CITI Training Complete Research Ethics & Certification | CITI
Program Research Ethics Study Guide & Certification Exam
Prep 2026/2027 | Human Subjects Research, Belmont Report,
IRB Review, Informed Consent, Vulnerable Populations,
Privacy & Confidentiality, HIPAA, Research Misconduct,
Responsible Conduct of Research, Conflicts of Interest,
Federal Regulations, Good Clinical Practice, Practice
Questions, Answers & Detailed Rationales
Question 1: Which of the following are the three fundamental ethical
principles outlined in the Belmont Report?
A. Respect for Persons, Justice, and Non-maleficence
B. Informed Consent, Risk-Benefit Analysis, and Equitable Selection
C. Respect for Persons, Beneficence, and Justice
D. Privacy, Confidentiality, and Autonomy
CORRECT ANSWER: C. Respect for Persons, Beneficence, and Justice
Rationale: The Belmont Report, published in 1979, identifies three core principles for
the ethical conduct of human subjects research: Respect for Persons (treating individuals
as autonomous agents and protecting those with diminished autonomy), Beneficence
(maximizing benefits and minimizing harms), and Justice (ensuring the fair distribution
of risks and benefits) .
Question 2: What is the primary purpose of obtaining informed consent in
research?
A. To provide legal protection for the researcher and institution against lawsuits
B. To ensure that the researcher has explained all study procedures in detail
C. To provide potential participants with comprehensive information so they can make a
voluntary, autonomous decision about participation
D. To obtain a legally valid signature on a document to meet regulatory requirements
CORRECT ANSWER: C. To provide potential participants with comprehensive
information so they can make a voluntary, autonomous decision about
participation
Rationale: The core ethical principle of Respect for Persons is operationalized through
the informed consent process. Its goal is to ensure that prospective participants are
provided with all necessary information to make a knowledgeable and voluntary
decision about their involvement in the research.
Question 3: The principle of beneficence in research requires that:
A. Subjects derive direct individual benefit from participating in the study
B. The research must make a significant contribution to generalizable knowledge
C. Anticipated benefits justify the risks of harm to participants
D. All research risks are managed to a minimal level
,CORRECT ANSWER: C. Anticipated benefits justify the risks of harm to
participants
Rationale: The Belmont principle of Beneficence refers to the ethical obligation to "do
no harm" and to actively "do good." In research, this translates to a requirement that the
potential benefits of the study (to science, society, or subjects) must be carefully weighed
against the potential risks of harm to participants, and the benefits must be sufficient to
justify the risks .
Question 4: The principle of justice in the Belmont Report primarily addresses:
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
CORRECT ANSWER: B. The fair and equitable distribution of the burdens and
benefits of research
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.
Question 5: According to the Belmont Report, which of the following best
describes the ethical obligation to protect persons with diminished autonomy?
A. They should be excluded from all research to prevent harm
B. They may only participate in research that holds out a prospect of direct benefit
C. They are entitled to special protection while still being included in research where
appropriate
D. Their legally authorized representative can waive any and all research protections
CORRECT ANSWER: C. They are entitled to special protection while still being
included in research where appropriate
Rationale: The principle of Respect for Persons requires that autonomous individuals be
given the opportunity to choose what shall or shall not happen to them. It also requires
that persons with diminished autonomy (e.g., children, individuals with cognitive
impairments) are entitled to protection, but this does not necessarily mean excluding
them from research entirely .
Question 6: Which of the following is the most accurate definition of "human
subjects" research under the federal Common Rule?
A. Any study that involves interaction or intervention with living individuals
B. Research that gathers data about living individuals through intervention or
interaction, or uses identifiable private information
C. Any project that involves interviewing individuals
D. Research conducted at a university that is funded by the federal government
,CORRECT ANSWER: B. Research that gathers data about living individuals
through intervention or interaction, or uses identifiable private information
Rationale: The Common Rule (45 CFR 46) defines a human subject as a living individual
about whom an investigator conducting research obtains (1) data through intervention
or interaction with the individual, or (2) identifiable private information. This definition is
critical for determining what activities require IRB oversight.
Question 7: An investigator is conducting a study that involves only interviews
with adults about their opinions on public transportation. The data is collected
anonymously and the research poses no more than minimal risk. This study
would most likely qualify for:
A. Full IRB review at a convened meeting
B. Expedited IRB review
C. Exempt review
D. A waiver of all IRB oversight
CORRECT ANSWER: C. Exempt review
Rationale: Research that is of minimal risk, does not involve vulnerable populations, and
uses benign interventions (such as interviews or surveys on non-sensitive topics) often
falls into a category of research that is exempt from the full IRB review process. The
determination of exemption is made by the IRB, not the researcher .
Question 8: Which of the following research activities would likely NOT be
considered "human subjects" research requiring IRB review?
A. A researcher conducts in-depth interviews with cancer survivors about their
treatment experiences.
B. A researcher administers a survey on university students' attitudes toward academic
honesty.
C. A historian analyzes diaries and letters from the 19th century that are found in a
public archive.
D. A researcher observes interactions in a public park and records data that identifies
individuals.
CORRECT ANSWER: C. A historian analyzes diaries and letters from the 19th
century that are found in a public archive.
Rationale: Research activities that do not meet the regulatory definition of research with
human subjects may not require IRB review. Research on historical documents, even if
they contain personal information, is generally not considered human subjects research
if the information is not about a "living individual" and was obtained from a public
source.
Question 9: What is the primary function of an Institutional Review Board
(IRB)?
, A. To provide scientific peer review of research proposals
B. To manage research budgets and ensure projects are funded
C. To conduct research on the effectiveness of new treatments
D. To review research protocols to ensure the protection of human subjects' rights and
welfare
CORRECT ANSWER: D. To review research protocols to ensure the protection
of human subjects' rights and welfare
Rationale: The IRB's primary responsibility is to protect the rights and welfare of human
subjects involved in research. It reviews, approves, and monitors research protocols to
ensure that risks to participants are minimized, informed consent is adequate, and the
selection of subjects is equitable.
Question 10: An IRB member may have a potential conflict of interest with a
study under review. What is the appropriate procedure for that member?
A. They must leave the room and are prohibited from any involvement in the review.
B. They may answer questions and participate in the discussion but must recuse
themselves from the final vote.
C. They may vote as long as they disclose the conflict before the vote.
D. They may serve as the primary reviewer but cannot vote on the final approval.
CORRECT ANSWER: B. They may answer questions and participate in the
discussion but must recuse themselves from the final vote.
Rationale: To maintain the integrity and impartiality of the IRB review process, any
member with a potential conflict of interest (e.g., a financial interest in the research or a
collaborative relationship with the investigator) must disclose that conflict. They may
participate in the discussion to provide their perspective but must recuse themselves
from the final vote to avoid bias .
Question 11: Research that involves no more than minimal risk and fits into
specific categories defined by the federal regulations can be reviewed through
which process?
A. Convened IRB meeting
B. Expedited review
C. Full-board review
D. Administrative review
CORRECT ANSWER: B. Expedited review
Rationale: The federal regulations permit expedited review for certain types of research
that involve no more than minimal risk and are on a list of eligible categories. This
review is conducted by the IRB chairperson or by one or more experienced reviewers
designated by the chairperson, rather than by the full convened board.
Question 12: Which of the following is a key criterion for granting a waiver of
the requirement to obtain a signed consent form?
Program Research Ethics Study Guide & Certification Exam
Prep 2026/2027 | Human Subjects Research, Belmont Report,
IRB Review, Informed Consent, Vulnerable Populations,
Privacy & Confidentiality, HIPAA, Research Misconduct,
Responsible Conduct of Research, Conflicts of Interest,
Federal Regulations, Good Clinical Practice, Practice
Questions, Answers & Detailed Rationales
Question 1: Which of the following are the three fundamental ethical
principles outlined in the Belmont Report?
A. Respect for Persons, Justice, and Non-maleficence
B. Informed Consent, Risk-Benefit Analysis, and Equitable Selection
C. Respect for Persons, Beneficence, and Justice
D. Privacy, Confidentiality, and Autonomy
CORRECT ANSWER: C. Respect for Persons, Beneficence, and Justice
Rationale: The Belmont Report, published in 1979, identifies three core principles for
the ethical conduct of human subjects research: Respect for Persons (treating individuals
as autonomous agents and protecting those with diminished autonomy), Beneficence
(maximizing benefits and minimizing harms), and Justice (ensuring the fair distribution
of risks and benefits) .
Question 2: What is the primary purpose of obtaining informed consent in
research?
A. To provide legal protection for the researcher and institution against lawsuits
B. To ensure that the researcher has explained all study procedures in detail
C. To provide potential participants with comprehensive information so they can make a
voluntary, autonomous decision about participation
D. To obtain a legally valid signature on a document to meet regulatory requirements
CORRECT ANSWER: C. To provide potential participants with comprehensive
information so they can make a voluntary, autonomous decision about
participation
Rationale: The core ethical principle of Respect for Persons is operationalized through
the informed consent process. Its goal is to ensure that prospective participants are
provided with all necessary information to make a knowledgeable and voluntary
decision about their involvement in the research.
Question 3: The principle of beneficence in research requires that:
A. Subjects derive direct individual benefit from participating in the study
B. The research must make a significant contribution to generalizable knowledge
C. Anticipated benefits justify the risks of harm to participants
D. All research risks are managed to a minimal level
,CORRECT ANSWER: C. Anticipated benefits justify the risks of harm to
participants
Rationale: The Belmont principle of Beneficence refers to the ethical obligation to "do
no harm" and to actively "do good." In research, this translates to a requirement that the
potential benefits of the study (to science, society, or subjects) must be carefully weighed
against the potential risks of harm to participants, and the benefits must be sufficient to
justify the risks .
Question 4: The principle of justice in the Belmont Report primarily addresses:
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
CORRECT ANSWER: B. The fair and equitable distribution of the burdens and
benefits of research
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.
Question 5: According to the Belmont Report, which of the following best
describes the ethical obligation to protect persons with diminished autonomy?
A. They should be excluded from all research to prevent harm
B. They may only participate in research that holds out a prospect of direct benefit
C. They are entitled to special protection while still being included in research where
appropriate
D. Their legally authorized representative can waive any and all research protections
CORRECT ANSWER: C. They are entitled to special protection while still being
included in research where appropriate
Rationale: The principle of Respect for Persons requires that autonomous individuals be
given the opportunity to choose what shall or shall not happen to them. It also requires
that persons with diminished autonomy (e.g., children, individuals with cognitive
impairments) are entitled to protection, but this does not necessarily mean excluding
them from research entirely .
Question 6: Which of the following is the most accurate definition of "human
subjects" research under the federal Common Rule?
A. Any study that involves interaction or intervention with living individuals
B. Research that gathers data about living individuals through intervention or
interaction, or uses identifiable private information
C. Any project that involves interviewing individuals
D. Research conducted at a university that is funded by the federal government
,CORRECT ANSWER: B. Research that gathers data about living individuals
through intervention or interaction, or uses identifiable private information
Rationale: The Common Rule (45 CFR 46) defines a human subject as a living individual
about whom an investigator conducting research obtains (1) data through intervention
or interaction with the individual, or (2) identifiable private information. This definition is
critical for determining what activities require IRB oversight.
Question 7: An investigator is conducting a study that involves only interviews
with adults about their opinions on public transportation. The data is collected
anonymously and the research poses no more than minimal risk. This study
would most likely qualify for:
A. Full IRB review at a convened meeting
B. Expedited IRB review
C. Exempt review
D. A waiver of all IRB oversight
CORRECT ANSWER: C. Exempt review
Rationale: Research that is of minimal risk, does not involve vulnerable populations, and
uses benign interventions (such as interviews or surveys on non-sensitive topics) often
falls into a category of research that is exempt from the full IRB review process. The
determination of exemption is made by the IRB, not the researcher .
Question 8: Which of the following research activities would likely NOT be
considered "human subjects" research requiring IRB review?
A. A researcher conducts in-depth interviews with cancer survivors about their
treatment experiences.
B. A researcher administers a survey on university students' attitudes toward academic
honesty.
C. A historian analyzes diaries and letters from the 19th century that are found in a
public archive.
D. A researcher observes interactions in a public park and records data that identifies
individuals.
CORRECT ANSWER: C. A historian analyzes diaries and letters from the 19th
century that are found in a public archive.
Rationale: Research activities that do not meet the regulatory definition of research with
human subjects may not require IRB review. Research on historical documents, even if
they contain personal information, is generally not considered human subjects research
if the information is not about a "living individual" and was obtained from a public
source.
Question 9: What is the primary function of an Institutional Review Board
(IRB)?
, A. To provide scientific peer review of research proposals
B. To manage research budgets and ensure projects are funded
C. To conduct research on the effectiveness of new treatments
D. To review research protocols to ensure the protection of human subjects' rights and
welfare
CORRECT ANSWER: D. To review research protocols to ensure the protection
of human subjects' rights and welfare
Rationale: The IRB's primary responsibility is to protect the rights and welfare of human
subjects involved in research. It reviews, approves, and monitors research protocols to
ensure that risks to participants are minimized, informed consent is adequate, and the
selection of subjects is equitable.
Question 10: An IRB member may have a potential conflict of interest with a
study under review. What is the appropriate procedure for that member?
A. They must leave the room and are prohibited from any involvement in the review.
B. They may answer questions and participate in the discussion but must recuse
themselves from the final vote.
C. They may vote as long as they disclose the conflict before the vote.
D. They may serve as the primary reviewer but cannot vote on the final approval.
CORRECT ANSWER: B. They may answer questions and participate in the
discussion but must recuse themselves from the final vote.
Rationale: To maintain the integrity and impartiality of the IRB review process, any
member with a potential conflict of interest (e.g., a financial interest in the research or a
collaborative relationship with the investigator) must disclose that conflict. They may
participate in the discussion to provide their perspective but must recuse themselves
from the final vote to avoid bias .
Question 11: Research that involves no more than minimal risk and fits into
specific categories defined by the federal regulations can be reviewed through
which process?
A. Convened IRB meeting
B. Expedited review
C. Full-board review
D. Administrative review
CORRECT ANSWER: B. Expedited review
Rationale: The federal regulations permit expedited review for certain types of research
that involve no more than minimal risk and are on a list of eligible categories. This
review is conducted by the IRB chairperson or by one or more experienced reviewers
designated by the chairperson, rather than by the full convened board.
Question 12: Which of the following is a key criterion for granting a waiver of
the requirement to obtain a signed consent form?
