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Test 11
判断题
Medical human subject research often involves analysis of biological specimens, epidemiological, and behavioral studies and medical chart review studies.
A. 对
B. 错
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判断题
A specific, and especially heavily regulated, type of medical human subject research is the "clinical trial", in which drugs, vaccines and medical devices are evaluated (clinical trials generate data on safety and efficacy).
A. 对
B. 错
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判断题
As defined by US HHS regulations: "Private Information" refers to information about behavior that occurs in a context in which an individual can reasonably expect that observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public.
A. 对
B. 错
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判断题
Studies intended solely to refine measures are considered clinical trials. Studies that involve secondary research with biological specimens or health information are not clinical trials.
A. 对
B. 错
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判断题
Clinical research refers to the subset of human subjects research which focuses on interventions to improve human health and well-being.
A. 对
B. 错
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判断题
Formalized phase 0 studies are a relatively recent phenomenon involving the testing of interventions and methods which might be used in later phase studies. A phase 0 study might be designed to determine the mechanism of action of a particular drug and evaluate different ways to administer it.
A. 对
B. 错
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判断题
If phase 1 testing is successful, potential new treatments go on to larger phase 2 studies which are designed to further assess risks and also to evaluate whether there is any evidence that the treatment might be beneficial.
A. 对
B. 错
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判断题
Clinical research which poses net risks raises important ethical concern. Net-risk studies raise concern that subjects are being used as mere means to collect information to benefit future patients. Research procedures that pose net risks may seem to raise more concern when they are embedded within a study which offers a favorable risk-benefit profile overall.
A. 对
B. 错
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判断题
James Lind's (1716-1794) experiments on the treatment of scurvy inBritish sailors represent perhaps the first modern clinical trial because he attempted to address one of the primary challenges facing those who set out to evaluate medical treatments.
A. 对
B. 错
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判断题
Hippocratic medicine tended to be very aggressive and observational rather than experimental. Common remedies prescribed by Hippocratic physicians included special diets, herbal medicines, exercise, baths, and massage.
A. 对
B. 错
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