Multiple Choice Questions

Hearing/augiological screenings
  • Which of the following most accurately describes the risks associated with SBR?
  • Which of the following is included in the Nuremberg Code?
  • Which of the following was the result of the Beecher article?
  • Which of the following is not considered an SBR data collections method?
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.
  • 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?
  • 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?
  • 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?
  • 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 changes must be immediately implemented for the health & well being of the subject.
  • The use of prisoners in research is a concern under the Belmont principle of Justice because:
  • How long is an investigator required to keep consent documents, IRB correspondence & research records?
  • Amendments involving changes to IRB approved protocols do not need prior IRB approval if:
  • Under which of the following conditions is it appropriate to recontact the individuals who provided biological specimens?
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?
  • 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?
  • 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?
  • 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:
To provide a potential subject with appropriate information in an appropriate manner & allow that person to make an informed decision about participation in research.
  • The use of prisoners in research is a concern under the Belmont principle of Justice because:
  • The purpose of informed consent is:
  • According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
  • How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?
Less predictable, more variable & less treatable than physical harms
  • Which of the following is not considered an SBR data collections method?
  • Which of the following was the result of the Beecher article?
  • Which of the following is included in the Nuremberg Code?
  • Which of the following most accurately describes the risks associated with SBR?
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 brought increased public attention to the problems with the IRB system?
  • 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?
  • 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?
  • 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?
Realization that ethical abuses are not limited to the Nazi regime
  • Which of the following is included in the Nuremberg Code?
  • Which of the following is not considered an SBR data collections method?
  • Which of the following was the result of the Beecher article?
  • Which of the following most accurately describes the risks associated with SBR?
Confidentiality of the individual subject's responses
  • 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?
  • 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?
  • 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?
  • 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:
Effects of findings on other family members
  • 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?
  • 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?
  • 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?
  • Which of the following brought increased public attention to the problems with the IRB system?
Breach of confidentiality from the focus group partcipants
  • 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?
  • 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?
  • 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?
  • 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?
The study is human subject research which is eligible for expedited review
  • 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?
  • According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
  • Amendments involving changes to IRB approved protocols do not need prior IRB approval if:
  • 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?
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)
  • Which of the following most accurately describes the risks associated with SBR?
  • According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
  • How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?
  • Informed consent is considered an application of which Belmont principle? ****
I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
  • Which of the following brought increased public attention to the problems with the IRB system?
  • 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?
  • 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?
  • 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?
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".)
  • Informed consent is considered an application of which Belmont principle? ****
  • The purpose of informed consent is:
  • Issued in 1974, 45 CFR 46 raised to regulatory status:
  • IRB continuing review of an approved protocol must:
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.
  • 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?
  • 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?
  • Which of the following brought increased public attention to the problems with the IRB system?
  • 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?
The study involves no more than minimal risk & meets one of the allowable categories of expedited review specified in federal regulations.
  • How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?
  • 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?
  • How long is an investigator required to keep consent documents, IRB correspondence & research records?
  • According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
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Multiple Choice Questions
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