Vulnerable Subjects in Research: Why Do They Need Special Protection?
PublisherMonroe Community College
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AbstractEthical research on humans should be guided by the principles of justice, respect, and beneficence. Special protections should be provided to vulnerable participates. This paper reviews the different categories of vulnerable subjects including prisoners, students, employees, the terminally ill, impoverished individuals, minorities and those lacking clear decision making such as the cognitively impaired, children, and fetuses. Examples are provided of unethical research practices performed on vulnerable subjects through history including the Nazi experiments on prisoners, Tuskegee experiment on African-Americans, Willowbrook research on the mentally ill, and the recent Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) on premature babies. Regulatory agencies and guidelines have been established as a consequence of unethical research practices, and are summarized. The special regulatory protections that have been put in place for vulnerable subjects are described along with common sense advice to vulnerable individuals or legal representatives of vulnerable individuals who are considering participating in a research study.
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