CITI Training Quiz Questions Latest Update

CITI Training Quiz Questions Latest Update 2024-2025 Exam 250 Questions and 100% Verified Correct Answers Guaranteed A+

• Which of the following are the three principles discussed in the Belmont Report? -

CORRECT 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: - CORRECT 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? - CORRECT ANSWER: Determining that

the study has a maximization of benefits and a minimization of risks.

• The Data Manager should review the study protocol: - CORRECT ANSWER: to

understand primary and secondary endpoints

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

Manager should: - CORRECT ANSWER: Use standards to reduce the time required to set up the database and to increase the consistency of the data

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?

• 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.

• Tell the subject about the new drug but discourage him from switching treatments

until the study is completed

• Withhold this new information to avoid confusing the subject with other treatment

options or alternatives

• Do not tell the subject about the new drug since physicians have the right to try out

new treatments with their patients - CORRECT ANSWER: 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.

A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include 1 / 4

any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects.

Which of the following considerations was relevant to the IRB's determination that this activity does not constitute research with human subjects? - CORRECT ANSWER: The researcher will not be interacting/intervening with subjects and the data has no identifiers.

According to U.S. Federal Research Misconduct Policy, which of the following is considered to be research misconduct?

• Gift authorship
• Plagiarism
• Conflict of interest

D. Harassing a co-worker - CORRECT ANSWER: B. Plagiarism

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. - CORRECT

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.

An investigator obtains consent and HIPAA authorization from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with subject identifiers in a database that he keeps on

his laptop computer. His laptop is stolen. This incident constitutes: - CORRECT

ANSWER: A breach of confidentiality

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: - CORRECT ANSWER: De- Identified

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

CORRECT ANSWER: At study startup

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Every member of a study team must define quality the same way in order to produce a

high quality database. - CORRECT ANSWER: False

Identify the example of when situation and time are key to assessing risk of harm in a research study: - CORRECT ANSWER: Asking women if they have had an abortion

Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA) protects individuals from: - CORRECT ANSWER: Health insurance and employment discrimination

If a researcher creates the idea for a project and is not listed in the preferred author order position on resulting publications, is this considered to be research misconduct under federal policy?

• Yes because it involves a form of falsification.
• No; instead it is a type of authorship dispute.
• No; instead it is a type of financial conflict of interest.
• Yes because it involves a form of fabrication. - CORRECT ANSWER: B. No; instead

it is a type of authorship dispute.

If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the

research, which of the following would be most helpful:

• Obtain a waiver of documentation of informed consent.
• Have the subject sign the consent form under an assumed name.
• Code the subjects' responses.
• Obtain a Certificate of Confidentiality. - CORRECT ANSWER: A. Obtain a waiver of

documentation of informed consent.

In order for a quality process to work, study team members must understand all of the following EXCEPT: - CORRECT ANSWER: how to perform the other team members' jobs

In order to grant a waiver or alteration of the requirements of informed consent, an IRB

must find ? - CORRECT ANSWER: The research could not practicably be carried out

without the waiver of consent.

Informed consent is considered an application of which Belmont principle?

• Beneficence
• Justice
• Non-maleficence

D. Respect for Persons - CORRECT ANSWER: Respect for persons

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Prior to locking a database, a data manager should ensure all data have been entered

and all queries are resolved. - CORRECT ANSWER: True

Risk of harm in social and behavioral sciences generally fall in three categories, which

are:

• Invasion of privacy, adverse reaction to study drug, and discrimination
• Breach of confidentiality, loss of autonomy, and study procedures
• Invasion of privacy, breach of confidentiality, and study procedures
• Study procedures, breach of confidentiality, and loss of employment - CORRECT

ANSWER: Invasion of privacy, breach of confidentiality, and study procedures

The internet can be used as a research tool or as the object of a study. Which of the following examples best describes an investigator using the internet as a research tool?

• An investigator designs a computer program to extract work experience information

from LinkedIn profiles.

• An investigator analyzes user comments on articles posted on her university's

website.

• An investigator uses his Facebook wall to post a URL link to a survey he is hosting

on SurveyMonkey.

• An investigator registers an account on SecondLife to observe the way people

interact with each other. - CORRECT ANSWER: C.

The primary purpose of a Certificate of Confidentiality is to:

• Allow law enforcement to investigate abuse cases.
• Protect researchers from disclosing conflicts of interest.
• Prevent subjects from knowing the purpose of a study.
• Protect identifiable research information from compelled disclosure. - CORRECT

ANSWER: Protect identifiable research information from compelled disclosure.

The typical first main phase in response to a research misconduct allegation is called:

• The audit
• Remediation
• The inquiry

D. The adjudication - CORRECT ANSWER: C. The inquiry

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
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