CITI Certification Exam 2025/2026 | Test
Questions with 100% Verified Correct Answers
CITI Program Certification | Human Subjects Research, IRB Compliance, Informed Consent,
Data & Privacy Protection, Biomedical and Social/Behavioral Research Ethics | Expert-Verified
Q&A | Certification-Ready
Introduction
This document provides the updated CITI Certification Exam Study Material for the 2025/2026
cycle. It contains verified test questions and correct answers aligned with the Collaborative
Institutional Training Initiative (CITI) program. Covered topics include research ethics,
informed consent, HIPAA and data protection, Institutional Review Board (IRB) processes,
conflict of interest management, and good clinical practice guidelines. All answers have been
validated for accuracy, ensuring complete preparation for compliance training and certification
success.
Answer Format
All correct answers are highlighted in bold and green, with clear and concise explanations that
reinforce understanding of responsible research conduct and ethical standards.
CITI Certification Exam Q&A | Verified 2025/2026 Content | Exam-Aligned |
Compliance-Ready for Research Excellence
1. What is the primary purpose of the CITI Program training?
a) To provide statistical analysis training
b) To ensure ethical conduct in research involving human subjects
c) To teach laboratory techniques
d) To certify medical professionals
b) To ensure ethical conduct in research involving human subjects
Rationale: The CITI Program provides training on ethical standards and regulatory compliance
for human subjects research.
2. Which regulation governs the protection of human subjects in the U.S.?
a) HIPAA
b) 45 CFR 46
c) 21 CFR 50
d) FERPA
b) 45 CFR 46
Rationale: 45 CFR 46 is the federal regulation for protecting human subjects in research,
enforced by the Office for Human Research Protections (OHRP).
, 3. What is a key element of informed consent?
a) Providing financial compensation
b) Ensuring participant understanding of risks and benefits
c) Requiring all participants to sign immediately
d) Limiting information to protect privacy
b) Ensuring participant understanding of risks and benefits
Rationale: Informed consent requires clear communication of study risks, benefits, and
procedures to ensure voluntary participation.
4. Who is responsible for reviewing research protocols involving human
subjects?
a) Principal investigator
b) Institutional Review Board (IRB)
c) Data safety monitoring board
d) Study sponsor
b) Institutional Review Board (IRB)
Rationale: The IRB reviews and approves research protocols to ensure ethical standards and
participant safety.
5. What does HIPAA protect in the context of research?
a) Intellectual property
b) Protected health information (PHI)
c) Research funding
d) Participant consent forms
b) Protected health information (PHI)
Rationale: HIPAA ensures the confidentiality and security of identifiable health information in
research.
6. What is considered a vulnerable population in research?
a) Healthy adult volunteers
b) Pregnant women
c) University faculty
d) Medical researchers
b) Pregnant women
Rationale: Vulnerable populations, like pregnant women, require additional protections due to
potential risks to them or their fetus.
7. What is the purpose of a Data Safety Monitoring Board (DSMB)?
a) To recruit participants
b) To monitor participant safety and study data integrity
c) To conduct statistical analysis
d) To approve research funding
b) To monitor participant safety and study data integrity
Rationale: A DSMB oversees ongoing clinical trials to ensure participant safety and valid data.
Questions with 100% Verified Correct Answers
CITI Program Certification | Human Subjects Research, IRB Compliance, Informed Consent,
Data & Privacy Protection, Biomedical and Social/Behavioral Research Ethics | Expert-Verified
Q&A | Certification-Ready
Introduction
This document provides the updated CITI Certification Exam Study Material for the 2025/2026
cycle. It contains verified test questions and correct answers aligned with the Collaborative
Institutional Training Initiative (CITI) program. Covered topics include research ethics,
informed consent, HIPAA and data protection, Institutional Review Board (IRB) processes,
conflict of interest management, and good clinical practice guidelines. All answers have been
validated for accuracy, ensuring complete preparation for compliance training and certification
success.
Answer Format
All correct answers are highlighted in bold and green, with clear and concise explanations that
reinforce understanding of responsible research conduct and ethical standards.
CITI Certification Exam Q&A | Verified 2025/2026 Content | Exam-Aligned |
Compliance-Ready for Research Excellence
1. What is the primary purpose of the CITI Program training?
a) To provide statistical analysis training
b) To ensure ethical conduct in research involving human subjects
c) To teach laboratory techniques
d) To certify medical professionals
b) To ensure ethical conduct in research involving human subjects
Rationale: The CITI Program provides training on ethical standards and regulatory compliance
for human subjects research.
2. Which regulation governs the protection of human subjects in the U.S.?
a) HIPAA
b) 45 CFR 46
c) 21 CFR 50
d) FERPA
b) 45 CFR 46
Rationale: 45 CFR 46 is the federal regulation for protecting human subjects in research,
enforced by the Office for Human Research Protections (OHRP).
, 3. What is a key element of informed consent?
a) Providing financial compensation
b) Ensuring participant understanding of risks and benefits
c) Requiring all participants to sign immediately
d) Limiting information to protect privacy
b) Ensuring participant understanding of risks and benefits
Rationale: Informed consent requires clear communication of study risks, benefits, and
procedures to ensure voluntary participation.
4. Who is responsible for reviewing research protocols involving human
subjects?
a) Principal investigator
b) Institutional Review Board (IRB)
c) Data safety monitoring board
d) Study sponsor
b) Institutional Review Board (IRB)
Rationale: The IRB reviews and approves research protocols to ensure ethical standards and
participant safety.
5. What does HIPAA protect in the context of research?
a) Intellectual property
b) Protected health information (PHI)
c) Research funding
d) Participant consent forms
b) Protected health information (PHI)
Rationale: HIPAA ensures the confidentiality and security of identifiable health information in
research.
6. What is considered a vulnerable population in research?
a) Healthy adult volunteers
b) Pregnant women
c) University faculty
d) Medical researchers
b) Pregnant women
Rationale: Vulnerable populations, like pregnant women, require additional protections due to
potential risks to them or their fetus.
7. What is the purpose of a Data Safety Monitoring Board (DSMB)?
a) To recruit participants
b) To monitor participant safety and study data integrity
c) To conduct statistical analysis
d) To approve research funding
b) To monitor participant safety and study data integrity
Rationale: A DSMB oversees ongoing clinical trials to ensure participant safety and valid data.
