Assessment of the risk/benefit ratio of phase II cancer clinical trials by Institutional Review Board (IRB) members
نویسندگان
چکیده
منابع مشابه
The evaluation of the risks and benefits of phase II cancer clinical trials by institutional review board (IRB) members: a case study.
OBJECTIVES There are indications that institutional review board (IRB) members do not find it easy to assess the risks and benefits in medical experiments, although this is their principal duty. This study examined how IRB members assessed the risk/benefit ratio (RBR) of a specific phase II breast cancer clinical trial. PARTICIPANTS AND METHODS The trial was evaluated by means of a questionna...
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13 T he Declaration of Helsinki and other national and international regulations oblige Institutional Review Boards (IRBs) to weigh the risks of medical research against its benefits, and to assess the ratio between the two. In the Netherlands, the Medical Research Involving Human Subjects Act (WMO) states that a review committee may only approve a research study when " it is reasonable to expe...
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Dear Editor,I read with interest the article on outpatient management of burn wounds published in a recent issue of the IJMS.1 There are many questions that arise which are worth mentioning. Under the methodology section, no description was provided on how patients were randomized into the two treatment arms and, therefore, it is not possible to assess how confounding variables were controlled....
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ژورنال
عنوان ژورنال: Annals of Oncology
سال: 2002
ISSN: 0923-7534
DOI: 10.1093/annonc/mdf209