CITI Training ACTUAL UPDATED Exam
Questions and 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 place that ensure that
Questions and 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 place that ensure that
