CITI Quiz

Which of the following are the three principles discussed in the Belmont Report?

Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects?

All of the following are true regarding the Belmont Report, EXCEPT:

The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies?

Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?

Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:

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 Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:

The Belmont Principle of beneficence requires that

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?

How long is an investigator required to keep consent documents, IRB correspondence, and 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?

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

IRB continuing review of an approved protocol must:

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?

A general requirement for 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?

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 waiver of the requirement for documentation of informed consent may be granted when:

As part of the consent process, the federal regulations require researchers to:

Data are made anonymous by

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?

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)?

In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information?

When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?

In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for:

A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of

Which is an example of a situation where deferential vulnerability might be a factor?

Which is true of inducements in research?

Subjects with a serious illness may be at risk for exploitation since they may be desperate for a possible cure. This is an example of

The most important ethical concerns related to conflicts of interest in research are:

Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:

The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:

A financial conflict of interest could involve:

A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of:

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?

Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C and D with additional protections:

Significant financial interest, as defined by the 2011 final rule that amended Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94), include(s) (Check all that apply):