Aligning Regulations and Ethics in Human Research
نویسندگان
چکیده
منابع مشابه
[Ethics and medical research: principles, guidelines, and regulations].
The issue of ethics in medical research grew in importance at the end of World War II, after the Nuremberg Code. In this period, some cases in the United States had demonstrated the need for the establishment of rules and procedures in medical research. In this article, the authors discuss some ethical concepts and their philosophical basis, stressing aspects related to research. Ethics in medi...
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In response to criticism of ethical review of a South African clinical trial, we contrast aspects of the United States Common Rule with South African research ethics requirements. In the USA the Common Rule does not apply to all health research and allows many exemptions from ethics review and waivers of informed consent. At a structural level research ethics review in South Africa is in many c...
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The Medical Devices Amendment was published in 1976, when the Food & Drug Administration regulations were amended to include devices, basically to protect the public. I’m also going to talk about CLIA 1988 (Clinical Laboratory Improvement Act), which was passed by Congress in 1988 and regulates laboratory operation. It really has not yet been implemented, although it took effect on January 1st ...
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There are an increasing number of medical research studies involving children, including many long-term birth cohort studies. Involving children raises many issues, and little is known about children’s own views. This study explored children’s views (N = 5,851) on participation in a long-term screening study for type 1 diabetes. The results show that children 10 to 13 years of age have in gener...
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ژورنال
عنوان ژورنال: Science
سال: 2012
ISSN: 0036-8075,1095-9203
DOI: 10.1126/science.1218323