Which of the following methods could be considered a "best practice" in terms of
informing respondents how their answers to an on-line survey about personal
information will be protected? - ANSWERS-The investigator uses the informed
consent process to explain how respondent data will be transmitted from the
website to his encrypted database without ever recording respondents' IP
addresses, but explains that on the internet confidentiality cannot be absolutely
guaranteed.
Data are made anonymous by - ANSWERS-Destroying all identifiers connected to
the data.
Which of the following examples of using the internet to conduct research meets
the federal definition of research with human subjects? - ANSWERS-Conducting
an on-line focus group with cancer survivors to determine familial support
systems. The researcher also invites subjects' significant others to be a part of the
focus group.
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
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.
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.
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.
The provisions of Subpart D, of the HHS regulations, Additional Protections for
Children Involved as Subjects in Research apply to: - ANSWERS-All research
funded by HHS
A researcher wants to observe preschoolers at a local public playground to
evaluate levels of cooperation. The researcher will not interact with the children
or record information in such a manner that the identity of the subjects can be
readily ascertained. Which of the following statements is true? - ANSWERS-This
research would be eligible for exemption because the researcher is not
interacting with the children and the playground is a public setting.
, According to federal regulations, "children" are defined as: - ANSWERS-Persons
who have not yet attained the legal age of consent under the applicable laws in
the jurisdiction in which the research will be conducted.
Which of the following statements most accurately describes the requirement for
the documentation of minors' assent to participate in research? - ANSWERS-
Federal regulations do not require the documentation of minors' assent.
The specific Department of Health and Human Services (HHS) regulations that
apply to research with children are known as: - ANSWERS-Subpart D: Additional
Protections for Children Involved as Subjects in Research
What procedures must be described in an agreement called an "assurance of
compliance" with OHRP? - ANSWERS-Procedures in place that ensure that
subjects will be protected in a manner commensurate with the Common Rule,
including review by an independent committee comparable to an IRB.
A researcher proposes to conduct a study at a foreign site that has been
determined to be exempt from the federal regulations by institutional policy.
According to federal regulations, is review required at the foreign site? -
ANSWERS-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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