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CITI Training, Modules 1-24 (Biomedical
Research) | Comprehensive Questions With
Correct Detailed Answers
Which of the following statements is accurate in determining subject risk involved
in a genetic study:
A. Understanding the risks involved in other genetic studies is critical in
determining the risk involved in a new study
B. All genetic studies should be considered greater than minimal risk
C. All genetic studies should be considered no more than minimal risk
D. Understanding the purpose and context of a specific study is critical in
determining the risk involved - Correct-answer-D. Understanding the purpose and
context of a specific study is critical in determining the risk involved
Under which of the following conditions is it appropriate to re-contact the
individuals who provided biological specimens?
A. Subjects received financial compensation for participation in the study
B. Original signed consent documents include provisions for recontacting subjects
C. Discovery of related clinical information requires contacting subjects for follow-
up
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D. Biological specimens need to be replenished - Correct-answer-B. Original
signed consent documents include provisions for recontacting subjects
Which choice best describes the purpose of most pharmacogenomic research?
A. To evaluate the association between individual genotypes and the safety and
efficacy of a particular drug or class of drugs
B. To evaluate how different racial and ethnic groups respond to certain drugs or
classes of drugs
C. To evaluate how the genomes of infectious agents impact the efficacy of
certain antibiotics
D. To evaluate whether genetic testing can reduce the cost of pharmaceuticals -
Correct-answer-A. To evaluate the association between individual genotypes and
the safety and efficacy of a particular drug or class of drugs
Investigator A conducts research on emphysema using biospecimens from human
subjects. The consent form indicates that the research will focus exclusively on
emphysema. Investigator B wishes to use the biospecimens for research on lung
cancer. Can Investigator B use the specimens for cancer research without re-
consent if the specimens are de-identified?
A. No, because it would be unethical to conduct research that is not consistent
with the consent form the subjects originally signed.
B. Yes, if the biospecimens are de-identified then the research is no longer
considered human subjects research.
C. Yes, because research with biospecimens is minimal risk.
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D. No, the original research subjects must be re-consented for the cancer
research. - Correct-answer-B. Yes, if the biospecimens are de-identified then the
research is no longer considered human subjects research.
Which choice is the best definition of "genetic determinism?"
A. Genetic information about an individual can foster stigma and discrimination
B. Genetic testing can determine appropriate treatments for certain health
conditions
C. Parents determine the nature of their children through the inheritance of
genes
D. Genes are primarily responsible for human traits, including health, behavior,
and disease - Correct-answer-D. Genes are primarily responsible for human traits,
including health, behavior, and disease
Which choice best describes the purpose of most pharmacogenomic research?
A. To evaluate whether genetic testing can reduce the cost of pharmaceuticals
B. To evaluate the association between individual genotypes and the safety and
efficacy of a particular drug or class of drugs
C. To evaluate how the genomes of infectious agents impact the efficacy of
certain antibiotics
D. To evaluate how different racial and ethnic groups respond to certain drugs or
classes of drugs - Correct-answer-B. To evaluate the association between
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individual genotypes and the safety and efficacy of a particular drug or class of
drugs
Under which of the following conditions is it appropriate to re-contact the
individuals who provided biological specimens?
A. Original signed consent documents include provisions for recontacting subjects
B. Biological specimens need to be replenished
C. Discovery of related clinical information requires contacting subjects for follow-
up
D. Subjects received financial compensation for participation in the study -
Correct-answer-A. Original signed consent documents include provisions for
recontacting subjects
When conducting research that involves collecting biological specimens for
genetic testing, which of the following issues is the most important for the IRB to
consider?
A. Need for publication of results
B. Ownership of biological specimens
C. Effects of findings on other family members
D. Long term financial impact of results - Correct-answer-C. Effects of findings on
other family members
CITI Training, Modules 1-24 (Biomedical
Research) | Comprehensive Questions With
Correct Detailed Answers
Which of the following statements is accurate in determining subject risk involved
in a genetic study:
A. Understanding the risks involved in other genetic studies is critical in
determining the risk involved in a new study
B. All genetic studies should be considered greater than minimal risk
C. All genetic studies should be considered no more than minimal risk
D. Understanding the purpose and context of a specific study is critical in
determining the risk involved - Correct-answer-D. Understanding the purpose and
context of a specific study is critical in determining the risk involved
Under which of the following conditions is it appropriate to re-contact the
individuals who provided biological specimens?
A. Subjects received financial compensation for participation in the study
B. Original signed consent documents include provisions for recontacting subjects
C. Discovery of related clinical information requires contacting subjects for follow-
up
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D. Biological specimens need to be replenished - Correct-answer-B. Original
signed consent documents include provisions for recontacting subjects
Which choice best describes the purpose of most pharmacogenomic research?
A. To evaluate the association between individual genotypes and the safety and
efficacy of a particular drug or class of drugs
B. To evaluate how different racial and ethnic groups respond to certain drugs or
classes of drugs
C. To evaluate how the genomes of infectious agents impact the efficacy of
certain antibiotics
D. To evaluate whether genetic testing can reduce the cost of pharmaceuticals -
Correct-answer-A. To evaluate the association between individual genotypes and
the safety and efficacy of a particular drug or class of drugs
Investigator A conducts research on emphysema using biospecimens from human
subjects. The consent form indicates that the research will focus exclusively on
emphysema. Investigator B wishes to use the biospecimens for research on lung
cancer. Can Investigator B use the specimens for cancer research without re-
consent if the specimens are de-identified?
A. No, because it would be unethical to conduct research that is not consistent
with the consent form the subjects originally signed.
B. Yes, if the biospecimens are de-identified then the research is no longer
considered human subjects research.
C. Yes, because research with biospecimens is minimal risk.
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D. No, the original research subjects must be re-consented for the cancer
research. - Correct-answer-B. Yes, if the biospecimens are de-identified then the
research is no longer considered human subjects research.
Which choice is the best definition of "genetic determinism?"
A. Genetic information about an individual can foster stigma and discrimination
B. Genetic testing can determine appropriate treatments for certain health
conditions
C. Parents determine the nature of their children through the inheritance of
genes
D. Genes are primarily responsible for human traits, including health, behavior,
and disease - Correct-answer-D. Genes are primarily responsible for human traits,
including health, behavior, and disease
Which choice best describes the purpose of most pharmacogenomic research?
A. To evaluate whether genetic testing can reduce the cost of pharmaceuticals
B. To evaluate the association between individual genotypes and the safety and
efficacy of a particular drug or class of drugs
C. To evaluate how the genomes of infectious agents impact the efficacy of
certain antibiotics
D. To evaluate how different racial and ethnic groups respond to certain drugs or
classes of drugs - Correct-answer-B. To evaluate the association between
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individual genotypes and the safety and efficacy of a particular drug or class of
drugs
Under which of the following conditions is it appropriate to re-contact the
individuals who provided biological specimens?
A. Original signed consent documents include provisions for recontacting subjects
B. Biological specimens need to be replenished
C. Discovery of related clinical information requires contacting subjects for follow-
up
D. Subjects received financial compensation for participation in the study -
Correct-answer-A. Original signed consent documents include provisions for
recontacting subjects
When conducting research that involves collecting biological specimens for
genetic testing, which of the following issues is the most important for the IRB to
consider?
A. Need for publication of results
B. Ownership of biological specimens
C. Effects of findings on other family members
D. Long term financial impact of results - Correct-answer-C. Effects of findings on
other family members
