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The current regulations in clinical research originated from a combination of history and ethical thoughts. The term ‘ethics’ is from ‘ethos’, which is a Greek word for character or custom. …
Ethics is contrasted with the term morality that frequently relates to how the way a person was raised and the values learned from the culture, parents or religion. Ethics refers to the systematic study of the basis of right or wrong decision. The regulations for protection of human subject in United States provide a minimum baseline through which every person must comply when operating the institutional review board, IRB, when obtaining consent from the research subjects, and when conducting the research. The ethical thought has shaped the regulations, though ethics require more conditions than what regulations require (Steinberg, 2007). Throughout the history of ethics, various theories have been formulated on what ethics ought to be. When these theories are critically examined, the procedure, rules and outlooks of ethics are justified. The major challenge in a practical environment, particularly in medical research, is the translation of the theoretical concepts of ethics into action. Regulations will thus come into place and help in accomplishing such tasks (Chamberlain, 2008). Development of the research ethics has evolved over time. Many tragedies have been reported through the research history involving the human subjects. Many people suffered as they participated in the research. ...
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