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Citi Training, Assessing Risk - SBE, CITI Questions And Answers
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Citi Training, Assessing Risk - SBE,CITI Questions And Answers
The researcher's failure to protect research subjects from deductive
disclosure is the primary ethical violation in which of the following studies?
Correct 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 principle of:
Correct Ans - Justice
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:
Correct Ans - Respect for persons
The Belmont principle of beneficence requires that: Correct 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? Correct 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: Correct 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: Correct 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? Correct Ans - Prisoners
,According to the federal regulations, research is eligible for exemption, if:
Correct Ans - The research falls into one of eight categories of research
activity described in the regulations.
Which of the following statements about the relationship between an
institution and the institution's IRB(s) is correct? Correct Ans -
Officials of the institution may overrule an IRB approval.
Risk of harm in social and behavioral sciences generally fall in three
categories, which are: Correct 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:
Correct Ans - Experience emotional or psychological distress.
The primary purpose of a Certificate of Confidentiality is to: Correct Ans -
Protect identifiable research information from compelled disclosure.
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: Correct 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: Correct Ans - Both the magnitude (or
severity) and the probability (or likelihood) of harm.
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? Correct 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? Correct 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.
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: Correct 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: Correct Ans - The only record linking the subject and
the research is the consent document and the principal risk is a breach of
confidentiality.
As part of the consent process, the federal regulations require researchers to:
Correct Ans - Provide potential subjects with information at the
appropriate reading comprehension level.
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? Correct 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)? Correct Ans - 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.
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? Correct Ans -
Securing a Certificate of Confidentiality
Data are made anonymous by Correct Ans - Destroying all identifiers
connected to the data.
When a focus group deals with a potentially sensitive topic, which of the
following statements about providing confidentiality to focus group
participants is correct? Correct Ans - The researcher cannot control
what participants repeat about others outside the group.
A researcher conducts a focus group to learn about attitudes towards hygiene
and disease prevention. Two weeks after the focus group, the researcher
learns one of the subjects had a heart attack at home and was hospitalized, but
made a full recovery. Based on HHS regulations, should the researcher report
this event to the IRB? Correct Ans - No, this does not need to be
reported because it is unrelated to participation in the study.
According to OHRP, a problem is an "unanticipated problem" when it meets
which of the following criteria: Correct Ans - Unexpected, related or
possibly related to the research, suggests the research puts subjects or others
at greater risk
A researcher conducting behavioral research collects individually identifiable
sensitive information about illicit drug use and other illegal behaviors by
surveying college students. One of the subjects is in an automobile accident
two weeks after participating in the research study. Is this an example of an
unanticipated problem that requires reporting to the IRB? Correct Ans -
No, this does not need to be reported because it was assessed by the
researcher as unrelated to the research study.
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