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CITI Questions With Complete Solutions
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CITI Questions With Complete SolutionsThe FDA regulations governing disclosure of individual COIs require:
Correct Ans - Applicants submitting marketing applications to disclose
financial COIs of researchers who conducted clinical studies
The PHS regulations about financial conflict of interests require which party
to disclose significant financial conflicts of interest? Correct Ans -
Researcher
What is the term for management controls that are built in to a research study
(for example, independent data analysis)? Correct Ans - Inherent
controls
A researcher's membership on an advisory board with an organization
sponsoring research can create a COI because: Correct Ans - It may be
difficult for the researcher to appear neutral, as the researcher may have an
interest in the research's success
A researcher calls you stating that he plans to submit a proposal to the NIH for
a human subjects research study. He wants to know at what point he and his
study team must submit COI disclosures to comply with the PHS regulation.
Correct Ans - No later than the time of proposal submission
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 DHHS regulations, should the researcher
report this event to the IRB? Correct Ans - No, this does not need to be
reported since it is unrelated to participation in the study.
The procedures for reporting potential unanticipated problems involving risk
to subjects or others to the IRB are: Correct Ans - Determined by the
institution in its written policies and procedures
Researchers must report potential unanticipated problems that involve risks
to others directly to: Correct Ans - Institutional Review Board (IRB)
,A researcher conducting behavioral research collects individually identifiable
sensitive information about illicit drug use and other illegal behaviors by
surveying college students. The data are stored on a laptop computer without
encryption, and the laptop computer is stolen from the researcher's car on the
way home from work. This is an unanticipated problem that must be reported
because the incident was (a) unexpected (i.e., the researchers did not
anticipate the theft); (b) related to participation in the research; and (c)
placed the subjects at a greater risk of psychological and social harm from the
breach in confidentiality of the study data than was previously known or
recognized. According to OHRP, this unanticipated problem must be reported
to the IRB in which timeframe? Correct Ans - Promptly
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.
According to OHRP, a problem is an "unanticipated problem" when it meets
which of the following criteria: Correct Ans - Unexpected, related or
possible related to the research, suggests the research puts subjects or others
at greater risk
During an Institutional Review Board (IRB) meeting, any IRB member who
may have a potential COI with a study under review should: Correct Ans -
Disclose their potential COI and may answer questions, but recuse themselves
from voting
The peer review process can create conflicts of interest because the choice of
who reviews a potentially publishable project may show: Correct Ans -
There may be bias by the peer reviewer as to the area of research
An example of an institutional COI is: Correct Ans - An industry
sponsor pays for the construction of a new research laboratory at the
organization
,The COI management plan aims to: Correct Ans - Provide procedures
or extras steps to be taken to minimize the risk of bias when a COI is disclosed
What is the term for management controls that are built in to a research study
(for example, independent data analysis)? Correct Ans - Inherent
controls
An example of an individual financial COI is: Correct Ans - A
researcher's wife holds equity in a publicly traded pharmaceutical company
that is also the sponsor of the researcher's study.
The peer review process can create conflicts of interest because the choice of
who reviews a potentially publishable project may show: Correct Ans -
There may be bias by the peer reviewer as to the area of research
The FDA regulations governing disclosure of individual COIs require:
Correct Ans - Applicants submitting marketing applications to disclose
financial COIs of researchers who conducted clinical studies
The COI management plan aims to: Correct Ans - Provide procedures
or extras steps to be taken to minimize the risk of bias when a COI is disclosed
An example of an institutional COI is: Correct Ans - An industry
sponsor pays for the construction of a new research laboratory at the
organization
An example of an individual financial COI is: Correct Ans - A
researcher's wife holds equity in a publicly traded pharmaceutical company
that is also the sponsor of the researcher's study.
A researcher calls you stating that he plans to submit a proposal to the NIH for
a human subjects research study. He wants to know at what point he and his
study team must submit COI disclosures to comply with the PHS regulation.
Correct Ans - No later than the time of proposal submission
The PHS regulations about financial conflict of interests require which party
to disclose significant financial conflicts of interest? Correct Ans -
Researcher
, A researcher's membership on an advisory board with an organization
sponsoring research can create a COI because: Correct Ans - It may be
difficult for the researcher to appear neutral, as the researcher may have an
interest in the research's success
Correct Ans -
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.
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 Tuskegee Study of Untreated Syphilis in the Negro Male.
The researcher's failure to protect research subjects from deductive
disclosure is the primary ethical violation in which of the following studies?
Correct Ans - Harvard "Tastes, Ties, and Time (T3)" study (2006-2009)"
study
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
Which of the following is an example of how the principle of beneficence is
applied to a study involving human subjects? Correct Ans - Ensuring
that risks are reasonable in relationship to anticipated benefits.
Correct Ans -
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: Correct Ans - Identifiable private information.
A medical record is an example of: Correct Ans - Private information.
According to the federal regulations, which of the following studies meets the
definition of research with human subjects? Correct Ans - A cognitive
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