CITI Training Questions & Answers | 100% Correct | Verified | Latest Update 2024
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
In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for: - ✔✔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: - ✔✔Is there a power differential between researchers and subjects?
Which is true of inducements in research? - ✔✔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: - ✔✔Pregnant women, prisoners, children
DSMBs are typically needed: - ✔✔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: - ✔✔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? - ✔✔They have overlapping responsibilities for trial oversight
DSMB members should have - ✔✔No significant conflicts of interest 1 / 2
The type of member expertise needed on almost all DSMBs includes: - ✔✔Statistics
DSMB meetings should be held - ✔✔It depends
A risk mitigation plan might include - ✔✔Criteria for reducing a subject's medication dose
: A DSMP includes a safety monitoring plan and what other component? - ✔✔Data management plan
Confidentiality of the interim results of a randomized trial is important because: - ✔✔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: - ✔✔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: - ✔✔Persons with diminished autonomy are entitled to protection.
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.
The Belmont principle of beneficence requires that: - ✔✔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? - ✔✔Ensuring that risks are reasonable in relationship to anticipated benefits
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