CITI Modules with complete solutions.
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? -
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? - 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. - 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. - 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. - 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
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. - 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
, CITI Modules with complete solutions.
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. - 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: - Answer Economic
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? -
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? - 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: - 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.
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
The National Research Act of 1974 - Answer Established the National Commission.
Issued in 1974, 45 CFR 46 raised to regulatory status: - Answer US Public Health
Service Policy
Informed consent is considered an application of which Belmont principle? - Answer
Respect for Persons
Which of the following was the result of the Beecher article? - Answer Realization that
ethical abuses are not limited to the Nazi regime
Which of the following is included in the Nuremberg Code: - Answer Voluntary consent
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? -
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? - 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. - 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. - 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. - 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
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. - 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
, CITI Modules with complete solutions.
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. - 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: - Answer Economic
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? -
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? - 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: - 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.
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
The National Research Act of 1974 - Answer Established the National Commission.
Issued in 1974, 45 CFR 46 raised to regulatory status: - Answer US Public Health
Service Policy
Informed consent is considered an application of which Belmont principle? - Answer
Respect for Persons
Which of the following was the result of the Beecher article? - Answer Realization that
ethical abuses are not limited to the Nazi regime
Which of the following is included in the Nuremberg Code: - Answer Voluntary consent
