NIH EXAM STUDY QUESTIONS WITH
CORRECT ANSWERS!!
21CFR50.51 Subpart D
Clinical Investigations not involving greater than minimal risk - children
This form is used for the mandatory reporting of serious adverse events
FDA form 3500A
What is 45CFR46?
HHS Regulations for the Protection of Human Subjects of Research
What are the three principles of ethical human subject research identified in the Belmont
Report?
Beneficence, Justice, Respect for Persons
What was the Belmont Report?
The Ethical Principles and Guidelines for the Protection of Human Subjects of Research
(45CFR46)
What are the challenges in applying the Belmont principle of "respect for persons"?
- Making sure that potential participants comprehend the risks and potential benefits of
participating in research
- Avoiding influencing potential participants' decisions either through explicit or implied threats
(coercion) or through excessive compensation (undue influence)
What are the challenges in applying the Belmont principle of "beneficence"?
how to determine when potential benefits outweigh considerations of risks and vice versa
What are the challenges in applying the Belmont principle of "justice"?
how to decide which criteria should be used to ensure that harms and benefits of research are
equitably distributed to individuals and populations.
,What organization follows all subparts of 45CFR46 (Belmont Report)
NIH
45CFR46 Subpart A - "The Common Rule"
Basic HHS Policy for Protection of Human Research Subjects
45CFR46 Subpart B
Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
45CFR46 Subpart C
Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as
Subjects
45CFR46 Subpart D
Additional Protections for Children Involved as Subjects in Research
45CFR46Subpart E
Registration of Institutional Review Boards
What is the definition of a human subject?
(45CFR46 Subpart A)
"a living individual about whom an investigator...conducting research obtains:
Data through intervention or interaction with the individual, or
Identifiable private information."
What is the definition of research?
(45CFR46 Subpart A)
a systematic investigation...designed to develop or contribute to generalizable knowledge
through research development, testing, and/or evaluation
, Case Study:
An investigator will be using human hearts in order to study factors leading to heart
failure. One group of normal, control hearts will be obtained from cadavers. A set of
diseased hearts will be obtained from individuals who are to receive a heart transplant.
Does this study involve human subjects?
Yes, this study involves human subjects.
The use of the diseased hearts removed during transplant surgery is human subject research,
since the donors are alive.
Individuals with (blank) may need additional protections based on the Belmont principle of
respect for persons
diminished autonomy
In 45CFR46 Subpart B what individuals have diminished autonomy and require additional
protection?
Pregnant women, fetuses, and neonates
In 45CFR46 Subpart C what individuals have diminished autonomy and require additional
protection?
Prisoners
In 45CFR46 Subpart D what individuals have diminished autonomy and require additional
protection?
Children
This HHS regulation requires that investigators include additional safeguards in the study
to protect the rights and welfare of vulnerable populations "when some or all of the
subjects are likely to be vulnerable to coercion or undue influence."
45CFR46.111
CORRECT ANSWERS!!
21CFR50.51 Subpart D
Clinical Investigations not involving greater than minimal risk - children
This form is used for the mandatory reporting of serious adverse events
FDA form 3500A
What is 45CFR46?
HHS Regulations for the Protection of Human Subjects of Research
What are the three principles of ethical human subject research identified in the Belmont
Report?
Beneficence, Justice, Respect for Persons
What was the Belmont Report?
The Ethical Principles and Guidelines for the Protection of Human Subjects of Research
(45CFR46)
What are the challenges in applying the Belmont principle of "respect for persons"?
- Making sure that potential participants comprehend the risks and potential benefits of
participating in research
- Avoiding influencing potential participants' decisions either through explicit or implied threats
(coercion) or through excessive compensation (undue influence)
What are the challenges in applying the Belmont principle of "beneficence"?
how to determine when potential benefits outweigh considerations of risks and vice versa
What are the challenges in applying the Belmont principle of "justice"?
how to decide which criteria should be used to ensure that harms and benefits of research are
equitably distributed to individuals and populations.
,What organization follows all subparts of 45CFR46 (Belmont Report)
NIH
45CFR46 Subpart A - "The Common Rule"
Basic HHS Policy for Protection of Human Research Subjects
45CFR46 Subpart B
Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
45CFR46 Subpart C
Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as
Subjects
45CFR46 Subpart D
Additional Protections for Children Involved as Subjects in Research
45CFR46Subpart E
Registration of Institutional Review Boards
What is the definition of a human subject?
(45CFR46 Subpart A)
"a living individual about whom an investigator...conducting research obtains:
Data through intervention or interaction with the individual, or
Identifiable private information."
What is the definition of research?
(45CFR46 Subpart A)
a systematic investigation...designed to develop or contribute to generalizable knowledge
through research development, testing, and/or evaluation
, Case Study:
An investigator will be using human hearts in order to study factors leading to heart
failure. One group of normal, control hearts will be obtained from cadavers. A set of
diseased hearts will be obtained from individuals who are to receive a heart transplant.
Does this study involve human subjects?
Yes, this study involves human subjects.
The use of the diseased hearts removed during transplant surgery is human subject research,
since the donors are alive.
Individuals with (blank) may need additional protections based on the Belmont principle of
respect for persons
diminished autonomy
In 45CFR46 Subpart B what individuals have diminished autonomy and require additional
protection?
Pregnant women, fetuses, and neonates
In 45CFR46 Subpart C what individuals have diminished autonomy and require additional
protection?
Prisoners
In 45CFR46 Subpart D what individuals have diminished autonomy and require additional
protection?
Children
This HHS regulation requires that investigators include additional safeguards in the study
to protect the rights and welfare of vulnerable populations "when some or all of the
subjects are likely to be vulnerable to coercion or undue influence."
45CFR46.111
