CITI Training Questions With All 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
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
