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 …show more content…
The subject demonstrates his understanding and willingness to participate, but is not able to sign or mark the informed consent document due to a recent accident where he burned both hands. The subject's wife is his legally authorized representative, but she is out of town on a business trip. Which of the following is the most appropriate action to take for the investigator?
Send a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator and her husband, she can sign the informed consent and fax it back.
An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual's legal representative and no alternative method or recognized therapy is available. Under the FDA regulations for using test articles, which of the following describes the best course of action for the investigator:
The investigator and an independent physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later.
The purpose of informed consent is:
To provide a potential subject with appropriate information in an appropriate manner & allow that person to make an informed decision about participation in research.