CITI Training 2023 Complete Solutions
Three principles of Belmont Report Ans- Respect for Persons
Beneficence
Justice
The Belmont Report
Principle of Beneficence Ans- MAXIMIZATION of benefits and MINIMIZATION of risks
T/F
Belmont Report indicates it is necessary to rigorously avoid conflicts...
CITI Training 2023 Complete Solutions
Three principles of Belmont Report Ans- Respect for Persons
Beneficence
Justice
The Belmont Report
Principle of Beneficence Ans- MAXIMIZATION of benefits and MINIMIZATION of risks
T/F
Belmont Report indicates it is necessary to rigorously avoid conflicts of interest Ans- TRUE
The Belmont Report
Respect for Person Ans- 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... Ans- "Practice" and "Research"
The Belmont Report
The Principle of Justice Ans- 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 Ans- FALSE
Students in Research
The history of ethical regulations in human subjects research began with the Ans- Nuremberg Code
Nuremberg Code Ans- Human subjects research guidelines and regulations
,Year of the Nuremberg Code Ans- 1949
Additional resources regarding IRB approval process Ans- Faculty advisor/Research Mentor
IRB office
Human subjects research websites
What element must be included in an informed consent? Ans- All foreseeable risks and discomforts
Which type of IRB review does not require and IRB approval but DOES require a Determination by the
IRB? Ans- If the study qualifies for EXEMPTION
Another name for the "Exempt" status Ans- the Common Rule
stated in Title 45 Part 46 Subpart A
How can faculty researchers avoid coercion of student subjects? Ans- 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. Ans- 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. Ans- 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 Ans- 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 Ans- Not Human Subjects
, Federal regulations define human subjects as "living individual about whom an investigator conducting
research obtains"...? (2 components) Ans- "1.data through intervention or interaction with the
individual
2. identifiable private information"
Name the 3 responsibilities the IRB is charged with Ans- 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
IRB's do not review manuscripts prior to submission for publication Ans- True
DHHS
FDA Ans- 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 Ans- The Public
Health Service Tuskegee Study of Untreated Syphilis in the Negro Male
The Tuskegee Study relates to which Belmont principle? Ans- 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: Ans- Respect for persons
Belmont Report
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