PSYCHOLOGY 430 CITI Assignment
Question 1
Question Which of the following are the three principles discussed in the Belmont
Report?
Your Answer Respect for Persons, Beneficence, Justice
Result Correct
Comment The three principles discussed in the Belmont Report are Respect for
Persons, Beneficence, Justice.
Question 2
Question 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:
Your Answer Persons with diminished autonomy are entitled to protection.
Result Correct
Comment 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. Persons with diminished autonomy should not be
excluded from participating in research, because then they would be
excluded from receiving the benefits of research. The Belmont Report does
not limit persons with diminished autonomy with participating in greater
than minimal risk research. The Belmont Report also does not limit persons
involved in research from benefitting financially.
Question 3
Question Which of the following is an example of how the principle of beneficence
can be applied to a study employing human subjects?
Your Answer Determining that the study has a maximization of benefits and a
minimization of risks.
Result Correct
,PSYCHOLOGY 430 CITI Assignment
Recognizing and Reporting
Unanticipated Problems Involving
Risks to Subjects or Others in
Biomedical Research
Comment The principle of beneficence includes the obligation of researchers to strive to do
no harm and to maximize benefits and minimize harms. "Persons are treated in
an ethical manner not only by respecting their decisions and protecting them
from harm, but also by making efforts to secure their well-being" (The National
Commission 1979). The principle of beneficence can be applied to a study
employing human subjects by determining that the study has a maximization of
benefits and a minimization of risks. Providing detailed information during
consent and ensuring persons with diminished autonomy are protected would be
examples of applying the principle of respect for persons. Ensuring the selection
of subjects is equitable is an example of applying the principle of justice.
Question 1
Question 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.
Your Answer This is an unanticipated problem requiring notification to the IRB and
FDA.
Result Correct
Comment This is an unanticipated problem because the screening procedure
problem was not anticipated; both the subject and others were
exposed to risk and could have been infected with Hepatitis B or HIV.
A Phase II clinical trial involving a biologic falls under the jurisdiction
of the FDA.
,PSYCHOLOGY 430 CITI Assignment
Question 2
Question 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.
Your Answer This is an unanticipated problem.
Result Correct
Comment This is an unanticipated problem because the actual rate for the
adverse event was significantly higher than expected, placing
subjects at increased risk. The IRB should be notified of all
unanticipated problems. Subjects should always be reconsented
when there is a significant change in risk, which may affect their
willingness to continue in the study. Depending on the funding of the
study, OHRP must be notified. Because the study falls under the
FDA regulations, FDA must be notified.
Question 3
Question 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.
Your Answer This is an unanticipated problem, which resulted in an adverse
event.
Result Correct
Comment Receiving the wrong study drug is an unanticipated problem because
all the criteria for an unanticipated problem are met. This subject
required medical treatment suggesting the increased risk was
serious. This event is also an adverse event because the subject
required medical treatment. The IRB was properly notified and
, PSYCHOLOGY 430 CITI Assignment
approved a change in pharmacy procedures to increase subject
safety. The FDA must be notified.
Question 4
Question 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.
Your Answer This is an unanticipated problem and not an adverse event.
Result Correct
Comment Regardless of the type of study, when subjects’ research records
containing protected health information (PHI) are lost, the event is
considered an unanticipated problem. This event required the
subjects be notified of the increased risk, and required a change in
the way data were stored and protected. This is not an adverse
event because there was no medical occurrence involved. OHRP
should be notified.
Question 5
Question 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.
Question 1
Question Which of the following are the three principles discussed in the Belmont
Report?
Your Answer Respect for Persons, Beneficence, Justice
Result Correct
Comment The three principles discussed in the Belmont Report are Respect for
Persons, Beneficence, Justice.
Question 2
Question 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:
Your Answer Persons with diminished autonomy are entitled to protection.
Result Correct
Comment 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. Persons with diminished autonomy should not be
excluded from participating in research, because then they would be
excluded from receiving the benefits of research. The Belmont Report does
not limit persons with diminished autonomy with participating in greater
than minimal risk research. The Belmont Report also does not limit persons
involved in research from benefitting financially.
Question 3
Question Which of the following is an example of how the principle of beneficence
can be applied to a study employing human subjects?
Your Answer Determining that the study has a maximization of benefits and a
minimization of risks.
Result Correct
,PSYCHOLOGY 430 CITI Assignment
Recognizing and Reporting
Unanticipated Problems Involving
Risks to Subjects or Others in
Biomedical Research
Comment The principle of beneficence includes the obligation of researchers to strive to do
no harm and to maximize benefits and minimize harms. "Persons are treated in
an ethical manner not only by respecting their decisions and protecting them
from harm, but also by making efforts to secure their well-being" (The National
Commission 1979). The principle of beneficence can be applied to a study
employing human subjects by determining that the study has a maximization of
benefits and a minimization of risks. Providing detailed information during
consent and ensuring persons with diminished autonomy are protected would be
examples of applying the principle of respect for persons. Ensuring the selection
of subjects is equitable is an example of applying the principle of justice.
Question 1
Question 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.
Your Answer This is an unanticipated problem requiring notification to the IRB and
FDA.
Result Correct
Comment This is an unanticipated problem because the screening procedure
problem was not anticipated; both the subject and others were
exposed to risk and could have been infected with Hepatitis B or HIV.
A Phase II clinical trial involving a biologic falls under the jurisdiction
of the FDA.
,PSYCHOLOGY 430 CITI Assignment
Question 2
Question 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.
Your Answer This is an unanticipated problem.
Result Correct
Comment This is an unanticipated problem because the actual rate for the
adverse event was significantly higher than expected, placing
subjects at increased risk. The IRB should be notified of all
unanticipated problems. Subjects should always be reconsented
when there is a significant change in risk, which may affect their
willingness to continue in the study. Depending on the funding of the
study, OHRP must be notified. Because the study falls under the
FDA regulations, FDA must be notified.
Question 3
Question 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.
Your Answer This is an unanticipated problem, which resulted in an adverse
event.
Result Correct
Comment Receiving the wrong study drug is an unanticipated problem because
all the criteria for an unanticipated problem are met. This subject
required medical treatment suggesting the increased risk was
serious. This event is also an adverse event because the subject
required medical treatment. The IRB was properly notified and
, PSYCHOLOGY 430 CITI Assignment
approved a change in pharmacy procedures to increase subject
safety. The FDA must be notified.
Question 4
Question 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.
Your Answer This is an unanticipated problem and not an adverse event.
Result Correct
Comment Regardless of the type of study, when subjects’ research records
containing protected health information (PHI) are lost, the event is
considered an unanticipated problem. This event required the
subjects be notified of the increased risk, and required a change in
the way data were stored and protected. This is not an adverse
event because there was no medical occurrence involved. OHRP
should be notified.
Question 5
Question 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.
