Citi Training, Assessing Risk - SBE,
CITI Questions & Answers
The researcher's failure to protect research subjects from deductive disclosure is the primary
ethical violation in which of the following studies? - ANSWERS-"Tastes, Ties, and Time (T3)"
study (2006-2009)
According to the Belmont Report, the moral requirement that there be fair outcomes in the
selection of research subjects, expresses the principle of: - ANSWERS-Justice
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: - ANSWERS-Respect for persons
The Belmont principle of beneficence requires that: - ANSWERS-Potential benefits justify the
risks of harm.
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? - ANSWERS-The Public Health Service Study of Untreated Syphilis
Continuing review of an approved and ongoing study posing more than minimal risk that was
initially approved by a convened IRB: - ANSWERS-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: - ANSWERS-No more than minimal risk and the research activities fall within
regulatory categories identified as eligible.
,In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations
provides additional protections for which of the following vulnerable populations? - ANSWERS-
Prisoners
According to the federal regulations, research is eligible for exemption, if: - ANSWERS-The
research falls into one of eight categories of research activity described in the regulations.
Which of the following statements about the relationship between an institution and the
institution's IRB(s) is correct? - ANSWERS-Officials of the institution may overrule an IRB
approval.
Risk of harm in social and behavioral sciences generally fall in three categories, which are: -
ANSWERS-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: - ANSWERS-Experience emotional or psychological distress.
The primary purpose of a Certificate of Confidentiality is to: - ANSWERS-Protect identifiable
research information from compelled disclosure.
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: - ANSWERS-Obtain a waiver of documentation of informed
consent.
A researcher wants to do a web-based survey of college students to collect information about
their sexual behavior and drug use. Direct identifiers will not be collected; however, IP
addresses may be present in the data set. Risk of harm should be evaluated by: - ANSWERS-
Both the magnitude (or severity) and the probability (or likelihood) of harm.
,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? - ANSWERS-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? - ANSWERS-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: -
ANSWERS-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: -
ANSWERS-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: - ANSWERS-
Provide potential subjects with information at the appropriate reading comprehension level.
A researcher leaves a research file in her car while she attends a concert and her car is stolen.
The file contains charts of aggregated numerical data from a research study with human
subjects, but no other documents. The consent form said that no identifying information would
be retained, and the researcher adhered to that component. Which of the following statements
, best characterizes what occurred? - ANSWERS-There was neither a violation of privacy nor a
breach of confidentiality.
Which of the following constitutes both a breach of confidentiality (the research data have been
disclosed, counter to the agreement between researcher and subjects) and a violation of
subjects' privacy (the right of the individuals to be protected against intrusion into their
personal lives or affairs)? - ANSWERS-A faculty member makes identifiable data about sexual
behavior available to graduate students, although the subjects were assured that the data
would be de-identified.
In a longitudinal study that will follow children from kindergarten through high school and will
collect information about illegal activities, which of the following confidentiality procedures
would protect against compelled disclosure of individually identifiable information? - ANSWERS-
Securing a Certificate of Confidentiality
Data are made anonymous by - ANSWERS-Destroying all identifiers connected to the data.
When a focus group deals with a potentially sensitive topic, which of the following statements
about providing confidentiality to focus group participants is correct? - ANSWERS-The
researcher cannot control what participants repeat about others outside the group.
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 HHS regulations,
should the researcher report this event to the IRB? - ANSWERS-No, this does not need to be
reported because it is unrelated to participation in the study.
According to OHRP, a problem is an "unanticipated problem" when it meets which of the
following criteria: - ANSWERS-Unexpected, related or possibly related to the research, suggests
the research puts subjects or others at greater risk
CITI Questions & Answers
The researcher's failure to protect research subjects from deductive disclosure is the primary
ethical violation in which of the following studies? - ANSWERS-"Tastes, Ties, and Time (T3)"
study (2006-2009)
According to the Belmont Report, the moral requirement that there be fair outcomes in the
selection of research subjects, expresses the principle of: - ANSWERS-Justice
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: - ANSWERS-Respect for persons
The Belmont principle of beneficence requires that: - ANSWERS-Potential benefits justify the
risks of harm.
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? - ANSWERS-The Public Health Service Study of Untreated Syphilis
Continuing review of an approved and ongoing study posing more than minimal risk that was
initially approved by a convened IRB: - ANSWERS-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: - ANSWERS-No more than minimal risk and the research activities fall within
regulatory categories identified as eligible.
,In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations
provides additional protections for which of the following vulnerable populations? - ANSWERS-
Prisoners
According to the federal regulations, research is eligible for exemption, if: - ANSWERS-The
research falls into one of eight categories of research activity described in the regulations.
Which of the following statements about the relationship between an institution and the
institution's IRB(s) is correct? - ANSWERS-Officials of the institution may overrule an IRB
approval.
Risk of harm in social and behavioral sciences generally fall in three categories, which are: -
ANSWERS-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: - ANSWERS-Experience emotional or psychological distress.
The primary purpose of a Certificate of Confidentiality is to: - ANSWERS-Protect identifiable
research information from compelled disclosure.
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: - ANSWERS-Obtain a waiver of documentation of informed
consent.
A researcher wants to do a web-based survey of college students to collect information about
their sexual behavior and drug use. Direct identifiers will not be collected; however, IP
addresses may be present in the data set. Risk of harm should be evaluated by: - ANSWERS-
Both the magnitude (or severity) and the probability (or likelihood) of harm.
,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? - ANSWERS-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? - ANSWERS-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: -
ANSWERS-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: -
ANSWERS-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: - ANSWERS-
Provide potential subjects with information at the appropriate reading comprehension level.
A researcher leaves a research file in her car while she attends a concert and her car is stolen.
The file contains charts of aggregated numerical data from a research study with human
subjects, but no other documents. The consent form said that no identifying information would
be retained, and the researcher adhered to that component. Which of the following statements
, best characterizes what occurred? - ANSWERS-There was neither a violation of privacy nor a
breach of confidentiality.
Which of the following constitutes both a breach of confidentiality (the research data have been
disclosed, counter to the agreement between researcher and subjects) and a violation of
subjects' privacy (the right of the individuals to be protected against intrusion into their
personal lives or affairs)? - ANSWERS-A faculty member makes identifiable data about sexual
behavior available to graduate students, although the subjects were assured that the data
would be de-identified.
In a longitudinal study that will follow children from kindergarten through high school and will
collect information about illegal activities, which of the following confidentiality procedures
would protect against compelled disclosure of individually identifiable information? - ANSWERS-
Securing a Certificate of Confidentiality
Data are made anonymous by - ANSWERS-Destroying all identifiers connected to the data.
When a focus group deals with a potentially sensitive topic, which of the following statements
about providing confidentiality to focus group participants is correct? - ANSWERS-The
researcher cannot control what participants repeat about others outside the group.
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 HHS regulations,
should the researcher report this event to the IRB? - ANSWERS-No, this does not need to be
reported because it is unrelated to participation in the study.
According to OHRP, a problem is an "unanticipated problem" when it meets which of the
following criteria: - ANSWERS-Unexpected, related or possibly related to the research, suggests
the research puts subjects or others at greater risk
