IRB Review Questions with 100% Verified & Correct
Answers Rated A
A subject in a clinical research trial experiences a
serious, unanticipated adverse drug experience. The study involves no more than minimal risk and
How should the investigator proceed, with meets one of the allowable categories of
respect to the IRB, after the discovery of the expedited review specified in federal regulations.
adverse event occurrence? - ANSWER - Expedited review procedures are appropriate
Report the adverse drug experience in a timely only for protocols that present no greater than
manner, in keeping with the IRB's policies and "minimal risk" to subjects and involve only
procedures, using the forms or the mechanism procedures included in federally specified
provided by the IRB. categories. Population considerations, such as
healthy volunteers, are only relevant insofar as
The most appropriate action for the investigator they affect the assessment of risk. The IRB may
to take is to report the adverse drug experience not conduct an expedited review for the
in a timely manner using the forms provided by convenience of either the IRB or a student
the institution. researcher, if the protocol is otherwise not
eligible.
How long is an investigator required to keep
consent documents, IRB correspondence, and Amendments involving changes to IRB-approved
research records? - ANSWER -For a protocols do NOT need prior IRB approval if: -
minimum of three years after completion of the ANSWER -The changes must be
study immediately implemented for the health and well-
being of the subject.
Research investigators are responsible for
retaining signed consent documents, IRB All amendments involving changes to IRB-
correspondence, and research records for at approved protocols must be reviewed and
least three years after completion of the approved in advance of implementation, unless
research. Because research records are the changes must be put in place immediately to
property of the institution, local institutional policy respond to an unexpected risk or problem arising
or sponsoring agency requirements may dictate during the course of a study.
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. IRB continuing review of a greater than minimal
risk approved protocol that is currently enrolling
subjects must: - ANSWER -Occur at least
annually.
According to federal regulations, which of the
following best describes when expedited review Approved greater than minimal risk protocols
of a new, proposed study may be used by the must be reviewed at least annually, although
IRB? - ANSWER -The study involves no IRBs may specify a shorter review period. It is the
more than minimal risk and meets one of the responsibility of the principal investigator to hold
allowable categories of expedited review signed consent forms in confidentiality. Copies of
specified in federal regulations these forms are not required by federal regulation
,IRB Review Questions with 100% Verified & Correct
Answers Rated A
to be reviewed by the IRB. Please note, ANSWER -Prisoners may not be used to
however, that an institution's local policy may conduct research that only benefits the larger
require copies of signed consent forms as part of society
the IRB continuing review process.
The Belmont Principle of Justice requires the
equitable distribution of both the benefits and
burdens of research. Prisoners should not bear
Which of the following is included in the the burden of participating in research that only
Nuremberg Code: - ANSWER -Voluntary benefits the larger society.
consent
The Nuremberg Code included the requirement
of the voluntary consent of subjects. While all of Informed consent is considered an application of
the choices are valid ethical concerns, none of which Belmont principle? - ANSWER -
the other choices were included in the Respect for Persons
Nuremberg Code.
Respect for persons involves respecting
individual autonomy in the decision to participate
in research. That respect is implemented through
Issued in 1974, 45 CFR 46 raised to regulatory the process of informed consent.
status: - ANSWER -US Public Health
Service Policy
45 CFR 46 raised to regulatory status the US A 46-year-old man is currently enrolled in a
Public Health Service policy of 1966 "Clinical Phase 2 study of a drug for severe diabetic
research and investigation involving human neuropathy. While the study is on-going, a new
beings". drug becomes commercially available that may
have equal or greater benefit to the subject. The
investigator should do which of the following? -
ANSWER -Give the subject comprehensive
Which of the following was the result of the information about the new drug, including its side
Beecher article? - ANSWER -Realization effects. Discuss the pros and cons of both the
that ethical abuses are not limited to the Nazi investigational drug and the commercially
regime available drug and then allow the subject to
decide whether to withdraw from the research to
The primary result of the Beecher article was to take the new drug.
expose ethical abuses occurring in research
involving human subjects in the US, well after the Phase 2 clinical trials involve volunteers who
revelations about research by the Nazi regime. 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
The use of prisoners in research is a concern targeted disease or condition. Several different
under the Belmont principle of Justice because: - doses of the drug may be tested to see which
, IRB Review Questions with 100% Verified & Correct
Answers Rated A
dose has the desired effects. Subjects are be notified later.
monitored for side effects and for any
improvement in their illness, symptoms, or both. The life- threatening situation requires a timely
Informed consent is not a one-time procedure but decision so that the test article can be ethically
a continuing and ongoing process. 45 CFR used. It would be unethical to withhold
116(b) and 21 CFR 50.25(b) require that the emergency treatment until a research protocol is
Informed Consent document include a statement submitted and approved by the IRB. Not using
indicating that if significant new findings are the test article in a situation where it might save a
developed during research which may relate to life is also unethical. The Federal regulations (21
the subject's willingness to continue, they will beCFR 50.24) provide the option of using the test
explained to the subject. The Informed Consent article in a life-threatening condition involving an
document must also describe the process individual subject where the following
whereby subjects will be notified of significant requirements for an exception from informed
new findings. consent are met. 1. The investigator, with the
concurrence of another physician, believes the
situation necessitates the use of a test article
(i.e., an investigational drug, device, or biologic).
The purpose of informed consent is: - 2. The subject and/or legally authorized
ANSWER -To provide a potential subject representative is unable to communicate consent
with appropriate information in an appropriate 3. There is insufficient time to obtain consent.
manner and allow that person to make an And 4. No alternative exists that will provide an
informed decision about participation in research. equal or better chance of saving the subject's life.
The purpose of the Informed Consent process is
to ensure human research subjects are provided
all of the information necessary to make informed An elderly gentleman, whose wife is his legally
choices about participating in research. authorized representative (LAR) since his strokes
several years ago, was recently diagnosed with
lung cancer. He is eligible for a clinical trial using
a new investigational drug that aims to treat lung
An investigator is confronted with a life- cancer. He is able to express interest, shows a
threatening situation that necessitates using a basic understanding of the nature of the trial, and
test article in a human subject who is unable to gives his assent to participation. The subject's
provide informed consent and there is no time to wife is out of town on a business trip.
obtain consent from the individual's LAR and no Which of the following is the most appropriate
alternative method or recognized therapy is action to take for the investigator? -
available. Under the FDA regulations for using ANSWER -Send a copy of the informed
test articles, which of the following describes the consent via facsimile to the subject's wife. After
best course of action for the investigator: - she has had the opportunity to speak to the
ANSWER -The investigator and an investigator, she can sign the informed consent
independent physician agree that the situation and fax it back.
necessitates the use of the test article. An
exception or waiver for informed consent can be The IRB will not provide a waiver of consent
made under these circumstances. The IRB will under these circumstances and the man should
Answers Rated A
A subject in a clinical research trial experiences a
serious, unanticipated adverse drug experience. The study involves no more than minimal risk and
How should the investigator proceed, with meets one of the allowable categories of
respect to the IRB, after the discovery of the expedited review specified in federal regulations.
adverse event occurrence? - ANSWER - Expedited review procedures are appropriate
Report the adverse drug experience in a timely only for protocols that present no greater than
manner, in keeping with the IRB's policies and "minimal risk" to subjects and involve only
procedures, using the forms or the mechanism procedures included in federally specified
provided by the IRB. categories. Population considerations, such as
healthy volunteers, are only relevant insofar as
The most appropriate action for the investigator they affect the assessment of risk. The IRB may
to take is to report the adverse drug experience not conduct an expedited review for the
in a timely manner using the forms provided by convenience of either the IRB or a student
the institution. researcher, if the protocol is otherwise not
eligible.
How long is an investigator required to keep
consent documents, IRB correspondence, and Amendments involving changes to IRB-approved
research records? - ANSWER -For a protocols do NOT need prior IRB approval if: -
minimum of three years after completion of the ANSWER -The changes must be
study immediately implemented for the health and well-
being of the subject.
Research investigators are responsible for
retaining signed consent documents, IRB All amendments involving changes to IRB-
correspondence, and research records for at approved protocols must be reviewed and
least three years after completion of the approved in advance of implementation, unless
research. Because research records are the changes must be put in place immediately to
property of the institution, local institutional policy respond to an unexpected risk or problem arising
or sponsoring agency requirements may dictate during the course of a study.
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. IRB continuing review of a greater than minimal
risk approved protocol that is currently enrolling
subjects must: - ANSWER -Occur at least
annually.
According to federal regulations, which of the
following best describes when expedited review Approved greater than minimal risk protocols
of a new, proposed study may be used by the must be reviewed at least annually, although
IRB? - ANSWER -The study involves no IRBs may specify a shorter review period. It is the
more than minimal risk and meets one of the responsibility of the principal investigator to hold
allowable categories of expedited review signed consent forms in confidentiality. Copies of
specified in federal regulations these forms are not required by federal regulation
,IRB Review Questions with 100% Verified & Correct
Answers Rated A
to be reviewed by the IRB. Please note, ANSWER -Prisoners may not be used to
however, that an institution's local policy may conduct research that only benefits the larger
require copies of signed consent forms as part of society
the IRB continuing review process.
The Belmont Principle of Justice requires the
equitable distribution of both the benefits and
burdens of research. Prisoners should not bear
Which of the following is included in the the burden of participating in research that only
Nuremberg Code: - ANSWER -Voluntary benefits the larger society.
consent
The Nuremberg Code included the requirement
of the voluntary consent of subjects. While all of Informed consent is considered an application of
the choices are valid ethical concerns, none of which Belmont principle? - ANSWER -
the other choices were included in the Respect for Persons
Nuremberg Code.
Respect for persons involves respecting
individual autonomy in the decision to participate
in research. That respect is implemented through
Issued in 1974, 45 CFR 46 raised to regulatory the process of informed consent.
status: - ANSWER -US Public Health
Service Policy
45 CFR 46 raised to regulatory status the US A 46-year-old man is currently enrolled in a
Public Health Service policy of 1966 "Clinical Phase 2 study of a drug for severe diabetic
research and investigation involving human neuropathy. While the study is on-going, a new
beings". drug becomes commercially available that may
have equal or greater benefit to the subject. The
investigator should do which of the following? -
ANSWER -Give the subject comprehensive
Which of the following was the result of the information about the new drug, including its side
Beecher article? - ANSWER -Realization effects. Discuss the pros and cons of both the
that ethical abuses are not limited to the Nazi investigational drug and the commercially
regime available drug and then allow the subject to
decide whether to withdraw from the research to
The primary result of the Beecher article was to take the new drug.
expose ethical abuses occurring in research
involving human subjects in the US, well after the Phase 2 clinical trials involve volunteers who
revelations about research by the Nazi regime. 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
The use of prisoners in research is a concern targeted disease or condition. Several different
under the Belmont principle of Justice because: - doses of the drug may be tested to see which
, IRB Review Questions with 100% Verified & Correct
Answers Rated A
dose has the desired effects. Subjects are be notified later.
monitored for side effects and for any
improvement in their illness, symptoms, or both. The life- threatening situation requires a timely
Informed consent is not a one-time procedure but decision so that the test article can be ethically
a continuing and ongoing process. 45 CFR used. It would be unethical to withhold
116(b) and 21 CFR 50.25(b) require that the emergency treatment until a research protocol is
Informed Consent document include a statement submitted and approved by the IRB. Not using
indicating that if significant new findings are the test article in a situation where it might save a
developed during research which may relate to life is also unethical. The Federal regulations (21
the subject's willingness to continue, they will beCFR 50.24) provide the option of using the test
explained to the subject. The Informed Consent article in a life-threatening condition involving an
document must also describe the process individual subject where the following
whereby subjects will be notified of significant requirements for an exception from informed
new findings. consent are met. 1. The investigator, with the
concurrence of another physician, believes the
situation necessitates the use of a test article
(i.e., an investigational drug, device, or biologic).
The purpose of informed consent is: - 2. The subject and/or legally authorized
ANSWER -To provide a potential subject representative is unable to communicate consent
with appropriate information in an appropriate 3. There is insufficient time to obtain consent.
manner and allow that person to make an And 4. No alternative exists that will provide an
informed decision about participation in research. equal or better chance of saving the subject's life.
The purpose of the Informed Consent process is
to ensure human research subjects are provided
all of the information necessary to make informed An elderly gentleman, whose wife is his legally
choices about participating in research. authorized representative (LAR) since his strokes
several years ago, was recently diagnosed with
lung cancer. He is eligible for a clinical trial using
a new investigational drug that aims to treat lung
An investigator is confronted with a life- cancer. He is able to express interest, shows a
threatening situation that necessitates using a basic understanding of the nature of the trial, and
test article in a human subject who is unable to gives his assent to participation. The subject's
provide informed consent and there is no time to wife is out of town on a business trip.
obtain consent from the individual's LAR and no Which of the following is the most appropriate
alternative method or recognized therapy is action to take for the investigator? -
available. Under the FDA regulations for using ANSWER -Send a copy of the informed
test articles, which of the following describes the consent via facsimile to the subject's wife. After
best course of action for the investigator: - she has had the opportunity to speak to the
ANSWER -The investigator and an investigator, she can sign the informed consent
independent physician agree that the situation and fax it back.
necessitates the use of the test article. An
exception or waiver for informed consent can be The IRB will not provide a waiver of consent
made under these circumstances. The IRB will under these circumstances and the man should
