ANSWERS|LATEST UPDATE!!!!!!2026|GUARANTEED
CORRECT = 100
100
INCORRECT=0
STUDY MATERIALS.......DESIGNED TO HELP YOU SUCCEED
SPOTLIGHT 1
1
, DETAILED ANSWERS|LATEST
UPDATE!!!!!!2026|GUARANTEED PASS|GRADED
21CFR50.51 Subpart D - ANSWER Clinical Investigations not involving greater than
minimal risk - children
This form is used for the mandatory reporting of serious adverse events -
ANSWER FDA form 3500A
What is 45CFR46? - ANSWER 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? - ANSWER Beneficence, Justice, Respect for Persons
What was the Belmont Report? - ANSWER 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"? -
ANSWER - 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)
2
,What are the challenges in applying the Belmont principle of "beneficence"? -
ANSWER how to determine when potential benefits outweigh considerations of
risks and vice versa
What are the challenges in applying the Belmont principle of "justice"? -
ANSWER 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) - ANSWER NIH
45CFR46 Subpart A - "The Common Rule" - ANSWER Basic HHS Policy for Protection
of Human Research Subjects
45CFR46 Subpart B - ANSWER Additional Protections for Pregnant Women, Human
Fetuses and Neonates Involved in Research
45CFR46 Subpart C - ANSWER Additional Protections Pertaining to Biomedical and
Behavioral Research Involving Prisoners as Subjects
45CFR46 Subpart D - ANSWER Additional Protections for Children Involved as
Subjects in Research
45CFR46Subpart E - ANSWER Registration of Institutional Review Boards
What is the definition of a human subject?
(45CFR46 Subpart A) - ANSWER "a living individual about whom an
investigator...conducting research obtains:
Data through intervention or interaction with the individual, or
3
, Identifiable private information."
What is the definition of research?
(45CFR46 Subpart A) - ANSWER 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? - ANSWER 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 - ANSWER diminished autonomy
In 45CFR46 Subpart B what individuals have diminished autonomy and require additional
protection? - ANSWER Pregnant women, fetuses, and neonates
In 45CFR46 Subpart C what individuals have diminished autonomy and require additional
protection? - ANSWER Prisoners
4
CORRECT = 100
100
INCORRECT=0
STUDY MATERIALS.......DESIGNED TO HELP YOU SUCCEED
SPOTLIGHT 1
1
, DETAILED ANSWERS|LATEST
UPDATE!!!!!!2026|GUARANTEED PASS|GRADED
21CFR50.51 Subpart D - ANSWER Clinical Investigations not involving greater than
minimal risk - children
This form is used for the mandatory reporting of serious adverse events -
ANSWER FDA form 3500A
What is 45CFR46? - ANSWER 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? - ANSWER Beneficence, Justice, Respect for Persons
What was the Belmont Report? - ANSWER 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"? -
ANSWER - 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)
2
,What are the challenges in applying the Belmont principle of "beneficence"? -
ANSWER how to determine when potential benefits outweigh considerations of
risks and vice versa
What are the challenges in applying the Belmont principle of "justice"? -
ANSWER 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) - ANSWER NIH
45CFR46 Subpart A - "The Common Rule" - ANSWER Basic HHS Policy for Protection
of Human Research Subjects
45CFR46 Subpart B - ANSWER Additional Protections for Pregnant Women, Human
Fetuses and Neonates Involved in Research
45CFR46 Subpart C - ANSWER Additional Protections Pertaining to Biomedical and
Behavioral Research Involving Prisoners as Subjects
45CFR46 Subpart D - ANSWER Additional Protections for Children Involved as
Subjects in Research
45CFR46Subpart E - ANSWER Registration of Institutional Review Boards
What is the definition of a human subject?
(45CFR46 Subpart A) - ANSWER "a living individual about whom an
investigator...conducting research obtains:
Data through intervention or interaction with the individual, or
3
, Identifiable private information."
What is the definition of research?
(45CFR46 Subpart A) - ANSWER 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? - ANSWER 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 - ANSWER diminished autonomy
In 45CFR46 Subpart B what individuals have diminished autonomy and require additional
protection? - ANSWER Pregnant women, fetuses, and neonates
In 45CFR46 Subpart C what individuals have diminished autonomy and require additional
protection? - ANSWER Prisoners
4
