citi training and belmont report| 531 QUESTIONS| WITH COMPLETE SOLUTION
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Citi training
Institution
KAPLAN UNIVERSITY
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 interes...
citi training and belmont report| 531 questions| with complete solution
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citi training and belmont report| 531
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 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?
Developmental psychologist videotapes interactions between groups of toddlers and their care
givers to determine which intervention methods most effectively manage aggression Correct
Answer: Yes
Human subject study or not?
The study of a list with deceased passengers Correct Answer: No:Human subject is a living
individual
Human subject study or not?Questioning individuals to acquire data about the number of newly
diagnosed HIV cases? Correct Answer: No: 'what' question rather than 'who' question
Human subject study or not?
Conducting linguistic analysis of comments posted on a public blog Correct Answer: Not:
involves neither interaction with individuals nor collecting private identified info
Human subject study or not?
A study proposed by developmental psychologist involving interactions with living individuals
and designed to contribute to field of knowledge Correct Answer: Yes: humans
Human subject study?
A cognitive psychologist enrolls undergraduate students for a computer-based study about the
effect of mood on problem solving behaviors Correct Answer: Yes: Interacting w/ living
individuals.
Human subject study or not?
, Questioning a superintendent of schools to acquire data about the ethnic composition of a school
Correct Answer: No: it is an "about what" question rather than "about whom" question
Human subject study or not?
Study of 20 4th grade classrooms in which researchers ask the schools to systematically vary the
time of day reading is taught, and collect weekly assessments of reading comprehension for each
child over 3-month period Correct Answer: Yes: contributes to generalizable knowledge about
student performance and research question can only be answered using systematic investigation
Human subject study or not?
Info collected by play ground designer Correct Answer: No: does not involve info about human
subjects even though there is interactions between designer and school staff.
Human subject study or not?
An analysis of aggregate data Correct Answer: No: doesn't involve interactions w/ living
individuals nor collection of private identifiable data
Human subject study or not?
An economic feasibility study Correct Answer: No: does gather info from people with relevant
info and expertise but does not meet the definition of research w/ human subjects, because the
intention of the study is to answer "about what" ? rather than "about whom" ?
According to fed. regulations, human subjects are living human beings about whom an
investigator obtains data through interactions or intervention with the individual or: Correct
Answer: identifiable PRIVATE information
(Public info does not meet criteria)
Subpart of DHHS regulations provides additional protections for which vulnerable populations?
Correct Answer: 1. Pregnant women
2. Fetuses
3. Neonates
4. Prisoners
Subpart of DHHS regulations Does NOT provide additional protections for which vulnerable
populations? Correct Answer: 1. elderly
2. students
3. for persons whose decision-making capabilities are impaired
The expedited review process may be used when the study procedures pose: Correct Answer:
No more than minimal risk and the research activities fall within regulatory categories identified
as eligible
The expedited review process may NOT be used when the study procedures pose: Correct
Answer: -more than minimal risk, even if the subjects are adults,
-the sponsor is in a hurry
-the study replicates previously approved research
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