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Titlebook: Human Subjects Research; A Handbook for Insti Robert A. Greenwald,Mary Kay Ryan,James E. Mulvihi Book 1982 Plenum Press, New York 1982 effi

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书目名称Human Subjects Research
副标题A Handbook for Insti
编辑Robert A. Greenwald,Mary Kay Ryan,James E. Mulvihi
视频video
图书封面Titlebook: Human Subjects Research; A Handbook for Insti Robert A. Greenwald,Mary Kay Ryan,James E. Mulvihi Book 1982 Plenum Press, New York 1982 effi
描述For an increasing number of hospitals and universities the institutional review board (lRB) has become a way of life. Spurred into existence by public outcries about the unethical nature of certain modern scientific experiments, the IRB represents the most visible evidence of institutional commitment to ethical review of clinical research. However, this exponential growth of IRB activities has not occurred without growing pains. Like the Environmental Protection Agency, IRBs have had to develop procedures and standards without a clear consensus as to what would be optimal for science and society. Each IRB has perforce devised its own modus operandi, subject to general principles and guidelines laid down by others but still relatively free to stipulate the details of its functioning. Thus one can applaud the general idea as well as the overall performance of IRBs without asserting that the millenium has arrived. The composition, philosophy, efficiency, responsibilities, and powers of IRBs remain topics suit­ able for debate. It is still possible (and appropriate) for IRB members to worry both about the propriety of their decisions and the personal costs of their service.
出版日期Book 1982
关键词efficiency; environmental protection; evolution; experiment; growth; interview; nature; research; science; se
版次1
doihttps://doi.org/10.1007/978-1-4684-4157-4
isbn_softcover978-1-4684-4159-8
isbn_ebook978-1-4684-4157-4
copyrightPlenum Press, New York 1982
The information of publication is updating

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Research Involving Medical Devicesmedical device regulation. While there is a history of product failures and recall of devices having potentially serious consequences (Beck, 1979b), the impetus behind government regulation of medical devices seems to have been the increasing complexity of medical technology, the number of new thera
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Continuing Review of Researchis amendments of 1962, requested, and most research publications in turn required, investigators’ assurances that informed consent had been obtained. In the 1971 Institutional Guide to HEW policy, IRBs were charged with establishing a basis for continuing review in keeping with initial review determ
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Studies Involving Childrenaining a truly informed consent and the method for assessment of risk/benefit ratio. Since standard procedures for IRB review of research have already been covered in a prior chapter, this chapter will deal solely with those added dimensions regarding the use of minors. Children are defined as perso
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