CITI TRAINING QUIZ -

CITI TRAINING QUIZ -

QUESTIONS AND CORRECT DETAILED

ANSWERS||AGRADE

• Which of the following are the three principles discussed in the Belmont

Report? - ANSWER- Respect for Persons, Beneficence, Justice

• 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: - ANSWER- 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? - ANSWER- Determining that the study has a maximization of benefits and a minimization of risks.

4. The Data Manager should review the study protocol: - ANSWER- to understand

primary and secondary endpoints

• When designing a database and data collection instruments for a study, the Data

Manager should: - ANSWER- Use standards to reduce the time required to set up

the database and to increase the consistency of the data

Every member of a study team must define quality the same way in order to produce a high quality database. - ANSWER- False

Which member of a study team is ultimately responsible for the conduct of the study at a site? - ANSWER- The Investigator

Which member of a study team acts as the liaison between a sponsor and site, ensuring that reported data are verifiable to source documentation? - ANSWER- The Clinical Research Associate

In order for a quality process to work, study team members must understand all of

the following EXCEPT: - ANSWER- how to perform the other team members'

jobs

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Typical study conduct activities performed by the data manager include all of the

following EXCEPT: - ANSWER- defining edit checks

At what point should a Data Manager get involved with the database development?

• ANSWER- At study startup

Prior to locking a database, a data manager should ensure all data have been entered and all queries are resolved. - ANSWER- True

Which of the following is included in the Nuremberg Code:

• Voluntary consent
• Confidentiality of data
• Equitable selection of subjects
• Additional protection for vulnerable subjects - ANSWER- Voluntary consent

Which of the following brought increased public attention to the problems with the IRB system?

• Death of Research Subject (Jesse Gelsinger)
• "Shut Downs" by OHRP
• HHS Inspector General Report of 1998
• 1983 Presidential Commission Report - ANSWER- Death of Research Subject

(Jesse Gelsinger)

The use of prisoners in research is a concern under the Belmont principle of Justice

because:

• Prisoners are not a representative sample of the general population
• Prisoners are not free to say no
• Prisoners may not be used to conduct research that only benefits the larger

society

• Prisoners are less educated that the general population and have difficulty

understanding research - ANSWER- Prisoners may not be used to conduct research that only benefits the larger society

Informed consent is considered an application of which Belmont principle?

• Beneficence
• Justice 2 / 4

• Non-maleficence
• Respect for Persons - ANSWER- Respect for persons

Which of the following was the result of the Beecher article?

• Additional FDA regulations
• Realization that ethical abuses are not limited to the Nazi regime
• An identification of basic ethical principles
• Multiple Congressional hearings - ANSWER- Realization that ethical abuses

are not limited to the Nazi regime

Which of the following statements is accurate in determining subject risk involved

in a genetic study: - ANSWER- Understanding the purpose and context of a

specific study is critical in determining the risk involved

As of January 2015, the NIH expects investigators to obtain the informed (valid) consent of research participants in NIH -funded genetic research for broad research use of data and data sharing, even if the cell lines or specimens are: - ANSWER- De-Identified

Under which of the following conditions is it appropriate to re-contact the individuals who provided biological specimens? - ANSWER- Original signed consent documents include provisions for recontacting subjects

Identify which types of discrimination the Genetic Information Non-

Discrimination Act (GINA) protects individuals from: - ANSWER- Health

insurance and employment discrimination

Which choice is the best definition of "genetic determinism?" - ANSWER- Genes are primarily responsible for human traits, including health, behavior, and disease

Under which circumstance does the FDA allow verbal consent prior to participation in a research study?

• The subject has a legally authorized representative (LAR).
• The study is minimal risk.
• The subject is illiterate.
• The study is greater than minimal risk. - ANSWER- The study is minimal risk.
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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 for the individual's legal representative.Under the FDA regulations, which of the following describes the best course of

action for the investigator:

• Do not use the test article until either the subject or the subject's legally

authorized representative can give consent.

• Submit a research protocol to the IRB and justify an expedited review approval

of the consent document so the test article can be used immediately.

• The investigator and another physician not part of the study team agree that the

situation necessitates the use of the test article and the IRB will be notified later.

• Sign the consent form on behalf of the subject and use the test article. -

ANSWER- The investigator and another physician not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later.

Which of the following statements in a consent form is an example of exculpatory language?

• In the event of any injury related to this research, you will be given medical

treatment.

• 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.

• 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 research, you may have to drop out.

• I waive any possibility of compensation for injuries that I may receive as a

result of participation in this research. - ANSWER- I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.

A 46-year-old man is currently enrolled in a Phase III study of a drug for severe diabetic neuropathy. While the study is ongoing, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?

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