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CITI 7 EXAM/153 QUESTIONS WITH ANSWERS
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CITI 7 EXAM/153 QUESTIONS WITHANSWERS
The provisions of Subpart D, of the HHS regulations, Additional Protections
for Children Involved as Subjects in Research apply to: - -All research funded
by HHS
-The provisions of Subpart D must be applied to all research funded by the
HHS (which includes NIH). However, not all federal agencies that have
adopted the Common Rule have also adopted Subpart D. In addition to HHS,
only the U.S. Food and Drug Administration and the Department of Education
have adopted it. Institutions may elect to apply the subpart to all research,
regardless of the source of funding. - -
-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? - -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.
-Research involving children may be expedited if the level of risk is no more
than minimal and if the research falls into a category of research identified
as eligible for expedited review. Therefore, unless the nature of the topic
would raise the level to more than minimal risk to the adolescent subjects,
the study previously approved for adults through expedited review
procedures would also be eligible for expedited review. It is not necessary for
adolescents to have obtained some adult rights through emancipation
procedures, nor must the reading level of the subjects be predetermined in
order for a study involving minors to be eligible for expedited review.
Consent forms, including the readability of the information, must always be
tailored to the particular subject population of a study. - -
-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? - -This research would be eligible for exemption because the
researcher is not interacting with the children and the playground is a public
setting.
-The exemption categories that may be used with children include
observations of children in public settings, as long as the researcher does not
,participate in the activities being observed or record information in such a
manner that the identity of the subjects can be readily ascertained. Research
does not require full committee review when it involves children, unless it
does not fall into an exempt or expedited category. - -
-The specific 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
-The provisions of Subpart D, of the HHS regulations, Additional Protections
for Children Involved as Subjects in Research are the specific Department of
Health and Human Services (HHS) regulations that apply to research with
children. Subpart B specifies Additional Protections for Pregnant Women,
Human Fetuses and Neonates Involved in Research, Subpart C specifies
Additional Protections Pertaining to Biomedical and Behavioral Research
Involving Prisoners as Subjects and Subpart A is the Basic HHS Policy for
Protection of Human Research Subjects (generally referred to as the
Common Rule). - -
-According to federal regulations, "children" are defined as: - -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.
-According to the federal regulations, children are 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. Generally, though not always, the
age of consent is the age at which minors reach the age of majority and are
considered adults. In the United States, state law dictates the age of
majority. In most states, the age of majority is 18. This means that a 17-year-
old may be considered a child when applying the federal regulations for
protecting research subjects. - -
-According to Subpart D, research with children may be eligible for
exemption under Category 2 when: - -The research involves the use of
educational tests
-Subpart D restricts the use of exemptions when children are research
subjects. Research that involves interviews, surveys, or participant
observation when the researcher interacts with the children is not eligible for
exemption under Category 2. - -
-Which of the following statements most accurately describes the
requirement for the documentation of minors' assent to participate in
research? - -Federal regulations do not require the documentation of minors'
assent.
, -The federal regulations do not require that child assent be documented.
Therefore it is not necessary to request a waiver of a requirement to
document assent. An IRB will determine whether and how documentation is
required for a particular study. The document does not require parental input
or parental review. - -
-The provisions of Subpart D, of the HHS regulations, Additional Protections
for Children Involved as Subjects in Research apply to: - -All research funded
by HHS
-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? - -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.
-According to Subpart D, research with children may be eligible for
exemption when: - -The research involves the use of educational tests
-Which of the following statements most accurately describes the
requirement for the documentation of minors' assent to participate in
research? - -Federal regulations do not require the documentation of minors'
assent.
-A researcher asks an IRB to waive the requirement for parental permission
for a study conducted in schools because the nature of the research requires
participation of all the children present in classrooms on the day the
research will take place. Assuming that the basic research design could be
approved by the IRB and the school, which of the following requirements
must be met before an IRB could waive parental permission? - -The research
must pose no more than minimal risk.
-A sociologist wants to study a culture that occurs in some women's prisons:
"state families," in which individual prisoners take on certain roles within a
group of like-minded prisoners. There is previous evidence that younger
prisoners will use older inmates who play the roles of grandparents as a
resource before they will turn to staff for help and advice. The lieutenant in
charge of a dorm of long-term prisoners offers to gather volunteers to speak
to the researcher and also offers to vouch for the integrity of the researcher.
The use of this staff is: - -Wrong and is prohibited; subject selection needs to
be free from intervention by prison authorities or prisoners.
-Neither Subpart C (Prisoners) nor Subpart D (Children) applies to juveniles
in the correctional systems since Wardens of Juvenile prisoners - unlike those
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