CITI Training
: A DSMP includes a safety monitoring plan and what other component? - ANS - Data
management plan
A census is a regularly-occurring and official count of a particular population. Census
data available at the United States Census Bureau website are an example of: - ANS -
Public information
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: - ANS - 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 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? - ANS - 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 medical record is an example of: - ANS - Private information
A professor at Big State University is writing a biography about Bill Gates and
conducting oral histories with all of Bill Gates' friends, family members, and business
acquaintances. The researcher submits the research proposal to the institution's IRB.
What action can he expect by the IRB? - ANS - The IRB will not review this study
because it is not research as defined by the federal regulations.
A researcher asks an IRB to waive the requirement for parental permission for a study
conducted in schools because the nature of the research requires participation of all the
children present in classrooms on the day the research will take place. Assuming that
, the basic research design could be approved by the IRB and the school, which of the
following requirements must be met before an IRB could waive parental permission? -
ANS - The research must pose no more than minimal risk.
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? - ANS - No, this does not need to be reported because it was
assessed by the researcher as unrelated to the research study.
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
(in other words, 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? - ANS - Promptly
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? - ANS -
No, this does not need to be reported because it is unrelated to participation in the
study.
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: - ANS - Public behavior
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
: A DSMP includes a safety monitoring plan and what other component? - ANS - Data
management plan
A census is a regularly-occurring and official count of a particular population. Census
data available at the United States Census Bureau website are an example of: - ANS -
Public information
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: - ANS - 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 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? - ANS - 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 medical record is an example of: - ANS - Private information
A professor at Big State University is writing a biography about Bill Gates and
conducting oral histories with all of Bill Gates' friends, family members, and business
acquaintances. The researcher submits the research proposal to the institution's IRB.
What action can he expect by the IRB? - ANS - The IRB will not review this study
because it is not research as defined by the federal regulations.
A researcher asks an IRB to waive the requirement for parental permission for a study
conducted in schools because the nature of the research requires participation of all the
children present in classrooms on the day the research will take place. Assuming that
, the basic research design could be approved by the IRB and the school, which of the
following requirements must be met before an IRB could waive parental permission? -
ANS - The research must pose no more than minimal risk.
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? - ANS - No, this does not need to be reported because it was
assessed by the researcher as unrelated to the research study.
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
(in other words, 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? - ANS - Promptly
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? - ANS -
No, this does not need to be reported because it is unrelated to participation in the
study.
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: - ANS - Public behavior
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
