◉ CITI Program
C
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Collaborative Institutional Training Initiative — A Division of BRANY
EST. 2000
A D V A N C I N G R E S E A R C H E T H I C S A N D E D U C AT I O N
CITI Training Quiz — Research Ethics & Compliance
B E L M O N T R E P O RT · I R B · I N FO R M E D CO N S E N T · DATA M A N AG E M E N T · R E S E A R C H
M I S CO N D U CT
INSTITUTION CITI Program / BRANY PROGRAM Research Ethics & Compliance
Training
ACADEMIC YEAR EXAM TITLE CITI Training Quiz —
Comprehensive Review
TOTAL QUESTIONS 35 Questions COURSE TITLE Human Subjects Research /
Responsible Conduct of Research
FORMAT Multiple Choice — Select the HQ Fort Lauderdale, Florida
Single Best Answer
EXAMINATION INSTRUCTIONS
▸ Select the single best answer for each question.
▸ Content spans the Belmont Report, Nuremberg Code, IRB regulations, informed consent, data
management, and research misconduct.
▸ Correct answers and detailed rationales appear below each question for certification preparation.
▸ All content reflects current federal regulations and CITI Program standards.
, SECTION I — BELMONT REPORT, HISTORICAL
Questions 1 – 10
FRAMEWORKS & ETHICAL PRINCIPLES
1. Which of the following are the three principles discussed in the Belmont Report?
A. Autonomy, Non-maleficence, Confidentiality
B. Respect for Persons, Beneficence, Justice
C. Veracity, Fidelity, Integrity
D. Accountability, Transparency, Equity
CORRECT ANSWER B — Respect for Persons, Beneficence, Justice
RATIONALE The Belmont Report (1979) established three foundational ethical principles for
human subjects research: (1) Respect for Persons — acknowledges autonomy and
requires informed consent, (2) Beneficence — maximize benefits and minimize
harms, and (3) Justice — fair distribution of research burdens and benefits. These
principles form the ethical framework for the Common Rule (45 CFR 46) and FDA
regulations. Autonomy, non-maleficence, and confidentiality are important
concepts but are not the three Belmont principles.
, 2. 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. All persons must be compensated for research participation.
B. Persons with diminished autonomy are entitled to protection.
C. Research benefits must outweigh research risks.
D. Research subjects must be randomly selected.
CORRECT ANSWER B — Persons with diminished autonomy are entitled to protection.
RATIONALE The Belmont Report articulates two moral requirements under Respect for
Persons: (1) individuals with capacity for self-determination should be treated as
autonomous agents whose considered opinions and choices must be honored,
and (2) persons with diminished autonomy — due to immaturity, illness,
disability, or circumstances that severely restrict liberty — are entitled to special
protections. This principle underlies the requirement for informed consent and
the need for additional safeguards for vulnerable populations (children,
prisoners, cognitively impaired, economically disadvantaged).
3. 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 all subjects are paid equally for participation.
B. Determining that the study has a maximization of benefits and a minimization of risks.
C. Obtaining signed informed consent from every subject.
D. Selecting subjects from diverse demographic groups.
CORRECT ANSWER B — Determining that the study has a maximization of benefits and a
minimization of risks.
RATIONALE Beneficence requires a systematic risk-benefit assessment — maximizing
potential benefits (to subjects and society) while minimizing potential harms. The
IRB evaluates whether risks are reasonable in relation to anticipated benefits.
Equal payment (A) relates to justice, not beneficence. Obtaining consent (C)
applies respect for persons. Diverse selection (D) relates to justice. The risk-
benefit analysis is the core operationalization of beneficence in research review.