NEWEST Certified IRB Professional EXAM |
Public Responsibility in Medicine and
Research | ULTIMATE EXAM WITH
CORRECT ANSWERS AND RATIONALES
FOR CERTIFICATION SUCCESS
1. The primary purpose of an Institutional Review
Board (IRB) is to:
A) Ensure scientific validity of all research
B) Protect the rights and welfare of human research
subjects
C) Secure funding for research projects
D) Publish research results
Correct answer: B
Rationale: The IRB's core mission is ethical and
regulatory protection of human subjects, not
scientific review or funding.
2. Which federal regulation is known as the "Common
Rule"?
A) 21 CFR Part 50
B) 45 CFR Part 46
,C) 42 CFR Part 11
D) 38 CFR Part 16
Correct answer: B
Rationale: 45 CFR Part 46 is the Common Rule,
adopted by multiple federal departments for human
subject protections.
3. The Belmont Report identifies which three basic
ethical principles?
A) Respect for persons, beneficence, justice
B) Autonomy, non-maleficence, confidentiality
C) Informed consent, privacy, confidentiality
D) Honesty, integrity, transparency
Correct answer: A
Rationale: Belmont Report (1979) established respect
for persons, beneficence, and justice as foundational
principles.
4. "Respect for persons" under the Belmont Report
requires:
A) Maximizing benefits and minimizing harms
B) Treating individuals as autonomous agents and
protecting those with diminished autonomy
,C) Fair distribution of research burdens and benefits
D) Publishing all research results
Correct answer: B
Rationale: Respect for persons includes informed
consent and special protections for vulnerable
populations.
5. "Beneficence" in human subjects research
requires:
A) Do not harm and maximize possible benefits while
minimizing harms
B) Treat all subjects equally
C) Respect subject autonomy
D) Obtain a signed consent form
Correct answer: A
Rationale: Beneficence is the ethical obligation to
secure well-being by minimizing risks and maximizing
benefits.
6. "Justice" under the Belmont Report primarily
addresses:
A) Fair procedures and equitable distribution of
research risks and benefits
, B) Legal representation for subjects
C) Speedy IRB review
D) Publication authorship
Correct answer: A
Rationale: Justice prohibits exploiting vulnerable
populations and requires fair subject selection.
7. Which of the following is NOT a valid IRB authority
under the Common Rule?
A) Approve research
B) Require modifications to secure approval
C) Disapprove research
D) Conduct scientific experiments independently
Correct answer: D
Rationale: IRBs review research proposed by others;
they do not conduct their own experiments.
8. The "exempt" category of research under 45 CFR
46.104 means:
A) No IRB review of any kind is required
B) Limited IRB review is required for exempt
determinations, but not full board review
Public Responsibility in Medicine and
Research | ULTIMATE EXAM WITH
CORRECT ANSWERS AND RATIONALES
FOR CERTIFICATION SUCCESS
1. The primary purpose of an Institutional Review
Board (IRB) is to:
A) Ensure scientific validity of all research
B) Protect the rights and welfare of human research
subjects
C) Secure funding for research projects
D) Publish research results
Correct answer: B
Rationale: The IRB's core mission is ethical and
regulatory protection of human subjects, not
scientific review or funding.
2. Which federal regulation is known as the "Common
Rule"?
A) 21 CFR Part 50
B) 45 CFR Part 46
,C) 42 CFR Part 11
D) 38 CFR Part 16
Correct answer: B
Rationale: 45 CFR Part 46 is the Common Rule,
adopted by multiple federal departments for human
subject protections.
3. The Belmont Report identifies which three basic
ethical principles?
A) Respect for persons, beneficence, justice
B) Autonomy, non-maleficence, confidentiality
C) Informed consent, privacy, confidentiality
D) Honesty, integrity, transparency
Correct answer: A
Rationale: Belmont Report (1979) established respect
for persons, beneficence, and justice as foundational
principles.
4. "Respect for persons" under the Belmont Report
requires:
A) Maximizing benefits and minimizing harms
B) Treating individuals as autonomous agents and
protecting those with diminished autonomy
,C) Fair distribution of research burdens and benefits
D) Publishing all research results
Correct answer: B
Rationale: Respect for persons includes informed
consent and special protections for vulnerable
populations.
5. "Beneficence" in human subjects research
requires:
A) Do not harm and maximize possible benefits while
minimizing harms
B) Treat all subjects equally
C) Respect subject autonomy
D) Obtain a signed consent form
Correct answer: A
Rationale: Beneficence is the ethical obligation to
secure well-being by minimizing risks and maximizing
benefits.
6. "Justice" under the Belmont Report primarily
addresses:
A) Fair procedures and equitable distribution of
research risks and benefits
, B) Legal representation for subjects
C) Speedy IRB review
D) Publication authorship
Correct answer: A
Rationale: Justice prohibits exploiting vulnerable
populations and requires fair subject selection.
7. Which of the following is NOT a valid IRB authority
under the Common Rule?
A) Approve research
B) Require modifications to secure approval
C) Disapprove research
D) Conduct scientific experiments independently
Correct answer: D
Rationale: IRBs review research proposed by others;
they do not conduct their own experiments.
8. The "exempt" category of research under 45 CFR
46.104 means:
A) No IRB review of any kind is required
B) Limited IRB review is required for exempt
determinations, but not full board review
