CITI Training| 120 questions| with complete solution
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
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
