IRB Review Questions Correctly
Answered.
A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How
should the investigator proceed, with respect to the IRB, after the discovery of the adverse event
occurrence? - CORRECT ANSWER Report the adverse drug experience in a timely manner, in keeping
with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB.
The most appropriate action for the investigator to take is to report the adverse drug experience in a
timely manner using the forms provided by the institution.
How long is an investigator required to keep consent documents, IRB correspondence, and research
records? - CORRECT ANSWER For a minimum of three years after completion of the study
Research investigators are responsible for retaining signed consent documents, IRB correspondence,
and research records for at least three years after completion of the research. Because research records
are the property of the institution, local institutional policy or sponsoring agency requirements may
dictate these records are kept longer. The sponsor and the IRB office should be contacted to make sure
that the minimum of three years meets their requirements.
According to federal regulations, which of the following best describes when expedited review of a new,
proposed study may be used by the IRB? - CORRECT ANSWER The study involves no more than minimal
risk and meets one of the allowable categories of expedited review specified in federal regulations
The study involves no more than minimal risk and meets one of the allowable categories of expedited
review specified in federal regulations. Expedited review procedures are appropriate only for protocols
that present no greater than "minimal risk" to subjects and involve only procedures included in federally
specified categories. Population considerations, such as healthy volunteers, are only relevant insofar as
they affect the assessment of risk. The IRB may not conduct an expedited review for the convenience of
either the IRB or a student researcher, if the protocol is otherwise not eligible.
Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if: - CORRECT
ANSWER The changes must be immediately implemented for the health and well-being of the subject.
,All amendments involving changes to IRB-approved protocols must be reviewed and approved in
advance of implementation, unless changes must be put in place immediately to respond to an
unexpected risk or problem arising during the course of a study.
IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling
subjects must: - CORRECT ANSWER Occur at least annually.
Approved greater than minimal risk protocols must be reviewed at least annually, although IRBs may
specify a shorter review period. It is the responsibility of the principal investigator to hold signed
consent forms in confidentiality. Copies of these forms are not required by federal regulation to be
reviewed by the IRB. Please note, however, that an institution's local policy may require copies of signed
consent forms as part of the IRB continuing review process.
Which of the following is included in the Nuremberg Code: - CORRECT ANSWER Voluntary consent
The Nuremberg Code included the requirement of the voluntary consent of subjects. While all of the
choices are valid ethical concerns, none of the other choices were included in the Nuremberg Code.
Issued in 1974, 45 CFR 46 raised to regulatory status: - CORRECT ANSWER US Public Health Service Policy
45 CFR 46 raised to regulatory status the US Public Health Service policy of 1966 "Clinical research and
investigation involving human beings".
Which of the following was the result of the Beecher article? - CORRECT ANSWER Realization that ethical
abuses are not limited to the Nazi regime
The primary result of the Beecher article was to expose ethical abuses occurring in research involving
human subjects in the US, well after the revelations about research by the Nazi regime.
The use of prisoners in research is a concern under the Belmont principle of Justice because: - CORRECT
ANSWER Prisoners may not be used to conduct research that only benefits the larger society
, The Belmont Principle of Justice requires the equitable distribution of both the benefits and burdens of
research. Prisoners should not bear the burden of participating in research that only benefits the larger
society.
Informed consent is considered an application of which Belmont principle? - CORRECT ANSWER Respect
for Persons
Respect for persons involves respecting individual autonomy in the decision to participate in research.
That respect is implemented through the process of informed consent.
A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy.
While the study is on-going, a new drug becomes commercially available that may have equal or greater
benefit to the subject. The investigator should do which of the following? - CORRECT ANSWER Give the
subject comprehensive information about the new drug, including its side effects. Discuss the pros and
cons of both the investigational drug and the commercially available drug and then allow the subject to
decide whether to withdraw from the research to take the new drug.
Phase 2 clinical trials involve volunteers who have the disease or condition to be treated. These trials
help physicians and researchers begin to learn more about the safety of the new drug treatment and
how well the drug treats the targeted disease or condition. Several different doses of the drug may be
tested to see which dose has the desired effects. Subjects are monitored for side effects and for any
improvement in their illness, symptoms, or both. Informed consent is not a one-time procedure but a
continuing and ongoing process. 45 CFR 116(b) and 21 CFR 50.25(b) require that the Informed Consent
document include a statement indicating that if significant new findings are developed during research
which may relate to the subject's willingness to continue, they will be explained to the subject. The
Informed Consent document must also describe the process whereby subjects will be notified of
significant new findings.
The purpose of informed consent is: - CORRECT ANSWER To provide a potential subject with appropriate
information in an appropriate manner and allow that person to make an informed decision about
participation in research.
The purpose of the Informed Consent process is to ensure human research subjects are provided all of
the information necessary to make informed choices about participating in research.
An investigator is confronted with a life-threatening situation that necessitates using a test article in a
human subject who is unable to provide informed consent and there is no time to obtain consent from
Answered.
A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How
should the investigator proceed, with respect to the IRB, after the discovery of the adverse event
occurrence? - CORRECT ANSWER Report the adverse drug experience in a timely manner, in keeping
with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB.
The most appropriate action for the investigator to take is to report the adverse drug experience in a
timely manner using the forms provided by the institution.
How long is an investigator required to keep consent documents, IRB correspondence, and research
records? - CORRECT ANSWER For a minimum of three years after completion of the study
Research investigators are responsible for retaining signed consent documents, IRB correspondence,
and research records for at least three years after completion of the research. Because research records
are the property of the institution, local institutional policy or sponsoring agency requirements may
dictate these records are kept longer. The sponsor and the IRB office should be contacted to make sure
that the minimum of three years meets their requirements.
According to federal regulations, which of the following best describes when expedited review of a new,
proposed study may be used by the IRB? - CORRECT ANSWER The study involves no more than minimal
risk and meets one of the allowable categories of expedited review specified in federal regulations
The study involves no more than minimal risk and meets one of the allowable categories of expedited
review specified in federal regulations. Expedited review procedures are appropriate only for protocols
that present no greater than "minimal risk" to subjects and involve only procedures included in federally
specified categories. Population considerations, such as healthy volunteers, are only relevant insofar as
they affect the assessment of risk. The IRB may not conduct an expedited review for the convenience of
either the IRB or a student researcher, if the protocol is otherwise not eligible.
Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if: - CORRECT
ANSWER The changes must be immediately implemented for the health and well-being of the subject.
,All amendments involving changes to IRB-approved protocols must be reviewed and approved in
advance of implementation, unless changes must be put in place immediately to respond to an
unexpected risk or problem arising during the course of a study.
IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling
subjects must: - CORRECT ANSWER Occur at least annually.
Approved greater than minimal risk protocols must be reviewed at least annually, although IRBs may
specify a shorter review period. It is the responsibility of the principal investigator to hold signed
consent forms in confidentiality. Copies of these forms are not required by federal regulation to be
reviewed by the IRB. Please note, however, that an institution's local policy may require copies of signed
consent forms as part of the IRB continuing review process.
Which of the following is included in the Nuremberg Code: - CORRECT ANSWER Voluntary consent
The Nuremberg Code included the requirement of the voluntary consent of subjects. While all of the
choices are valid ethical concerns, none of the other choices were included in the Nuremberg Code.
Issued in 1974, 45 CFR 46 raised to regulatory status: - CORRECT ANSWER US Public Health Service Policy
45 CFR 46 raised to regulatory status the US Public Health Service policy of 1966 "Clinical research and
investigation involving human beings".
Which of the following was the result of the Beecher article? - CORRECT ANSWER Realization that ethical
abuses are not limited to the Nazi regime
The primary result of the Beecher article was to expose ethical abuses occurring in research involving
human subjects in the US, well after the revelations about research by the Nazi regime.
The use of prisoners in research is a concern under the Belmont principle of Justice because: - CORRECT
ANSWER Prisoners may not be used to conduct research that only benefits the larger society
, The Belmont Principle of Justice requires the equitable distribution of both the benefits and burdens of
research. Prisoners should not bear the burden of participating in research that only benefits the larger
society.
Informed consent is considered an application of which Belmont principle? - CORRECT ANSWER Respect
for Persons
Respect for persons involves respecting individual autonomy in the decision to participate in research.
That respect is implemented through the process of informed consent.
A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy.
While the study is on-going, a new drug becomes commercially available that may have equal or greater
benefit to the subject. The investigator should do which of the following? - CORRECT ANSWER Give the
subject comprehensive information about the new drug, including its side effects. Discuss the pros and
cons of both the investigational drug and the commercially available drug and then allow the subject to
decide whether to withdraw from the research to take the new drug.
Phase 2 clinical trials involve volunteers who have the disease or condition to be treated. These trials
help physicians and researchers begin to learn more about the safety of the new drug treatment and
how well the drug treats the targeted disease or condition. Several different doses of the drug may be
tested to see which dose has the desired effects. Subjects are monitored for side effects and for any
improvement in their illness, symptoms, or both. Informed consent is not a one-time procedure but a
continuing and ongoing process. 45 CFR 116(b) and 21 CFR 50.25(b) require that the Informed Consent
document include a statement indicating that if significant new findings are developed during research
which may relate to the subject's willingness to continue, they will be explained to the subject. The
Informed Consent document must also describe the process whereby subjects will be notified of
significant new findings.
The purpose of informed consent is: - CORRECT ANSWER To provide a potential subject with appropriate
information in an appropriate manner and allow that person to make an informed decision about
participation in research.
The purpose of the Informed Consent process is to ensure human research subjects are provided all of
the information necessary to make informed choices about participating in research.
An investigator is confronted with a life-threatening situation that necessitates using a test article in a
human subject who is unable to provide informed consent and there is no time to obtain consent from
