Human Research Protection Training
Ultimate Exam
**Question 1.** Which document first articulated the principle of voluntary informed consent for
human subjects?
A) Declaration of Helsinki
B) Belmont Report
C) Nuremberg Code
D) Common Rule
Answer: C
Explanation: The 1947 Nuremberg Code was the earliest formal statement requiring voluntary consent
from research participants.
**Question 2.** The Belmont Report identifies three core ethical principles. Which of the following is
NOT one of them?
A) Respect for Persons
B) Beneficence
C) Justice
D) Autonomy
Answer: D
Explanation: Autonomy is encompassed within Respect for Persons; the three distinct Belmont
principles are Respect for Persons, Beneficence, and Justice.
**Question 3.** In the context of the Common Rule, which definition best describes “human subject”?
A) Any living organism used in a laboratory experiment.
B) A living individual about whom an investigator obtains data through interaction or identifiable private
information.
C) Only individuals who provide written consent.
D) Persons who are paid for participation.
, Human Research Protection Training
Ultimate Exam
Answer: B
Explanation: The Common Rule defines a human subject as a living individual about whom research
obtains data via interaction, intervention, or identifiable private information.
**Question 4.** Which of the following activities would most likely be classified as “exempt” research
under the Revised Common Rule?
A) A randomized controlled trial of a new drug.
B2) Collection of blood samples for genetic analysis.
C) Educational testing of normal classroom practices.
D) Study involving vulnerable prisoners.
Answer: C
Explanation: Educational tests, surveys, or observations of normal educational practices often qualify for
exemption because they involve minimal risk.
**Question 5.** Under the Revised Common Rule, which level of IRB review is required for a study that
involves non-invasive MRI scans of healthy volunteers with no more than minimal risk?
A) Full Board Review
B) Expedited Review
C) Exempt Review
D) No review needed
Answer: B
Explanation: Non-invasive imaging with minimal risk fits categories eligible for expedited review.
**Question 6.** Which of the following is a required element of informed consent according to 45 CFR
46.116?
A) A detailed description of the researcher’s qualifications.
B) Disclosure of all possible risks, no matter how remote.
, Human Research Protection Training
Ultimate Exam
C) Statement that participation is voluntary and may be withdrawn at any time.
D) A guarantee of compensation for any injury.
Answer: C
Explanation: The consent form must explicitly state that participation is voluntary and that the subject
may withdraw without penalty.
**Question 7.** An IRB may waive the requirement for a signed consent form when:
A) The research involves children.
B) The study presents more than minimal risk.
C) The only record linking participants to the research is the consent form itself.
D) The investigator is a student.
Answer: C
Explanation: The Common Rule allows a waiver when the only link between the subject and the data is
the consent form, reducing privacy risk.
**Question 8.** Which Subpart of 45 CFR 46 provides additional protections for pregnant women,
human fetuses, and neonates?
A) Subpart B
B) Subpart C
C) Subpart D
D) Subpart E
Answer: A
Explanation: Subpart B specifically addresses protections for pregnant women, fetuses, and neonates.
**Question 9.** In research involving children, which term describes the child’s affirmative agreement
to participate?
, Human Research Protection Training
Ultimate Exam
A) Consent
B) Assent
C) Authorization
D) Permission
Answer: B
Explanation: Children provide assent, while parents or guardians give permission (parental consent).
**Question 10.** According to the Belmont principle of justice, which of the following is an appropriate
way to select participants?
A) Recruit only from the most convenient population.
B) Target a vulnerable group because they are easy to access.
C) Ensure that the benefits and burdens of research are fairly distributed across society.
D) Choose participants who will provide the most data irrespective of risk.
Answer: C
Explanation: Justice requires equitable selection so that no group bears undue burdens or is excluded
from potential benefits.
**Question 11.** The term “minimal risk” is defined as risk that is:
A) No greater than the risks encountered in everyday life.
B) No greater than the risks associated with routine clinical care.
C) No greater than the risks of a standard laboratory experiment.
D) No greater than the risks of a typical classroom activity.
Answer: B
Explanation: Minimal risk means that the probability and magnitude of harm are not greater than those
ordinarily encountered in daily life or during routine medical examinations.
Ultimate Exam
**Question 1.** Which document first articulated the principle of voluntary informed consent for
human subjects?
A) Declaration of Helsinki
B) Belmont Report
C) Nuremberg Code
D) Common Rule
Answer: C
Explanation: The 1947 Nuremberg Code was the earliest formal statement requiring voluntary consent
from research participants.
**Question 2.** The Belmont Report identifies three core ethical principles. Which of the following is
NOT one of them?
A) Respect for Persons
B) Beneficence
C) Justice
D) Autonomy
Answer: D
Explanation: Autonomy is encompassed within Respect for Persons; the three distinct Belmont
principles are Respect for Persons, Beneficence, and Justice.
**Question 3.** In the context of the Common Rule, which definition best describes “human subject”?
A) Any living organism used in a laboratory experiment.
B) A living individual about whom an investigator obtains data through interaction or identifiable private
information.
C) Only individuals who provide written consent.
D) Persons who are paid for participation.
, Human Research Protection Training
Ultimate Exam
Answer: B
Explanation: The Common Rule defines a human subject as a living individual about whom research
obtains data via interaction, intervention, or identifiable private information.
**Question 4.** Which of the following activities would most likely be classified as “exempt” research
under the Revised Common Rule?
A) A randomized controlled trial of a new drug.
B2) Collection of blood samples for genetic analysis.
C) Educational testing of normal classroom practices.
D) Study involving vulnerable prisoners.
Answer: C
Explanation: Educational tests, surveys, or observations of normal educational practices often qualify for
exemption because they involve minimal risk.
**Question 5.** Under the Revised Common Rule, which level of IRB review is required for a study that
involves non-invasive MRI scans of healthy volunteers with no more than minimal risk?
A) Full Board Review
B) Expedited Review
C) Exempt Review
D) No review needed
Answer: B
Explanation: Non-invasive imaging with minimal risk fits categories eligible for expedited review.
**Question 6.** Which of the following is a required element of informed consent according to 45 CFR
46.116?
A) A detailed description of the researcher’s qualifications.
B) Disclosure of all possible risks, no matter how remote.
, Human Research Protection Training
Ultimate Exam
C) Statement that participation is voluntary and may be withdrawn at any time.
D) A guarantee of compensation for any injury.
Answer: C
Explanation: The consent form must explicitly state that participation is voluntary and that the subject
may withdraw without penalty.
**Question 7.** An IRB may waive the requirement for a signed consent form when:
A) The research involves children.
B) The study presents more than minimal risk.
C) The only record linking participants to the research is the consent form itself.
D) The investigator is a student.
Answer: C
Explanation: The Common Rule allows a waiver when the only link between the subject and the data is
the consent form, reducing privacy risk.
**Question 8.** Which Subpart of 45 CFR 46 provides additional protections for pregnant women,
human fetuses, and neonates?
A) Subpart B
B) Subpart C
C) Subpart D
D) Subpart E
Answer: A
Explanation: Subpart B specifically addresses protections for pregnant women, fetuses, and neonates.
**Question 9.** In research involving children, which term describes the child’s affirmative agreement
to participate?
, Human Research Protection Training
Ultimate Exam
A) Consent
B) Assent
C) Authorization
D) Permission
Answer: B
Explanation: Children provide assent, while parents or guardians give permission (parental consent).
**Question 10.** According to the Belmont principle of justice, which of the following is an appropriate
way to select participants?
A) Recruit only from the most convenient population.
B) Target a vulnerable group because they are easy to access.
C) Ensure that the benefits and burdens of research are fairly distributed across society.
D) Choose participants who will provide the most data irrespective of risk.
Answer: C
Explanation: Justice requires equitable selection so that no group bears undue burdens or is excluded
from potential benefits.
**Question 11.** The term “minimal risk” is defined as risk that is:
A) No greater than the risks encountered in everyday life.
B) No greater than the risks associated with routine clinical care.
C) No greater than the risks of a standard laboratory experiment.
D) No greater than the risks of a typical classroom activity.
Answer: B
Explanation: Minimal risk means that the probability and magnitude of harm are not greater than those
ordinarily encountered in daily life or during routine medical examinations.
