Rm Citi Modules Essay

1283 Words Feb 26th, 2015 6 Pages
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Which of the following was the result of the Beecher article?

Realization that ethical abuses are not limited to the Nazi regime
The use of prisoners in research is a concern under the Belmont principle of Justice because:

Prisoners may be used to conduct research that only benefits the larger society
Issued in 1974, 45 CFR 46 raised to regulatory status:

US Public Health Service Policy (45 CFR 46 raised to regulatory status the US Public Health Service policy of 1966 "Clinical research and investigation involving human beings".)
Which of the following brought increased public attention to the problems with the IRB system?

Death of Jesse Gelsinger (Although all of these are related to the
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IRB continuing review of an approved protocol must:

Occur at least annually.
A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is on going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?

Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.
A general requirement for the informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?

I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
A man in his early 50s, who was recently diagnosed with lung cancer, is screened for a clinical trial using a new investigational drug. The investigator…