Safeguarding Humans as Research Subjects
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Research studies that use human beings as subjects must adhere to a series of federal regulations that safeguard the people involved. When deciding whether a given study should go forward, decision-makers must weigh the potential benefits of the study against any harm the study may cause to its subjects. This is particularly difficult in studies that feature so called ôvulnerable populations,ö which are composed of people whose consent to study cannot easily be ascertained due to their impaired ability to make decisions. This paper will analyze the legal and ethical principles that underpin human research on the most vulnerable populations. The main regulations that govern human research are found at 45 Code of Federal Regulations Part 46 and were established in 1981 by the Public Health Service. Subpart A of this regulation, known as ôthe Common Rule,ö governs all federally supported human research. Institutions receiving federal funds for research projects using human beings as subjects must inform the federal government, in a document called an Assurance, how the human subjects in the study will be protected from harm. Additionally, these studies must be presented before an Institutional Review Board (IRB) that is charged with reviewing all potential studies and deciding whether they can go forward or not. The federal government, however, also strongly encourages all research institutions to abide by Subpart A for all their research projects, regardless of the so
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Some common words found in the essay are:
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Approximate Word count = 920
Approximate Pages = 4 (250 words per page)
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