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What is child assent, and how do the requirements vary with the age of the research subjects? Assent is defined by the regulations as follows: Assent means a childs affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.
Do federal regulations require the documentation of minor 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.
At what age is a child able to take part in the assent process?
Children 7 to 12 years old In most cases, children this age will be able to participate in the assent process, using a simplified assent form (Assent Form). A separate, more detailed permission form will be needed for the parents or guardians (Parent Permission).
Which of the following statements most accurately describes the requirement for documentation of minor assent?
The most accurate statement that describes the requirement for the documentation of minors assent to participate in research is: Documentation is required unless waived by an IRB.
At what age is assent necessary in research?
NOTE: Participants older than 7 but under the age of 18 will need to complete an Assent form; a separate parental consent form is required for these participants providing parental permission to participate.
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Documentation of assent is required for participants between the ages 7 and 18 years of age unless the participant is incapable, either decisionally or emotionally, of being reasonably consulted about participating.
What age is minor assent?
The IRB presumes that minors ages 7 and older should be given an opportunity to provide assent. Written assent using a physical document is usually sought in these cases.
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Consent/assent forms. Mock discussion session (staff can evaluate flow of discussion). Train staff using standardized training materials (e.g., training
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