CITI Training- Questions With All Correct Answers
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.
correct answer -True
According to Subpart D, research with children may be eligible for exemption
under Category 2 when: correct answer -The research involves the use of
educational tests
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 additional
changes are planned. Which of the following statements about review of the
revised protocol is accurate? correct answer -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? correct
answer -Federal regulations do not require the documentation of minors'
assent.
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.
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)?
correct answer -Research about aptitude testing
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.
, 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.
The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:
correct answer -Provide parents certain rights over their children's
educational 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: correct answer -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? correct answer -Will
the researchers have collaborators at the research site abroad?
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?
correct answer -If a proposed study qualifies for exemption, federal
regulations do not require review at the foreign site where it will be
conducted.
A researcher proposes a study and wants to recruit subjects from health care
clinics in Jamaica. The survey will be conducted by the U.S. researchers at the
clinic. The nurses at the clinic will inform prospective subjects about the
availability of the research, but will not consent the subjects nor perform any
research procedures (even screening procedures). Are the nurses engaged in
the research according to federal regulations? correct answer -No, they are
not engaged because they are only informing the subjects and not consenting
or performing any research procedures, or receiving or sharing any private,
identifiable information.
What procedures must be described in an agreement called an "assurance of
compliance" with a U.S. federal agency? correct answer -Procedures in
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.
correct answer -True
According to Subpart D, research with children may be eligible for exemption
under Category 2 when: correct answer -The research involves the use of
educational tests
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 additional
changes are planned. Which of the following statements about review of the
revised protocol is accurate? correct answer -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? correct
answer -Federal regulations do not require the documentation of minors'
assent.
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.
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)?
correct answer -Research about aptitude testing
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.
, 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.
The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:
correct answer -Provide parents certain rights over their children's
educational 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: correct answer -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? correct answer -Will
the researchers have collaborators at the research site abroad?
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?
correct answer -If a proposed study qualifies for exemption, federal
regulations do not require review at the foreign site where it will be
conducted.
A researcher proposes a study and wants to recruit subjects from health care
clinics in Jamaica. The survey will be conducted by the U.S. researchers at the
clinic. The nurses at the clinic will inform prospective subjects about the
availability of the research, but will not consent the subjects nor perform any
research procedures (even screening procedures). Are the nurses engaged in
the research according to federal regulations? correct answer -No, they are
not engaged because they are only informing the subjects and not consenting
or performing any research procedures, or receiving or sharing any private,
identifiable information.
What procedures must be described in an agreement called an "assurance of
compliance" with a U.S. federal agency? correct answer -Procedures in
