CITI RESEARCH ETHICS REVIEW 2026
QUESTIONS WITH SOLUTIONS TESTED
QUESTIONS.
⫸ 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. Ans- This is an unanticipated
problem that does not include an adverse event.
⫸ 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. Ans- This
is an unanticipated problem, which resulted in 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. Ans- This is an
unanticipated problem.
⫸ The NBAC looks at characteristics individuals might have that would
prevent them from being able to provide voluntary informed consent.
The traits may be thought of as falling into six broad areas: cognitive or
communicative, institutional, deferential, medical, economic, and social.
Prospective research subjects who are not able to comprehend
information, deliberate, and make decisions about participation in a
proposed research study have a:. Ans- Cognitive or communicative
vulnerability
⫸ In considering NBAC's analytic approach, an otherwise competent
person who is acutely ill might be considered at especially high risk of
harm for:. Ans- Situational cognitive vulnerability
⫸ 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. Ans- Economic vulnerability
QUESTIONS WITH SOLUTIONS TESTED
QUESTIONS.
⫸ 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. Ans- This is an unanticipated
problem that does not include an adverse event.
⫸ 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. Ans- This
is an unanticipated problem, which resulted in 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. Ans- This is an
unanticipated problem.
⫸ The NBAC looks at characteristics individuals might have that would
prevent them from being able to provide voluntary informed consent.
The traits may be thought of as falling into six broad areas: cognitive or
communicative, institutional, deferential, medical, economic, and social.
Prospective research subjects who are not able to comprehend
information, deliberate, and make decisions about participation in a
proposed research study have a:. Ans- Cognitive or communicative
vulnerability
⫸ In considering NBAC's analytic approach, an otherwise competent
person who is acutely ill might be considered at especially high risk of
harm for:. Ans- Situational cognitive vulnerability
⫸ 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. Ans- Economic vulnerability
