CITI Modules, Questions with accurate
answers, graded A./ 100% verified.
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.
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. - ✔✔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. - ✔✔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. - ✔✔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. - ✔✔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. - ✔✔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: - ✔✔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? - ✔✔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? - ✔✔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: - ✔✔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.
answers, graded A./ 100% verified.
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.
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. - ✔✔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. - ✔✔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. - ✔✔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. - ✔✔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. - ✔✔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: - ✔✔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? - ✔✔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? - ✔✔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: - ✔✔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.
