Citi Training, Assessing Risk - SBE, CITI Questions
and Correct Answers | Latest Update
The researcher's failure to protect research subjects from deductive
disclosure is the primary ethical violation in which of the following
studies?
Ans: "Tastes, Ties, and Time (T3)" study (2006-2009)
According to the Belmont Report, the moral requirement that there be
fair outcomes in the selection of research subjects, expresses the
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principle of:
Ans: Justice
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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:
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Ans: Respect for persons
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The Belmont principle of beneficence requires that:
Ans: Potential benefits justify the risks of harm.
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?
Ans: The Public Health Service Study of Untreated Syphilis
Continuing review of an approved and ongoing study posing more than
minimal risk that was initially approved by a convened IRB:
Ans: Must occur within 12 months of the approval date.
According to federal regulations, the expedited review process may be
used when the study procedures pose:
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Ans: No more than minimal risk and the research activities fall within
regulatory categories identified as eligible.
In addition to pregnant women, fetuses, and neonates, another subpart of
the HHS regulations provides additional protections for which of the
following vulnerable populations?
Ans: Prisoners
According to the federal regulations, research is eligible for exemption,
if:
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Ans: The research falls into one of eight categories of research activity
described in the regulations.
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Which of the following statements about the relationship between an
institution and the institution's IRB(s) is correct?
Ans: Officials of the institution may overrule an IRB approval.
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Risk of harm in social and behavioral sciences generally fall in three
categories, which are:
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Ans: Invasion of privacy, breach of confidentiality, and study
procedures
A researcher wishes to study generational differences in coping
mechanisms among adults who experienced abuse as children. Adequate
measures will be instituted to obtain informed consent and ensure that
there is no breach of confidentiality. The most likely additional risk is
that some subjects may:
Ans: Experience emotional or psychological distress.
The primary purpose of a Certificate of Confidentiality is to:
Ans: Protect identifiable research information from compelled
disclosure.
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If disclosure of a subject's involvement in a specific research study can
be potentially harmful to the subject, and the consent form is the only
record linking the subject to the research, which of the following would
be most helpful:
Ans: Obtain a waiver of documentation of informed consent.
A researcher wants to do a web-based survey of college students to
collect information about their sexual behavior and drug use. Direct
identifiers will not be collected; however, IP addresses may be present in
the data set. Risk of harm should be evaluated by:
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Ans: Both the magnitude (or severity) and the probability (or likelihood)
of harm.
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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
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collect about the children for a case-based research project. Which of the
following statements about parental permission is correct?
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Ans: The parents of the children might feel pressure to give permission
to the therapist to use their children's data so that she will continue to
provide services to their children.
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?
Ans: Taking part in the research is voluntary, but if you choose to take
part, you waive the right to legal redress for any research-related
injuries.
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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:
Ans: A study in which subjects were assigned to study activities based
on an undesirable or unflattering physical characteristic as assessed by
members of the research team.
A waiver of the requirement for documentation of informed consent may
be granted when:
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Ans: The only record linking the subject and the research is the consent
document and the principal risk is a breach of confidentiality.
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As part of the consent process, the federal regulations require
researchers to:
Ans: Provide potential subjects with information at the appropriate
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reading comprehension level.
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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?
Ans: There was neither a violation of privacy nor a breach 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)?