Codes and Regulations

main menu | glossary | help

Section Quiz
You got 6 correct out of 6.
Please answer all questions below
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. What are the three ethical principles 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 for PHSfunded research?
A. OHRP
B. NIH
C. Institutions that receive Federal funds
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 determine that proposed studies are exempt from regulatory requirements.
A. True
B. False
6. Which of the following should be eliminated or minimized in the research design?
A. Coercion
B. Research risks
C. Repeated recruitment of research participants for new protocols
D. All of the above

Back to Main Menu

Respect for Persons

main menu | glossary | help

Section Quiz
You got 6 correct out of 6.
Please answer all questions below
1. 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 private
information from or about research participants.
D. All of the above
2. True or False: After informed consent for a research study is given, a research
participant must complete the study.
A. True
B. False
3. True or False: In general, informed consent should be a process rather than a onetime event.
A. True
B. False
4. 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
D. Sign, or put an X on the assent document
5. 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.
6. 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.
Back to Main Menu

Beneficence
main menu | glossary | help

Section Quiz
You got 5 correct out of 5.
Please answer all questions below
1. True or False: Risks to research participants must be completely eliminated for the
study to be considered ethical.
A. True
B. False
2. When are researchers specifically required by NIH policy to describe Data and Safety
Monitoring?
A. For all research involving human subjects
B. For all research involving children as subjects in research
C. For all clinical trials
D. For all research with prisoners
3. True or False: There must be equipoise in order to justify conducting a clinical trial.
A. True
B. False
4. 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
5. True or False: 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
Back to Main Menu

Justice
main menu | glossary | help

Section Quiz
You got 4 correct out of 4.
Please answer all questions below
1. Children must be included in all NIH-supported human subjects research unless:
A. The researcher is not a pediatrician
B. Past experience has shown it is time-consuming and expensive to recruit children
C. There are scientific and ethical reasons to exclude them
D. The researcher does not possess the pediatric equipment necessary to involve
children in the proposed research
2. True or False: For HIV antiretroviral treatment trials conducted in developing
countries, the NIH expects investigators/contractors to address the provision of
antiretroviral treatment to trial participants after their completion of participation in
the clinical trial.
A. True
B. False
3. Which of the following is TRUE regarding applications for NIH-funded research
overseas?
A. It is illegal to spend NIH funds in research overseas
B. Research conducted overseas is subject to HHS Human Subjects Regulations (45
CFR 46) and local regulations and policies
C. Research conducted overseas is only subject to local regulations and policies
D. Research conducted overseas need not address human subjects protections

4. 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
Back to Main Menu