The Belmont Report's principle of respect for persons incorporates at least two ethical
convictions: first, that individuals should be treated as
... [Show More] 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.
An investigational biologic administered to the first two subjects in a Phase II clinical trial
was not appropriately screened for two viral contaminants, HIV and Hepatitis B, due to
human error in the screening process. Follow-up testing indicated that the subjects and
their partners were not infected. The subjects and others were notified of the increased
risk. - Correct answer-This is an unanticipated problem requiring notification to the IRB
and FDA
Housekeeping employees of the medical center were recruited for a federally funded
study of blood pressure, blood count levels, infectious disease history, and job stress.
The interviews and blood tests were conducted in a private location not affiliated with
the study center. Follow-up interviews were conducted in the same location. The study
coordinator stopped at the cafeteria on her way back to the study office after the second
study visit for the last three study subjects and lost the three file folders. Records of one
subject indicated he had a history of a sexually transmitted disease and another had
recently been treated for tuberculosis. The subjects were notified of the loss. Following
this event, the IRB approved a protocol change requiring that all records be transmitted
electronically to the study office using the medical center's secure network. - Correct
answer-This is an unanticipated problem and not an adverse event.
A Data Safety Monitoring Board report for an investigator-initiated investigational drug
study indicates a significantly higher than anticipated rate of an expected adverse event.
This event required revision of the informed consent form to disclose the higher rate. A
change in the eligibility criteria of the protocol to reduce the risk was implemented.
Current subjects would be reconsented. - Correct answer-This is an unanticipated
problem
A subject received the wrong study drug resulting in severe nausea and vomiting, and a
visit to the emergency room for treatment. The subject notified the study coordinator the
day after the emergency room visit. The study coordinator reviewed the subject's study
records and discovered the error. The coordinator notified the subject of the study drug
CITI ALL MODULES EXAM 200 QUESTIONS WITH
VERIFIED CORRECT AND UPDATED ANSWERS (100%
CORRECT) /A+ GRADE/2023 VERSION
error, which caused the nausea and vomiting. The investigator notified the IRB and the
IRB approved a revision of the standard pharmacy procedure for administering
investigational drugs. - Correct answer-This is an unanticipated problem, which resulted
in an adverse event.
A study requires that each subject be given two study drugs. The first study drug is
given on Day 1. A second study drug is given on Day 7 to counteract the toxicity of Drug
1. Subject # 4-706 is given Drug 1 on Day 1. Due to a snowstorm, Subject 4-706 is
delayed for several days before returning to the site for Drug 2. Missing the
administration of Drug 2 on Day 7 placed the subject at risk of significant toxicity. This
event required the subject be notified of the increased risk and required close
monitoring of the subject by phone. - Correct answer-This is an unanticipated problem
that does not include an adverse event
A subject participates in a drug study because treatment is available at no or reduced
cost, and he could not otherwise afford it. This is an example of: - Correct answerEconomic vulnerability
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
NBAC proposed a concept of vulnerability in research based on features of potential
subjects or of their situation. Which of the following was not included as possibly leading
to vulnerability? - Correct answer-High potential for individual benefit from participating
in research
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.
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 answerSituational cognitive vulnerability
The National Research Act of 1974 - Correct answer-Established the National
Commission.
Issued in 1974, 45 CFR 46 raised to regulatory status: - Correct answer-US Public
Health Service Policy
CITI ALL MODULES EXAM 200 QUESTIONS WITH
VERIFIED CORRECT AND UPDATED ANSWERS (100%
CORRECT) /A+ GRADE/2023 VERSION
Informed consent is considered an application of which Belmont principle? - Correct
answer-Respect for Persons
Which of the following was the result of the Beecher article? - Correct answerRealization that ethical abuses are not limited to the Nazi regime
Which of the following is included in the Nuremberg Code: - Correct answer-Voluntary
consent
Which of the following brought increased public attention to the problems with the IRB
system? - Correct answer-Death of Research Subject (Jesse Gelsinger)
The use of prisoners in research is a concern under the Belmont principle of Justice
because: - Correct answer-Prisoners may be used to conduct research that only
benefits the larger society
A subject in a clinical research trial experiences a serious, unanticipated adverse drug
experience. How should the investigator proceed, with respect to the IRB, after the
discovery of the adverse event occurrence? - Correct answer-Report the adverse drug
experience in a timely manner, in keeping with the IRB's policies and procedures, using
the forms or the mechanism provided by the IRB.
How long is an investigator required to keep consent documents, IRB correspondence,
and research records? - Correct answer-For a minimum of three years after completion
of the study
According to federal regulations, which of the following best describes when expedited
review of a new, proposed study may be used by the IRB? - Correct answer-The study
involves no more than minimal risk and meets one of the allowable categories of
expedited review specified in federal regulations
Amendments involving changes to IRB-approved protocols do NOT need prior IRB
approval if: - Correct answer-The changes must be immediately implemented for the
health and well-being of the subject.
IRB continuing review of a greater than minimal risk approved protocol that is currently
enrolling subjects must: - Correct answer-Occur at least annually.
An elderly gentleman, whose wife is his legally authorized representative (LAR) since
his strokes several years ago, was recently diagnosed with lung cancer. He is eligible
for a clinical trial using a new investigational drug that aims to treat lung cancer. He is
able to express interest, shows a basic understanding of the nature of the trial, and
gives his assent to participation. The subject's wife is out of town on a business trip.
Which of the following is the most appropriate action to take for the investigator? -
Correct answer-Send a copy of the informed consent via facsimile to the subject's wife. [Show Less]