Nursing

Pharmacology

Public Health Service

Control And Prevention

Policies And Procedures

Термины в модуле (24)

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 problems with the IRB system royalessays.co.uk, the death of Jesse Gelsinger was what received public attention.)

Which of the following is included in the Nuremberg Code?

Voluntary Consent

Informed consent is considered an application of which Belmont principle? ****

Respect for Persons (Respect for persons involves respecting individual autonomy in the decision to participate in research. That respect is implemented through the process of informed consent)

How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?

Report the adverse drug experience in a timely manner, in keeping with the IRB"s policies and procedures, using the forms or the mechanism provided by the IRB.

How long is an investigator required to keep consent documents, IRB correspondence & research records?

For a minimum of three years after completion of the study. (May be required to keep them longer than 3 years)

According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?

The study involves no more than minimal risk & meets one of the allowable categories of expedited review specified in federal regulations.

Amendments involving changes to IRB approved protocols do not need prior IRB approval if:

The changes must be immediately implemented for the health & well being of the subject.

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 has carefully explained all of the required information about the study to the subject and the subject's daughter. 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.

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