CITI TRAINING EXAM STUDY GUIDE
2026/2027 300 Verified Questions with Answers
& Rationales
SECTION 1: BELMONT REPORT & ETHICAL PRINCIPLES (Q1–Q30)
Q1. 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
Rationale: : The Belmont Report (1979) established these three principles as the ethical
foundation for human subjects research.
Q2. The Belmont principle of respect for persons includes the requirement that:
A. Risks be minimized and benefits maximized
B. Persons with diminished autonomy are entitled to protection
C. Subjects be selected fairly
D. The research be published
Rationale: : Respect for persons has two parts: acknowledge autonomy and protect
those with diminished autonomy (e.g., children, prisoners).
Q3. Which historical event directly led to the creation of the Belmont Report?
A. Nazi medical experiments
B. The Tuskegee Syphilis Study
C. The Willowbrook Study
D. The Milgram study
Rationale: : The Tuskegee Study (1932–1972) caused public outrage and led to the
National Research Act of 1974, which created the Belmont Report.
Q4. The principle of beneficence requires researchers to:
A. Obtain informed consent
B. Minimize risks and maximize potential benefits
C. Select subjects equitably
D. Respect autonomy
Rationale: : Beneficence is “do no harm” plus actively maximize benefits.
,Q5. Justice in the Belmont Report refers to:
A. Respecting the subject’s decision
B. Using a fair consent process
C. Fair distribution of the burdens and benefits of research
D. Honoring confidentiality
Rationale: : Justice prohibits selecting vulnerable groups only for convenience or
because they are easy to manipulate.
Q6. The National Research Act of 1974 created the National Commission that
produced the Belmont Report and also required:
A. Animal welfare committees
B. Institutional Review Boards (IRBs)
C. Informed consent for all research
D. Certificates of Confidentiality
Rationale: : The Act mandated IRBs at institutions receiving federal funds to review
human subjects research.
Q7. Which of the following is an example of how the principle of beneficence is
applied?
A. Ensuring non-English speakers have translated consent forms
B. Assessing that the risks are reasonable in relation to anticipated benefits
C. Including women and minorities in research
D. Providing a Certificate of Confidentiality
Rationale: : Risk-benefit analysis is the core of beneficence.
Q8. The concept of “minimal risk” means that the probability and magnitude of
harm in research are not greater than:
A. Those experienced in a medical procedure
B. Those ordinarily encountered in daily life or routine physical/psychological
examinations
C. Those of a strenuous workout
D. Those of a car accident
Rationale: : This is the regulatory definition (45 CFR 46.102(i)).
Q9. The Nuremberg Code (1947) emphasized which of the following as absolutely
essential?
A. IRB approval
B. Voluntary consent of the human subject
C. Risk-benefit analysis
D. Animal studies first
,Rationale: : The first principle of the Nuremberg Code is that “the voluntary consent of
the human subject is absolutely essential.”
Q10. The Declaration of Helsinki was developed by:
A. The US Department of Health and Human Services
B. The World Medical Association
C. The United Nations
D. The National Institutes of Health
Rationale: : The Declaration of Helsinki (1964) is a statement of ethical principles for
medical research involving human subjects, developed by the World Medical
Association.
Q11. In the Belmont Report, “respect for persons” translates into the requirement
for:
A. Informed consent and protection of vulnerable populations
B. Risk-benefit analysis
C. Equitable selection
D. Confidentiality
Rationale: : Informed consent operationalizes respect for autonomy; additional
protections address diminished autonomy.
Q12. A researcher wants to study a new drug in children. Which Belmont principle
requires that children not be enrolled simply because they are easy to access?
A. Respect for persons
B. Beneficence
C. Justice
D. Non-maleficence
Rationale: : Justice demands fair distribution of research burdens. Easy access does not
justify enrolling vulnerable populations unless the research is directly relevant to them.
Q13. The Belmont Report’s requirement that risks and benefits be assessed is
derived from which principle?
A. Respect for persons
B. Beneficence
C. Justice
D. Confidentiality
Rationale: : Beneficence requires systematic consideration of risk-benefit ratios.
Q14. Which of the following statements about the Belmont Report is true?
A. It is a legally binding regulation.
B. It provided the ethical framework for the Common Rule.
, C. It only applies to biomedical research.
D. It replaced the Nuremberg Code.
Rationale: : The Belmont Report’s principles were incorporated into the federal
regulations (Common Rule).
Q15. The principle of respect for persons is violated when:
A. Subjects are not compensated.
B. A researcher enrolls a cognitively impaired adult without a legally authorized
representative’s consent.
C. The study has high risk but low benefit.
D. Only men are included in a study of heart disease.
Rationale: : Failing to protect those with diminished autonomy violates respect for
persons.
Q16. Which of the following studies would most clearly raise concerns about the
principle of justice?
A. A study of a new cancer drug in adult volunteers.
B. A study of a risky procedure conducted only on prisoners and not on
non-prisoners, without any potential benefit to prisoners.
C. A study that uses deception but debriefs subjects.
D. A study that collects anonymous survey data.
Rationale: : Justice prohibits using vulnerable populations for risky research that will not
benefit them when less vulnerable populations could be used.
Q17. The Belmont Report’s principle of beneficence is often expressed as two
general rules: do not harm and:
A. Respect autonomy
B. Maximize possible benefits and minimize possible harms
C. Treat all subjects equally
D. Obtain informed consent
Rationale: : This is the classic formulation of beneficence.
Q18. A researcher fails to inform subjects that they will receive a placebo instead
of an active drug. Which principle is most directly violated?
A. Justice
B. Respect for persons (because informed consent is incomplete)
C. Beneficence
D. Confidentiality
Rationale: : Informed consent is required to respect autonomy; omission of critical
information violates that.
2026/2027 300 Verified Questions with Answers
& Rationales
SECTION 1: BELMONT REPORT & ETHICAL PRINCIPLES (Q1–Q30)
Q1. 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
Rationale: : The Belmont Report (1979) established these three principles as the ethical
foundation for human subjects research.
Q2. The Belmont principle of respect for persons includes the requirement that:
A. Risks be minimized and benefits maximized
B. Persons with diminished autonomy are entitled to protection
C. Subjects be selected fairly
D. The research be published
Rationale: : Respect for persons has two parts: acknowledge autonomy and protect
those with diminished autonomy (e.g., children, prisoners).
Q3. Which historical event directly led to the creation of the Belmont Report?
A. Nazi medical experiments
B. The Tuskegee Syphilis Study
C. The Willowbrook Study
D. The Milgram study
Rationale: : The Tuskegee Study (1932–1972) caused public outrage and led to the
National Research Act of 1974, which created the Belmont Report.
Q4. The principle of beneficence requires researchers to:
A. Obtain informed consent
B. Minimize risks and maximize potential benefits
C. Select subjects equitably
D. Respect autonomy
Rationale: : Beneficence is “do no harm” plus actively maximize benefits.
,Q5. Justice in the Belmont Report refers to:
A. Respecting the subject’s decision
B. Using a fair consent process
C. Fair distribution of the burdens and benefits of research
D. Honoring confidentiality
Rationale: : Justice prohibits selecting vulnerable groups only for convenience or
because they are easy to manipulate.
Q6. The National Research Act of 1974 created the National Commission that
produced the Belmont Report and also required:
A. Animal welfare committees
B. Institutional Review Boards (IRBs)
C. Informed consent for all research
D. Certificates of Confidentiality
Rationale: : The Act mandated IRBs at institutions receiving federal funds to review
human subjects research.
Q7. Which of the following is an example of how the principle of beneficence is
applied?
A. Ensuring non-English speakers have translated consent forms
B. Assessing that the risks are reasonable in relation to anticipated benefits
C. Including women and minorities in research
D. Providing a Certificate of Confidentiality
Rationale: : Risk-benefit analysis is the core of beneficence.
Q8. The concept of “minimal risk” means that the probability and magnitude of
harm in research are not greater than:
A. Those experienced in a medical procedure
B. Those ordinarily encountered in daily life or routine physical/psychological
examinations
C. Those of a strenuous workout
D. Those of a car accident
Rationale: : This is the regulatory definition (45 CFR 46.102(i)).
Q9. The Nuremberg Code (1947) emphasized which of the following as absolutely
essential?
A. IRB approval
B. Voluntary consent of the human subject
C. Risk-benefit analysis
D. Animal studies first
,Rationale: : The first principle of the Nuremberg Code is that “the voluntary consent of
the human subject is absolutely essential.”
Q10. The Declaration of Helsinki was developed by:
A. The US Department of Health and Human Services
B. The World Medical Association
C. The United Nations
D. The National Institutes of Health
Rationale: : The Declaration of Helsinki (1964) is a statement of ethical principles for
medical research involving human subjects, developed by the World Medical
Association.
Q11. In the Belmont Report, “respect for persons” translates into the requirement
for:
A. Informed consent and protection of vulnerable populations
B. Risk-benefit analysis
C. Equitable selection
D. Confidentiality
Rationale: : Informed consent operationalizes respect for autonomy; additional
protections address diminished autonomy.
Q12. A researcher wants to study a new drug in children. Which Belmont principle
requires that children not be enrolled simply because they are easy to access?
A. Respect for persons
B. Beneficence
C. Justice
D. Non-maleficence
Rationale: : Justice demands fair distribution of research burdens. Easy access does not
justify enrolling vulnerable populations unless the research is directly relevant to them.
Q13. The Belmont Report’s requirement that risks and benefits be assessed is
derived from which principle?
A. Respect for persons
B. Beneficence
C. Justice
D. Confidentiality
Rationale: : Beneficence requires systematic consideration of risk-benefit ratios.
Q14. Which of the following statements about the Belmont Report is true?
A. It is a legally binding regulation.
B. It provided the ethical framework for the Common Rule.
, C. It only applies to biomedical research.
D. It replaced the Nuremberg Code.
Rationale: : The Belmont Report’s principles were incorporated into the federal
regulations (Common Rule).
Q15. The principle of respect for persons is violated when:
A. Subjects are not compensated.
B. A researcher enrolls a cognitively impaired adult without a legally authorized
representative’s consent.
C. The study has high risk but low benefit.
D. Only men are included in a study of heart disease.
Rationale: : Failing to protect those with diminished autonomy violates respect for
persons.
Q16. Which of the following studies would most clearly raise concerns about the
principle of justice?
A. A study of a new cancer drug in adult volunteers.
B. A study of a risky procedure conducted only on prisoners and not on
non-prisoners, without any potential benefit to prisoners.
C. A study that uses deception but debriefs subjects.
D. A study that collects anonymous survey data.
Rationale: : Justice prohibits using vulnerable populations for risky research that will not
benefit them when less vulnerable populations could be used.
Q17. The Belmont Report’s principle of beneficence is often expressed as two
general rules: do not harm and:
A. Respect autonomy
B. Maximize possible benefits and minimize possible harms
C. Treat all subjects equally
D. Obtain informed consent
Rationale: : This is the classic formulation of beneficence.
Q18. A researcher fails to inform subjects that they will receive a placebo instead
of an active drug. Which principle is most directly violated?
A. Justice
B. Respect for persons (because informed consent is incomplete)
C. Beneficence
D. Confidentiality
Rationale: : Informed consent is required to respect autonomy; omission of critical
information violates that.
