Is withholding clinical trial results "research misconduct"?
نویسنده
چکیده
منابع مشابه
Fraud and misconduct in clinical research.
The clinical research industry is one of the most heavily regulated industries that exists. One cannot function in this industry in a compliant manner without knowing the regulations and the responsibilities they are expected to maintain. Good Clinical Practice (GCP) is a set of guidelines for the design, performance, monitoring, recording, analysis, and reporting of clinical trials. Only by ma...
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IMPORTANCE Every year, the US Food and Drug Administration (FDA) inspects several hundred clinical sites performing biomedical research on human participants and occasionally finds evidence of substantial departures from good clinical practice and research misconduct. However, the FDA has no systematic method of communicating these findings to the scientific community, leaving open the possibil...
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Background: Designing a comprehensive model for verified relationships based on the actual tested data can help to better understand and explain the factors affecting research misconduct. The purpose of this study is to validate the model for factors affecting research misconduct in Iranian medical research. Method: This is a descriptive correlational study. The statistical population consiste...
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Clinical and research practices designed by developed countries are often implemented in host nations of the Third World. In recent years, a number of papers have presented a diversity of arguments to justify these practices which include the defence of research with placebos even though best proven treatments exist; the distribution of drugs unapproved in their country of origin; withholding o...
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BACKGROUND Neutralizing antibodies in breast milk may adversely influence the immune response to live oral vaccines. Withholding breastfeeding around the time of vaccine administration has been suggested for improving vaccine performance. However, we do not know whether mothers find withholding breastfeeding around the time of vaccination acceptable and how they perceive this recommendation. ...
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عنوان ژورنال:
- CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne
دوره 187 10 شماره
صفحات -
تاریخ انتشار 2015