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True or False: The specific U.S. Department of Health and Human
Services (HHS) regulations that apply to research with children are known
as Subpart D: Additional Protections for Children Involved as Subjects in
Research.
Ans: True
According to Subpart D, research with children may be eligible for
Assignment Expert
exemption under Category 2 when:
Ans: The research involves the use of educational tests
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A study that involves interviews of adults is eligible for expedited review.
The researcher wants to add an adolescent population (aged 12 to 17) to
the study and has designed a parental permission and assent process. No
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additional changes are planned. Which of the following statements about
review of the revised protocol is accurate?
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Ans: Unless the nature of the questions would raise the level of risk to
more than minimal for adolescents, the research would still qualify for
expedited review.
Which of the following statements most accurately describes the
requirement for the documentation of minors' assent to participate in
research?
Ans: Federal regulations do not require the documentation of minors'
assent.
According to federal regulations, "children" are defined as:
Ans: 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.
, 2 for specific request mail
If the research is subject to Subpart D, which of the following research
activities with children would qualify for an exemption under Category 2
(research that includes educational tests, surveys, interviews,
observation)?
Ans: Research about aptitude testing
Which federal regulation or law governs how researchers can obtain data
about subjects' disciplinary status in school from academic records?
Ans: The Family Educational Rights and Privacy Act.
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Which of the following types of information may schools disclose
without consent from the parent or student to a researcher at a local
university?
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Ans: Directory information.
The purpose of the Family Educational Rights and Privacy Act (FERPA) is
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to:
Ans: Provide parents certain rights over their children's educational
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records.
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:
Ans: FERPA, PPRA, and Subpart D of 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?
Ans: Will the researchers have collaborators at the research site abroad?