Ethical Principles of Clinical Studies

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 human subjects (2). The Commission accomplished this through the publication of the Belmont Report, which summarizes the Commission’s findings resultant from its four day deliberation (2). Through inspection of the Belmont Report, the ethical principles of respect of persons, beneficence and justice are revealed to have great application in biomedical research using human patients.

The respect for those persons participating in the study is upheld through the application of deontological principles on autonomy. First, “individuals should be treated as autonomous agents” (The Belmont Report, 4). An autonomous individual is someone who can make a decision through their own reasoning. People have different degrees of autonomy due to various reasons, such as age or a disability. This leads to the second principle that “persons with diminished autonomy are entitled to protection” (4). Those who are too young to fully understand a decision, as well as those who have been incapacitated in some way, require some extent of protection. Failing to pr...

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...t, physicians must make every effort to have respect for people, beneficence, and justice. Respect for people consists of allowing individuals to make their own decisions unless they are incapable, which is accomplished using informed consent. Respecting beneficence consists of looking out for the well-being of another individual; in the medical industry, this is best accomplished by assessing risks and benefits, and attempting to obtain the most favorable ratio between the two. Respect for justice ensures that benefits and burdens of a study are equally distributed so that no one individual must bear all the burdens or receive all the benefits. The Belmont Report provides “basic ethical principles and guidelines” that physicians performing medical research studies can follow to provide the most ethical treatment possible to their patients (The Belmont Report 2).