Multiple Choice Questions

Pregnant women, prisoners, children
  • Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C and D with additional protections:
  • Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection?
  • Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?
  • According to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or:
Ensuring that risks are reasonable in relationship to anticipated benefits.
  • Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C and D with additional protections:
  • As part of the consent process, the federal regulations require researchers to:
  • Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?
  • Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection?
Public information.
  • According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:
  • A medical record is an example of:
  • As part of the consent process, the federal regulations require researchers to:
  • Census data (the final report as published by the Census Bureau) is an example of:
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.
  • According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
  • A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?
  • A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent:
  • A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct?
Harvard "Tastes, Ties, and Time (T3)" study (2006-2009)" study
  • The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies?
  • According to the authors, there are four common abuses that historically are described as giving rise to vulnerability . Which response below contains the correct four?
  • A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred?
  • How long is an investigator required to keep consent documents, IRB correspondence, and research records?
Private information.
  • Census data (the final report as published by the Census Bureau) is an example of:
  • A medical record is an example of:
  • IRB continuing review of an approved protocol must:
  • The Belmont principle of beneficence requires that:
The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.
  • Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?
  • Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection?
  • Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?
  • NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their situation. Which of the following was NOT included as possibly leading to vulnerability?
Inducements constitute an "undue influence" if they alter a potential subject's decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research.
  • Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection?
  • According to the federal regulations, which of the following studies meets the definition of research with human subjects?
  • Which is true of inducements in research?
  • Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?
A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors.
  • According to the federal regulations, which of the following studies meets the definition of research with human subjects?
  • According to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or:
  • According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:
  • According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
Physical control, coercion, undue influence, and manipulation
  • According to the federal regulations, which of the following studies meets the definition of research with human subjects?
  • According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
  • According to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or:
  • According to the authors, there are four common abuses that historically are described as giving rise to vulnerability . Which response below contains the correct four?
The changes must be immediately implemented for the health and well being of the subject.
  • How long is an investigator required to keep consent documents, IRB correspondence, and research records?
  • A waiver of the requirement for documentation of informed consent may be granted when:
  • Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if:
  • According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
High potential for individual benefit from participating in research
  • Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection?
  • NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their situation. Which of the following was NOT included as possibly leading to vulnerability?
  • As part of the consent process, the federal regulations require researchers to:
  • According to the authors, there are four common abuses that historically are described as giving rise to vulnerability . Which response below contains the correct four?
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Multiple Choice Questions
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