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|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.
|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.
An independent consultant must approve the waiver.
Parents must be notified that the study is taking place.
The students must be offered an optional classroom activity.
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