CITI Certification Test Questions and Answers.
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.
Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice
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:
Persons with diminished autonomy are entitled to protection.
According to the authors, there are four common abuses that historically are described
as giving rise to vulnerability. Which response below contains the correct four?
Physical control, coercion, undue influence, and manipulation
When an IRB is reviewing a research study and they are considering if a potential
subject population is vulnerable, they should consider:
Is there a power differential between researchers and subjects?
Subjects with a serious illness may be at risk for exploitation because they may be
desperate for a possible cure. This is an example of:
Medical vulnerability
The NBAC looks at characteristics individuals might have that would prevent them from
being able to provide voluntary informed consent. The traits may be thought of as falling
into six broad areas: cognitive or communicative, institutional, deferential, medical,
economic, and social. Prospective research subjects who are not able to comprehend
information, deliberate, and make decisions about participation in a proposed research
study have a:
Cognitive or communicative vulnerability
Which is an example of a situation where deferential vulnerability might be a factor?
A physician recruiting patients to be subjects
An example of an individual financial COI is:
A researcher's spouse holds equity in a publicly traded pharmaceutical company that is
also the sponsor of the researcher's study.
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
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
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
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
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
The researcher's failure to protect research subjects from deductive disclosure is the
primary ethical violation in which of the following studies?
"Tastes, Ties, and Time (T3)" study (2006-2009)
The Belmont principle of beneficence requires that:
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?
The Public Health Service Study of Untreated Syphilis
A professor at Big State University is writing a biography about Bill Gates and
conducting oral histories with all of Bill Gates' friends, family members, and business
acquaintances. The researcher submits the research proposal to the institution's IRB.
What action can he expect by the IRB?
The IRB will not review this study because it is not research as defined by the federal
regulations.
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?
An experiment is proposed on the relationship between gender-related stereotypes in
math and the subsequent performance by males and females on math tests.
Census data (the final report as published by the Census Bureau) is an example of:
public 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, research is eligible for exemption, if:
No more than minimal risk and the research activities fall within regulatory categories
identified as eligible
Which of the following statements about the relationship between an institution and the
institution's IRB(s) is correct?
Officials of the institution may overrule an IRB approval.
Continuing review of an approved and ongoing study posing more than minimal risk that
was initially approved by a convened IRB:
Must occur within 12 months of the approval date.
In addition to pregnant women, fetuses, and neonates, another subpart of the HHS
regulations provides additional protections for which of the following vulnerable
populations?
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.
Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice
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:
Persons with diminished autonomy are entitled to protection.
According to the authors, there are four common abuses that historically are described
as giving rise to vulnerability. Which response below contains the correct four?
Physical control, coercion, undue influence, and manipulation
When an IRB is reviewing a research study and they are considering if a potential
subject population is vulnerable, they should consider:
Is there a power differential between researchers and subjects?
Subjects with a serious illness may be at risk for exploitation because they may be
desperate for a possible cure. This is an example of:
Medical vulnerability
The NBAC looks at characteristics individuals might have that would prevent them from
being able to provide voluntary informed consent. The traits may be thought of as falling
into six broad areas: cognitive or communicative, institutional, deferential, medical,
economic, and social. Prospective research subjects who are not able to comprehend
information, deliberate, and make decisions about participation in a proposed research
study have a:
Cognitive or communicative vulnerability
Which is an example of a situation where deferential vulnerability might be a factor?
A physician recruiting patients to be subjects
An example of an individual financial COI is:
A researcher's spouse holds equity in a publicly traded pharmaceutical company that is
also the sponsor of the researcher's study.
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
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
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
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
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
The researcher's failure to protect research subjects from deductive disclosure is the
primary ethical violation in which of the following studies?
"Tastes, Ties, and Time (T3)" study (2006-2009)
The Belmont principle of beneficence requires that:
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?
The Public Health Service Study of Untreated Syphilis
A professor at Big State University is writing a biography about Bill Gates and
conducting oral histories with all of Bill Gates' friends, family members, and business
acquaintances. The researcher submits the research proposal to the institution's IRB.
What action can he expect by the IRB?
The IRB will not review this study because it is not research as defined by the federal
regulations.
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?
An experiment is proposed on the relationship between gender-related stereotypes in
math and the subsequent performance by males and females on math tests.
Census data (the final report as published by the Census Bureau) is an example of:
public 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, research is eligible for exemption, if:
No more than minimal risk and the research activities fall within regulatory categories
identified as eligible
Which of the following statements about the relationship between an institution and the
institution's IRB(s) is correct?
Officials of the institution may overrule an IRB approval.
Continuing review of an approved and ongoing study posing more than minimal risk that
was initially approved by a convened IRB:
Must occur within 12 months of the approval date.
In addition to pregnant women, fetuses, and neonates, another subpart of the HHS
regulations provides additional protections for which of the following vulnerable
populations?
