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 PHS-funded 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 one-time event.
In order to participate in research, children must ...
A. Provide written informed consent
B. Provide written permission