CITI TRAINING QUIZ EXAM 2026/2027 | Questions and
Answers | Research Ethics and Compliance
Table of Contents
Section Topic Question Range
Section 1 Belmont Report and Core Ethical Principles Q1–Q20
Section 2 Federal Regulations and the Common Rule Q21–Q40
Section 3 Institutional Review Boards (IRBs) Q41–Q55
Section 4 Informed Consent Requirements and Documentation Q56–Q70
Section 5 Vulnerable Populations and Protections Q71–Q85
Section 6 Privacy, Confidentiality, and HIPAA Q86–Q95
Section 7 Conflicts of Interest Q96–Q110
Section 8 Responsible Conduct of Research (RCR) Q111–Q125
Section 9 Good Clinical Practice (GCP) Q126–Q135
Section 10 Research Misconduct and Integrity Q136–Q145
Section 11 International Research Ethics and Cultural Competence Q146–Q155
Section 12 Data Management and Security Q156–Q165
Section 13 Integrated Clinical and Behavioral Scenarios Q166–Q180
,Section 1: Belmont Report and Core Ethical Principles (Q1–Q20)
Q1. Which of the following are the three core ethical principles outlined in the Belmont
Report? (Select all that apply.)
A) Respect for Persons
B) Beneficence
C) Justice
D) Non-maleficence
E) Autonomy
F) Confidentiality
Correct Answers: A, B, C
Rationale: The Belmont Report, published in 1979 by the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research, identifies three
fundamental ethical principles for human subjects research: Respect for Persons, Beneficence,
and Justice. Non-maleficence is a related concept but is not one of the three Belmont principles.
Autonomy is a component of Respect for Persons, and confidentiality is an application of
Respect for Persons and Beneficence.
Q2. The Belmont principle of Respect for Persons incorporates which of the following ethical
convictions? (Select all that apply.)
A) Individuals should be treated as autonomous agents.
B) Persons with diminished autonomy are entitled to protection.
C) Research risks should be minimized.
D) Benefits of research should be distributed fairly.
E) Participants must sign a consent form.
F) Researchers must obtain IRB approval.
Correct Answers: A, B
Rationale: Respect for Persons has two core ethical convictions: first, that individuals should be
treated as autonomous agents capable of making their own decisions; second, that persons
with diminished autonomy (such as children, prisoners, or individuals with cognitive
impairments) are entitled to protection. Options C and D relate to Beneficence and Justice,
respectively. Options E and F are applications of these principles, not the underlying convictions.
Q3. Which of the following are examples of how the principle of Beneficence can be applied
to a study employing human subjects? (Select all that apply.)
A) Determining that the study has a maximization of benefits and a minimization of risks.
B) Ensuring that persons with diminished autonomy are protected.
C) Providing detailed information about the study and obtaining the subject's consent.
D) Ensuring that the selection of subjects is equitable.
,E) Conducting a careful risk-benefit assessment.
F) Obtaining a legally valid informed consent form.
Correct Answers: A, E
Rationale: Beneficence is the ethical obligation to "do no harm" and to maximize potential
benefits while minimizing potential harms. This involves a careful risk-benefit assessment to
ensure that the anticipated benefits of the research justify the risks to subjects. Options B and D
relate more directly to Respect for Persons and Justice, respectively. Options C and F are
applications of Respect for Persons through the informed consent process.
Q4. The Belmont principle of Beneficence requires that: (Select all that apply.)
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.
E) Benefits to society are maximized and risks are minimized.
F) The research is approved by an IRB.
Correct Answers: B, E
Rationale: Beneficence requires that the anticipated benefits of research outweigh the risks to
subjects. It involves an obligation to maximize potential benefits (to science, society, or subjects)
and minimize potential harms. Subjects do not necessarily need to derive direct individual
benefit from participation (option A is incorrect). While a significant contribution to knowledge
is desirable, it is not the specific requirement of Beneficence. Minimizing risks to no more than
minimal is a regulatory threshold, not the full ethical obligation of Beneficence.
Q5. The use of a consent form is an example of which Belmont principle? (Select all that
apply.)
A) Justice
B) Beneficence
C) Respect for Persons
D) Non-maleficence
Correct Answers: C
Rationale: Respect for Persons requires acknowledging the autonomy of individuals and
treating them as capable of making their own decisions. This principle is operationalized
through the informed consent process, which ensures that prospective participants are
provided with comprehensive information so they can make a voluntary, autonomous decision
about participation. A consent form documents this process.
Q6. The principle of Justice in the Belmont Report primarily addresses which of the following?
(Select all that apply.)
, A) Obtaining a legally valid informed consent from all participants.
B) The fair and equitable distribution of the burdens and benefits of research.
C) The requirement for IRB review of all research protocols.
D) The minimization of psychological and physical harms to participants.
E) Ensuring that no particular group bears an undue burden of research while others enjoy its
benefits.
F) Equitable selection of subjects.
Correct Answers: B, E, F
Rationale: The principle of Justice demands that the selection of research subjects is fair and
that no particular group of people bears an undue burden of research while others enjoy its
benefits. It addresses issues of exploitation and equitable access to the benefits of research.
Option A relates to Respect for Persons. Option D relates to Beneficence. Option C is an
application of all three principles but is not the primary focus of Justice.
Q7. According to the Belmont Report, which of the following best describes the ethical
obligation to protect persons with diminished autonomy? (Select all that apply.)
A) They should be excluded from all research to prevent harm.
B) They may only participate in research that holds out the prospect of direct benefit.
C) They are entitled to protection.
D) They should be allowed to participate in any research as long as they sign a consent form.
E) Additional safeguards may be required to protect their welfare.
F) Their participation should be limited to no more than minimal risk research unless there is a
prospect of direct benefit.
Correct Answers: C, E, F
Rationale: Respect for Persons requires that persons with diminished autonomy are entitled to
protection. While they should not be categorically excluded from research (option A is
incorrect), additional safeguards may be required, such as limiting participation to no more than
minimal risk research unless there is a prospect of direct benefit. Simply signing a consent form
may not be sufficient if the person lacks decision-making capacity.
Q8. Which historical event is most directly linked to the creation of the Belmont Report?
(Select all that apply.)
A) Nazi medical experiments
B) The Tuskegee Syphilis Study
C) The Willowbrook Study
D) The Milgram study
E) The thalidomide tragedy
F) The Declaration of Helsinki
Answers | Research Ethics and Compliance
Table of Contents
Section Topic Question Range
Section 1 Belmont Report and Core Ethical Principles Q1–Q20
Section 2 Federal Regulations and the Common Rule Q21–Q40
Section 3 Institutional Review Boards (IRBs) Q41–Q55
Section 4 Informed Consent Requirements and Documentation Q56–Q70
Section 5 Vulnerable Populations and Protections Q71–Q85
Section 6 Privacy, Confidentiality, and HIPAA Q86–Q95
Section 7 Conflicts of Interest Q96–Q110
Section 8 Responsible Conduct of Research (RCR) Q111–Q125
Section 9 Good Clinical Practice (GCP) Q126–Q135
Section 10 Research Misconduct and Integrity Q136–Q145
Section 11 International Research Ethics and Cultural Competence Q146–Q155
Section 12 Data Management and Security Q156–Q165
Section 13 Integrated Clinical and Behavioral Scenarios Q166–Q180
,Section 1: Belmont Report and Core Ethical Principles (Q1–Q20)
Q1. Which of the following are the three core ethical principles outlined in the Belmont
Report? (Select all that apply.)
A) Respect for Persons
B) Beneficence
C) Justice
D) Non-maleficence
E) Autonomy
F) Confidentiality
Correct Answers: A, B, C
Rationale: The Belmont Report, published in 1979 by the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research, identifies three
fundamental ethical principles for human subjects research: Respect for Persons, Beneficence,
and Justice. Non-maleficence is a related concept but is not one of the three Belmont principles.
Autonomy is a component of Respect for Persons, and confidentiality is an application of
Respect for Persons and Beneficence.
Q2. The Belmont principle of Respect for Persons incorporates which of the following ethical
convictions? (Select all that apply.)
A) Individuals should be treated as autonomous agents.
B) Persons with diminished autonomy are entitled to protection.
C) Research risks should be minimized.
D) Benefits of research should be distributed fairly.
E) Participants must sign a consent form.
F) Researchers must obtain IRB approval.
Correct Answers: A, B
Rationale: Respect for Persons has two core ethical convictions: first, that individuals should be
treated as autonomous agents capable of making their own decisions; second, that persons
with diminished autonomy (such as children, prisoners, or individuals with cognitive
impairments) are entitled to protection. Options C and D relate to Beneficence and Justice,
respectively. Options E and F are applications of these principles, not the underlying convictions.
Q3. Which of the following are examples of how the principle of Beneficence can be applied
to a study employing human subjects? (Select all that apply.)
A) Determining that the study has a maximization of benefits and a minimization of risks.
B) Ensuring that persons with diminished autonomy are protected.
C) Providing detailed information about the study and obtaining the subject's consent.
D) Ensuring that the selection of subjects is equitable.
,E) Conducting a careful risk-benefit assessment.
F) Obtaining a legally valid informed consent form.
Correct Answers: A, E
Rationale: Beneficence is the ethical obligation to "do no harm" and to maximize potential
benefits while minimizing potential harms. This involves a careful risk-benefit assessment to
ensure that the anticipated benefits of the research justify the risks to subjects. Options B and D
relate more directly to Respect for Persons and Justice, respectively. Options C and F are
applications of Respect for Persons through the informed consent process.
Q4. The Belmont principle of Beneficence requires that: (Select all that apply.)
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.
E) Benefits to society are maximized and risks are minimized.
F) The research is approved by an IRB.
Correct Answers: B, E
Rationale: Beneficence requires that the anticipated benefits of research outweigh the risks to
subjects. It involves an obligation to maximize potential benefits (to science, society, or subjects)
and minimize potential harms. Subjects do not necessarily need to derive direct individual
benefit from participation (option A is incorrect). While a significant contribution to knowledge
is desirable, it is not the specific requirement of Beneficence. Minimizing risks to no more than
minimal is a regulatory threshold, not the full ethical obligation of Beneficence.
Q5. The use of a consent form is an example of which Belmont principle? (Select all that
apply.)
A) Justice
B) Beneficence
C) Respect for Persons
D) Non-maleficence
Correct Answers: C
Rationale: Respect for Persons requires acknowledging the autonomy of individuals and
treating them as capable of making their own decisions. This principle is operationalized
through the informed consent process, which ensures that prospective participants are
provided with comprehensive information so they can make a voluntary, autonomous decision
about participation. A consent form documents this process.
Q6. The principle of Justice in the Belmont Report primarily addresses which of the following?
(Select all that apply.)
, A) Obtaining a legally valid informed consent from all participants.
B) The fair and equitable distribution of the burdens and benefits of research.
C) The requirement for IRB review of all research protocols.
D) The minimization of psychological and physical harms to participants.
E) Ensuring that no particular group bears an undue burden of research while others enjoy its
benefits.
F) Equitable selection of subjects.
Correct Answers: B, E, F
Rationale: The principle of Justice demands that the selection of research subjects is fair and
that no particular group of people bears an undue burden of research while others enjoy its
benefits. It addresses issues of exploitation and equitable access to the benefits of research.
Option A relates to Respect for Persons. Option D relates to Beneficence. Option C is an
application of all three principles but is not the primary focus of Justice.
Q7. According to the Belmont Report, which of the following best describes the ethical
obligation to protect persons with diminished autonomy? (Select all that apply.)
A) They should be excluded from all research to prevent harm.
B) They may only participate in research that holds out the prospect of direct benefit.
C) They are entitled to protection.
D) They should be allowed to participate in any research as long as they sign a consent form.
E) Additional safeguards may be required to protect their welfare.
F) Their participation should be limited to no more than minimal risk research unless there is a
prospect of direct benefit.
Correct Answers: C, E, F
Rationale: Respect for Persons requires that persons with diminished autonomy are entitled to
protection. While they should not be categorically excluded from research (option A is
incorrect), additional safeguards may be required, such as limiting participation to no more than
minimal risk research unless there is a prospect of direct benefit. Simply signing a consent form
may not be sufficient if the person lacks decision-making capacity.
Q8. Which historical event is most directly linked to the creation of the Belmont Report?
(Select all that apply.)
A) Nazi medical experiments
B) The Tuskegee Syphilis Study
C) The Willowbrook Study
D) The Milgram study
E) The thalidomide tragedy
F) The Declaration of Helsinki
