Sample Questions – Protection of Human Participants Research
1. Identify the most influential event that led to the development of ethical standards for research with human subjects:
A. Nuremburg Trials
B. Syphilis Study at Tuskgee
C. Jewish Chronic Disease Hospital Study
D. Willowbrook Study
2. What are the three ethical principles from the Belmont Report that constitute the basis for the HHS Human Subjects
Regulations (45 CFR 46)?
A. Honesty, Trust, Respect
B. Informed consent, IRB review, Research integrity
C. Respect for Persons, Beneficence, Justice
D. Protections for Pregnant Women, Prisoners, Children
3. Which entity has regulatory authority for the protection of human subjects research?
A. OHRP
B. NIH
C. ORI
D. HHS
4. True or False: All research that involves interaction or intervention with humans or human samples/data, whether they are
alive or dead, is human subjects research.
A. True
B. False
5. True or False: An institutionally designated authority, other than the investigator, should make the determination of the
whether a proposed study is exempt from regulatory requirements.
A. True
B. False
6. Which of the following should be eliminated or minimized in a research design?
A. Confidentiality
B. Research risks
C. Compensation provided to the research participants
D. All of the above
7. When might human subjects research require investigators to obtain informed consent?
A. Investigators must obtain informed consent if the study involves interactions with research participants.
B. Investigators must obtain informed consent if the study involves interventions with research participants.
C. Investigators must obtain informed consent if the study involves collection of identifiable private information from or
about research participants.
D. All of the above
8. True or False: After informed consent for a research study is given, a research participant must complete the study.
A. True
B. False
9. True or False: In general, informed consent should be a process rather than a one-time event.
A. True
B. False
10. In order for children to participate in a research study, which of the following is applicable?
A. Passive consent (opt out method) is acceptable as long as parents have been properly informed about the research
B. Written parental permission is required
C. The child must provide written informed consent
D. All of the above are applicable.
11. Why might an individual have diminished autonomy and thus have special protections in research?
A. There are old.
B. They are incarcerated or involuntarily confined.
C. They are pregnant.
D. All of the above.
12. True or False: Risks to research participants must be completely eliminated for the study to be approved by the IRB.
A. True
B. False
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 data in a secured cabinet.
C. Coding data or specimens and keeping the key to the code in a separate location.
D. All of the above are ways to maintain confidentiality.
14 True or False: If a researcher makes the judgment 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. What is the cornerstone document of ethical principles upon which HHS regulations for the protection of research subjects
is based?
A. Nuremberg Code
B. Declaration of Helsinki
C. Belmont Report
D. HIPAA Privacy Rule
16. The principle requiring that individuals and groups be treated fairly and equitably in terms of bearing the burdens and
receiving the benefits of research is called …
A. Autonomy
B. Justice
C. Beneficence
D. Respect for Persons
17. A study was approved by the IRB as exempt from continuing review. Six months into the study, the PI determines that the
research instrument should be changed. Does the PI have to request approval from the IRB for the proposed modification?
A. Yes
B. No
18. True or False: A quality improvement project involving a survey of employees in which the results are used only for
internal purposes does not require IRB review and approval.
A. True
B. False
19. A student researcher wants to survey elementary school principals to find out school policies on disciplinary action and the
implementation of student behavior plans. Does this constitute human subjects research?
A. Yes
B. No
C. It depends if opinions are sought from the principals.
20. Which of the following represents a vulnerable population for which additional protections are required?
A. Minority race or ethnic group
B. Women over age 60
C. Children
D. All are considered a vulnerable population