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CITI Training, Modules 1-24 (Biomedical Research)
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CITI Training, Modules 1-24 (Biomedical Research)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:
A. Persons with diminished autonomy should only participate in no more than
minimal risk research.
B. Persons with diminished autonomy should be excluded from research.
C. Persons with diminished autonomy are entitled to protection.
D. Persons involved in research cannot financially benefit. - -C. Persons with
diminished autonomy are entitled to protection.
-Which of the following is an example of how the principle of beneficence
can be applied to a study employing human subjects?
A. Ensuring that persons with diminished autonomy are protected.
B. Providing detailed information about the study and obtaining the subject's
consent to participate.
C. Determining that the study has a maximization of benefits and a
minimization of risks.
D. Ensuring that the selection of subjects includes people from all segments
of the population. - -C. Determining that the study has a maximization of
benefits and a minimization of risks.
-Which of the following are the three principles discussed in the Belmont
Report?
A. IRB Review, Federal Regulations, Declaration of Helsinki
B. Privacy, Confidentiality, Equitable Selection of Subjects
C. Informed Consent, Institutional Assurance, Researcher Responsibility
D. Respect for Persons, Beneficence, Justice - -D. Respect for Persons,
Beneficence, Justice
-When an IRB is reviewing a research study and they are considering if a
potential subject population is vulnerable, they should consider:
A. Are there adequate resources to conduct the study?
B. Is there a power differential between researchers and subjects?
C. Has the researcher completed required training?
D. Are the research procedures greater than minimal risk of harm? - -B. Is
there a power differential between researchers and subjects?
-Which is an example of a situation where deferential vulnerability might be
a factor?
A. An army medical officer recruiting subjects among lower ranks
B. A college professor recruiting among their students
C. A physician recruiting patients to be subjects
,D. An employer recruiting among persons who directly report to them - -C. A
physician recruiting patients to be subjects
-In considering NBAC's analytic approach, an otherwise competent person
who is acutely ill might be considered at especially high risk of harm for:
A. Economic vulnerability
B. Situational cognitive vulnerability
C. Capacity-related cognitive vulnerability
D. Communicative vulnerability - -B. Situational cognitive vulnerability
-Identify the following groups that are protected in the federal regulations
(45 CFR 46), specifically in Subparts B, C, and D with additional protections:
A. Pregnant women, prisoners, and mentally disabled
B. Children, prisoners, and terminally ill
C. Prisoners, children, and elderly
D. Pregnant women, prisoners, children - -D. Pregnant women, prisoners,
children
-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:
A. Institutional vulnerability
B. Cognitive or communicative vulnerability
C. Physical vulnerability
D. Economic or social vulnerability - -B. Cognitive or communicative
vulnerability
-The use of prisoners in research is a concern under the Belmont principle of
Justice because:
A. Prisoners are less educated that the general population and have difficulty
understanding research
B. Prisoners may not be used to conduct research that only benefits the
larger society
C. Prisoners are not a representative sample of the general population
D. Prisoners are not free to say no - -B. Prisoners may not be used to
conduct research that only benefits the larger society
-Which of the following is included in the Nuremberg Code:
A. Additional protection for vulnerable subjects
B. Equitable selection of subjects
C. Confidentiality of data
D. Voluntary consent - -D. Voluntary consent
, -Which of the following brought increased public attention to the problems
with the IRB system?
A. 1983 Presidential Commission Report
B. HHS Inspector General Report of 1998
C. "Shut Downs" by OHRP
D. Death of Research Subject (Jesse Gelsinger) - -D. Death of Research
Subject (Jesse Gelsinger)
-Informed consent is considered an application of which Belmont principle?
A. Non-maleficence
B. Justice
C. Beneficence
D. Respect for Persons - -D. Respect for Persons
-The National Research Act of 1974
A. Required that all federal agencies have the same regulations governing
human subjects research.
B. Identified guidelines to ensure the ethical conduct of research.
C. Established the National Commission.
D. Identified the basic ethical principles of human subjects research. - -C.
Established the National Commission.
-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?
A. 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.
B. Report the adverse drug experience as part of the continuing review
report.
C. Do not report the adverse drug experience to the IRB since it is a common
adverse experience.
D. Report the adverse drug experience to the IRB only if there are several
other occurrences. - -A. 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.
-How long is an investigator required to keep consent documents, IRB
correspondence, and research records?
A. As long as the investigator is at that institution
B. For a minimum of three years after completion of the study
C. Until data analysis is complete
D. Until the study is closed - -B. For a minimum of three years after
completion of the study
, -According to federal regulations, which of the following best describes when
expedited review of a new, proposed study may be used by the IRB?
A. The study is required for a student research project
B. The study includes only research subjects that are healthy volunteers.
C. The study does not require informed consent or survey instruments.
D. The study involves no more than minimal risk and meets one of the
allowable categories of expedited review specified in federal regulations - -
D. The study involves no more than minimal risk and meets one of the
allowable categories of expedited review specified in federal regulations
-Amendments involving changes to IRB-approved protocols do NOT need
prior IRB approval if:
A. They only involve changes to the consent form.
B. The changes must be immediately implemented for the health and well-
being of the subject.
C. They are eligible for review using expedited procedures.
D. The investigator keeps careful records of all changes and includes them in
the final report. - -B. The changes must be immediately implemented for the
health and well-being of the subject.
-IRB continuing review of a greater than minimal risk approved protocol that
is currently enrolling subjects must:
A. Include copies of all signed consent forms.
B. Occur at least annually.
C. Be conducted by an expedited review.
D. Occur only when the level of risk changes. - -B. Occur at least annually.
-A general requirement for the informed consent form is that it may not
include any exculpatory language. Exculpatory language is that which waives
or appears to waive any of the subject's legal rights or releases or appears to
release those conducting the research from liability for negligence. Which of
the following statements in a consent form is an example of exculpatory
language?
A. In the event of any injury you may have related to this research, you will
be given medical treatment.
B. Your participation in this research is voluntary. If you choose not to
participate, or change your mind later, your decision will not affect your
relationship with your doctor or your right to health care or other services
that you may be eligible for.
C. The investigator may stop you from participating in this research without
your consent if you experience side effects that make your condition worse.
If you become ill during the - -D. I waive any possibility of compensation for
injuries that I may receive as a result of participation in this 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
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