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Citi Training, CITI IRB (Conflicts of
Interest & Basics of Info Security),
Internet-Based research SBE CITI, Citi
Questions & Answers
What is the term for management controls that are built in to a research study
(for example, independent data analysis)? Correct Ans - Inherent
controls
An example of an individual financial COI is: Correct Ans - A
researcher's wife holds equity in a publicly traded pharmaceutical company
that is also the sponsor of the researcher's study.
The peer review process can create conflicts of interest because the choice of
who reviews a potentially publishable project may show: Correct Ans -
There may be bias by the peer reviewer as to the area of research
The FDA regulations governing disclosure of individual COIs require:
Correct Ans - Applicants submitting marketing applications to disclose
financial COIs of researchers who conducted clinical studies
The COI management plan aims to: Correct Ans - Provide procedures
or extras steps to be taken to minimize the risk of bias when a COI is disclosed
An example of an institutional COI is: Correct Ans - An industry
sponsor pays for the construction of a new research laboratory at the
organization
An example of an individual financial COI is: Correct Ans - A
researcher's wife holds equity in a publicly traded pharmaceutical company
that is also the sponsor of the researcher's study.
A researcher calls you stating that he plans to submit a proposal to the NIH for
a human subjects research study. He wants to know at what point he and his
,study team must submit COI disclosures to comply with the PHS regulation.
Correct Ans - No later than the time of proposal submission
The PHS regulations about financial conflict of interests require which party
to disclose significant financial conflicts of interest? Correct Ans -
Researcher
A researcher's membership on an advisory board with an organization
sponsoring research can create a COI because: Correct Ans - It may be
difficult for the researcher to appear neutral, as the researcher may have an
interest in the research's success
Correct 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:
Correct Ans - Respect for persons.
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? Correct Ans - The
Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.
The researcher's failure to protect research subjects from deductive
disclosure is the primary ethical violation in which of the following studies?
Correct Ans - 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:
Correct Ans - Justice
Which of the following is an example of how the principle of beneficence is
applied to a study involving human subjects? Correct Ans - Ensuring
that risks are reasonable in relationship to anticipated benefits.
Correct Ans -
,According to the federal regulations, human subjects are living human beings
about whom an investigator obtains data through interaction or intervention
with the individual or: Correct Ans - Identifiable private information.
A medical record is an example of: Correct Ans - Private information.
According to the federal regulations, which of the following studies meets the
definition of research with human subjects? Correct Ans - A cognitive
psychologist enrolls undergraduate students for a computer-based study
about the effect of mood on problem solving behaviors.
According to the federal regulations, which of the following studies meets the
definition of research with human subjects? Correct Ans - A
developmental psychologist videotapes interactions between groups of
toddlers and their care givers to determine which intervention methods most
effectively manage aggression.
According to the federal regulations, which of the following studies meets the
definition of research with human subjects? Correct Ans - 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 federal regulations, the expedited review process may be used
when the study procedures pose: Correct Ans - 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
Correct Ans - The research falls into one of six categories of research
activity described in the regulations.
Continuing review of an approved and ongoing protocol Correct Ans -
Must occur within 12 months of the approval date.
Which of the following statements about the relationship between an
institution and the institution's IRB(s) is correct? Correct Ans -
Officials of the institution may overrule an IRB approval.
, In addition to pregnant women, fetuses, and neonates, another subpart of the
HHS regulations provides additional protections for which of the following
vulnerable populations? Correct Ans - Prisoners.
The primary purpose of a Certificate of Confidentiality is to: Correct Ans -
Protect identifiable research information from compelled disclosure.
Additional safeguards that may be included in a social and behavioral study
may include: Correct Ans - Remove all direct identifiers from the data
as soon as possible.
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: Correct Ans - Obtain a waiver of documentation of informed
consent.
Risk of harm in social and behavioral sciences generally fall in three
categories, which are: Correct Ans - Invasion of privacy, breach of
confidentiality, and study procedures
Identify the example of when situation and time are key to assessing risk of
harm in a research study: Correct Ans - 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? Correct Ans - 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
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