,CITI TRAINING PROGRAM EXAM
Complete Study Guide 2026/2027
300 Practice Questions with Verified Answers & Detailed Rationales
EXAM OVERVIEW
Aspect Details
Belmont Report, IRB History, Informed Consent
Modules Covered Vulnerable Populations, HIPAA, Data Management
, Research Misconduct, Good Clinical Practice
Format Multiple-choice, True/False, Select-All-That-Apply
Research ethics, human subjects protection,
Key Topics
regulatory compliance, IRB processes, privacy/confidentiality
Certification Required by most universities and research institutions
SECTION 1: THE BELMONT REPORT & HISTORICAL CONTEXT (Questions 1-50)
1. Which historical event led directly to the creation of the Belmont Report?
,• A) The Nuremberg Trials
• B) The Tuskegee Syphilis Study
• C) The Willowbrook Hepatitis Study
• D) The Milgram Obedience Study
Answer: B) The Tuskegee Syphilis Study
Rationale: The Tuskegee Syphilis Study (1932–1972) observed untreated syphilis in
African American men without informed consent, leading to the Belmont Report
(1979), which established ethical principles for human subjects research.
2. Which of the following are the three core ethical principles of the Belmont
Report?
• A) Respect for Persons, Beneficence, Justice
• B) Confidentiality, Integrity, Objectivity
• C) Honesty, Transparency, Accountability
• D) Privacy, Autonomy, Fairness
Answer: A) Respect for Persons, Beneficence, Justice
Rationale: The Belmont Report's three principles are Respect for Persons
(autonomy, informed consent), Beneficence (maximize benefits, minimize harms),
and Justice (fair distribution of research burdens and benefits).
3. The Nuremberg Code of 1947 emphasized which primary requirement for
human subjects research?
• A) IRB review
• B) Voluntary informed consent
• C) Payment for participation
• D) Publication of results
Answer: B) Voluntary informed consent
, Rationale: The Nuremberg Code was developed after Nazi experiments. Its first
principle states that voluntary consent of the human subject is absolutely
essential.
4. What year was the Nuremberg Code established?
• A) 1945
• B) 1947
• C) 1949
• D) 1953
Answer: C) 1949
Rationale: The Nuremberg Code was established in 1949 following the Nuremberg
Trials of Nazi doctors.
5. 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) 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 with diminished autonomy must have a legally authorized
representative
Answer: C) Persons with diminished autonomy are entitled to protection
Rationale: Respect for persons requires that individuals be treated as autonomous
agents and that persons with diminished autonomy are entitled to protection.
Complete Study Guide 2026/2027
300 Practice Questions with Verified Answers & Detailed Rationales
EXAM OVERVIEW
Aspect Details
Belmont Report, IRB History, Informed Consent
Modules Covered Vulnerable Populations, HIPAA, Data Management
, Research Misconduct, Good Clinical Practice
Format Multiple-choice, True/False, Select-All-That-Apply
Research ethics, human subjects protection,
Key Topics
regulatory compliance, IRB processes, privacy/confidentiality
Certification Required by most universities and research institutions
SECTION 1: THE BELMONT REPORT & HISTORICAL CONTEXT (Questions 1-50)
1. Which historical event led directly to the creation of the Belmont Report?
,• A) The Nuremberg Trials
• B) The Tuskegee Syphilis Study
• C) The Willowbrook Hepatitis Study
• D) The Milgram Obedience Study
Answer: B) The Tuskegee Syphilis Study
Rationale: The Tuskegee Syphilis Study (1932–1972) observed untreated syphilis in
African American men without informed consent, leading to the Belmont Report
(1979), which established ethical principles for human subjects research.
2. Which of the following are the three core ethical principles of the Belmont
Report?
• A) Respect for Persons, Beneficence, Justice
• B) Confidentiality, Integrity, Objectivity
• C) Honesty, Transparency, Accountability
• D) Privacy, Autonomy, Fairness
Answer: A) Respect for Persons, Beneficence, Justice
Rationale: The Belmont Report's three principles are Respect for Persons
(autonomy, informed consent), Beneficence (maximize benefits, minimize harms),
and Justice (fair distribution of research burdens and benefits).
3. The Nuremberg Code of 1947 emphasized which primary requirement for
human subjects research?
• A) IRB review
• B) Voluntary informed consent
• C) Payment for participation
• D) Publication of results
Answer: B) Voluntary informed consent
, Rationale: The Nuremberg Code was developed after Nazi experiments. Its first
principle states that voluntary consent of the human subject is absolutely
essential.
4. What year was the Nuremberg Code established?
• A) 1945
• B) 1947
• C) 1949
• D) 1953
Answer: C) 1949
Rationale: The Nuremberg Code was established in 1949 following the Nuremberg
Trials of Nazi doctors.
5. 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) 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 with diminished autonomy must have a legally authorized
representative
Answer: C) Persons with diminished autonomy are entitled to protection
Rationale: Respect for persons requires that individuals be treated as autonomous
agents and that persons with diminished autonomy are entitled to protection.
