Citi Exams Questions And Answers
Which of the following is included in the Nuremberg Code: – voluntary consent
The National Research Act of 1974 – Established the National Commission.
Informed consent is considered an application of which Belmont principle? – Respect for
Persons
Issued in 1974, 45 CFR 46 raised to regulatory status: – US Public Health Service Policy
Which of the following brought increased public attention to the problems with the IRB
system? – Death of Jesse Gelsinger
The use of prisoners in research is a concern under the Belmont principle of Justice
because: – Prisoners may be used to conduct research that only benefits the larger society
Which of the following was the result of the Beecher article? – Realization that ethical
abuses are not limited to the Nazi regime
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? – Report the adverse drug experience in a
timely manner, in keeping with the IRB’s policies and procedures, using the forms or the
mechanism provided by the IRB.
How long is an investigator required to keep consent documents, IRB correspondence, and
research records? – For a minimum of three years after completion of the study
According to federal regulations, which of the following best describes when expedited
review of a new, proposed study may be used by the IRB? – The study involves no more
than minimal risk and meets one of the allowable categories of expedited review specified
in federal regulations
Amendments involving changes to IRB approved protocols do NOT need prior IRB approval
if: – The changes must be immediately implemented for the health and well being of the
subject.
IRB continuing review of an approved protocol must: – Occur at least annually.
An investigator is confronted with a life-threatening situation that necessitates using a test
article in a human subject who is unable to provide informed consent and there is no time
to obtain consent from the individual’s legal representative and no alternative method or
recognized therapy is available. Under the FDA regulations for using test articles, which of
the following describes the best course of action for the investigator: – The investigator and
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persons with diminished autonomy are entitled to protection – The Belmont Report’s
principle of respect for persons incorporates at least two ethical convictions: first, that
individuals should be treated as autonomous agents, and second, that:
Determining that the study has a maximization of benefits and a minimization of risks. –
Which of the following is an example of how the principle of beneficence can be applied to a
study employing human subjects?
Respect for Persons, Beneficence, Justice – Which of the following are the three principles
discussed in the Belmont Report?
The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male. – 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?
Respect for persons. – 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:
Harvard “Tastes, Ties, and Time (T3)” study (2006-2009)” study – The researcher’s failure
to protect research subjects from deductive disclosure is the primary ethical violation in
which of the following studies?
Justice – According to the Belmont Report, the moral requirement that there be fair
outcomes in the selection of research subjects, expresses the principle of:
Potential benefits justify the risks of harm. – The Belmont principle of beneficence requires
that:
- Protecting the rights and welfare of human subjects.
- Assuring that all applicable institutional policies and federal regulations related to
research with human subjects are followed. - Reviewing subject recruitment materials and strategies. – What is the Institutional Review
Board (IRB) charged with? (There may be more than one correct answer. Please be sure to
select all correct answers.)
Exempt – Which type of IRB review does not require an IRB approval but does require a
determination by the IRB or an IRB designee?
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What is the term for management controls that are built in to a research study (for
example, independent data analysis)? – Inherent controls
An example of an individual financial COI is: – 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: – There may be bias by the peer reviewer as to
the area of research
The FDA regulations governing disclosure of individual COIs require: – Applicants
submitting marketing applications to disclose financial COIs of researchers who conducted
clinical studies
The COI management plan aims to: – 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: – An industry sponsor pays for the construction of a
new research laboratory at the organization
An example of an individual financial COI is: – 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. – 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? – Researcher
A researcher’s membership on an advisory board with an organization sponsoring
research can create a COI because: – It may be difficult for the researcher to appear neutral,
as the researcher may have an interest in the research’s success
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: – 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? – 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? – 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: – Justice
Which of the following is an example of how the principle of beneficence is applied to a
study involving human subjects? – Ensuring that risks are reasonable in relationship to
anticipated benefits.
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: –
Identifiable private information.
A medical record is an example of: – Private information.
According to the federal regulations, which of the following studies meets the definition of
research with human subjects? – A cognitive psychologist enrolls undergraduate students
for a computer-based study about the effect of mood on problem solving behaviors.
According to the federal regulations, which of the following studies meets the definition of
research with human subjects? – A developmental psychologist videotapes interactions
between groups of toddlers and their care givers to determine which intervention methods
most effectively manage aggression.
According to the federal regulations, which of the following studies meets the definition of
research with human subjects? – A study of twenty 4th grade classrooms in which
researchers ask the schools to systematically vary the time of day reading is taught, and
collect weekly assessments of reading comprehension for each child over a three-month
period.
According to federal regulations, the expedited review process may be used when the study
procedures pose: – No more than minimal risk and the research activities fall within
regulatory categories identified as eligible.
According to the federal regulations, research is eligible for exemption, if – The research
falls into one of six categories of research activity described in the regulations.
Continuing review of an approved and ongoing protocol – Must occur within 12 months of
the approval date
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Which of the following are the three principles discussed in the Belmont Report? – Respect
for Persons, Beneficence, Justice.
Which of the following is an example of how the Principle of Beneficence can be applied to
a study employing human subjects? – Determining that the study has a maximization of
benefits and a minimization of risks.
All of the following are true regarding the Belmont Report, EXCEPT: – The Belmont Report
indicates that it is necessary to rigorously avoid conflicts of interest.
The researcher’s failure to protect research subjects from deductive disclosure is the
primary ethical violation in which of the following studies? – Harvard “Tastes, Ties, and
Time (T3)” study (2006-2009)” study
Which of the following is an example of how the principle of beneficence is applied to a
study involving human subjects? – Ensuring that risks are reasonable in relationship to
anticipated benefits.
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: – 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? – The Public Health Service Tuskegee Study of Untreated
Syphilis in the Negro Male.
According to the Belmont Report, the moral requirement that there be fair outcomes in the
selection of research subjects, expresses the principle of: – Justice.
The Belmont Principle of beneficence requires that – Potential benefits justify the risks of
harm.
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? – Report the adverse drug experience in a
timely manner, in keeping with the IRB’s policies and procedures, using the forms or the
mechanism provided by the IRB.
How long is an investigator required to keep consent documents, IRB correspondence, and
research records? – For a minimum of three years after completion of the study