CITI Training Modules 1–24 Biomedical
Research Exam 2026 – Complete Questions
& Verified Answers (Latest Updated Study
Guide)
• This study guide covers 200 exam-style questions drawn from CITI Training
Modules 1–24 for Biomedical Research, designed to help you prepare thoroughly
for your certification exam.
• Use this material by reading each question carefully, attempting an answer before
checking the highlighted correct option and EXPERT RATIONALE below it.
1. What is the primary purpose of the Belmont Report?
A. To establish guidelines for clinical drug trials
B. To define the role of the FDA in research oversight
C. To provide ethical principles and guidelines for research involving human
subjects
D. To regulate animal research in biomedical studies
E. To outline funding requirements for federally sponsored research
C. To provide ethical principles and guidelines for research involving
human subjects
EXPERT RATIONALE: The Belmont Report, published in 1979, was produced by the
National Commission for the Protection of Human Subjects. It established three core
principles — respect for persons, beneficence, and justice — that form the foundation of
human subjects research ethics.
2. Which of the following best describes the principle of "Respect for Persons"
in the Belmont Report?
A. Maximizing benefits and minimizing harms in research
B. Ensuring fair distribution of research benefits and burdens
,C. Treating individuals as autonomous agents and protecting those with diminished
autonomy
D. Requiring informed consent from all participants without exception
E. Ensuring researchers disclose all potential conflicts of interest
C. Treating individuals as autonomous agents and protecting those with
diminished autonomy
EXPERT RATIONALE: Respect for Persons involves recognizing individuals' capacity to
make their own decisions and providing additional protections to those who may not be
able to do so fully, such as children or cognitively impaired individuals.
3. The principle of Beneficence in the Belmont Report requires researchers to:
A. Obtain written consent from all participants
B. Maximize possible benefits and minimize possible harms
C. Ensure equal selection of research subjects
D. Report all adverse events to the IRB
E. Compensate subjects fairly for their participation
B. Maximize possible benefits and minimize possible harms
EXPERT RATIONALE: Beneficence obligates researchers to actively promote the well-
being of participants by maximizing benefits and minimizing risks, going beyond simply
avoiding harm.
4. The principle of Justice in the Belmont Report primarily refers to:
A. Legal accountability for research misconduct
B. Ensuring that researchers are qualified to conduct studies
C. Fair distribution of the benefits and burdens of research
D. Guaranteeing that all research produces beneficial outcomes
,E. Requiring judicial review of high-risk studies
C. Fair distribution of the benefits and burdens of research
EXPERT RATIONALE: Justice requires that no group is unfairly burdened by research
risks while another group receives its benefits. Historically, vulnerable populations were
exploited in research, making this principle critical.
5. Which historical event most directly led to the creation of the Belmont
Report?
A. The Tuskegee Syphilis Study
B. The Nuremberg Trials
C. The thalidomide tragedy
D. The Declaration of Helsinki
E. The Willowbrook hepatitis experiments
A. The Tuskegee Syphilis Study
EXPERT RATIONALE: The Tuskegee Syphilis Study, in which African American men with
syphilis were denied treatment for decades, was a primary catalyst for the National
Research Act of 1974 and the subsequent Belmont Report.
6. What does IRB stand for in the context of human subjects research?
A. Independent Research Bureau
B. Institutional Review Board
C. Internal Research Branch
D. Investigational Review Body
E. Institutional Research Bureau
B. Institutional Review Board
, EXPERT RATIONALE: An IRB is a committee established to review and approve research
involving human subjects, ensuring ethical standards and federal regulations are met
before a study begins.
7. Which federal regulation governs the protection of human subjects in
research funded by the U.S. Department of Health and Human Services?
A. 21 CFR Part 50
B. 45 CFR Part 46
C. 40 CFR Part 26
D. 21 CFR Part 312
E. 45 CFR Part 164
B. 45 CFR Part 46
EXPERT RATIONALE: 45 CFR Part 46 is the primary federal regulation protecting human
research subjects and includes the Common Rule, which was most recently revised in
2018.
8. The "Common Rule" refers to:
A. Standard operating procedures for clinical trials
B. The FDA's guidelines for drug approval
C. The federal policy for the protection of human subjects adopted by multiple
agencies
D. A universal consent form used across all institutions
E. The rule requiring dual IRB review for multi-site studies
C. The federal policy for the protection of human subjects adopted by
multiple agencies
Research Exam 2026 – Complete Questions
& Verified Answers (Latest Updated Study
Guide)
• This study guide covers 200 exam-style questions drawn from CITI Training
Modules 1–24 for Biomedical Research, designed to help you prepare thoroughly
for your certification exam.
• Use this material by reading each question carefully, attempting an answer before
checking the highlighted correct option and EXPERT RATIONALE below it.
1. What is the primary purpose of the Belmont Report?
A. To establish guidelines for clinical drug trials
B. To define the role of the FDA in research oversight
C. To provide ethical principles and guidelines for research involving human
subjects
D. To regulate animal research in biomedical studies
E. To outline funding requirements for federally sponsored research
C. To provide ethical principles and guidelines for research involving
human subjects
EXPERT RATIONALE: The Belmont Report, published in 1979, was produced by the
National Commission for the Protection of Human Subjects. It established three core
principles — respect for persons, beneficence, and justice — that form the foundation of
human subjects research ethics.
2. Which of the following best describes the principle of "Respect for Persons"
in the Belmont Report?
A. Maximizing benefits and minimizing harms in research
B. Ensuring fair distribution of research benefits and burdens
,C. Treating individuals as autonomous agents and protecting those with diminished
autonomy
D. Requiring informed consent from all participants without exception
E. Ensuring researchers disclose all potential conflicts of interest
C. Treating individuals as autonomous agents and protecting those with
diminished autonomy
EXPERT RATIONALE: Respect for Persons involves recognizing individuals' capacity to
make their own decisions and providing additional protections to those who may not be
able to do so fully, such as children or cognitively impaired individuals.
3. The principle of Beneficence in the Belmont Report requires researchers to:
A. Obtain written consent from all participants
B. Maximize possible benefits and minimize possible harms
C. Ensure equal selection of research subjects
D. Report all adverse events to the IRB
E. Compensate subjects fairly for their participation
B. Maximize possible benefits and minimize possible harms
EXPERT RATIONALE: Beneficence obligates researchers to actively promote the well-
being of participants by maximizing benefits and minimizing risks, going beyond simply
avoiding harm.
4. The principle of Justice in the Belmont Report primarily refers to:
A. Legal accountability for research misconduct
B. Ensuring that researchers are qualified to conduct studies
C. Fair distribution of the benefits and burdens of research
D. Guaranteeing that all research produces beneficial outcomes
,E. Requiring judicial review of high-risk studies
C. Fair distribution of the benefits and burdens of research
EXPERT RATIONALE: Justice requires that no group is unfairly burdened by research
risks while another group receives its benefits. Historically, vulnerable populations were
exploited in research, making this principle critical.
5. Which historical event most directly led to the creation of the Belmont
Report?
A. The Tuskegee Syphilis Study
B. The Nuremberg Trials
C. The thalidomide tragedy
D. The Declaration of Helsinki
E. The Willowbrook hepatitis experiments
A. The Tuskegee Syphilis Study
EXPERT RATIONALE: The Tuskegee Syphilis Study, in which African American men with
syphilis were denied treatment for decades, was a primary catalyst for the National
Research Act of 1974 and the subsequent Belmont Report.
6. What does IRB stand for in the context of human subjects research?
A. Independent Research Bureau
B. Institutional Review Board
C. Internal Research Branch
D. Investigational Review Body
E. Institutional Research Bureau
B. Institutional Review Board
, EXPERT RATIONALE: An IRB is a committee established to review and approve research
involving human subjects, ensuring ethical standards and federal regulations are met
before a study begins.
7. Which federal regulation governs the protection of human subjects in
research funded by the U.S. Department of Health and Human Services?
A. 21 CFR Part 50
B. 45 CFR Part 46
C. 40 CFR Part 26
D. 21 CFR Part 312
E. 45 CFR Part 164
B. 45 CFR Part 46
EXPERT RATIONALE: 45 CFR Part 46 is the primary federal regulation protecting human
research subjects and includes the Common Rule, which was most recently revised in
2018.
8. The "Common Rule" refers to:
A. Standard operating procedures for clinical trials
B. The FDA's guidelines for drug approval
C. The federal policy for the protection of human subjects adopted by multiple
agencies
D. A universal consent form used across all institutions
E. The rule requiring dual IRB review for multi-site studies
C. The federal policy for the protection of human subjects adopted by
multiple agencies
