NIH Training Exam Questions and
Answers
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. Willow-brook Study
Answer B
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
Answer C
3. Which entity has regulatory authority for the protection of human subjects for
PHS-funded research?
A. OHRP
B. NIH
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, C. Institutions that receive Federal funds
D. HHS
Answer A
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.
Answer False
5. True or False
An institutionally designated authority, other than the investigator, should determine
that proposed studies are exempt from regulatory requirements.
Answer True
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
Answer D
7. When might human subjects research require investigators to obtain in-
formed consent?
A. Investigators must obtain informed consent if the study involves interactions with
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15
Answers
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. Willow-brook Study
Answer B
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
Answer C
3. Which entity has regulatory authority for the protection of human subjects for
PHS-funded research?
A. OHRP
B. NIH
1/
15
, C. Institutions that receive Federal funds
D. HHS
Answer A
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.
Answer False
5. True or False
An institutionally designated authority, other than the investigator, should determine
that proposed studies are exempt from regulatory requirements.
Answer True
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
Answer D
7. When might human subjects research require investigators to obtain in-
formed consent?
A. Investigators must obtain informed consent if the study involves interactions with
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15
