CITI TRAINING QUESTIONS WITH
ANSWERS.
An example of an institutional COI is: ANS -An industry sponsor pays for the construction of a new
research laboratory at the organization
The peer review process can create conflicts of interest because the choice of who reviews a potentially
publishable project may show: ANS -There may be bias by the peer reviewer as to the area of research
During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with
a study under review should: ANS -Disclose their potential COI and may answer questions, but recuse
themselves from voting
A researcher's membership on an advisory board with an organization sponsoring research can create a
COI because: ANS -It may be difficult for the researcher to appear neutral, as the researcher may have
an interest in the research's success
The FDA regulations governing disclosure of individual COIs require: ANS -Applicants submitting
marketing applications to disclose financial COIs of researchers who conducted clinical studies
An example of an individual financial COI is: ANS -A researcher's spouse 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. ANS -No later than the time of proposal submission
For clinical trials, what should be reported to the Office for Clinical Research (OCR) to confirm
ClinicalTrials.gov registration and for the purpose of ensuring Medicare reimbursement? ANS -NCT
number
,The Sunshine Act requires manufacturers to report "payments of transfers of value" for how much
annually? ANS -$10.00
Which department reviews a sample of clinical trials being conducted in each department and provides
education, tools, and corrective and preventative action plans, when needed? ANS -Clinical Trials Audit
and Compliance
Getting your proposal prepared for review and approval can be cumbersome. Which department in the
Office of Research Administration assists with proposal preparation? ANS -Research Administration
Services (RAS)
Which best matches the NIH definition of a clinical trial? ANS -A research study in which one or more
humans subjects are assigned to evaluate the effects of those interventions involving health-related
biomedical and behavioral outcomes.
Adjudication of research participant's bills allows which department to direct charges to the correct
payer? ANS -Clinical Trials Billing Department (CTBD)
To facilitate Pre-award submissions and their approval, the study team should submit to the Institutional
Review Board (IRB) at the same time they are submitting to OCR, and OSP/OTT. ANS -True
Non-licensed clinicians can dispense and educate subjects about their medication. ANS -False
Which system provides the status of a clinical trial agreement (CTA)? ANS -Emory Contracts Tracking
System (eCTS)
If the FDA schedules an appointment to inspect your studies, which department at Emory should you
contact first in preparation for the FDA visit? ANS -Office of Compliance
How often should research administrators or PIs initiate a routine "New Proposal Financial Interest in
Research Report" for each project in eCOI? ANS -Annually
,The Prospective Reimbursement Analysis (PRA) and a Medicare Coverage Analysis (MCA) are used
interchangeably. At Emory, the purpose of the PRA is to assist with research billing compliance, which is
ANS -Billing the appropriate party (i.e. Medicare, Insurance, or a grant) for subjects involved in a
research study.
When patients receive a copy of an organization's privacy notice, why are they asked to sign an
acknowledgment? ANS -It shows they received it.
HIPAA's "incidental uses and disclosures" provision excuses deviations from the minimum necessary
standard. What is excused? ANS -Truly accidental "excess" uses and disclosures, where reasonable
caution was otherwise used and there was no negligence.
What kinds of persons and organizations are affected by HIPAA's requirements? ANS -Healthcare
providers, health plans, and health information clearinghouses, as well as their business associates and
by extension the workers for those organizations.
With respect to permissions for uses and disclosures, HIPAA divides health information into three
categories. Into which category does information related to research, marketing, and fundraising go?
ANS -Uses or disclosures that generally require specific written authorization.
HIPAA privacy protections cover identifiable personal information about the "past, present or future
physical or mental health condition." What does that include? ANS -Health information in any form or
medium, as long as it is identified (or identifiable) as a particular person's information.
Which of the following statements is true regarding the International Committee of Medical Journal
Editors (ICMJE) guidelines? ANS -Individuals who do not meet the criteria for authorship but who have
made a noteworthy contribution are normally listed in the acknowledgments section.
Which author is normally responsible for sharing reprints of a publication with readers? ANS -The
corresponding author.
Which of the following is true regarding an acknowledgments section? ANS -The contributions of
technicians and other researchers are often listed in the acknowledgments section if they do not meet
all of the criteria for authorship.
, Which of the following most accurately describes the practice of ghost authorship? ANS -It is a situation
where the individual who wrote the manuscript is not listed as an author.
Which of the following statements is true regarding authorship practices? ANS -Different disciplines
have different practices about who should be included as an author.
What is the main function of the Bayh-Dole Act of 1980 as it relates to academic institutions? ANS -It
allows institutions to have control over the intellectual property from federally-funded research.
The most important factor determining whether a research collaboration will be successful is: ANS -
Whether there is ongoing communication about goals and responsibilities.
A research collaboration can be enhanced by: ANS -Discussing intellectual property issues while the
collaboration is forming.
What is the most appropriate process for determining which journal a collaborative research team
should submit their work to? ANS -The research team should discuss the issue early on and while the
project is ongoing.
Data ownership is typically determined by: ANS -The type and source of funds used to support the
project.
Which of the following most accurately describes a conflict of commitment? ANS -It occurs when
outside activities interfere with obligations to one's primary employer.
The main focus of NIH's conflict of interest policy is: ANS -Financial conflicts of interest
The entity that normally is supposed to determine whether an academic researcher's conflict of interest
can be managed is: ANS -A conflict of interest committee
Which of the following is true about the management of conflicts of interest? ANS -Management plans
are often created to reduce the impact of conflicts of interest.
ANSWERS.
An example of an institutional COI is: ANS -An industry sponsor pays for the construction of a new
research laboratory at the organization
The peer review process can create conflicts of interest because the choice of who reviews a potentially
publishable project may show: ANS -There may be bias by the peer reviewer as to the area of research
During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with
a study under review should: ANS -Disclose their potential COI and may answer questions, but recuse
themselves from voting
A researcher's membership on an advisory board with an organization sponsoring research can create a
COI because: ANS -It may be difficult for the researcher to appear neutral, as the researcher may have
an interest in the research's success
The FDA regulations governing disclosure of individual COIs require: ANS -Applicants submitting
marketing applications to disclose financial COIs of researchers who conducted clinical studies
An example of an individual financial COI is: ANS -A researcher's spouse 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. ANS -No later than the time of proposal submission
For clinical trials, what should be reported to the Office for Clinical Research (OCR) to confirm
ClinicalTrials.gov registration and for the purpose of ensuring Medicare reimbursement? ANS -NCT
number
,The Sunshine Act requires manufacturers to report "payments of transfers of value" for how much
annually? ANS -$10.00
Which department reviews a sample of clinical trials being conducted in each department and provides
education, tools, and corrective and preventative action plans, when needed? ANS -Clinical Trials Audit
and Compliance
Getting your proposal prepared for review and approval can be cumbersome. Which department in the
Office of Research Administration assists with proposal preparation? ANS -Research Administration
Services (RAS)
Which best matches the NIH definition of a clinical trial? ANS -A research study in which one or more
humans subjects are assigned to evaluate the effects of those interventions involving health-related
biomedical and behavioral outcomes.
Adjudication of research participant's bills allows which department to direct charges to the correct
payer? ANS -Clinical Trials Billing Department (CTBD)
To facilitate Pre-award submissions and their approval, the study team should submit to the Institutional
Review Board (IRB) at the same time they are submitting to OCR, and OSP/OTT. ANS -True
Non-licensed clinicians can dispense and educate subjects about their medication. ANS -False
Which system provides the status of a clinical trial agreement (CTA)? ANS -Emory Contracts Tracking
System (eCTS)
If the FDA schedules an appointment to inspect your studies, which department at Emory should you
contact first in preparation for the FDA visit? ANS -Office of Compliance
How often should research administrators or PIs initiate a routine "New Proposal Financial Interest in
Research Report" for each project in eCOI? ANS -Annually
,The Prospective Reimbursement Analysis (PRA) and a Medicare Coverage Analysis (MCA) are used
interchangeably. At Emory, the purpose of the PRA is to assist with research billing compliance, which is
ANS -Billing the appropriate party (i.e. Medicare, Insurance, or a grant) for subjects involved in a
research study.
When patients receive a copy of an organization's privacy notice, why are they asked to sign an
acknowledgment? ANS -It shows they received it.
HIPAA's "incidental uses and disclosures" provision excuses deviations from the minimum necessary
standard. What is excused? ANS -Truly accidental "excess" uses and disclosures, where reasonable
caution was otherwise used and there was no negligence.
What kinds of persons and organizations are affected by HIPAA's requirements? ANS -Healthcare
providers, health plans, and health information clearinghouses, as well as their business associates and
by extension the workers for those organizations.
With respect to permissions for uses and disclosures, HIPAA divides health information into three
categories. Into which category does information related to research, marketing, and fundraising go?
ANS -Uses or disclosures that generally require specific written authorization.
HIPAA privacy protections cover identifiable personal information about the "past, present or future
physical or mental health condition." What does that include? ANS -Health information in any form or
medium, as long as it is identified (or identifiable) as a particular person's information.
Which of the following statements is true regarding the International Committee of Medical Journal
Editors (ICMJE) guidelines? ANS -Individuals who do not meet the criteria for authorship but who have
made a noteworthy contribution are normally listed in the acknowledgments section.
Which author is normally responsible for sharing reprints of a publication with readers? ANS -The
corresponding author.
Which of the following is true regarding an acknowledgments section? ANS -The contributions of
technicians and other researchers are often listed in the acknowledgments section if they do not meet
all of the criteria for authorship.
, Which of the following most accurately describes the practice of ghost authorship? ANS -It is a situation
where the individual who wrote the manuscript is not listed as an author.
Which of the following statements is true regarding authorship practices? ANS -Different disciplines
have different practices about who should be included as an author.
What is the main function of the Bayh-Dole Act of 1980 as it relates to academic institutions? ANS -It
allows institutions to have control over the intellectual property from federally-funded research.
The most important factor determining whether a research collaboration will be successful is: ANS -
Whether there is ongoing communication about goals and responsibilities.
A research collaboration can be enhanced by: ANS -Discussing intellectual property issues while the
collaboration is forming.
What is the most appropriate process for determining which journal a collaborative research team
should submit their work to? ANS -The research team should discuss the issue early on and while the
project is ongoing.
Data ownership is typically determined by: ANS -The type and source of funds used to support the
project.
Which of the following most accurately describes a conflict of commitment? ANS -It occurs when
outside activities interfere with obligations to one's primary employer.
The main focus of NIH's conflict of interest policy is: ANS -Financial conflicts of interest
The entity that normally is supposed to determine whether an academic researcher's conflict of interest
can be managed is: ANS -A conflict of interest committee
Which of the following is true about the management of conflicts of interest? ANS -Management plans
are often created to reduce the impact of conflicts of interest.
