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

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

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

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.

True or False: An institutionally designated authority, other than the investigator, 

should determine that proposed studies are exempt from regulatory 

requirements.

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

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

True or False: After informed consent for a research study is given, a research 

participant must complete the study.

True or False: In general, informed consent should be a process rather than a 

one­time event.

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

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.

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.

True or False: Risks to research participants must be completely eliminated for 

the study to be considered ethical.