RM- Citi Modules

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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 <b>Belmont principle of Justice</b> 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, 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 &amp; 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.

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.

A researcher is conducting a written survey about people’s attitudes toward walking as an exercise option at the local shopping mall that supports a walking program. The survey is anonymous (without codes, names or other information) and volunteers may complete the survey and place it in a box at the shopping mall exits. Which of the following is the most important issue that the researcher addressed in planning the research?

Confidentiality of the individual subject’s responses

A researcher wants to invite therapists to participate in small focus groups to discuss their perceptions regarding "troubled" adolescent girls and the relationships they have with their parents. Specific clients of the therapists will not be discussed. Which of the following will be the most important issue for the researcher to consider when planning the research?

Breach of confidentiality from the focus group partcipants

Which of the following most accurately describes the risks associated with SBR?

Less predictable, more variable & less treatable than physical harms

Which of the following is not considered an SBR data collections method?

Hearing/augiological screenings

A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects. Which of the following considerations was relevant to the IRB’s determination that this activity does not constitute research with human subjects?

The researcher will not be interacting/intervening with subjects and the data has no identifiers.

As part of a research study, a physician plans to review medical records of the next 50 of her patients who require magnetic resonance imaging (MRI) scans for clinical treatment. The physician will review the medical records, and write down the clinical indication for the scans, any existing injuries, current prescriptions, as well as other clinical data. The clinical indication for the scans and the other clinical data will be collected in the medical records for treatment purposes as part of standard clinical care. The physician will use a coding system to be able to identify the patient’s information; however, the "key" to the coding system will be stored separately from the data in a locked cabinet that only she will have access to. Which of the following is true?

The study is human subject research which is eligible for expedited review

Under which of the following conditions is it appropriate to recontact the individuals who provided biological specimens?

Original signed consent documents inclue provisions for recontacting subjects

When conducting research that involves collecting biological specimens for genetic testing, which of the following issues is the most important for the IRB to consider?

Effects of findings on other family members

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