IRB Considerations & Ethical Leadership in DNP Practice 2026 |Galen
College
1. What is the primary purpose of an Institutional Review Board (IRB)?
A. To ensure the clinical project achieves statistical significance
B. To evaluate the financial feasibility of a DNP project
C. To protect the rights and welfare of human research subjects
D. To provide clinical mentorship to doctoral students
Answer: C
Rationale: The primary mission of the IRB is to ensure that human subjects are protected
from harm and that their rights are maintained throughout the research process.
2. Which historical document established the three core ethical principles:
Respect for Persons, Beneficence, and Justice?
A. The Nuremberg Code
B. The Declaration of Helsinki
C. The Belmont Report
D. The HIPAA Privacy Rule
Answer: C
Rationale: The Belmont Report (1979) is the foundational document for ethical research
in the United States, outlining the three core principles.
,3. In the context of the Belmont Report, the principle of ‘Justice’ refers to:
A. Maximizing possible benefits and minimizing potential harms
B. Ensuring participants are treated as autonomous agents
C. Securing informed consent from all participants
D. Fairness in the distribution of the burdens and benefits of research
Answer: D
Rationale: Justice requires that the selection of subjects is fair and that the benefits and
burdens of research are distributed equitably.
4. A DNP student is conducting a project that involves no more than ‘minimal
risk’ to participants. Which type of IRB review is most likely appropriate?
A. Expedited Review
B. Full Committee Review
C. Exempt Review
D. Preliminary Review
Answer: A
Rationale: Expedited review is used for research involving no more than minimal risk and
fits into specific categories defined by federal regulations.
5. What defines ‘minimal risk’ in human subjects research?
A. The probability of harm is zero
B. The project is a Quality Improvement initiative
C. Risk is only psychological and not physical
D. Harm is not greater than those ordinarily encountered in daily life
Answer: D
Rationale: Minimal risk means the probability and magnitude of harm or discomfort are
not greater than those ordinarily encountered in daily life or during routine physical or
psychological exams.
, 6. Which group is specifically classified as a ‘vulnerable population’ requiring
extra protections under 45 CFR 46?
A. Prisoners
B. College Students
C. Registered Nurses
D. Senior Citizens over 65
Answer: A
Rationale: Federal regulations (Subpart C) provide additional protections for prisoners
due to their incarcerated status and potential for coercion.
7. What is the difference between ‘Anonymity’ and ‘Confidentiality’?
A. Anonymity means the researcher cannot link data to a participant; confidentiality means the link is
protected
B. Confidentiality means the researcher cannot link data; anonymity means the link is protected
C. They are legally the same term under HIPAA
D. Anonymity applies to data, while confidentiality applies to the IRB process
Answer: A
Rationale: Anonymity exists when no one, including the researcher, can identify the
participant. Confidentiality is the researcher’s management of private information so that it
is not shared.
8. A DNP leader is fostering an ‘Ethical Climate’ in their organization. This is best
described as:
A. Enforcing strict punishments for clinical errors
B. The personal moral code of the Chief Nursing Officer
C. Shared perceptions of what is ethically correct behavior and how ethical issues should be handled
D. The annual review of the hospital’s financial statements
Answer: C
College
1. What is the primary purpose of an Institutional Review Board (IRB)?
A. To ensure the clinical project achieves statistical significance
B. To evaluate the financial feasibility of a DNP project
C. To protect the rights and welfare of human research subjects
D. To provide clinical mentorship to doctoral students
Answer: C
Rationale: The primary mission of the IRB is to ensure that human subjects are protected
from harm and that their rights are maintained throughout the research process.
2. Which historical document established the three core ethical principles:
Respect for Persons, Beneficence, and Justice?
A. The Nuremberg Code
B. The Declaration of Helsinki
C. The Belmont Report
D. The HIPAA Privacy Rule
Answer: C
Rationale: The Belmont Report (1979) is the foundational document for ethical research
in the United States, outlining the three core principles.
,3. In the context of the Belmont Report, the principle of ‘Justice’ refers to:
A. Maximizing possible benefits and minimizing potential harms
B. Ensuring participants are treated as autonomous agents
C. Securing informed consent from all participants
D. Fairness in the distribution of the burdens and benefits of research
Answer: D
Rationale: Justice requires that the selection of subjects is fair and that the benefits and
burdens of research are distributed equitably.
4. A DNP student is conducting a project that involves no more than ‘minimal
risk’ to participants. Which type of IRB review is most likely appropriate?
A. Expedited Review
B. Full Committee Review
C. Exempt Review
D. Preliminary Review
Answer: A
Rationale: Expedited review is used for research involving no more than minimal risk and
fits into specific categories defined by federal regulations.
5. What defines ‘minimal risk’ in human subjects research?
A. The probability of harm is zero
B. The project is a Quality Improvement initiative
C. Risk is only psychological and not physical
D. Harm is not greater than those ordinarily encountered in daily life
Answer: D
Rationale: Minimal risk means the probability and magnitude of harm or discomfort are
not greater than those ordinarily encountered in daily life or during routine physical or
psychological exams.
, 6. Which group is specifically classified as a ‘vulnerable population’ requiring
extra protections under 45 CFR 46?
A. Prisoners
B. College Students
C. Registered Nurses
D. Senior Citizens over 65
Answer: A
Rationale: Federal regulations (Subpart C) provide additional protections for prisoners
due to their incarcerated status and potential for coercion.
7. What is the difference between ‘Anonymity’ and ‘Confidentiality’?
A. Anonymity means the researcher cannot link data to a participant; confidentiality means the link is
protected
B. Confidentiality means the researcher cannot link data; anonymity means the link is protected
C. They are legally the same term under HIPAA
D. Anonymity applies to data, while confidentiality applies to the IRB process
Answer: A
Rationale: Anonymity exists when no one, including the researcher, can identify the
participant. Confidentiality is the researcher’s management of private information so that it
is not shared.
8. A DNP leader is fostering an ‘Ethical Climate’ in their organization. This is best
described as:
A. Enforcing strict punishments for clinical errors
B. The personal moral code of the Chief Nursing Officer
C. Shared perceptions of what is ethically correct behavior and how ethical issues should be handled
D. The annual review of the hospital’s financial statements
Answer: C
