CITI Questions and Answers Fully Solved Latest Version 2025-2026
The FDA regulations governing disclosure of individual COIs require: - AnswersApplicants
submitting marketing applications to disclose financial COIs of researchers who conducted
clinical studies
The PHS regulations about financial conflict of interests require which party to disclose
significant financial conflicts of interest? - AnswersResearcher
What is the term for management controls that are built in to a research study (for example,
independent data analysis)? - AnswersInherent controls
A researcher's membership on an advisory board with an organization sponsoring research can
create a COI because: - AnswersIt may be difficult for the researcher to appear neutral, as the
researcher may have an interest in the research's success
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. - AnswersNo later than the time of proposal
submission
A researcher conducts a focus group to learn about attitudes towards hygiene and disease
prevention. Two weeks after the focus group, the researcher learns one of the subjects had a
heart attack at home and was hospitalized, but made a full recovery. Based on DHHS
regulations, should the researcher report this event to the IRB? - AnswersNo, this does not need
to be reported since it is unrelated to participation in the study.
The procedures for reporting potential unanticipated problems involving risk to subjects or
others to the IRB are: - AnswersDetermined by the institution in its written policies and
procedures
Researchers must report potential unanticipated problems that involve risks to others directly to:
- AnswersInstitutional Review Board (IRB)
A researcher conducting behavioral research collects individually identifiable sensitive
information about illicit drug use and other illegal behaviors by surveying college students. The
data are stored on a laptop computer without encryption, and the laptop computer is stolen
from the researcher's car on the way home from work. This is an unanticipated problem that
must be reported because the incident was (a) unexpected (i.e., the researchers did not
anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a
greater risk of psychological and social harm from the breach in confidentiality of the study data
than was previously known or recognized. According to OHRP, this unanticipated problem must
be reported to the IRB in which timeframe? - AnswersPromptly
A researcher conducting behavioral research collects individually identifiable sensitive
,information about illicit drug use and other illegal behaviors by surveying college students. One
of the subjects is in an automobile accident two weeks after participating in the research study.
Is this an example of an unanticipated problem that requires reporting to the IRB? - AnswersNo,
this does not need to be reported because it was assessed by the researcher as unrelated to the
research study.
According to OHRP, a problem is an "unanticipated problem" when it meets which of the
following criteria: - AnswersUnexpected, related or possible related to the research, suggests
the research puts subjects or others at greater risk
During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential
COI with a study under review should: - AnswersDisclose their potential COI and may answer
questions, but recuse themselves from voting
The peer review process can create conflicts of interest because the choice of who reviews a
potentially publishable project may show: - AnswersThere may be bias by the peer reviewer as
to the area of research
An example of an institutional COI is: - AnswersAn industry sponsor pays for the construction of
a new research laboratory at the organization
The COI management plan aims to: - AnswersProvide procedures or extras steps to be taken to
minimize the risk of bias when a COI is disclosed
What is the term for management controls that are built in to a research study (for example,
independent data analysis)? - AnswersInherent controls
An example of an individual financial COI is: - AnswersA 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: - AnswersThere may be bias by the peer reviewer as
to the area of research
The FDA regulations governing disclosure of individual COIs require: - AnswersApplicants
submitting marketing applications to disclose financial COIs of researchers who conducted
clinical studies
The COI management plan aims to: - AnswersProvide 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: - AnswersAn industry sponsor pays for the construction of
a new research laboratory at the organization
An example of an individual financial COI is: - AnswersA 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. - AnswersNo 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? - AnswersResearcher
A researcher's membership on an advisory board with an organization sponsoring research can
create a COI because: - AnswersIt may be difficult for the researcher to appear neutral, as the
researcher may have an interest in the research's success
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: - AnswersRespect 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? - AnswersThe 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? - AnswersHarvard "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: - AnswersJustice
Which of the following is an example of how the principle of beneficence is applied to a study
involving human subjects? - AnswersEnsuring that risks are reasonable in relationship to
anticipated benefits.
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: -
AnswersIdentifiable private information.
A medical record is an example of: - AnswersPrivate information.
According to the federal regulations, which of the following studies meets the definition of
research with human subjects? - AnswersA 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? - AnswersA 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? - AnswersA 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: - AnswersNo 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 - AnswersThe research
falls into one of six categories of research activity described in the regulations.
Continuing review of an approved and ongoing protocol - AnswersMust 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? - AnswersOfficials 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? -
AnswersPrisoners.
The primary purpose of a Certificate of Confidentiality is to: - AnswersProtect identifiable
research information from compelled disclosure.
Additional safeguards that may be included in a social and behavioral study may include: -
AnswersRemove 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: - AnswersObtain a waiver of documentation of informed
consent.
Risk of harm in social and behavioral sciences generally fall in three categories, which are: -
AnswersInvasion 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: - AnswersAsking 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? - AnswersThe 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.
The FDA regulations governing disclosure of individual COIs require: - AnswersApplicants
submitting marketing applications to disclose financial COIs of researchers who conducted
clinical studies
The PHS regulations about financial conflict of interests require which party to disclose
significant financial conflicts of interest? - AnswersResearcher
What is the term for management controls that are built in to a research study (for example,
independent data analysis)? - AnswersInherent controls
A researcher's membership on an advisory board with an organization sponsoring research can
create a COI because: - AnswersIt may be difficult for the researcher to appear neutral, as the
researcher may have an interest in the research's success
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. - AnswersNo later than the time of proposal
submission
A researcher conducts a focus group to learn about attitudes towards hygiene and disease
prevention. Two weeks after the focus group, the researcher learns one of the subjects had a
heart attack at home and was hospitalized, but made a full recovery. Based on DHHS
regulations, should the researcher report this event to the IRB? - AnswersNo, this does not need
to be reported since it is unrelated to participation in the study.
The procedures for reporting potential unanticipated problems involving risk to subjects or
others to the IRB are: - AnswersDetermined by the institution in its written policies and
procedures
Researchers must report potential unanticipated problems that involve risks to others directly to:
- AnswersInstitutional Review Board (IRB)
A researcher conducting behavioral research collects individually identifiable sensitive
information about illicit drug use and other illegal behaviors by surveying college students. The
data are stored on a laptop computer without encryption, and the laptop computer is stolen
from the researcher's car on the way home from work. This is an unanticipated problem that
must be reported because the incident was (a) unexpected (i.e., the researchers did not
anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a
greater risk of psychological and social harm from the breach in confidentiality of the study data
than was previously known or recognized. According to OHRP, this unanticipated problem must
be reported to the IRB in which timeframe? - AnswersPromptly
A researcher conducting behavioral research collects individually identifiable sensitive
,information about illicit drug use and other illegal behaviors by surveying college students. One
of the subjects is in an automobile accident two weeks after participating in the research study.
Is this an example of an unanticipated problem that requires reporting to the IRB? - AnswersNo,
this does not need to be reported because it was assessed by the researcher as unrelated to the
research study.
According to OHRP, a problem is an "unanticipated problem" when it meets which of the
following criteria: - AnswersUnexpected, related or possible related to the research, suggests
the research puts subjects or others at greater risk
During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential
COI with a study under review should: - AnswersDisclose their potential COI and may answer
questions, but recuse themselves from voting
The peer review process can create conflicts of interest because the choice of who reviews a
potentially publishable project may show: - AnswersThere may be bias by the peer reviewer as
to the area of research
An example of an institutional COI is: - AnswersAn industry sponsor pays for the construction of
a new research laboratory at the organization
The COI management plan aims to: - AnswersProvide procedures or extras steps to be taken to
minimize the risk of bias when a COI is disclosed
What is the term for management controls that are built in to a research study (for example,
independent data analysis)? - AnswersInherent controls
An example of an individual financial COI is: - AnswersA 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: - AnswersThere may be bias by the peer reviewer as
to the area of research
The FDA regulations governing disclosure of individual COIs require: - AnswersApplicants
submitting marketing applications to disclose financial COIs of researchers who conducted
clinical studies
The COI management plan aims to: - AnswersProvide 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: - AnswersAn industry sponsor pays for the construction of
a new research laboratory at the organization
An example of an individual financial COI is: - AnswersA 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. - AnswersNo 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? - AnswersResearcher
A researcher's membership on an advisory board with an organization sponsoring research can
create a COI because: - AnswersIt may be difficult for the researcher to appear neutral, as the
researcher may have an interest in the research's success
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: - AnswersRespect 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? - AnswersThe 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? - AnswersHarvard "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: - AnswersJustice
Which of the following is an example of how the principle of beneficence is applied to a study
involving human subjects? - AnswersEnsuring that risks are reasonable in relationship to
anticipated benefits.
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: -
AnswersIdentifiable private information.
A medical record is an example of: - AnswersPrivate information.
According to the federal regulations, which of the following studies meets the definition of
research with human subjects? - AnswersA 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? - AnswersA 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? - AnswersA 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: - AnswersNo 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 - AnswersThe research
falls into one of six categories of research activity described in the regulations.
Continuing review of an approved and ongoing protocol - AnswersMust 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? - AnswersOfficials 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? -
AnswersPrisoners.
The primary purpose of a Certificate of Confidentiality is to: - AnswersProtect identifiable
research information from compelled disclosure.
Additional safeguards that may be included in a social and behavioral study may include: -
AnswersRemove 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: - AnswersObtain a waiver of documentation of informed
consent.
Risk of harm in social and behavioral sciences generally fall in three categories, which are: -
AnswersInvasion 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: - AnswersAsking 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? - AnswersThe 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.
