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Protecting Human Research Participants:
Select Quiz Questions
Codes and Regulations: Section Quiz
1. Identify the most influential event that led to the HHS Policy for Protection of Human
Research Subjects:
A. Nuremberg trials
B. Syphilis Study at Tuskegee
C. Jewish Chronic Disease Hospital Study
D. Willowbrook Study
2. An institutionally designated authority, other than the investigator, should determine
that proposed studies are exempt from regulatory requirements.
A. True
B. False
3. The Belmont Report is significant because:
A. It was written by the National Commission for the Protection of Human Subjects.
B. It articulated ethical principles that formed the basis for the HHS Human Subjects Regulations.
C. Belmont is another word for individual autonomy and respect.
D. It was a seminal document about the concept of informed consent.
4. 45 CFR 46 requires Federal Departments and Agencies to rely solely on IRBs to
evaluate risks to subjects, protection against these risks, potential benefits of the
research and the importance of the knowledge to be gained.
A. True
B. False
5. A "systematic investigation designed to develop or contribute to generalizable
knowledge" may include:
A. Evaluation
B. Research Development
C. Testing
D. All of the above
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6. An "autonomous person" is someone who:
A. Has reached the legal age to provide informed consent in the State.
B. Is willing to accept certain risks if the research will benefit others in the future.
C. Understands the risks and benefits of his or her participation and is able to make a voluntary
decision if adequate information is provided.
D. Meets all eligibility criteria for a study and asks the investigator if she or he may participate.
Respect for Persons: Section Quiz
7. Why might an individual have diminished autonomy?
A. They are a neonate.
B. They are incarcerated or involuntarily confined.
C. They are unconscious.
D. All of the above.
8. In order to participate in research, children must:
A. Provide written informed consent
B. Provide written permission
C. Provide assent, unless the IRB determines that they are too young
9. For research involving pregnant women, participation requires:
A. That women have completed the first trimester.
B. That the study be conducted first in men.
C. Permission of the father.
D. Consideration of risks and potential benefits for the fetus and the pregnant woman.
10. The three fundamental principles of Informed consent are:
A. Voluntariness, Equipoise, Respect
B. Voluntariness, Comprehension, Disclosure
C. Benefits, Comprehension, Privacy
D. Disclosure, Equipoise, Privacy
11. The regulations strongly suggest but do not require that the informed consent
process be delivered in a language that is understandable to the subject.
A. True
B. False
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12. If informed consent information is presented orally, it must be documented using a
short form that states that all the required elements were presented orally.
A. True
B. False
Beneficence: Section Quiz
13. What is an appropriate method for maintaining confidentiality of private information
obtained from human subjects?
A. Keeping data in a password-protected database
B. Storing images in a secured cabinet
C. Coding data or specimens and keeping the key to the code in a separate, locked drawer
D. All of the above are ways to maintain confidentiality
14. If a researcher determines that his/her study poses no more than minimal risk as
defined in 45 CFR 46, there is no need for the protocol to have IRB review and
approval.
A. True
B. False
15. Which of the following most accurately describes clinical equipoise?
A. Scientific uncertainty that one study intervention is superior to another
B. A reasonable balance of risks and benefits to research subjects
C. When the probability and magnitude of harm or discomfort is not greater than those ordinarily
encountered in daily life or during the performance of routine physical or psychological exams
D. A double blind controlled trial
16. Because the expedited IRB review process is generally used for certain types of
minimal risk research, it is less stringent than review by the full IRB.
A. True
B. False
17. Therapeutic misconception is the tendency for investigators to mislead research
participants about the research purpose, procedures or benefits.
A. True
B. False
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Justice: Section Quiz
18. In localities where community consent is the norm,
A. A family member's consent for another individual may be sufficient, as long as community
consent is given
B. Federal regulations preclude the conduct of PHS-funded research
C. Community consent to participate in the research study is sufficient and no IRB approval is
required
D. In addition to the cultural norm, individual informed consent is required
19. NIH has specific policies addressing:
A. Inclusion of children in research
B. Inclusion of women and minorities in research
C. Treatment for research subjects in HIV/AIDS antiretroviral studies following completing of trials
in developing countries
D. All of the above
20. IRBs reviewing research in a different geographical location and/or cultural context
have a responsibility to:
A. Obtain knowledge of the local context by talking to those who have traveled to the region
B. Defer to an IRB that is in the situated within the local research context
C. Ask specialists with direct knowledge of the local research context to participate in IRB
discussions
D. B or C
E. A or C
21. It is ethical to use deceptive methods in research when the scientific goals of the
project can be achieved by non-deceptive methods.
A. True
B. False
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Answer Key
Codes and Regulations
1. b) Syphilis Study at Tuskegee
2. a) True
3. b) It articulated ethical principles that formed the basis for the HHS Human Subjects Regulations
4. b) False
5. d) All of the above
6. c) Understands the risks and benefits of his or her participation and is able to make a voluntary
decision if adequate information is provided
Respect for Persons
7. d) All of the above
8. c) Provide assent, unless the IRB determines that they are too young
9. d) Consideration of risks and potential benefits for the fetus and the pregnant woman
10. b) Voluntariness, Comprehension, Disclosure
11. b) False
12. a) True
Beneficence
13. d) All of the above are ways to maintain confidentiality
14. b) False
15. a) Scientific uncertainty that one study intervention is superior to another
16. b) False
17. b) False
Justice
18. d) In addition to the cultural norm, individual informed consent is required
19. d) All of the above
20. d) B or C
21. b) False
