CITI TRAINING FINAL PAPER EXAM SCRIPT
TESTED QUESTIONS AND VERIFIED
SOLUTIONS
◉ A researcher is interested in assessing risk-taking by
individuals. The researcher is sitting on a bench near a busy four-
way stop intersection. She plans on recording the number of bike
riders wearing a safety helmet and whether they stop at the
intersection before proceeding in order to correlate use of safety
apparel with risk-taking. This collection of information is an
example of:
Answer: Public behavior
◉ A medical record is an example of:
Answer: private information
◉ 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.
,◉ 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.
◉ 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
◉ 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.
◉ 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.
◉ 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.
◉ 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
◉ The primary purpose of a Certificate of Confidentiality is to:
Answer: Protect identifiable research information from compelled
disclosure.
◉ 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:
Answer: Both the magnitude (or severity) and the probability (or
likelihood) of harm.
, ◉ 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.
◉ 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.
TESTED QUESTIONS AND VERIFIED
SOLUTIONS
◉ A researcher is interested in assessing risk-taking by
individuals. The researcher is sitting on a bench near a busy four-
way stop intersection. She plans on recording the number of bike
riders wearing a safety helmet and whether they stop at the
intersection before proceeding in order to correlate use of safety
apparel with risk-taking. This collection of information is an
example of:
Answer: Public behavior
◉ A medical record is an example of:
Answer: private information
◉ 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.
,◉ 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.
◉ 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
◉ 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.
◉ 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.
◉ 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.
◉ 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
◉ The primary purpose of a Certificate of Confidentiality is to:
Answer: Protect identifiable research information from compelled
disclosure.
◉ 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:
Answer: Both the magnitude (or severity) and the probability (or
likelihood) of harm.
, ◉ 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.
◉ 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.
