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What special considerations necessary when children are involved as research subjects?
Because a child cannot legally provide consent for research on his or her own behalf, permission by at least one parent or legal guardian is required before a minor is enrolled research study. Research involving no more than minimal risk requires permission from at least one parent/guardian.
Are children allowed to participate in research?
In most cases, you must obtain permission from one or both parents/guardians, although permission may be unnecessary or inappropriate in some circumstances. Assent is a childs affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.
How are children protected in research?
Agreement to Participate in Research Parental Permission Because children are not legally able to provide consent in their own right, the federal regulations generally require that parents or guardians provide permission before children can be enrolled in research.
What research with children may be eligible for exemption?
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.
What qualifies as exempt research?
Research can qualify for an exemption if it is no more than minimal risk and all of the research procedures fit within one or more of the exemption categories in the federal IRB regulations. Studies that qualify for exemption must be submitted to the IRB for review before starting the research.
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Children are considered a vulnerable research population because their intellectual and emotional capacities are limited. They are legally incompetent to give valid informed consent.
Is research with children eligible for exemption?
Research involving survey or interview procedures is not exempt when children are subjects. Research involving observation of public behavior is exempt only if the researcher does not participate in the activities being observed.
Can research with children be exempt?
Exempt Research Involving Minors Research involving minor children may be exempt only as it applies to categories 1, 4, 5, 6, 7 and 8. Research involving minors which falls under category 2 may be exempt for educational tests and observation (when the investigator does not participate in the activities being observed).
Related links
Special Protections for Children as Research Subjects
Mar 18, 2016 When a proposed research study involves children and is supported or conducted by HHS, the research institutions Institutional Review Board
This Policy describes the special categories of research involving children 45 CFR 46 Subpart D Additional Protections for Children Involved as Subjects in
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