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CITI Training Human Subjects Protection Basic Course, Research class Final Exam
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CITI Training Human SubjectsProtection Basic Course, Research
class Final Exam
persons with diminished autonomy are entitled to protection ✔️Ans - 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. ✔️Ans - 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 ✔️Ans - 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. ✔️Ans - 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. ✔️Ans - 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 ✔️Ans -
The researcher's failure to protect research subjects from deductive
disclosure is the primary ethical violation in which of the following studies?
Justice ✔️Ans - 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. ✔️Ans - 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. ✔️Ans - 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 ✔️Ans - 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. ✔️Ans - Which of the
following studies need IRB approval?
Full Board Review ✔️Ans - 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 ✔️Ans - The history of ethical regulations in human
subjects research began with the
All foreseeable risks and discomforts. ✔️Ans - Per federal regulations,
which of the following elements must be included in an informed consent
document?
Private information ✔️Ans - 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. ✔️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. What action can he expect by
the IRB?
Obtains, uses, studies, analyzes, or generates identifiable private information.
✔️Ans - 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. ✔️Ans - According to the federal regulations, which of the following
studies meets the definition of research with human subjects?
Public information ✔️Ans - Census data (the final report as published by the
Census Bureau) is an example of:
Officials of the institution may overrule an IRB approval. ✔️Ans - 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. ✔️Ans - 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. ✔️Ans - According to federal regulations,
the expedited review process may be used when the study procedures pose:
The research falls into one of eight categories of research activity described in
the regulations. ✔️Ans - According to the federal regulations, research is
eligible for exemption, if:
Prisoners ✔️Ans - In addition to pregnant women, fetuses, and neonates,
another subpart of the HHS regulations provides additional protections for
which of the following vulnerable populations?
Remove all direct identifiers from the data as soon as possible. ✔️Ans -
Additional safeguards that may be included in a social and behavioral study
may include:
, Invasion of privacy, breach of confidentiality, and study procedures ✔️Ans -
Risk of harm in social and behavioral sciences generally fall in three
categories, which are:
Experience emotional or psychological distress. ✔️Ans - A researcher
wishes to study generational differences in coping mechanisms among adults
who experienced abuse as children. Adequate measures will be instituted to
obtain informed consent and ensure that there is no breach of confidentiality.
The most likely additional risk is that some subjects may:
Obtain a waiver of documentation of informed consent. ✔️Ans - If
disclosure of a subject's involvement in a specific research study can be
potentially harmful to the subject, and the consent form is the only record
linking the subject to the research, which of the following would be most
helpful:
Asking women if they have had an abortion ✔️Ans - Identify the example of
when situation and time are key to assessing risk of harm in a research study:
The parents of the children might feel pressure to give permission to the
therapist to use their children's data so that she will continue to provide
services to their children. ✔️Ans - A therapist at a free university clinic
treats elementary school children with behavior problems who are referred
by a social service agency. She is also a doctoral candidate who proposes using
data she has and will collect about the children for a case-based research
project. Which of the following statements about parental permission is
correct?
Taking part in the research is voluntary, but if you choose to take part, you
waive the right to legal redress for any research-related injuries. ✔️Ans - A
general requirement for informed consent is that no informed consent may
include any exculpatory language. Exculpatory language is that which waives
or appears to waive any of the subject's legal rights or releases or appears to
release those conducting the research from liability for negligence. Which of
the following statements in a consent form is an example of exculpatory
language?
A study in which subjects were assigned to study activities based on an
undesirable or unflattering physical characteristic as assessed by members of
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