NIH Training Questions/Quiz answers
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.
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
True or False: There must be equipoise in order to justify conducting a clinical
trial.
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.
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
True or False: There must be equipoise in order to justify conducting a clinical
trial.
