CITI TRAINING CERTIFICATION
EVALUATION EXAMS SET WITH
COMPLETE ANSWERS AND EXPERT
REVIEW
◉ 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?
Answer: Securing a Certificate of Confidentiality
◉ 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)?
Answer: A faculty member makes identifiable data about sexual
behavior available to graduate students, although the subjects
were assured that the data would be de-identified.
◉ A researcher wants to observe preschoolers at a local public
playground to evaluate levels of cooperation. The researcher will
not interact with the children or record information in such a
manner that the identity of the subjects can be readily
ascertained. Which of the following statements is true?
,Answer: This research would be eligible for exemption because
the researcher is not interacting with the children and the
playground is a public setting.
◉ According to Subpart D, research with children may be eligible
for exemption under Category 2 when:
Answer: The research involves the use of educational tests
◉ A study that involves interviews of adults is eligible for
expedited review. The researcher wants to add an adolescent
population (aged 12 to 17) to the study and has designed a
parental permission and assent process. No additional changes
are planned. Which of the following statements about review of
the revised protocol is accurate?
Answer: Unless the nature of the questions would raise the level
of risk to more than minimal for adolescents, the research would
still qualify for expedited review.
◉ A researcher asks an IRB to waive the requirement for parental
permission for a study conducted in schools because the nature of
the research requires participation of all the children present in
classrooms on the day the research will take place. Assuming that
the basic research design could be approved by the IRB and the
school, which of the following requirements must be met before
an IRB could waive parental permission?
Answer: The research must pose no more than minimal risk.
, ◉ Which of the following statements most accurately describes
the requirement for the documentation of minors' assent to
participate in research?
Answer: Federal regulations do not require the documentation of
minors' assent.
◉ Which of the following methods could be considered a "best
practice" in terms of informing respondents how their answers to
an on-line survey about personal information will be protected?
Answer: The investigator uses the informed consent process to
explain how respondent data will be transmitted from the website
to his encrypted database without ever recording respondents' IP
addresses, but explains that on the internet confidentiality cannot
be absolutely guaranteed.
◉ Consent to participate in research is an ongoing process. Which
of the following strategies would help ensure that participation in
a survey about a sensitive personal topic remains voluntary
throughout a study?
Answer: Designing the survey so that subjects are not forced to
answer one question before going to the next.
◉ Which of the following on-line research strategies raises the
most concerns regarding the ethical principle of respecting the
autonomy of research subjects and the corresponding federal
regulations requiring informed consent?
EVALUATION EXAMS SET WITH
COMPLETE ANSWERS AND EXPERT
REVIEW
◉ 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?
Answer: Securing a Certificate of Confidentiality
◉ 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)?
Answer: A faculty member makes identifiable data about sexual
behavior available to graduate students, although the subjects
were assured that the data would be de-identified.
◉ A researcher wants to observe preschoolers at a local public
playground to evaluate levels of cooperation. The researcher will
not interact with the children or record information in such a
manner that the identity of the subjects can be readily
ascertained. Which of the following statements is true?
,Answer: This research would be eligible for exemption because
the researcher is not interacting with the children and the
playground is a public setting.
◉ According to Subpart D, research with children may be eligible
for exemption under Category 2 when:
Answer: The research involves the use of educational tests
◉ A study that involves interviews of adults is eligible for
expedited review. The researcher wants to add an adolescent
population (aged 12 to 17) to the study and has designed a
parental permission and assent process. No additional changes
are planned. Which of the following statements about review of
the revised protocol is accurate?
Answer: Unless the nature of the questions would raise the level
of risk to more than minimal for adolescents, the research would
still qualify for expedited review.
◉ A researcher asks an IRB to waive the requirement for parental
permission for a study conducted in schools because the nature of
the research requires participation of all the children present in
classrooms on the day the research will take place. Assuming that
the basic research design could be approved by the IRB and the
school, which of the following requirements must be met before
an IRB could waive parental permission?
Answer: The research must pose no more than minimal risk.
, ◉ Which of the following statements most accurately describes
the requirement for the documentation of minors' assent to
participate in research?
Answer: Federal regulations do not require the documentation of
minors' assent.
◉ Which of the following methods could be considered a "best
practice" in terms of informing respondents how their answers to
an on-line survey about personal information will be protected?
Answer: The investigator uses the informed consent process to
explain how respondent data will be transmitted from the website
to his encrypted database without ever recording respondents' IP
addresses, but explains that on the internet confidentiality cannot
be absolutely guaranteed.
◉ Consent to participate in research is an ongoing process. Which
of the following strategies would help ensure that participation in
a survey about a sensitive personal topic remains voluntary
throughout a study?
Answer: Designing the survey so that subjects are not forced to
answer one question before going to the next.
◉ Which of the following on-line research strategies raises the
most concerns regarding the ethical principle of respecting the
autonomy of research subjects and the corresponding federal
regulations requiring informed consent?
