CITI TRAINING QUIZ PRACTICE QUESTIONS
AND DETAILED SOLUTIONS
◉ In considering NBAC's analytic approach, an otherwise competent
person who is acutely ill might be considered at especially high risk
of harm for:
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:
Answer: Is there a power differential between researchers and
subjects?
◉ Which is true of inducements in research?
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:
Answer: Pregnant women, prisoners, children
,◉ DSMBs are typically needed:
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:
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?
Answer: They have overlapping responsibilities for trial oversight
◉ DSMB members should have
Answer: No significant conflicts of interest
◉ The type of member expertise needed on almost all DSMBs
includes:
Answer: Statistics
◉ DSMB meetings should be held
Answer: It depends
◉ A risk mitigation plan might include
, Answer: Criteria for reducing a subject's medication dose
◉ : A DSMP includes a safety monitoring plan and what other
component?
Answer: Data management plan
◉ Confidentiality of the interim results of a randomized trial is
important because:
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:
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:
Answer: Persons with diminished autonomy are entitled to
protection.
◉ Which of the following are the three principles discussed in the
Belmont Report?
AND DETAILED SOLUTIONS
◉ In considering NBAC's analytic approach, an otherwise competent
person who is acutely ill might be considered at especially high risk
of harm for:
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:
Answer: Is there a power differential between researchers and
subjects?
◉ Which is true of inducements in research?
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:
Answer: Pregnant women, prisoners, children
,◉ DSMBs are typically needed:
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:
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?
Answer: They have overlapping responsibilities for trial oversight
◉ DSMB members should have
Answer: No significant conflicts of interest
◉ The type of member expertise needed on almost all DSMBs
includes:
Answer: Statistics
◉ DSMB meetings should be held
Answer: It depends
◉ A risk mitigation plan might include
, Answer: Criteria for reducing a subject's medication dose
◉ : A DSMP includes a safety monitoring plan and what other
component?
Answer: Data management plan
◉ Confidentiality of the interim results of a randomized trial is
important because:
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:
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:
Answer: Persons with diminished autonomy are entitled to
protection.
◉ Which of the following are the three principles discussed in the
Belmont Report?
