CITI Training Review: Human Subjects Research
Questions and Correct Answers | Latest Update
Example of how the principle of beneficence is applied to a study
involving human subjects
Ans: Ensuring that the risks are reasonable in relationship to anticipated
benefits
Harvard "Tastes, Ties, and Time (T3)" (2006-2009) Study involves this
primary ethical violation
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Ans: The researcher's failure to protect research subjects from
deductive disclosure (primary ethical violation)
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"The Public Health Service Tuskegee Study of Untreated Syphilis in the
Negro Male" Study
Ans: The study most directly linked to the establishment of the
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"National Research Act" (1974) and ultimately the "Belmont Report and
Federal Regulations for Human Subject Protection"
©
The Belmont principle of Beneficence
Ans: Requires that: potential benefits justify the risks of harm
The Belmont principle of Justice
Ans: Moral Requirement that: there be fair outcomes in the selection of
research subjects
Identifiable Private Information (according to Federal regulations)
Ans: Data obtained by an investigator about human subjects/living
human beings through interaction/intervention with an individual
Example of a study that meets the definition of research with human
subjects (according to Federal regulations)
, 2 for specific request mail
Ans: 1 - A developmental psychologist videotapes interactions between
groups of toddlers and their care givers to determine which intervention
methods most effectively manage aggression.
2 - A study of twenty 4th grade classrooms in which researchers ask the
school 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.
3 - An experiment is proposed on the relationship between gender-related
stereotypes in math and the subsequent performance by males and
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females on math tests.
4 - A cognitive psychologist enrolls undergraduate students for a
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computer-based study about the effect of mood on problem solving
behaviors.
Example of Public Information
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Ans: Census data (final report as published by the Census Bureau)
©
Example of Private Information
Ans: A medical record
Example of a study the IRB will not review because it is not research (as
defined by the Federal regulations)
Ans: 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
A subject in a clinical trial experiences a serious, unanticipated adverse
drug experience. The investigator should proceed, with respect to the
IRB, after the discovery of the adverse event occurrence by: