Respecting a person’s autonomy by allowing them to make decisions for themselves is essential for ethical practice; however, this does not mean that physicians should not be concerned with the well-being of others.
Looking out for others well-being has fairly broad application, but with regards to the medical field, specifically research studies, respecting beneficence is accomplished by following specific deontological and utilitarian principles. The first rule, which is a variation of a deontological universal law, is “do not harm” (The Belmont Report, 5). This rule indicates that physicians should in no case harm “one person regardless of the benefits that might come to others” (5). The second rule, which is the dominant principle of utilitarianism, is to “maximize possible benefits and minimize possible harms” (5). This rule is fairly simple, in that one is asked to do the most good for the most people. However, this is often difficult to implement, especially in medicine, because it is challenging to successfully predict every possible benefit, and typically even harder to predict every possible harm. These two rules emphasize a need for physicians to assess the risks and benefits of a research study, and actively try to improve the ratio between the two. This consists of assessing the probability that some harm or benefit will occur, as well as the magnitude of the harm or benefit. The nature of this is in line with respecting beneficence as physicians are expected to protect the well-being of the stakeholders of their research study. In order to have respect for beneficence, physicians must maximize benefits and minimize risks, but to have ethical treatment, physicians must also consider how the benefits and risks are distributed among people.
Ensuring that the benefits and the burdens of a research study are fairly distributed represents a fundamental principle of applied ethics, that being justice. “The principle of justice is that equals ought to be treated equally” (The Belmont...

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