CITI Modules Questions and Answers
(Verified Answers)
1. 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.
2. Which of the following are the three principles discussed in the
Belmont Report>>>Respect for Persons, Beneficence, Justice
3. 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.
,4. An investigational biologic administered to the first two subjects in a
Phase II clinical trial was not appropriately screened for two viral
contam- inants, 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
5. Housekeeping employees of the medical center were recruited for a
feder- ally 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.
, 6. A Data Safety Monitoring Board report for an investigator-initiated inves-
tigational 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
7. A subject received the wrong study drug resulting in severe nausea
and vomiting, and a visit to the emergency room for treatment. The subject
noti- fied the study coordinator the day after the emergency room visit. The
study
(Verified Answers)
1. 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.
2. Which of the following are the three principles discussed in the
Belmont Report>>>Respect for Persons, Beneficence, Justice
3. 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.
,4. An investigational biologic administered to the first two subjects in a
Phase II clinical trial was not appropriately screened for two viral
contam- inants, 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
5. Housekeeping employees of the medical center were recruited for a
feder- ally 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.
, 6. A Data Safety Monitoring Board report for an investigator-initiated inves-
tigational 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
7. A subject received the wrong study drug resulting in severe nausea
and vomiting, and a visit to the emergency room for treatment. The subject
noti- fied the study coordinator the day after the emergency room visit. The
study
