Citi Training And Belmont Report
UPDATED ACTUAL Exam Questions and
CORRECT Answers
Three principles of Belmont Report - CORRECT ANSWER - Respect for Persons
Beneficence
Justice
The Belmont Report
Principle of Beneficence - CORRECT ANSWER - MAXIMIZATION of benefits and
MINIMIZATION of risks
T/F
Belmont Report indicates it is necessary to rigorously avoid conflicts of interest - CORRECT
ANSWER - TRUE
The Belmont Report
Respect for Person - CORRECT ANSWER - Requires that subjects freely choose to
participate in research (voluntariness) and that they are adequately informed about a study
(informed consent)
The Belmont Report defines and delineates... - CORRECT ANSWER - "Practice" and
"Research"
The Belmont Report
The Principle of Justice - CORRECT ANSWER - Research benefit and burden distribution
and that selection of subjects is fair.
T/F
,The Belmont report describes the necessity to effectively manage conflicts of interest -
CORRECT ANSWER - FALSE
Students in Research
The history of ethical regulations in human subjects research began with the - CORRECT
ANSWER - Nuremberg Code
Nuremberg Code - CORRECT ANSWER - Human subjects research guidelines and
regulations
Year of the Nuremberg Code - CORRECT ANSWER - 1949
Additional resources regarding IRB approval process - CORRECT ANSWER - Faculty
advisor/Research Mentor
IRB office
Human subjects research websites
What element must be included in an informed consent? - CORRECT ANSWER - All
foreseeable risks and discomforts
Which type of IRB review does not require and IRB approval but DOES require a Determination
by the IRB? - CORRECT ANSWER - If the study qualifies for EXEMPTION
Another name for the "Exempt" status - CORRECT ANSWER - the Common Rule
stated in Title 45 Part 46 Subpart A
How can faculty researchers avoid coercion of student subjects? - CORRECT ANSWER -
Avoid using their own students in their research
,Name the type of Review: Research study that involves use of educational tests, survey,
interviews, or observations of public behavior without identifiable information. - CORRECT
ANSWER - Exempt Review category 2
Name the type of review: A study involving data collected that could have an impact on human
subject's careers and it contains identifiers of the subjects. - CORRECT ANSWER - Full
Board Review
Type of review that qualifies if no identification of subjects and/or their responses would
reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial
standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and
appropriate protections will be implemented so that risks related to invasion of privacy and
breach of confidentiality are no greater than minimal - CORRECT ANSWER - Expedited
review
Type of review: data that is collected does not meet definition of human subjects research as
stated by federal regulations. No info ABOUT human ie. info about a business - CORRECT
ANSWER - Not Human Subjects
Federal regulations define human subjects as "living individual about whom an investigator
conducting research obtains"...? (2 components) - CORRECT ANSWER - "1.data through
intervention or interaction with the individual
2. identifiable private information"
Name the 3 responsibilities the IRB is charged with - CORRECT ANSWER - 1.
Protecting the rights and welfare of human subjects
2. Assuring that all applicable institutional policies and federal regulations related to research
with human subjects are followed
3. Reviewing subject recruitment materials and strategies
T/F
IRB's investigate scientific misconduct - CORRECT ANSWER - False
, T/F
IRB's do not review manuscripts prior to submission for publication - CORRECT
ANSWER - True
DHHS
FDA - CORRECT ANSWER - Depts. IRB's review for current policies
-Department of Health and Human Services
-Food and Drug Administration
Name the study that links most directly to the establishment of the National Research Act in
1974 and ultimately the Belmont Report and Federal regulations for human subject protection -
CORRECT ANSWER - The Public Health Service Tuskegee Study of Untreated Syphilis
in the Negro Male
The Tuskegee Study relates to which Belmont principle? - CORRECT ANSWER - The
principle of beneficence: Potential benefits justify the risks of harm
Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout
is an example of a violation of the principle of: - CORRECT ANSWER - Respect for
persons
Belmont Report
According to the Belmont Report, the moral requirement that there be fair outcomes in the
selection of research subjects, expresses the principle of: - CORRECT ANSWER - Justice
How is the principle of beneficence applied to a study involving human subjects? - CORRECT
ANSWER - Ensuring that risks are reasonable in relationship to anticipated benefits.
Human subject study or not?
UPDATED ACTUAL Exam Questions and
CORRECT Answers
Three principles of Belmont Report - CORRECT ANSWER - Respect for Persons
Beneficence
Justice
The Belmont Report
Principle of Beneficence - CORRECT ANSWER - MAXIMIZATION of benefits and
MINIMIZATION of risks
T/F
Belmont Report indicates it is necessary to rigorously avoid conflicts of interest - CORRECT
ANSWER - TRUE
The Belmont Report
Respect for Person - CORRECT ANSWER - Requires that subjects freely choose to
participate in research (voluntariness) and that they are adequately informed about a study
(informed consent)
The Belmont Report defines and delineates... - CORRECT ANSWER - "Practice" and
"Research"
The Belmont Report
The Principle of Justice - CORRECT ANSWER - Research benefit and burden distribution
and that selection of subjects is fair.
T/F
,The Belmont report describes the necessity to effectively manage conflicts of interest -
CORRECT ANSWER - FALSE
Students in Research
The history of ethical regulations in human subjects research began with the - CORRECT
ANSWER - Nuremberg Code
Nuremberg Code - CORRECT ANSWER - Human subjects research guidelines and
regulations
Year of the Nuremberg Code - CORRECT ANSWER - 1949
Additional resources regarding IRB approval process - CORRECT ANSWER - Faculty
advisor/Research Mentor
IRB office
Human subjects research websites
What element must be included in an informed consent? - CORRECT ANSWER - All
foreseeable risks and discomforts
Which type of IRB review does not require and IRB approval but DOES require a Determination
by the IRB? - CORRECT ANSWER - If the study qualifies for EXEMPTION
Another name for the "Exempt" status - CORRECT ANSWER - the Common Rule
stated in Title 45 Part 46 Subpart A
How can faculty researchers avoid coercion of student subjects? - CORRECT ANSWER -
Avoid using their own students in their research
,Name the type of Review: Research study that involves use of educational tests, survey,
interviews, or observations of public behavior without identifiable information. - CORRECT
ANSWER - Exempt Review category 2
Name the type of review: A study involving data collected that could have an impact on human
subject's careers and it contains identifiers of the subjects. - CORRECT ANSWER - Full
Board Review
Type of review that qualifies if no identification of subjects and/or their responses would
reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial
standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and
appropriate protections will be implemented so that risks related to invasion of privacy and
breach of confidentiality are no greater than minimal - CORRECT ANSWER - Expedited
review
Type of review: data that is collected does not meet definition of human subjects research as
stated by federal regulations. No info ABOUT human ie. info about a business - CORRECT
ANSWER - Not Human Subjects
Federal regulations define human subjects as "living individual about whom an investigator
conducting research obtains"...? (2 components) - CORRECT ANSWER - "1.data through
intervention or interaction with the individual
2. identifiable private information"
Name the 3 responsibilities the IRB is charged with - CORRECT ANSWER - 1.
Protecting the rights and welfare of human subjects
2. Assuring that all applicable institutional policies and federal regulations related to research
with human subjects are followed
3. Reviewing subject recruitment materials and strategies
T/F
IRB's investigate scientific misconduct - CORRECT ANSWER - False
, T/F
IRB's do not review manuscripts prior to submission for publication - CORRECT
ANSWER - True
DHHS
FDA - CORRECT ANSWER - Depts. IRB's review for current policies
-Department of Health and Human Services
-Food and Drug Administration
Name the study that links most directly to the establishment of the National Research Act in
1974 and ultimately the Belmont Report and Federal regulations for human subject protection -
CORRECT ANSWER - The Public Health Service Tuskegee Study of Untreated Syphilis
in the Negro Male
The Tuskegee Study relates to which Belmont principle? - CORRECT ANSWER - The
principle of beneficence: Potential benefits justify the risks of harm
Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout
is an example of a violation of the principle of: - CORRECT ANSWER - Respect for
persons
Belmont Report
According to the Belmont Report, the moral requirement that there be fair outcomes in the
selection of research subjects, expresses the principle of: - CORRECT ANSWER - Justice
How is the principle of beneficence applied to a study involving human subjects? - CORRECT
ANSWER - Ensuring that risks are reasonable in relationship to anticipated benefits.
Human subject study or not?
