(verified Q&A) CITI Training question & answer 2023 Graded A+++
According to the authors, there are four common abuses that historically are
... [Show More] 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
A researcher submits a study to the IRB that proposes to evaluate a new after-school on-line tutoring program for middle-school students in a local school district examining the effect on student grades. She proposes to perform this assessment at the school that her children attend, because she is familiar with the school district. Students may use either their personal smartphone or computer to participate in the program. This study might be determined to be violating which principle of the Belmont Report? - correct answer Justice
A study was submitted to the IRB designed to evaluate the effect of background noise on an individual's ability to concentrate and answer questions. The IRB approved the study and consent form. The consent form includes all the required information. The use of a consent form is an example of the Belmont principle of: - correct answer Respect for persons
According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of: - correct answer Justice
A census is a regularly-occurring and official count of a particular population. Census data available at the United States Census Bureau website are an example of: - correct answer Public information [Show Less]