CITI Training-Human Subjects-
Protection Basic Course, Research class
Final Exam with 363 Quiz And accurate
Answers.
CITI Training-Human Subjects-
Protection Basic Course, Research class
Final Exam with 363 Quiz And accurate
Answers.
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: - Answer - persons with diminished autonomy are entitled to protection
Which of the following is an example of how the principle of beneficence can be applied
to a study employing human subjects? - Answer - Determining that the study has a
maximization of benefits and a minimization of risks.
Which of the following are the three principles discussed in the Belmont Report? -
Answer - Respect for Persons, Beneficence, Justice
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? - Answer - The Public Health Service Tuskegee Study of
Untreated Syphilis in the Negro Male.
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: - Answer - Respect for persons.
The researcher's failure to protect research subjects from deductive disclosure is the
primary ethical violation in which of the following studies? - Answer - Harvard "Tastes,
Ties, and Time (T3)" study (2006-2009)" study
According to the Belmont Report, the moral requirement that there be fair outcomes in
the selection of research subjects, expresses the principle of: - Answer - Justice
The Belmont principle of beneficence requires that: - Answer - Potential benefits justify
the risks of harm.
,CITI Training-Human Subjects-
Protection Basic Course, Research class
Final Exam with 363 Quiz And accurate
Answers.
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.) - Answer - -
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.
Which type of IRB review does not require an IRB approval but does require a
determination by the IRB or an IRB designee? - Answer - Exempt
Which of the following studies need IRB approval? - Answer - Studies collecting data
about living individuals.
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? - Answer - Full Board Review
The history of ethical regulations in human subjects research began with the - Answer -
Nuremberg Code
Per federal regulations, which of the following elements must be included in an informed
consent document? - Answer - All foreseeable risks and discomforts.
A medical record is an example of: - Answer - Private information
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? - Answer - The IRB will not review this study
because it is not research as defined by the federal regulations.
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: -
Answer - Obtains, uses, studies, analyzes, or generates identifiable private information.
,CITI Training-Human Subjects-
Protection Basic Course, Research class
Final Exam with 363 Quiz And accurate
Answers.
According to the federal regulations, which of the following studies meets the definition
of research with human subjects? - Answer - 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.
Census data (the final report as published by the Census Bureau) is an example of: -
Answer - Public information
Which of the following statements about the relationship between an institution and the
institution's IRB(s) is correct? - Answer - Officials of the institution may overrule an IRB
approval.
Continuing review of an approved and ongoing study posing more than minimal risk that
was initially approved by a convened IRB: - Answer - Must occur within 12 months of
the approval date.
According to federal regulations, the expedited review process may be used when the
study procedures pose: - Answer - No more than minimal risk and the research
activities fall within regulatory categories identified as eligible.
According to the federal regulations, research is eligible for exemption, if: - Answer -
The research falls into one of eight categories of research activity described in the
regulations.
In addition to pregnant women, fetuses, and neonates, another subpart of the HHS
regulations provides additional protections for which of the following vulnerable
populations? - Answer - Prisoners
Additional safeguards that may be included in a social and behavioral study may
include: - Answer - Remove all direct identifiers from the data as soon as possible.
Risk of harm in social and behavioral sciences generally fall in three categories, which
are: - Answer - Invasion of privacy, breach of confidentiality, and study procedures
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: - Answer - Experience emotional or
psychological distress.
, CITI Training-Human Subjects-
Protection Basic Course, Research class
Final Exam with 363 Quiz And accurate
Answers.
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: - Answer - Obtain a waiver of
documentation of informed consent.
Identify the example of when situation and time are key to assessing risk of harm in a
research study: - Answer - Asking women if they have had an abortion
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? - Answer - 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.
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? - Answer - 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.
A criterion for waiving informed consent is that, when appropriate, subjects are provided
additional pertinent information after the study. In which of the following studies would it
NOT be appropriate to provide subjects with information about missing elements of
consent: - Answer - A study in which subjects were assigned to study activities based
on an undesirable or unflattering physical characteristic as assessed by members of the
research team.
A waiver of the requirement for documentation of informed consent may be granted
when: - Answer - The only record linking the subject and the research is the consent
document and the principal risk is a breach of confidentiality.
As part of the consent process, the federal regulations require researchers to: - Answer
- Provide potential subjects with information at the appropriate reading comprehension
level.
