Citi Training
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: - ✔✔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: - ✔✔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? - ✔✔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 graduate student wants to examine the effect of print media versus televised media on individuals' position
on several social issues. The superintendent of a local work release facility, a family friend, will allow the
graduate student access to the prison population to help her quickly accrue subjects. The student's IRB should:
- ✔✔not be approved because prison population is a convenience sample
A medical record is an example of: - ✔✔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? - ✔✔The IRB will not review this
study because it is not research as defined by the federal regulations.
A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile
surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order
to determine if this study should be reviewed by a local Chilean IRB or ethics committee, as well as the Big
State University IRB? - ✔✔Will the researchers have collaborators at the research site abroad?
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? -
✔✔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? - ✔✔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? - ✔✔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? - ✔✔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: - ✔✔Public behavior
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: - ✔✔Public behavior
A researcher is studying women recently admitted to a state prison. All potential subjects must have children
under the age of five. Research subjects will be given a basket of toys to use at their children's first visit that
the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are: -
✔✔Not an excessive incentive.
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? - ✔✔There
was neither a violation of privacy nor a breach of confidentiality.
A researcher proposes to conduct a study at a foreign site. The research has been determined to be exempt
from the federal regulations by institutional policy. According to federal regulations, is review required at the
foreign site? - ✔✔If a proposed study qualifies for exemption, federal regulations do not require review at the
foreign site where it will be conducted.
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