CITI Training Human Subjects Protection
Basic Course Latest Updated 2022
persons with diminished autonomy are entitled to protection ✔✔The Belmont Report's principle
of respect for persons incorporates at least two et
...
CITI Training Human Subjects Protection
Basic Course Latest Updated 2022
persons with diminished autonomy are entitled to protection ✔✔The Belmont Report's principle
of respect for persons incorporates at least two ethical convictions: first, that individuals should be
treated as autonomous agents, and second, that:
Determining that the study has a maximization of benefits and a minimization of risks. ✔✔Which
of the following is an example of how the principle of beneficence can be applied to a study
employing human subjects?
Respect for Persons, Beneficence, Justice ✔✔Which of the following are the three principles
discussed in the Belmont Report?
The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male. ✔✔Which
of the following studies is linked most directly to the establishment of the National Research Act
in 1974 and ultimately to the Belmont Report and Federal regulations for human subject
protection?
Respect for persons. ✔✔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:
Harvard "Tastes, Ties, and Time (T3)" study (2006-2009)" study ✔✔The researcher's failure to
protect research subjects from deductive disclosure is the primary ethical violation in which of the
following studies?
Justice ✔✔According to the Belmont Report, the moral requirement that there be fair outcomes in
the selection of research subjects, expresses the principle of:
Potential benefits justify the risks of harm. ✔✔The Belmont principle of beneficence requires that:
- Protecting the rights and welfare of human subjects.
- Assuring that all applicable institutional policies and federal regulations related to research with
human subjects are followed.
- Reviewing subject recruitment materials and strategies. ✔✔What is the Institutional Review
Board (IRB) charged with? (There may be more than one correct answer. Please be sure to select
all correct answers.)
Exempt ✔✔Which type of IRB review does not require an IRB approval but does require a
determination by the IRB or an IRB designee?
Studies collecting data about living individuals. ✔✔Which of the following studies need IRB
approval?
Full Board Review ✔✔A student working on his dissertation plans on interviewing 15 principals
in neighboring high schools. The student plans to collect data about the personal experiences the
principals have had with disruptive students, what types of disciplinary actions were taken
(including decisions they may have personally made), and their feelings or thoughts as to whether
those actions were appropriate. Identifiers will be collected. This study would be categorized as
which type of review?
Nuremberg Code ✔✔The history of ethical regulations in human subjects research began with the
All foreseeable risks and discomforts. ✔✔Per federal regulations, which of the following elements
must be included in an informed consent document?
Private information ✔✔A medical record is an example of:
The IRB will not review this study because it is not research as defined by the federal regulations.
✔✔A professor at Big State University is writing a biography about Bill Gates and conducting
oral histories with all of Bill Gates' friends, family members, and business acquaintances. The
researcher submits the research proposal to the institution's IRB. What action can he expect by the
IRB?
Obtains, uses, studies, analyzes, or generates identifiable private information. ✔✔According to
the federal regulations, human subjects are living individuals about whom an investigator
conducting research obtains information through interaction or intervention with the individual,
and uses, studies, or analyzes the information; or:
A study of twenty 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 a three-month period. ✔✔According to the federal regulations, which of the
following studies meets the definition of research with human subjects?
Public information ✔✔Census data (the final report as published by the Census Bureau) is an
example of:
Officials of the institution may overrule an IRB approval. ✔✔Which of the following statements
about the relationship between an institution and the institution's IRB(s) is correct?
Must occur within 12 months of the approval date. ✔✔Continuing review of an approved and
ongoing study posing more than minimal risk that was initially approved by a convened IRB:
No more than minimal risk and the research activities fall within regulatory categories identified
as eligible. ✔✔According to federal regulations, the expedited review process may be used when
the study procedures pose:
The research falls into one of eight categori
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