Citi Training- Questions With All Correct Answers
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? correct answer -Physical control, coercion, undue influence,
and manipulation
In considering NBAC's analytic approach, an otherwise competent person who
is acutely ill might be considered at especially high risk of harm for: correct
answer -Situational cognitive vulnerability
When an IRB is reviewing a research study and they are considering if a
potential subject population is vulnerable, they should consider: correct
answer -Is there a power differential between researchers and subjects?
Which is true of inducements in research? correct answer -Inducements
constitute an "undue influence" if they alter a potential subject's decision-
making processes, such that they do not appropriately weigh the risk-benefit
relationship of the research.
Identify the following groups that are protected in the federal regulations (45
CFR 46), specifically in Subparts B, C, and D with additional protections:
correct answer -Pregnant women, prisoners, children
DSMBs are typically needed: correct answer -For all randomized trials
when interim efficacy and/or safety comparisons are planned
Confidentiality of the interim results of a randomized trial is important
because: correct answer -Revealing interim results may affect the conduct
of the study and lead to biased results
Which of the following statements about IRBs and DSMBs is true? correct
answer -They have overlapping responsibilities for trial oversight
DSMB members should have correct answer -No significant conflicts of
interest
, The type of member expertise needed on almost all DSMBs includes: correct
answer -Statistics
DSMB meetings should be held correct answer -It depends
A risk mitigation plan might include correct answer -Criteria for reducing
a subject's medication dose
: A DSMP includes a safety monitoring plan and what other component?
correct answer -Data management plan
Confidentiality of the interim results of a randomized trial is important
because: correct answer -Revealing interim results may affect the conduct
of the study and lead to biased results
The only type of trial for which FDA regulations mandate a DMC is: correct
answer -A trial of emergency research using an exception from the informed
consent requirement
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: correct answer -Persons with
diminished autonomy are entitled to protection.
Which of the following are the three principles discussed in the Belmont
Report? correct answer -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? correct answer -
Determining that the study has a maximization of benefits and a minimization
of risks.
The Belmont principle of beneficence requires that: correct answer -Risks
to subjects are reasonable in relation to anticipated benefits.
Which of the following is an example of how the principle of beneficence is
applied to a study involving human subjects? correct answer -Ensuring
that risks are reasonable in relationship to anticipated benefits
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? correct answer -Physical control, coercion, undue influence,
and manipulation
In considering NBAC's analytic approach, an otherwise competent person who
is acutely ill might be considered at especially high risk of harm for: correct
answer -Situational cognitive vulnerability
When an IRB is reviewing a research study and they are considering if a
potential subject population is vulnerable, they should consider: correct
answer -Is there a power differential between researchers and subjects?
Which is true of inducements in research? correct answer -Inducements
constitute an "undue influence" if they alter a potential subject's decision-
making processes, such that they do not appropriately weigh the risk-benefit
relationship of the research.
Identify the following groups that are protected in the federal regulations (45
CFR 46), specifically in Subparts B, C, and D with additional protections:
correct answer -Pregnant women, prisoners, children
DSMBs are typically needed: correct answer -For all randomized trials
when interim efficacy and/or safety comparisons are planned
Confidentiality of the interim results of a randomized trial is important
because: correct answer -Revealing interim results may affect the conduct
of the study and lead to biased results
Which of the following statements about IRBs and DSMBs is true? correct
answer -They have overlapping responsibilities for trial oversight
DSMB members should have correct answer -No significant conflicts of
interest
, The type of member expertise needed on almost all DSMBs includes: correct
answer -Statistics
DSMB meetings should be held correct answer -It depends
A risk mitigation plan might include correct answer -Criteria for reducing
a subject's medication dose
: A DSMP includes a safety monitoring plan and what other component?
correct answer -Data management plan
Confidentiality of the interim results of a randomized trial is important
because: correct answer -Revealing interim results may affect the conduct
of the study and lead to biased results
The only type of trial for which FDA regulations mandate a DMC is: correct
answer -A trial of emergency research using an exception from the informed
consent requirement
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: correct answer -Persons with
diminished autonomy are entitled to protection.
Which of the following are the three principles discussed in the Belmont
Report? correct answer -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? correct answer -
Determining that the study has a maximization of benefits and a minimization
of risks.
The Belmont principle of beneficence requires that: correct answer -Risks
to subjects are reasonable in relation to anticipated benefits.
Which of the following is an example of how the principle of beneficence is
applied to a study involving human subjects? correct answer -Ensuring
that risks are reasonable in relationship to anticipated benefits
