CITI TRAINING 130 QUESTIONS WITH VERIFIED AND CORRECT
ANSWERS/ 2023-2024 VERSION/A+ GRADE
According to the authors, there are four common abuses that
... [Show More] 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
CITI TRAINING 130 QUESTIONS WITH VERIFIED AND CORRECT
ANSWERS/ 2023-2024 VERSION/A+ GRADE
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
CITI TRAINING 130 QUESTIONS WITH VERIFIED AND CORRECT
ANSWERS/ 2023-2024 VERSION/A+ GRADE
According to the federal regulations, which of the following studies meets the definition
of research with human subjects? - correct answer A study of twenty 4th grade
classrooms in which researchers ask the schools to systematically vary the time of day
reading is taught, and collect weekly assessments of reading comprehension for each
child over a three-month period.
A researcher is interested in assessing risk-taking by individuals. The researcher is
sitting on a bench near a busy four-way stop intersection. She plans on recording the
number of bike riders wearing a safety helmet and whether they stop at the intersection
before proceeding in order to correlate use of safety apparel with risk-taking. This
collection of information is an example of: - correct answer Public behavior
A medical record is an example of: - correct answer Private information
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? - correct answer The IRB will not review th [Show Less]