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LATEST UPDATED VERSION 2026/2027 |ALREADY
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1. 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
Answer D: Respect for Persons, Beneficence, Justice
Rationale: The Belmont Report outlines these three fundamental ethical principles for research involving
human subjects .
2. The Belmont 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.
Answer C: Persons with diminished autonomy are entitled to protection.
Rationale: Respect for Persons dictates that autonomous individuals should be free to make their own
decisions, and those with diminished autonomy deserve protection .
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 persons with diminished autonomy are protected.
,B) Providing detailed information about the study and obtaining the subject's consent.
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.
Answer C: Determining that the study has a maximization of benefits and a minimization of risks.
Rationale: Beneficence is the obligation to maximize potential benefits and minimize potential harms .
4. The Belmont principle of beneficence requires that:
A) Subjects derive individual benefit from study participation.
B) Potential benefits justify the risks of harm.
C) The study makes a significant contribution to generalizable knowledge.
D) Risks are managed so that they are no more than minimal.
Answer B: Potential benefits justify the risks of harm.
Rationale: Beneficence requires that the anticipated benefits of research outweigh the risks to subjects .
5. The use of a consent form is an example of the Belmont principle of:
A) Justice
B) Beneficence
C) Respect for persons
D) Non-maleficence
Answer C: Respect for persons
Rationale: Respect for persons requires acknowledging autonomy, which is implemented through the
informed consent process .
6. Which of the following is NOT one of the three core Belmont principles?
A) Respect for Persons
B) Beneficence
C) Confidentiality
D) Justice
,Answer C: Confidentiality
Rationale: Confidentiality is an important practical requirement but is not one of the three core Belmont
principles .
7. The Belmont Report was issued in response to which historical event?
A) The Nuremberg Trials
B) The Tuskegee Syphilis Study
C) The Willowbrook Study
D) The Milgram Experiment
Answer B: The Tuskegee Syphilis Study
Rationale: The Belmont Report (1979) was developed in response to ethical abuses including the
Tuskegee Syphilis Study.
8. The principle of justice in the Belmont Report requires that:
A) Risks are minimized
B) Benefits and burdens of research are distributed fairly
C) Subjects give informed consent
D) Vulnerable populations are excluded
Answer B: Benefits and burdens of research are distributed fairly
Rationale: Justice concerns fair selection of research subjects and equitable distribution of risks and
benefits.
9. A researcher wants to study a new drug in children. Under the Belmont principle of beneficence,
the study may proceed if:
A) Parents consent
B) Risk is minimal or the prospect of direct benefit outweighs risk
C) No placebo is used
D) The child is paid
, Answer B: Risk is minimal or the prospect of direct benefit outweighs risk
Rationale: Beneficence requires favorable risk-benefit; for children, additional Subpart D criteria apply .
10. The Belmont principle of respect for persons is operationalized through:
A) Risk-benefit analysis
B) The informed consent process
C) Equitable subject selection
D) Privacy protections
Answer B: The informed consent process
Rationale: Respect for persons requires that individuals be treated as autonomous agents and that those
with diminished autonomy be protected—achieved through informed consent .
11. Which of the following is a core requirement of the Belmont Report?
A) IRB approval
B) Ethical principles for research involving human subjects
C) Written consent forms
D) Research compliance training
Answer B: Ethical principles for research involving human subjects
Rationale: The Belmont Report provides a framework of ethical principles, not specific procedural
requirements.
12. A researcher must ensure that the selection of subjects is equitable. This reflects the principle
of:
A) Respect for Persons
B) Beneficence
C) Justice
D) Non-maleficence
Answer C: Justice