EXAM 2025 WITH ANSWERS.
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?
- correct answer -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: - correct answer -
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? - correct
answer -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: - correct answer -Subpart D:
Additional Protections for Children Involved as Subjects in Research
Parental notification, in lieu of active parental permission, is allowed when: -
,correct answer -An IRB has approved a waiver of the requirement for parental
permission.
Which of the following types of information may schools disclose without
consent from the parent or student to a researcher at a local university? -
correct answer -Directory information.
In addition to the general provisions of the Common Rule (the federal
regulations for protecting research subjects), the following regulations also
govern research in the public schools: - correct answer -FERPA, PPRA, and
Subpart D of the federal regulations
Which federal regulation or law governs how researchers can obtain data about
subjects' disciplinary status in school from academic records? - correct answer
-The Family Educational Rights and Privacy Act.
The COI management plan aims to: - correct answer -Provide procedures or
extras steps to be taken to minimize the risk of bias when a COI is disclosed
The peer review process can create conflicts of interest because the choice of
who reviews a potentially publishable project may show: - correct answer -
There may be bias by the peer reviewer as to the area of research
A researcher calls you stating that he plans to submit a proposal to the NIH for
a human subjects research study. He wants to know at what point he and his
, study team must submit COI disclosures to comply with the PHS regulation. -
correct answer - No later than the time of proposal submission
The FDA regulations governing disclosure of individual COIs require: - correct
answer -Applicants submitting marketing applications to disclose financial
COIs of researchers who conducted clinical studies
The PHS regulations about financial conflict of interests require which party to
disclose significant financial conflicts of interest? - correct answer -Researcher
Researchers must report potential unanticipated problems that involve risks to
others directly to the: - correct answer -Institutional Review Board (IRB)
The procedures for reporting potential unanticipated problems involving risk to
subjects or others to the IRB are: - correct answer
-Determined by the institution in its written policies and procedures
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? - correct answer -No,
this does not need to be reported because it was assessed by the researcher as
unrelated to the research study.