| 翻訳と辞書 |
| Human subject research legislation in the United States ： ウィキペディア英語版 |
Human subject research legislation in the United States
Human subject research legislation in the United States can be traced to the early 20th century. Human subject research in the United States was mostly unregulated until the 20th century, as it was throughout the world, until the establishment of various governmental and professional regulations and codes of ethics. Notable - and in some cases, notorious - human subject experiments performed in the USA include the Tuskegee syphilis experiment, human radiation experiments, the Milgram obedience experiment and Stanford prison experiments and Project MKULTRA. With growing public awareness of such experimentation, and the evolution of professional ethical standards, such research became regulated by various legislation, most notably, those that introduced and then empowered the Institutional Review Boards.〔(【引用サイトリンク】title=History of Research Ethics )〕
==Early research and legislation==
Aside from the Pure Food and Drug Act of 1906 and the Harrison Act of 1914 banning the sale of some narcotic drugs, there was no federal regulatory control ensuring the safety of new drugs. Thus the early calls for regulation of human experimentation concerned medicine, and in particular, testing of new pharmaceutical drugs and their release on the market.〔Paul Murray McNeill, ''The ethics and politics of human experimentation'', CUP Archive, 1993, ISBN 0-521-41627-2, 〕
In 1937, a drug known as ''Elixir Sulfanilamide'' was released without any clinical trials.〔 Reports in the press about potentially lethal side effects led to a public outcry. Investigation by the American Medical Association showed that a poisonous compound, diethylene glycol, was present in the drug.〔 The AMA concluded that the drug caused more than a hundred deaths - yet the contemporary law did not require the company that released it to test it (the existing laws required only that a drug be clearly labeled, no false claims be made about it, and that it was not adulterated).〔 A new legislation was proposed by the Secretary of Agriculture to address the issue but was weakened after opposition from business interests. It was finally included in the Federal Food, Drug, and Cosmetic Act of 1938.〔
In the aftermath of World War II, and what became recognized as deeply unethical human experimentation carried out by the Nazis, the Nuremberg Code - ethical principles governing international human experimentation - were founded.〔James J. F. Forest, Kevin Kinser, ''Higher education in the United States: an encyclopedia, Volume 1education '', ABC-CLIO, 2002, ISBN 1-57607-248-7, 〕 The code highlighted 3 key elements (voluntary informed consent, favorable risk/benefit analysis, and right to withdraw without repercussions) which later became the foundation for further human research regulations.〔Rice, Todd. "The historical, ethical, and legal background of human-subjects research". Respiratory Care. 53.10 (Oct. 2008): p1325.〕 However, neither the Nuremberg Code nor the Federal Food, Drug and Cosmetic Act of 1938 prevented the "thalidomide tragedy" of the early 1960s.〔Paul Murray McNeill, ''The ethics and politics of human experimentation'', CUP Archive, 1993, ISBN 0-521-41627-2, 〕 Thalidomide was introduced in 1958, and there were reports of it being unsafe for certain groups, such as pregnant women and young children; however, although the Food and Drug Administration did not approve it for market, the existing regulations allowed relatively unrestricted testing of the drug.〔 This led to the abuse of approved drug testing as the means to further a promotional marketing strategy.〔 This was addressed by the Drug Amendments legislation of 1962, which introduced a requirement for a series of animal tests before proceeding with human experimentation, and a total of three phases of human clinical trials before a drug can be approved for the market.〔〔Vera Hassner Sharav, ''(Human Experiments: A Chronology of Human Research )''〕 The inadequacy of the 1938 and 1962 acts was exposed by revelations in the 1960s and 1970s.〔〔
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
■ウィキペディアで「Human subject research legislation in the United States」の詳細全文を読む
スポンサード リンク
| 翻訳と辞書 : 翻訳のためのインターネットリソース |
Copyright(C) kotoba.ne.jp 1997-2016. All Rights Reserved.
|
|